Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type 8

CA-Sept12-Doc.3.7a-rev1

Directive 98/8/EC concerning the placing biocidal products on the market

Inclusion of active substances in Annex I to Directive 98/8/EC

Assessment Report

Alkyl (C12-16) dimethylbenzyl ammonium chloride

Product-type 8 (Wood preservative)

September 2012

Annex I –Italy


Product-type 8 September 2012

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Alkyl (C12-16) dimethylbenzyl ammonium chloride (PT 8)

Finalised in the Standing Committee on Biocidal Products at its meeting on 21 September 2012 in view of its inclusion in Annex I to Directive 98/8/EC

CONTENTS

1. STATEMENT OF SUBJECT MATTER AND PURPOSE .................................. 4

1.1. Procedure followed .......................................................................................... 4

1.2. Purpose of the assessment report ................................................................... 5

1.3. Overall conclusion in the context of Directive 98/8/EC ............................... 5

2. OVERALL SUMMARY AND CONCLUSIONS ................................................... 7

2.1. Presentation of the Active Substance ............................................................ 7

2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis ........ 7

2.1.2. Intended Uses and Efficacy ............................................................. 12

2.1.3. Classification and Labelling ............................................................ 14

2.2. Summary of the Risk Assessment ................................................................ 16

2.2.1. Human Health Risk Assessment ...................................................... 16

2.2.1.1 Hazard identification ......................................................................... 16

2.2.1.2 Effects assessment ............................................................................. 17

2.2.1.3 Exposure assessment ......................................................................... 18

2.2.1.4 Risk characterization for local effects ............................................... 26

2.2.2 Environmental Risk Assessment ...................................................... 37

2.2.2.1 Fate and distribution in the environment ........................................... 37

2.2.2.2 Effects assessment ............................................................................. 40

2.2.2.3 PBT assessment ................................................................................. 42

2.2.2.4 Exposure assessment ......................................................................... 43

2.2.2.5 Risk characterisation ......................................................................... 46

3. DECISION ............................................................................................................... 50

3.1. Background to the Proposed Decision ......................................................... 50

3.2. Proposed Decision regarding Inclusion in Annex I .................................... 52

3.3. Elements to be taken into account by Member States when authorising products .......................................................................................................... 53



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3.4. Requirement for further information ......................................................... 54

3.5. Updating this Assessment Report ................................................................ 55

APPENDIX I: LIST OF END POINTS .................................................................. 56

Chapter 1: Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Proposed Classification and Labelling ........................................................................................... 56

Chapter 2: Methods of Analysis ........................................................ 59

Chapter 3: Impact on Human Health ............................................... 60

Chapter 4: Fate and Behaviour in the Environment ....................... 66

Chapter 5: Effects on Non-target Species ......................................... 68

Chapter 6: Other End Points ............................................................. 70

APPENDIX II: LIST OF USES SUPPORTED BY AVAILABLE DATA ................ 71

APPENDIX III: LIST OF STUDIES............................................................................. 72



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1. STATEMENT OF SUBJECT MATTER AND PURPOSE

1.1. Procedure followed

This assessment report has been established as a result of the evaluation of Alkyl (C12-16) dimethylbenzyl ammonium chloride as product-type 8 (wood preservative), carried out in the context of the work programme for the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC concerning the placing of biocidal products on the market1, with a view to the possible inclusion of this substance into Annex I or IA to the Directive.

Alkyl (C12-16) dimethylbenzyl ammonium chloride (CAS no. 68424-85-1) was notified as an existing active substance, by Lonza Cologne GmbH, Stepan Europe, Mason Europe Limited, hereafter referred to as the applicant, in product-type 8.

Commission Regulation (EC) No 2032/2003 of 4 November 20032 lays down the detailed rules for the evaluation of dossiers and for the decision-making process in order to include or not an existing active substance into Annex I or IA to the Directive.

In accordance with the provisions of Article 5(2) of that Regulation, Italy was designated as Rapporteur Member State to carry out the assessment on the basis of the dossier submitted by the applicant. The deadline for submission of a complete dossier for Alkyl (C12-16) dimethylbenzyl ammonium chloride as an active substance in Product Type 8 was 28th March 2004, in accordance with Annex V of Regulation (EC) No 2032/2003.

On 28th March 2004, the Italian Competent Authority received a dossier from the applicant. The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 28th September 2004.

On 27th June 2005 the time period was suspended and the evaluation taken up again on 27th March 2006 after the applicant has submitted the necessary data. After that, the evaluation phase was suspended again on the 17th July 2006 and taken up on 18th July 2007.

On 31st July 2007, the Rapporteur Member State submitted, in accordance with the provisions of Article 10(5) and (7) of Regulation (EC) No 2032/2003, to the Commission and the applicant a copy of the evaluation report, hereafter referred to as the competent authority report. The Commission made the report available to all Member States by electronic means on 19th

1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing biocidal products on the market. OJ L 123, 24.4.98, p.1

2 Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market and amending Regulation (EC) No 1896/2000. OJ L 307, 24.11.2003, p. 1



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September 2007. The competent authority report included a recommendation for the inclusion of Alkyl (C12-16) dimethylbenzyl ammonium chloridein Annex I to the Directive for PT 8.

In accordance with Article 12 of Regulation (EC) No 2032/2003, the Commission made the competent authority report publicly available by electronic means on 10th October 2007. This report did not include such information that was to be treated as confidential in accordance with Article 19 of Directive 98/8/EC.

In order to review the competent authority report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the Commission. Revisions agreed upon were presented at technical and competent authority meetings and the competent authority report was amended accordingly.

On the basis of the final competent authority report, the Commission proposed the inclusion of Alkyl (C12-16) dimethylbenzyl ammonium chloridein Annex I to Directive 98/8/EC and consulted the Standing Committee on Biocidal Product on 21 September 2012.

In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the present assessment report contains the conclusions of the Standing Committee on Biocidal Products, as finalised during its meeting held on 21 September 2012.

1.2. Purpose of the assessment report

This assessment report has been developed and finalised in support of the decision to include Alkyl (C12-16) dimethylbenzyl ammonium chloridein Annex I to Directive 98/8/EC for product-type 8. The aim of the assessment report is to facilitate the authorisation in Member States of individual biocidal products in product-type 8 that contain Alkyl (C12-16) dimethylbenzyl ammonium chloride. In their evaluation, Member States shall apply the provisions of Directive 98/8/EC, in particular the provisions of Article 5 as well as the common principles laid down in Annex VI.

For the implementation of the common principles of Annex VI, the content and conclusions of this assessment report, which is available at the Commission website3, shall be taken into account.

However, where conclusions of this assessment report are based on data protected under the provisions of Directive 98/8/EC, such conclusions may not be used to the benefit of another applicant, unless access to these data has been granted.

1.3. Overall conclusion in the context of Directive 98/8/EC

3 http://ec.europa.eu/comm/environment/biocides/index.htm



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The overall conclusion from the evaluation is that it may be expected that there are products containing Alkyl (C12-16) dimethylbenzyl ammonium chloridefor the product-type 8, which will fulfil the requirements laid down in Article 10(1) and (2) of Directive 98/8/EC. This conclusion is however subject to:

i. compliance with the particular requirements in the following sections of this assessment report,

ii. the implementation of the provisions of Article 5(1) of Directive 98/8/EC, and

iii. the common principles laid down in Annex VI to Directive 98/8/EC.

Furthermore, these conclusions were reached within the framework of the uses that were proposed and supported by the applicant (see Appendix II). Extension of the scenario beyond those described will require an evaluation at product authorisation level in order to establish whether the proposed extensions of use will satisfy the requirements of Article 5(1) and of the common principles laid down in Annex VI to Directive 98/8/EC.



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2. OVERALL SUMMARY AND CONCLUSIONS

2.1. Presentation of the Active Substance

2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis

Identification of the active substance

CAS No. 68424-85-1 EINECS No. 270-325-2 Other substance No.: None assigned IUPAC Name Not applicable Common name, synonyms Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl,

chlorides; ADBAC Alkylbenzyldimethylammonium Chloride Alkyl(C12-16)dimethylbenzylammonium chlorides Ammonium, alkyl(C12-C16)dimethylbenzyl-, chlorides Benzyl-C12-C16-alkyldimethyl ammonium chlorides

Chemical name (CA) Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides

Molecular formula C9 H13 N Cl R where R = C12 H25, C14 H29 or C16 H33

Structural formula

N+

RCl-

R = C12H25 C14H29 C16H33

Alkyl chain lengths distribution

Chain Length

Specification for 68424-85-1(§)

Typical Analysis of a Commercial Product

C12 39 - 75% 41.82% C14 20 - 52% 48.43% C16 < 12% 9.51%

Molecular weight (g/mol) 340.0 – 396.1 g/mol (Avg. = 359.6 g/mol) Purity 94 − 99% w/w dry weight (*) Impurities See Confidential Data The active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) does not contain additives or impurities that would be of toxicological/environmental concern.

(§) In May 2011 the RMS agreed with the amendment proposed by the joint Notifiers as regards the alkyl chain lengths distribution of the active substance. This amendment, reflecting the complexity of the raw materials and processes used in their manufacture, can be considered as a negligible change, which does not affect the overall assessment of the active substance for both human and environmental health that has been conducted so far.



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(*) The active substance is not manufactured solvent-free but always exists in process solvents.

Identification of the representative product

Trade name BQ-25 Manufacturers development code number Not assigned Active substance Quaternary ammonium compounds, benzyl-C12-

16-alkyldimethyl, chlorides Content of the active substance 25% (a.s. 94 − 99%) Function Fungistatic, insecticide Physical state of preparation Liquid Nature of preparation Solution The product does not contain substances of concern.

Physico-chemical properties

The active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) is a light beige solid which decomposes above 150°C before melting. Its relative density was determined to be 0.96 at 20 °C.

Its vapour pressure was calculated to be 6.03E-04 Pa at 20°C, 8.5E-04 at 25°C and 4.22E-03 at 50°C, with a Henry’s Law constant of 5.03E-07 Pa m3

mol –1 at 20°C.

C12-16-ADBAC is highly soluble in water (water solubility at 20°C is 409 g/l at pH 5.5; 431 g/l at pH 6.5; 379 g/l at pH 8.2). Furthermore, it is readily soluble in Ethanol (>250 g/l at 20°C), Isopropanol (>250 g/l at 20°C) and Octanol (>250 m/l at 20°C).

The partition coefficient n-octanol/water is not determinable since the active substance is a surfactant in the octanol/water system, thus preventing the use of the shake-flask method. The HPLC Method is not applicable either, due to the absence of suitable calibration compounds and to the fact that ionic compounds interact with the HPLC column by forces other than partitioning. Also the log Pow assessment by KOWWIN is deemed inaccurate, being the software database very limited for surface active substances. On the other hand, log Pow could be roughly obtained from solubility in n-octanol and water (Pow ≈ 1, log Pow ≈ 0). However, this result is of no use with regard to environmental fate and behaviour and secondary poisoning risk assessment, since there is an experimental BCF available.

C12-16-ADBAC does not exhibit hazardous physico-chemical properties. The substance is thermally stable, is not classified as highly flammable and does not show explosive or oxidising properties. C12-16-ADBAC has a low vapour pressure and is highly soluble in water. There is no risk to be expected due to the physico-chemical properties of the product BQ-25, either.



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Analytical methods

Analysis of the active substance as manufactured

The Applicant proposed a method in which the quaternary ammonium content was determined using a biphasic competitive titration between reagent water and chloroform with bromophenol blue indicator. The titrant, sodium tetraphenylborate (STPB), was standardized before being used to titrate triplicate 1:1:1 solutions of 5 mg/ml aqueous ADBAC Quat 80%, pH 10 phosphate buffer and chloroform containing indicator. Gas chromatography with flame ionization detection (GC-FID) was used to determine the distribution of the alkyl chain lengths of Alkyl Dimethyl Benzyl Ammonium Chloride. The test substance was diluted in isopropanol to yield solutions of 126 and 123 mg/ml which were injected (1μl) onto the GC. Following peak assignment relative to reference chromatograms, the alkyl chain lengths distribution was calculated assuming relative response coefficients of unity for duplicate analyses.

The requirements stated in TNsG Chapter 2 Section 4.1 were not accomplished. No data concerning recovery rates, linearity, limit of determination, specificity and intra-laboratory repeatability were available. A suitable method was requested.

An additional analytical method (“Kurz M. and Ranft V. (2007) “Determination of quaternary ammonium compounds and related quaternary impurities by HPLC-ELSD”, Section 4.1(2) Doc. IIIA) was submitted at the mid-July 2007. The method was not deemed acceptable, due to the deficiencies/mistakes affecting both the validation work and the original study report. Hence, the RMS required the full validation of the developed method for both C12-16-ADBAC and impurities > 0.1% w/w, in compliance with SANCO/3030/99 rev.4 11/07/00. Anyway, at the TMIV08 it was concluded that the HPLC-ELSD method could be considered acceptable for C12-16-ADBAC. It was also agreed that the Applicant should have provided further information on the analytical method and considered the possibility to use of an internal standard for quantitative analysis as suggested by AT.

In 2011, a new study (Zehr, P.S. (2010), “Methods Validation for the Preliminary Characterization Analyses of Alkyldimethyl[ethyl]benzyl Ammonium Biocides”) for the determination of the active substance C12-16-ADBAC, impurities and process solvents in commercially available technical concentrate Maquat MC1412-50% (nominal active substance content: 50% w/w) was submitted, superseding Doc. IIIA Sections 4.1(1) and (2). Results are now summarized in Section 4.1(3)(a) in Doc. IIIA and Section 4.1(3)(b)-(c) in the Confidential Data. Except for one impurity, valid analytical methods are available for impurities and process solvents in 50% w/w C12-16-ADBAC-based technical concentrate; additional information/clarification must be provided in any case (please refer to the RMS comments/requests in the evaluation box of the relevant study summaries).

Following the submission of Zehr, P.S. (2010), in April 2011 an additional study addressing batch-analysis (Dung Truong, M.S. (2011), “Batch analysis of Alkyl(C12-16)dimethylbenzyl Ammonium Chlorides”) was presented. Only two batches per Notifier have been investigated, whereas the TNsG for on the assessment of technical equivalence of substances regulated under 98/8/EC require the analytical profile of at least five different representative batches of each source for the purpose of Tier I assessment. In conclusion, a new five-batch analysis for each



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source of the active substance must be submitted to allow the assessment of the technical equivalence of the three joint Notifiers supporting C12-16-ADBAC and also to confirm the active substance specification under Sec. 2 Doc. IIIA. Data should be submitted to the RMS prior to product authorization phase at national level.

Residues

As regards the analysis of C12-16-ADBAC residues, LC-MS methods have been used in soil and water (drinking-, ground- and surface water) with a LOQ of 0.01 mg/kg and 0.1 μg/l as total C12-16-ADBAC, respectively. Only one mass fragment related to C12-ADBAC was used for the purpose of validation. During the evaluation of the Dossier in 2006, these methods were considered sufficiently specific, linear, accurate and precise by the RMS and were therefore accepted. At that time, the Addendum to TNsG on Data Requirements Analytical Methods (based on SANCO/825/00) had not been endorsed yet and the conclusion on the specificity of the methods had been drawn by the RMS on the following grounds: - no further fragmentation was likely to occur under the LC-MS experimental conditions adopted; - the chromatograms of untreated matrices showed no interferences; - the m/z of the ion monitored ([C12-ADBA]+, m/z = 304.3) was sufficiently high that in the RMS opinion LC-MS could be reasonably considered specific enough.

On the contrary, the Addendum (adopted in May 2009) states that a confirmatory method is not necessary in case of a highly specific technique, which means the use of three fragment ions (possibly with m/z ratio >100) when MS detection is carried out. So, according to the Addendum, the available data (given for one LC-MS ion only) are not actually sufficient to prove the specificity of the submitted methods, which are necessary for post-authorization control and monitoring purposes.

Furthermore, a bilateral discussion with DE occurred in 2010 on analogous LC-MS analytical methods for residues in soil and water for structurally-related quaternary ammonium compounds, with only one mass fragment (instead of three) validated. It was agreed that highly specific confirmatory methods for residues in soil and water were necessary and were to be submitted for the product authorization phase at national level. The same position (i.e. the request for additional validation data) has been recently agreed with DE-CA in the commenting step for the very same substance (CAS 68424-85-1) notified by another Applicant. In that case, LC/MS-MS analytical methods for residues in soil and water (both drinking- and surface-water) were available, with only one mass transition (instead of two) validated.

In conclusion, in line with the Addendum to TNsG on Data Requirements Analytical Methods and also for the sake of consistency with the approach adopted for structurally-related quaternary ammonium compounds and for the same active substance notified by another Applicant, additional highly-specific confirmatory methods for C12-16-ADBAC residues in soil and water (both drinking- and surface-water) are to be submitted at the product authorization phase at national level.

No analytical method is required for the determination of residues in air, since the a.s. is non-volatile and will not be used in spray application.



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No analytical method is deemed necessary for the determination of residues in body fluids and tissues, being the a.s. neither toxic nor highly toxic.

Wood treated with C12-16-ADBAC-containing biocidal product is not intended for and contains label restrictions against use in areas where food for human consumption is prepared, consumed or stored, or where the feedingstuff for livestock is prepared, consumed or stored. Therefore, no analytical method for the determination of residues in food/feed of plant/animal origin is required, either.



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2.1.2. Intended Uses and Efficacy

The active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) in Type 8 products acts as a fungistatic and an insecticide. It is used for preventive protection of wood and constructional timbers in Hazard Classes 1 to 4A according to ISO draft standard.

Effectiveness

C12-16-ADBAC is a cationic surfactant type active substance. Since it is surface active, it has fair wetting properties and reacts strongly with cell walls of micro-organisms. Its mode of action, therefore, is to destroy the cell walls by sticking on the exterior structures and by entering and disintegrating the inner phospholipid-bilayer-based membrane structures. Due to its interaction with phospholipid-bilayer-based structures, it severely alters the cell wall permeability, disturbs membrane-bound ion-translocation mechanisms and may facilitate the uptake of other biocides.

The field of application of Alkyldimethylbenzylammonium Chloride includes wood preservatives for the preventive treatment against wood destroying organisms and against wood discolouring moulds and fungi. The use concentration depends on the type of application technique, use class required, and on additional formulation components.

Quaternary amine (quat) biocides in the wood preservation market are always used in formulations in combination with other active substances. Efficacy studies with quats alone require considerably higher concentrations than those actually used in these formulations. Therefore, the use of “quat only” efficacy data for risk assessment may provide an exaggerated environmental exposure level.

Against fungi, a selective activity spectrum exists.

The biocidal product (BQ-25) contains 25% Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides in water.

It is used in drenching/dipping and vacuum pressure process applications. In practice it is always used in formulations in combination with other active substances.

The biocidal product concentrate is diluted to a suitable working strength with water. The degree of dilution will vary depending on the wood species, type of wood product and anticipated use. The requirements for the final concentration of C12-16-ADBAC vary between 0.4% and 2.0%. The application rate of C12-16-ADBAC in wood is 2.0 kg/m3. Number and timing of applications depends on application technique, wood species, moisture and hazard class. An uptake of approximately 2.0 kg/m3 should be achieved by these application methods in order to ensure the protection level for the different use classes required. BQ-25 is used for preventive protection of wood and constructional timbers in areas with moderate or subtropical climate in Hazard Classes 1 to 4A according to ISO draft standard

Since after approx. 40 years of use worldwide no reports of selective acquisition of C12-16-ADBA-resistance in the field of wood protection exists, the risk of development of resistance



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to is considered negligible. On the other hand, C12-16-ADBAC as a wood preservative works by preventing growth of organisms, not by killing organisms that are present thus reducing the potential for resistant organisms to develop. In addition, for hard surface sanitization/disinfection (where antimicrobial activity is based on direct killing of organisms present on surfaces), investigations on exposure of domestic microbial communities to quaternary ammonium biocidal substances showed no increased antimicrobial resistance (McBain A.J. et al. 2004). Therefore, we can agree that development of resistance can be considered negligible.



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2.1.3. Classification and Labelling

The proposed Classification and labelling of active substance based on Directive 67/548/EEC Class of danger Xn R22

C R34 N R50

R phrases R22 Harmful if swallowed R34 Causes burns R50 Very toxic to aquatic organisms

S phrases S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advise. S28 After contact with skin, wash immediately with plenty of………. S36/37/39 Wear suitable protective clothing, gloves and eye/face protection S45 In case of accident or if you feel unwell, seek medical advice immediately (show label where possible) S60 This material and its container must be disposed of as hazardous waste S61 Avoid release to the environment. Refer to special instructions/Safety data sets

Specific concentration limits for the environmental classification

Cn ≥ 0.25 %: N; R50

Justification for the proposal

The substance is currently not classified according to Annex I of Council Directive 67/548/EC (with amendments and adaptations).

On the basis of the results from studies presented in the dossier, classification of C12-16-ADBAC was proposed according to principles detailed in Annex VI of Council Directive 67/548/EEC (with amendments and adaptations). Related to N; R 50, LC50 is below 1 mg/l with proposal for specific concentration limits and the substance is readily biodegradable.



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Proposed Classification and labelling of the active substance based on Regulation EC 1272/2008:

Classification:

Hazard Class and Category

Acute toxicity (oral), Hazard Category 4 Skin Corrosion Hazard Category 1B_ Aquatic Acute 1_

Hazard Statement Codes

H302 H314 H400

Labelling:

GHS Pictogram GHS05, GHS07, GHS09

Signal Word Danger

Hazard Statement H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage H400: Very toxic to aquatic life.

Specific concentration limits for the aquatic hazard classification

M factor=100

As precautionary statements are not included in Annex VI of Regulation EC 1272/2008, no proposal is made.



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2.2. Summary of the Risk Assessment

2.2.1. Human Health Risk Assessment

2.2.1.1 Hazard identification

C12-16-ADBAC is not expected to be readily absorbed from the gastrointestinal tract or skin being a highly ionic compound. The oral absorption can be considered approximately 10% based on the 5-8% of the C12-16-ADBAC administered dose eliminated via urine and tissue residues (less than 1% of the administered dose seven days after single and repeated oral dosing). More than 90% is excreted in the faeces and the pattern did not change after repeated doses. Although it was not possible to discriminate between unabsorbed /absorbed material, based on the chemical nature of the test substance it can be anticipated that about 90% is present in faeces as unabsorbed material. The C12-16-ADBAC dermal absorption determined in an in vitro study using human skin at two different concentrations (0.03% and 0.3%) of the active substance is 8.3%.

The majority of C12-16-ADBAC metabolism is expected to be carried out by intestinal flora; the metabolites, which account for less than 60% of the administered dose, include hydroxyl and hydroxyketo derivatives of the dodecyl, tetradecyl and hexadecyl chains. There was no metabolite that accounted for more than 10% of the total dose administered.

The oral LD50 for Alkyl (C12-16) dimethylbenzyl ammonium chlorideis 344 mg/kg. No clinical signs or mortality were observed until a dosage or a concentration is attained that causes irritation of the gut mucosa or affects the gastrointestinal flora. Indeed, irritation and corrosivity are the major outcomes of toxicity related to C12-16-ADBAC.

The rabbit acute dermal LD50 of C12-16-ADBAC is 2848 mg/kg bw (at the application site clear signs of irritation and topic toxic effects were evident). Inhalation of C12-16-ADBAC is not considered a potential route of exposure based on scenarios and vapour pressure (< 1x10-3 Pa at 50ºC).

C12-16-ADBAC is a severe skin and eye irritant, classified as ‘Corrosive’(R34, may cause burns)

and on the basis of the available data is not a skin sensitizer .

From a two-week skin irritation study in rats, it can be derived a NOAEL/NOAEC for short term skin irritation equal to 0.3% C12-16-ADBAC in water at 2.0 ml/kg body weight per day.



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2.2.1.2 Effects assessment

Similarly to acute effects, repeated C12-16-ADBAC intake in the diet results in effects up to death in rodents at concentrations affecting the gastrointestinal mucosa and resulting in dehydration and wasting or affects the gastrointestinal flora. Indeed, again irritation and corrosivity are the major outcomes of toxicity related to C12-16-ADBAC and no specific organ toxicity was evidenced. The subchronic oral toxicity NO(A)ELs were 85 mg/kg/day in mice, 31 mg/kg/day in rats and 13.1 mg/kg/day in dogs, mainly based on decrease in body weights, reduced food consumption and appearance of clinical signs related to the irritation and damages to the gut mucosa.. The changes in haematology and clinical biochemistry reported at high doses of treatment appear to be secondary to a reduced food intake and dehydration very likely leading to a reduced renal blood flow. The NOELs related to non neoplastic effects in chronic oral toxicity studies were 44 mg/kg/day for rats and 73 mg/kg/day for mice. It appears that subchronic and chronic NOAEL are in the same order of magnitude, in line with the fact that the main outcome directly derives from the irritative/corrosive properties of the substance.

In a 90-day subchronic dermal study in rats, no systemic effects were seen at the highest dose that could be applied without excessive skin irritation (20 mg/kg/day). No systemic effects are anticipated after higher dermal or inhalation exposure. Indeed, due to its corrosive characteristics, C12-16-ADBAC will react locally and only a scant amount will become systemically available.

C12-16-ADBAC displayed no genotoxic activity in the three mutagenicity tests required for the authorisation of Biocidal Products: Salmonella mutagenicity assay, chromosomal aberration assay in human lymphocytes in vitro and mutagenicity test in CHO/HPRT forward mutation assay. Moreover, no clastogenic activity in vivo was observed in a mouse micronucleus study.

C12-16-ADBAC is not carcinogenic and does not affect reproduction or development at doses that are not toxic to the mother. No evidence of neurotoxicity was observed in any of the acute, subchronic or chronic studies, in line with the absence of any structural alert for neurotoxicity or similarity with any known neurotoxic agent.

Medical data

No medical reports on the manufacturing personnel have been submitted



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2.2.1.3 Exposure assessment

The biocidal product containing the active substance is used in two wood preservative treatment applications: dipping and vacuum pressure processes. For both processes, the preservative is delivered to the processing plant by tanker in the form of a concentrate. The concentrate contains 25% of the active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride. It is diluted down to a suitable working strength with water. The degree of dilution varies depending on the wood species, type of wood product and anticipated use. Alkyldimethylbenzylammonium Chloride concentrations in both processes vary between 0.4% and 2%.

Furthermore, the use classes 1 to 4A are envisaged for the Alkyl (C12-16) dimethylbenzyl ammonium chloride containing wood preservative product.

Due to the irritant/corrosive properties of C12-16-ADBAC, the systemic effects can be considered as secondary in comparison to the local ones. Nevertheless, a small amount of active substance becomes systematically available and gives rise to some non-significant systemic effects, such as decreasing of body weight. Therefore, both a systemic and a local exposure assessment have been connsidered so as to provide a comprehensive overview of the effects resulting from the use of C12-16-ADBAC.



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2.2.1.3.1 LOCAL EXPOSURE ASSESSMENT

C12-16-ADBAC exhibits irritant/corrosive properties which mainly affect the human exposure. In order to quantify the local exposure, the scenarios adopted have been selected from TNsG on Human Exposure and RISKOFDERM Model. In this context, it has not been taken into consideration any reduction factors from wearing clothes and/or Personal Protective Equipments; no dermal penetration has been considered, either.

C12-16-ADBAC is a non-volatile active substance and therefore the inhalation uptake can be considered as negligible in assessing the exposure due to the local effects.

Industrial/Professional users (primary exposure)

In the local exposure assessment the dermal route is deemed to be the most relevant one for industrial/professional users handling both concentrated (Mixing and loading process) and diluted C12-16-ADBAC-based solutions (dipping and vacuum-pressure applications). The resulted exposure values are reported below. Information on assumptions and input values used in the relevant scenarios are provided in Doc. IIB.

Table 2.2.1.3.1-1 Summary of the exposure local dose for industrial/professional users

EXPOSURE MODEL Hands exposure Body exposure Feet exposure

mg/cm2 mg/cm2 mg/cm2

MIXING&LOADING Riskofderm Connecting

lines 0.000275 - -

APPLICATION PHASE (Dipping

treatment): Handling Model1

0.0617 0.005 0.036

APPLICATION PHASE (Vacuum

Pressure treatment): Handling Model1

0.077 0.009 0.027



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Secondary exposure: Child playing on weathered structure and mouthing –ingestion (Local Exposure due to irritant effect)

The local irritant effect of the C12-16-ADBAC deems to be more relevant in the case of the secondary exposure than the systemic effect. In particular, this is the case of the scenario in which has taking into account the exposure for child chewing wood. Therefore it has been drafted an exposure scenario considering that the maximum absorption of product is 2 mg/cm3 (see above).

The volume of the timber chips is 16 cm3 (4 cm x 4 cm x 1 cm) as reported in the TNsG, Part 3, p. 50 and User Guidance, p. 52.

The fraction extracted by chewing is 10% as reported in User Guidance, p. 52.

The amount of saliva produced is 1.5 ml/min median value reported for stimulated saliva production (http://www.scopevic.org.au/therapy_crc_research_saliva_anatomy.html) .

A maximum absorption a.s mg/cm3 2B size of chewed timber cut-off (chip) cm2 16C depth of chewed timber cut-off (chip) cm 1D = B x C volume of chip cm3 16E a.s. extracted by chewing fraction 0.1F = A x D x E a.s. in the mouth mg 3.2G Amount of saliva produced ml/min 1.5H Event duration min 1

The event duration has been conservatively assumed to be of 1 min. Any increase in duration time is associated with an higher production of saliva and consequently with an higher dilution. Anyhow this has to be considered a very worst case scenario, as the release of the 10% of the active substance in a very short time (i.e. 1 min) has to be considered unrealistic.

The estimate of the concentration in the mouth has been derived with the above reported parameters revealing the following exposure calculation:

Amount of active substance in the mouth: F = A x D x E = 3.2 mg

Concentration in the mouth = F/(G x H) = 2.2 mg/ml = 2200 mg/kg

Local dose expressed as percentage of active substance = 0.22 %



21

2.2.1.3.2 SYSTEMIC EXPOSURE ASSESSMENT

Industrial/Professional exposure (Primary Exposure)

There are four main strata of workers that may potentially be exposed to the wood preservative in the process plant: workers that handle wet treated lumber, workers that handle treated wood after drying, maintenance workers of equipment, forklift operators.

Industrial/professional exposure from the use processes has been estimated using the scenarios reported in the Technical Notes for Guidance on Human Exposure to Biocidal Products. In a TIER 1 evaluation, representing a worst-case estimate, only the default values have been taken into account. As general assumptions, it was agreed that in the Tier 1 the estimate of the primary exposure has been carried without considering the use of the personal protective equipment (PPE) or a 100% clothing penetration with old gloves. A correction is applied for the maximum dermal absorption of 8%. As concerns the inhalation exposure, an agreed default value for inhalation uptake of 100% has been taken into account.

Furthermore, the value of 1.25 m3/hour for the inhalation rate, due to moderate physical activity, has been used. Furthermore, as a worst case scenario, all calculations are based on the wood treatment solution employed containing 2% a.s. The neat concentrate of the substance (containing 25% a.s.) is only handled under closed conditions during the Mixing and loading process.

The scenarios in TIER 1 predict potential exposure assuming that no PPE is employed. In reality due to the irritant/corrosive properties of the active substance, PPE will be worn, hence the estimates reported below have to be considered as overestimates.

In TIER 2, refined values have been considered and the assessment has been conducted assuming use of personal protective equipment including protective clothing, gloves and footwear. The exposure calculations were performed according to the recommendations of the TNsG (Human Exposure to Biocidal Products, as revised by User Guidance version 1 (EC, 2002a). Model calculations have been undertaken using measured data given in the TNsG as revised in the user guidance and are considered to represent a reasonable scenario for risk assessment purposes. For vacuum/pressure treatment, dermal exposure has been assessed assuming clothing penetration of 10% (User Guidance version 1, p42), except for certain exposure scenarios (dipping and cleaning out dipping tank) where it is assumed that impermeable coveralls will be worn (penetration = 4%; TNsG - Part 3, p60). Also, to reduce exposure via the hands, operators would be required to wear new protective gloves at the start of each daily dipping session. New gloves reduce hand-in-glove exposure by a factor of 0.6 (TNsG, Part 2, p.192). The dermal penetration of C12-16-ADBAC used for this assessment is 8% , as discussed in Section 4.1 of document IIB.

The duration of the tasks has been reviewed on the basis of more realistic values only for the dipping process and therefore, it has been considered an exposure period of 20 minutes for dermal exposure.



22

In TIER 2, for the Mixing and Loading process has been considered also the exposure scenario of RISKOFDERM Toolkit (Connecting lines). For automated transfer/pumping the Human Exposure Expert Group (HEEG) has concluded that in case of evaluated available data and models for the assessment of the exposure to operators during the loading of products into vessels or systems in industrial scale the exposure could be considered as negligible, with a very low or accidental exposure during connecting lines. Alternatively, the RISKOFDERM Connecting lines could be used. (Opinion presented and accepted at the March meeting (2008) in the Technical Meeting in the Biocides Group). Indicative dermal exposure values for RISKOFDERM Toolkit Connecting lines referred in the HEEG document are 0.066 mg/cm2/h (0.92 mg/min) for hands. The model is a semi-quantitative model and assumes that small contaminations and no body exposure take place during the task.

Being the Mixing and Loading an automated task, only the exposure assessment carried out by using RISKOFDERM should be taken into consideration for the purpose of Annex I inclusion.

For both the Tiers, the default value for body weight of an exposed adult is assumed to be 60 kg in order to include women (50th Percentile = 60.3 kg according to ECETOC, 2001).



23

In the following tables the estimates calculated on the basis of the TNsG scenarios for Total Exposure to Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) in Wood Preservation are reported.

Table 2.2.1.3.2-1- Exposure to Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) in Wood Preservation (Tiers 1-2)

Exposure scenario Dermal

Exposure (mg) Inhalation

Exposure (mg)

Total Exposure

(mg)

Total Systemic dose

(mg/kg/d)

Tier 1 Tier 2 Tier 1 Tier 2 Tier

1 Tier

2 Tier 1 Tier 2

Dipping

Mixing and loading concentrate

(25% solution)(Model 7)*

0.12 0.12 0.205 0.205 0.325 0.325 0.0054 0.0054

Dipping


(25% solution)(RISKOFDERM toolkit)

- 0.18 - - 0.18 0.0031

Automated Dipping

Application

(2% solution)

61.7 6.3 - - 61.7 6.3 1.03 0.11

Vacuum/pressure treatment

(2% solution)(including feet exposure assessment)

48 12 0.43 - 48.4 12.4 0.80 0.20

*This Model refers to a manual task. Being the mixing and loading for C12-16-ADBAC an automated task, only the RISKOFDERM model should be taken into account.



24

Non-professional exposure (Consumers) (Primary Exposure)

Consumers are not involved in the application (wood treatment) stage. Consumer exposure is restricted to handling of treated lumber in operations such as erecting fences. Consumers are not involved in the application stage. The level of exposure is considered to be comparable to (or less than) occupation exposure to workers that handle treated wood after it is dry.

Indirect exposure as a result of use of the active substance in biocidal product

The secondary human exposure estimates consider the potential for the exposure of professional adults, infants and children in a number of possible scenarios in which they may come into contact with C12-16-ADBAC treated timber.

The scenarios used in this assessment are described in the TNsG on Human Exposure to Biocidal Products Part 3, p50-51 as revised by User Guidance version 1 p50-54 (EC, 2002a).

For non-professional exposure (consumers) the following scenarios have been considered:

Acute phase reference scenarios

Adult (professionals): sanding treated wood from vacuum/pressure impregnated timber - inhalation and dermal route.

Adult (non-professionals): sanding treated wood from vacuum/pressure impregnated timber - inhalation and dermal route.

Infant: chewing wood off-cut – oral route (wood from vacuum/pressure impregnated timber)

Child not relevant.

Chronic phase reference scenarios

Adult inhalation route – not relevant

Child playing on playground structure outdoors - dermal route.

Infant playing on weathered structure and mouthing - dermal and ingestion.



25

In the following table are reported the systemic exposure values of total uptake for humans.

Table 2.2.1.3.2-2-Summary of the total systemic uptake for the secondary exposure.

Oral Dermal Inhalation Combined

Acute

Non-professionals

Adult

sanding -- 0.056 mg/kg/day 0.00052 mg/kg bw

0.0565

mg/kg/day

Infant

mouthing 0.32mg/kg/day -- -- --

Chronic

Professionals

Adult

sanding -- 0.056 mg/kg/day 0.0031 mg/kg bw

0.059

mg/kg/day

Non-professionals

Child

playing 0.0085 mg/kg bw/day --

Infant

playing 0.02 mg/kg/day 0.0128 mg/kg/day

0.0328 mg/kg

day



26

2.2.1.4 Risk characterization

2.2.1.4.1 Risk Characterisation for local effects

Considering the repeated dose studies, the main critical effects associated with C12-16-ADBAC are due to its corrosive prosperities. In this context, the systemic effects such as the reduction of body weight and food consumption can be considered secondary compared to the corrosive properties of C12-16-ADBAC. It can be concluded that C12-16-ADBAC actually does not cause ‘true’ systemic effects and the derivation of a systemic AEL is not considered as relevant.

As regards the operators dermal exposure, a dermal AEL could possibly be considered. In the 2-week skin irritation study with rats, no systemic effects were observed and the NOAEL for local effects has been set at 6 mg/kg bw/day (0.3% C12-16-ADBAC).

However, based on the new guideline for the Risk characterisation of local effects, it was agreed (TMIII09) to include also a quantitative assessment for the secondary exposure scenario (child mouthing treated wood). Therefore, the AEC for dermal route was derived as follows.

Local NOEC derivation - Dermal route

The NOEL derived for the C12-16-ADBAC is of 0.3% of active substance in water (i.e., 3 g/l or 3000 mg/l or 3mg/ml). The total volume applied is of 2 ml/kg bw per day. Therefore, the resulted NOEL is of 6 mg/kg bw/day (=3mg/ml x 2ml/kg bw per day).

In the skin irritation study the treated body surface has not been well defined and therefore, the assumption of 10% coverage of the animal body could be made based on the guideline recommendations. According to the TGD, the total surface body of rat (male and female) is 400 cm2 and the mean body weight is 300g. Assuming that 10% of the body surface has been exposed to the test substance, the resulting exposed area is of 40cm2.

For the characterization of the risk due to the local dermal effects a NO(A)EC (expressed in mg/cm2) has to be derived following the formula below:

2

2

)/()(

²/

cminsurfaceTreated

bwkgmgindosekginweightanimalaverage

cminsurfaceTreated

mginapplieddoseTotalcmmginNOAEC

×=

=

NOEC = (0.3kg x 6 mg/kg bw/day) / 40cm2 = 0.045mg/cm2

The NOEC value of 0.045 mg/cm2 is equivalent to a NOEC of 0.3%.



27

Selection of Assessment Factor for the dermal route (AF)

Given that local toxicity based on the chemical reactivity of QUATs is the basis for the risk characterization, a reduced inter-species AFs when extrapolating data obtained in rats to humans could be used. In fact, for the local effects the QUATs show its effects at port of entry and therefore, it is justified to assume that both the components (toxicokinetic and -dynamic) do not contribute to interspecies differences.

Regarding intra-species differences it could be acceptable to lower the default factor disregarding the TK contribution (again 3.16 ≈ 3.2), given that chemical reactivity is the principle concern. Therefore, for the intraspecies AF only the Toxicodynamic component (3.16 ≈ 3.2) could be taken into consideration.

Therefore, for the dermal route the overall AF turns out to be AF: 3.2 = 1x, interspecies; 3.2x, human variability.

AEC derivation

Based on the NOEC and the AF derived, the calculated AEC for dermal route is 0.014 mg/cm2 (0.045 mg/cm2 / 3.2) or 0.094% (0. 3% / 3.2).

Local AEC derivation – Oral route

For the oral AEC derivation no toxicological study is available.



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Exposure and risk from use of the product

For industrial/professional users, the risk resulting from the direct use of biocidal products containing C12-16-ADBAC has been assessed by applying the AEC approach. Therefore, the dermal loads have been compared to the calculated dermal AEC of 0.014 mg/cm2.

EXPOSURE MODEL

Hands exposure mg/cm2

AEChands% Body exposure

mg/cm2 AECbody%

Feet exposure mg/cm2

AECfeet%

MIXING&LOADING Riskofderm Connecting

lines 0.000275 1.96 - - - -

APPLICATION PHASE (Dipping

treatment): Handling Model1

0.0617 441 0.005 35.7 0.036 257

APPLICATION PHASE (Vacuum

Pressure treatment): Handling Model1

0.077 550 0.009 64.3 0.027 193

AEC% = (Exposure x 100)/AEC

Conclusion: for local effects, no unacceptable risk can occurs for industrial/professional users handling concentrate biocidal product during the mixing and loading phase. As regards, the application stage, no risk has been highlighted for body. On the other hand, an unacceptable risk can be envisaged for both hands and feet during the application phase. However, feet contamination can be reduced by prescribing that suitable impermeable boots are worn. In addition to that, the risk for hands can be lowered by using appropriate and suitable gloves. Furthermore, the gloves should be frequently replaced.

However, for the risk assessment this discussion is not really relevant, since the formulation BC-25 contains 25% C12-16-ADBAC, and in practice solutions of 2.0% and 0.4% C12-16-ADBAC are used. Therefore, at 0.3% C12-16-ADBAC (6 mg/kg bw/day) clear local effects are not observed in the study. For C12-16-ADBAC the primary effects are the local effects, hence for the risk assessment of C12-16-ADBAC it is more relevant to take into account the concentration of the active substance on the skin than the dose expressed in mg/kg bw/day (systemic effects). Being the concentrations of the C12-16-ADBAC solutions applied are equal or higher than the (marginal) NOEL from the 2-week skin irritation study, for all intended uses listed in the CAR, personal protective equipments (PPEs) should be used to protect operators against the local effects of C12-16-ADBAC. The conclusion from the qualitative risk assessment due to the corrosive properties of C12-16-ADBAC is that PPE are per definition required when applying C12-16-ADBAC.



29

Exposure and risk from indirect exposure to the product

As concerns the risks arising from the secondary exposure, the only scenario considered as relevant is child mouthing treated wood. The resulting local dose is 0.22% C12-16-ADBAC.

Text revised following a German comment raised during the 60-day commenting period:

(ADDED) Being the skin less sensitive than the mucosa membrane of the digestive tract, RMS agrees with Germany that the dermal 2-week study in rats is not fully representative of the oral local effects and therefore a route-to-route extrapolation without correction with an additional AF (although discussed and accepted during the TM) can lead to an underestimation of the AECoral. Therefore, RMS agrees with the German proposal to include an use restriction for ADBAC-treated wood possibly entering into contact with children.

In conclusion, not being fully addressed the risk arising from child sucking and mouthing treated wood, the scenario has not been assessed. Therefore, the use of ADBAC treated wood has to be restricted to applications where biocidal treatment is unavoidable (e.g., construction) but definitely excludes applications to treated wood composites which would otherwise come into contact with children. In order to overruled the use restriction at product authorization level an AECoral should be derived by either using an oral toxicity study for the local effects or considering an additional assessment factors when the dermal 2-week study in rats is used. In this regards, an oral toxicity study for a structurally similar compound (i.e., DDAC) could be also submitted. This on the basis of the scientific acceptability of the read-across already discussed and agreed during at the Technical Meetings. If this is the case, differences in the molecular weight between the tested material and the active substance (ADBAC) should be taken into account in the derivation of the oral AEC (agreed at TM).

The scenario estimated for the secondary exposure was agreed during the Technical Meetings when no specific guidelines were available on the risk characterization for the local effects. The assessment should not be considered as comprehensive of the overall exposure pathways. Thus, additional exposure scenarios covering any relevant exposure scenarios should be estimated at Product Authorization stage when the guidelines on the risk characterization for the local effects are finalized, depending on the use patterns.

Therefore, based on the above discussion, it is considered inappropriate to use an AEL approach for C12-16-ADBAC and similar quaternary amines, because there is no true systemic toxicity. C12-16-ADBAC, and other quaternary amine biocides, do not exhibit “systemic toxicity” as based on changes to organs or effects on reproduction, development, mutagenicity, carcinogenicity, neurobehavior or other key toxicological endpoints. Rather, effects observed in toxicity studies occur only at irritant doses and general effects, including body weight changes at lower doses and death at high doses, are secondary to these irritant responses.



30

2.2.1.4.2 Risk characterization for systemic effects

AEL (Acceptable exposure level)

The lowest NOAEL in a repeated dose study is the one of 13.1 mg/kg b.w/day derived from the 52 weeks study on dogs. This value is then used in deriving the AOEL. An assessment factor of 10 is used for interspecies variability and an assessment factor of 10 for taking into account intraspecies variability. The AEL value corresponds to 0.13 mg/kg/day

For the systemic AEL derivation was not deemed to be estimated as internal dose by including the oral absorption factor in the calculations. In fact, C12-16-ADBAC acts mainly on gut mucosa or at the site of application due to its corrosive effects: the effects seen in the toxicological studies are mainly secondary to this mode of action. For this reason in the CAR, it is proposed not to calculate any internal dose (correcting exposure value for the very low oral absorption). Indeed, due to its corrosive characteristics, C12-16-ADBAC will react immediately and only a limited amount of the active substance become systemically available. Based on these considerations, derivation of a systemic internal dose is not considered appropriate.


Total systemic dose values are taken from the calculations presented in Document IIB. For the Mixing and Loading stage, only the data derived by using the RISKOFDERM model have been considered. In Tier 2 a realistic approach is assumed. Therefore PPE (gloves 12% penetration) are considered to be worn.

Risk characterisation is expressed as the systemic dose as a percentage of the AEL% (exposure x 100/AEL).

Risk Characterisation Calculations for Industrial/Professional Users to Alkyl (C12-16) dimethylbenzyl ammonium chloridein Wood Preservation (Tier 2).

Exposure scenario Total Systemic dose

(mg/kg/d)

%AEL =

(Exposure x 100)/AEL (0.13

mg/kg bw/d)

Dipping


(25% solution)(Model 7)*

0.0054 4.15

Dipping


(25% solution)(RISKOFDERM toolkit)

0.0031 2.38

Automated Dipping

Application

(2% solution)

0.11 84

Vacuum/pressure treatment

(2% solution)(including feet exposure 0.20 153



31

assessment) *This Model refers to a manual task. Being the mixing and loading for C12-16-ADBAC an automated task, only the RISKOFDERM model should be taken into account.

A potential risk has identified only for Vacuum/pressure treatment using a 2% of C12-16-ADBAC-based solution. The risk will be avoided prescribing the Personal Protective Equipments as mandatory.

The C12-16-ADBAC-based products are not authorized to the general public so the risk from the primary exposure to consumers and man via the environment can be predicted as negligible exposure is predicted for.

Margin of Exposure (MOE) approach


The NOAEL for dermal sub-chronic effects (20 mg a.i./kg/day – highest possible dose that could be applied but no systemic toxicity observed) is used to determine the Margin of Exposure for dermal exposure. Anyway this value does not consider the dermal absorption/penetration of 8%. Therefore, NOAELdermal results to be 1.6 mg a.i./kg/day. A safety factor of 100 (10 for interspecies difference x 10 for intraspecies difference) is used, although there is no evidence of systemic toxicity from dermal application of C12-16-ADBAC. Therefore, the MOE (NOAEL/exposure) should be equal to or greater than 100 in order to determine no risk to human health.

The NOAEL for oral sub-chronic effects (13.1 mg a.i./kg/day) is used to determine the Margins of Exposure for inhalation exposure in the absence of sub-chronic inhalation toxicity data. A safety factor of 100 (10 for interspecies difference x 10 for intraspecies difference) is applied. Therefore, MOE (NOAEL/exposure) should be equal to or greater than 100 in order to determine no risk to human health.

Exposure scenario Dermal

Systemic uptake

(mg/kg/day)

MOE =

NOAEL (1.6 mg/kg/d)/ Exposure

(mg/kg bw/day)

Inhalation Systemic uptake

(mg/kg/day)

MOE =

NOAEL (13.1 mg/kg/d) / Exposure

(mg/kg bw/day) Dipping Mixing and loading concentrate (25% solution)(Model 7)*

0.00014 11429 0.0023 5652

Dipping Mixing and loading concentrate (25% solution)(RISKOFDERM toolkit)

0.00021 7619



32

Automated Dipping Application (2% solution)

0.11 15 - -

Vacuum/pressure treatment (2% solution)(including feet exposure assessment)

0.2 8 0.0012 10833

*This Model refers to a manual task. Being the mixing and loading for C12-16-ADBAC an automated task, only the RISKOFDERM model should be taken into account.

For industrial/professional workers there is a concern from dermal exposure during the applications (both automated dipping and vacuum pressure treatments) of the C12-16-ADBAC-based products. Hence, to avoid any risk, the use of Personal Protective Equipments has to be prescribe as mandatory by the RMS. On the other hand, C12-16-ADBAC does not pose any risk to industrial/professional workers with regard to inhalation effects.

Workers are not expected to be exposed by the oral route to the product. Although the active substance is harmful by acute oral exposure (LD50 rat, oral = 344 mg/kg), good industrial hygiene, such as washing before eating or smoking, will reduce the risk of accidental oral exposure. In conclusion, C12-16-ADBAC or BQ-25 is not a risk to industrial/professional workers with regard to oral exposure effects.

Indirect/Secondary exposure as a result of use

Indirect exposure to construction timber treated with wood preservatives is not directly related to the use of the wood preservative during application or handling of the wet treated wood, but to secondary exposure to the treated ready-to use wooden articles.

Three main exposure paths were identified that are (a) acute by adults sanding treated timber, (b) acute by children ingesting wood particles and (c) chronic by being exposed to the wood surface. The calculations were performed only for the highest loading rates (retentions) of 2.0 g/m2 and 2.0 kg/m3. For the contact assessment of treated timber a worst case leaching rate of 10% per day was chosen.

Acute:

On the basis of the analogy between DDAC and C12-16-ADBAC, for the acute toxicity it has been used the NOEL for DDAC. Therefore, Oral acute NOEL = 10 mg/kg bw/d

Inhalation acute = use oral NOEL = 10 mg/kg bw/d

Dermal acute NOEL = 6 mg/kg/day; the main acute effect is due to the irritant/corrosive properties of C12-16-ADBAC, the NOEL was set from a two-week skin irritation study

Chronic:

Dermal NOAEL = 1.6 mg/kg/day



33

Inhalation = use oral NOAEL = 13.1 mg/kg/day

Intermediate-term risk calculations will use the same NOAEL as the long-term assessments resulting in the same assessments. Therefore, the intermediate-term assessments have not calculated.



34

Following are reported the secondary exposure for Professional and non-professional users–MOEs for indirect exposure.

Oral Dermal Inhalation Combined NOEL/NOAE

L MOE

Acute

NON-PROFESSIONALS

Adult sanding

-- 0.056 mg/kg/day 0.00052

mg/kg bw 0.0565

mg/kg/day

Oral/Inhalation:

10 mg/kg bw/d

Dermal:

6 mg/kg bw/day

Dermal: 107

Inhalation: 19230

Infant mouthing

0.32mg/kg/day

-- -- -- Oral/Inhalation:

10 mg/kg bw/d

Oral: 31

Chronic

PROFESSIONALS

Adult sanding

-- 0.056 mg/kg/day 0.0031

mg/kg bw

0.059

mg/kg/day

Oral/Inhalation:

10 mg/kg bw/d

Dermal:

1.6 mg/kg bw/day

Dermal: 29

Inhalation:3226

NON-PROFESSIONALS

Child playing

0.0085 mg/kg bw/da

y --

Dermal:

1.6 mg/kg bw/day

Dermal: 188

Infant playing

0.02 mg/kg/day

0.0128 mg/kg/day 0.0328

mg/kg day

Oral:

13.1 mg/kg bw/day

Dermal:

1.6 mg/kg bw/day

Oral: 655

Dermal: 125

Conclusion: according to the TNsG exposure scenarios, a risk can be highlighted for professionals (during sanding treated wood) chronically exposed to wood treated with C12-16-ADBAC-based products (dermal exposure). Furthermore, a risk can occur also for infant mouthing wood treated with C12-16-ADBAC-based products (oral acute exposure).



35

Combined exposure

Combined exposure to Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) used in a wood preservative product is not expected to occur, since only industrial/professional use is envisaged. Theoretically, a combined exposure scenario is possible when an operator, after the working day, inhales the volatile residues indoors at home. However, due to the low vapour pressure of the active substance, this latter exposure can be considered as negligible. For this reason combined exposure has not been quantitatively evaluated in this dossier.

Biocidal Product

The C12-16-ADBAC dermal absorption is 8.3% as determined in an in vitro study using human skin. The value as been obtained summing up the radioactivity present in the receptor fluid (0.05%), at the application site (after 20 consecutive tape stripping procedures) and the one present in tape strips (n°6-20). The two different concentrations tested (0.03% and 0.3% in a.s. content) showed no significant differences in the absorption values.

An acute oral LD50= 344 mg/kg bw for C12-16-ADBAC lead the classification R22 being applied to the a.s. Therefore according to the provisions of directive 1999/45/EC this product is also classified as R22 (trigger concentration is >25%) for this endpoint.

An acute dermal toxicity study performed on C12-16-ADBAC (80% in aqueous: alcholic solution) resulting in an LD50 = 2730 mg/kg bw and does not lead to classification being applied. Therefore according to the provisions of directive 1999/45/EC3 this product is also not classified for this endpoint. Therefore an acute dermal toxicity study on the product is not required.

This product contains 25% C12-16-ADBAC in water and no other components. C12-16-ADBAC is not volatile as the vapour pressure is <10-5 hPa (<10-3 Pa) at 50°C. In addition, from the skin irritation endpoint the product is classified as corrosive and is assigned R34. Thus, it is considered that evaluation of the acute inhalation toxicity is not justified.

A skin irritation study performed on C12-16-ADBAC (80% in aqueous: alcholic solution) which leads to the classification Corrosive, R34 being applied. Therefore, according to the provisions of directive 1999/45/EC this product is also classified as Corrosive, R34 (trigger concentration is >10%)

C12-16-ADBAC has been shown to be corrosive to the eye in a test conducted using an 80% solution of the a.s. In addition, due to the classification of corrosive effects on skin, conducting an eye irritation study on the product cannot be justified on animal welfare grounds.

A skin sensitisation study has been performed on C12-16-ADBAC (80% in aqueous: alcholic solution) which did not lead to classification being applied. Therefore, according to the provisions of directive 1999/45/EC3 this product is also not classified for this endpoint



36



37

2.2.2 Environmental Risk Assessment

2.2.2.1 Fate and distribution in the environment

Biodegradation

Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) can be considered readily biodegradable.

A study to determine aerobic biodegradation in a sewage treatment plant is not justified since C12-16-ADBAC is readily biodegradable and there is negligible release of C12-16-ADBAC to the sewage treatment plant during use as a wood preservative within the EU. However, a study with the structural analogous, Didecyldimethylammonium Chloride in a simulated treatment system showed 93.3% CO2 evolution over 28 days indicating that these quaternary amines will rapidly degrade in a treatment system. A biodegradation study in two water/sediment systems has been performed and showed partial mineralisation of the test material under the test conditions used.

A biodegradation study in seawater was not carried out as C12-16-ADBAC as a wood preservative will not be used in the marine environment.

The test substance was predicted to be rapidly photo transformed in air since it had an atmospheric half-life of 0.25 days or 3.0 hours

Abiotic Degradation

Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) was hydrolytically stable during the 30-day hydrolysis study at pH 5, 7 or 9 at 25°C.

C12-16-ADBAC was found to be photolytically stable in the absence of a photosensitiser. An accurate estimate of the photolysis rate constants and the half-life for solutions containing no photosensitiser and all dark controls (both sensitised and non-sensitised) could not be determined since no significant degradation of the test substance was detected during the 30-day evaluation period. In the presence of the energy from a xenon arc lamp and the photosensitising agent, acetone, it appears that C12-16-ADBAC breaks down to form a single degradate. The half-life of the test compound was determined to be 10.9 days with 83% degradation after 30 days.

Estimation of Photodegradation in air was calculated using the Atmospheric Oxidation Program (AOPWIN) (Howes, D. 2004) Mean atmospheric half-life = 0.368 days (8.831 hours) assuming a 24 hour according to TGD (2003) chapter 2.3.6.3.



38

Distribution

C12-16-ADBAC can be classified as immobile in four soil/sediment types with adsorption(Ka) and mobility (Koc) coefficients of Ka=6'172 and Koc=6'171'657 for sand, Ka=5'123 and Koc=640'389 for sandy loam, Ka=32'429 and Koc=1'663'039 for clay loam, and Ka=10'797 and Koc=2'159'346 for silt loam.

The desorption (Kd) and mobility (Kdoc) coefficients are following reported: Kd=7173 and Kdoc=7137310 for sand, Kd=96540 and Kdoc=12067457 for sandy loam, Kd=165556 and Kdoc=8490062 for silty clay loam, and Kd=14083 and Kdoc=2816590 for silt loam.It is well known that because of their positive charge, the cationic surfactants adsorb strongly to the negatively charged surfaces of sludge, soil and sediments. The average Koc is 2658608 l/kg.

Due to the fact that C12-16-ADBAC was readily biodegradable, field studies on accumulation in the sediment, aerobic degradation studies in soil, field soil dissipation and accumulation studies were not needed.

Mobility

The results of this study indicated that C12-16-ADBAC had little or no potential for mobility in soil and should not pose an environmental risk for contamination of ground water. Therefore, mobility-lysimeter studies were not justified.

Bioaccumulation

The bioconcentration potential of C12-16-ADBAC in fish was investigated in a flow through test with bluegill (35 d exposure + 21 d depuration). Based on the measured 14C residues, the steady-state BCF (whole fish) was 79, indicating C12-16-ADBAC has a low potential for bioaccumulation.No data are available on the BCFearthworm and calculation according to TGD (eq. 82d) is not applicable to ionic substances, therefore bioaccumulation by terrestrial organisms cannot be estimated with the data available. Nevertheless, it has been calculated that risk of secondary poisoning would arise from a BCFearthworm close or higher to 2000 (see IIA, 4.1.3; IIB, 3.3.5; IIIA, 7.5.5.1), which is considered unrealistic, and therefore the measurement of a terrestrial BCF is deemed not necessary.

Leaching study

Read-across between ADBAC and DDAC was accepted at TM level (TMII 09).

The leaching values used in the calculation of Predicted Environmental Concentrations (PECs) are derived from laboratory tests, which were conducted according to the American Wood-Preserver’s Association Standard Method E11-97 being different from the OECD guidelines. The RMS considered this study acceptable, without an assessment factor, because it resembles a worst-case as the wooden blocks are continuously submerged in water taking into account the high water solubility for DDAC, that was accepted at TM level (TMI 09 and TMII 09). The leaching study provided a worst-case leaching value that was used for Risk Assessment. No assessment factors are applied to the leaching rate of 0.19% per day (i.e. 2.6% in 14 days) because higher leaching rates would indicate a commercially non-viable situation in which the



39

wood preservative would not be retained for sufficient time to warrant the expense of the treatment.

The FLUX and Q*Leach have been calculated according to the Appendices I and II of the OECD ESD. The FLUX and Q*Leach values are following reported:

Daily FLUX (TIME1) = 1.56 x 10-5 kg/m2/d

Daily FLUX (TIME2) = 1.52 x 10-7 kg/m2/d

Q*Leach (TIME1) = 5.52 x 10-4 kg/m2

Q*Leach (TIME2) = 1.19 x 10-3 kg/m2



40

2.2.2.2 Effects assessment

Aquatic Compartment

The toxicity of C12-16-ADBAC to aquatic organisms is documented by short- and long-term studies with fresh water species belonging to three trophic levels.

The results of short-term toxicity studies indicate that C12-16-ADBAC is very toxic to fish, daphnia, and plants. The most sensitive group is invertebrates (Daphnia magna, 48hEC50= 0.0058 mg a.s./l), followed by algae (Selenastrum capricornutum, with a 72 h ErC50 = 0.049 mg a.s./l), fish (fathead minnow, 96hLC50 = 0.28 mg a.s./l) and plants (Lemna gibba, ErC50 = 0.25 mg a.s./l). The chronic toxicity of C12-16-ADBAC is < 10 times higher than the acute toxicity, as expected for substances with a non specific mode of action. Also in long-term tests, Daphnia magna was the most sensitive organism with a 21d NOEC ≥ 4.15 µg a.s./l, followed by algae (ErC10 = 9 µg a.s./l) and fish (fathead minnow, 34d NOEC = 32.2 µg a.s./l). The PNEC aquatic is derived from the Daphnia NOEC, applying a factor of 10, therefore:

PNEC water = 0.000415 mg a.s./l.

The hazard of C12-16-ADBAC to sediment dwelling organisms is based on a chronic sediment-spiked test with Chironomus tentans from which a 28 d NOEC was 520 mg a.s./kg dw was derived (equivalent to 357.24 mg/kg wwt). Anyhow, it should be noted that in this test midge larvae were fed with fresh food and Chironomus is not a true endobenthic ingester, hence the toxicity of C12-16-ADBAC might have been underestimated, because of its high adsorption potential. The PNECsediment is calculated applying an assessment factor of 100 to this NOEC, therefore:

PNEC sediments = 3.57 mg a.s./kg wwt.

The effects of C12-16-ADBAC on microbial activity in STP has been investigated in one 3 hours respiration study on activated sewage sludge. From this test, a NOEC = 1.6 mg a.s./l and a EC50 = 7.75 mg a.s./l have been retrieved. The lowest PNEC is obtained from the EC50 divided by an assessment factor of 100:

PNECmicroorganisms = 0.0775 mg a.s./l.

Metabolites

No metabolites are known, following the degradation of C12-16-ADBAC in water.



41

Terrestrial Compartment

Acute toxicity tests have been conducted on soil dwelling invertebrates and plants and one 28d study on nitrogen and carbon transformation is available.

The effect of ADBAC on earthworms was assessed in an acute toxicity test with E. foetida. The 14-day LC50 was 7070 mg/kg dry soil, the NOEC was 953 mg/kg dry soil.

No effect of C12-16-ADBAC on nitrite, nitrate, ammonium and carbon dioxide formation was observed in a 28 d test at a concentration of 1000 mg/kg dry soil in two soil types.

In a 18-20 days seedling emergence and growth test with mustard, mung bean and wheat the lowest endopoint retrieved was for mustard, EC50 (based on growth) = 277 mg/kg. dw soil, equivalent to 274.8 mg/kg wwt soil.

The PNECsoil is derived from the toxicity endpoint of the most sensitive organism (plants, mustard) using the EC50 based on wet weight soil with an AF 1000, leading to:

PNECsoil = 0.275 mg/kg wwt.

The acute oral toxicity of C12-16-ADBAC to birds has been measured on northern bobwhite quail and provided a LD50 = 164 mg/kg b.w. In the two short term dietary toxicity tests conducted with bobwhite quail and mallard duck, no mortality was observed up to the highest tested concentration (5620 mg a.s./kg). The lowest endpoint is retrieved for mallard duck, i.e. LC50 > 2463 mg a.s./kg food (recalculated to account for food avoidance). An assessement factor of 3000 was used to derive the PNEC:

PNECbirds > 0.821 mg a.s./kg.

From the several studies with mammals available, the relevant lowest NOEC = 400 mg/Kg food was derived from a 52 weeks dietary repeated doses study with dogs.

For PNECoral calculation an assessment factor of 30 is applied, therefore:

PNECmammals = 400 mg/kg / AF30 = 13.33 mg/kg.

Endocrine effects.

Based on available experimental results, there is no indication that C12-16-ADBAC affects the endocrine system. Structural characteristics and SAR do not hint to possible effects of C12-16-ADBAC as endocrine disruptor.



42

2.2.2.3 PBT assessment

P criterion: Half life > >120 d in freshwater sediment.

From data of hydrolysis: C12-16-ADBAC is hydrolytically stable over an environmentally relevant pH range of 5-9. From data of photolysis in water, C12-16-ADBAC was found to be photolytically stable in the absence of a photosensitiser. C12-16-ADBAC is ready biodegradable therefore, according to the screening criteria for P, vP (ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment), the P criterion is not fulfilled.

B criterion: BCF > 2000

For C12-16-ADBAC the calculated bioconcentration factor in fish is 79. Therefore, the B criterion is not fulfilled.

T criterion: Chronic NOEC < 0.01 mg/L or CMR or endocrine disrupting effects, other evidence

The substance is classified as Xn;R22 C;R34 N;R50. The most sensitive species is Daphnia Magna for which a NOEC of 0.00415 mg/l has been derived from a 21 d reproduction study. The whole evidence of the available information indicates that the T criterion is fulfilled.

Conclusion for the risk characterisation: The active substance C12-16-ADBAC does not meet the PBT criteria.



43

2.2.2.4 Exposure assessment

Aquatic Compartment Exposure assessment

PECs have been calculated according to the OECD Emission Scenario Document for Wood Preservatives (ESD).

Local PEC

Scenario 1: Dipping treatment during application

PEClocalwater STP 0.0047 mg/l

PEClocalsed STP 271 mg/kgwwt

PECmicroorganism STP 0.237 mg/l

Scenario 2: Dipping treatment during storage

PEClocalwater run-off 2.3 x 10-3 mg/l

PEClocalsed run-off 133 mg/kgwwt

Scenario 3: Vacuum pressure treatment during application

PEClocalwater STP 0.0014 mg/l

PEClocalsed STP 82.3 mg/kgwwt

PECmicroorganism STP 0.071 mg/l

Scenario 4: Vacuum pressure treatment during storage

PEClocalwater 1.7 x 10-3 mg/l

PEClocalsed 98 mg/kgwwt

*Scenario 5: Bridge over pond

PEClocalwater Time1 0.09 mg/l

Time2 0.00006 mg/l

PEClocalsed Time1 5204 mg/kgwwt

Time2 3.5 mg/kgwwt

Scenario 6: Noise Barrier

PEClocalwater STP Time1 0.0025 mg/l

Time2 0.00002 mg/l

PEClocalsed STP Time1 60 mg/kgwwt

Time2 0.5 mg/kgwwt

PECmicroorganism STP Time1 0.02 mg/l



44

Time2 0.0002 mg/l *Not being supported by the Applicant, the risks occurring from the in situ application have not been evaluated. Consequently, the risk assessment for the use scenario 5 has been overruled.

Terrestrial Compartment Exposure assessment

In the following table has been reported the PECs calculated using the OECD Emission Scenario Document for Wood Preservatives (ESD).

The leaching values used in the calculation of Predicted Environmental Concentrations (PECs) are derived from laboratory tests, which were conducted according to the American Wood-Preserver’s Association Standard Method E11-97 being different from the OECD guidelines. The study was conduct on the analogue DDAC, the read-across between ADBAC and DDAC was accepted at TM level (TMII 09). The RMS considered this study acceptable, without an assessment factor, because it resembles a worst-case as the wooden blocks are continuously submerged in water taking into account the high water solubility for DDAC, that was accepted at TM level (TMI 09 and TMII 09). The leaching study provided a worst-case leaching value that was used for Risk Assessment. No assessment factors are applied to the leaching rate of 0.19% per day (i.e., 2.6% in 14 days) because higher leaching rates would indicate a commercially non-viable situation in which the wood preservative would not be retained for sufficient time to warrant the expense of the treatment.

Local PEC

Scenario 2: Dipping treatment during storage

PEClocalsoil (TIME 1) 3.0 mg/kg PEClocalsoil (TIME 2) 5.4 mg/kg PEClocalsoil, porew 9.0 x 10-5 mg/l Scenario 4: Vacuum pressure treatment during storage

PEClocalsoil (TIME 1) 3.0 mg/kg PEClocalsoil (TIME 2) 7.2 mg/kg PEClocalsoil, porew 2.3 x 10-4 mg/l Scenario 6: Treated wood in service Noise barrier

PEClocalsoil (TIME 1) 1.2 mg/kg PEClocalsoil (TIME 2) 2.5 mg/kg PEClocalsoil (TIME 2) refined including degradation* 0.5 mg/kg PECgw 3.0 x 10-5 mg/l Scenario 7: Treated wood in service Fence

PEClocalsoil (TIME 1) 2.6 mg/kg PEClocalsoil (TIME 2) 5.6 mg/kg PEClocalsoil (TIME 2) refined including degradation* 0.34 mg/kg PECgw max 6.0 x 10-5 mg/l



45

Scenario 8: Treated wood in service House

PEClocalsoil (TIME 1) 3.1 mg/kg PEClocalsoil (TIME 2) 6.7 mg/kg PEClocalsoil (TIME 2) refined including degradation* 0.4 mg/kg PECgw max 7.0 x 10-5 mg/l Scenario 9: Treated wood in service Transmission pole

PEClocalsoil (TIME 1) 0.4 mg/kg PEClocalsoil (TIME 2) 1.0 mg/kg PEClocalsoil (TIME 2) refined including degradation* 0.06 mg/kg PECgw max 1.0 x 10-6 mg/l Scenario 10: Treated wood in service fence post

PEClocalsoil (TIME 1) 0.4 mg/kg PEClocalsoil (TIME 2) 0.8 mg/kg PEClocalsoil (TIME 2) refined including degradation* 0.04 mg/kg PECgw max 1.0 x 10-6 mg/l * the equations available in the OECD ESD document (Chapter 7, Removal processes in the receiving compartment, p.115).

Atmospheric Compartment Exposure assessment

In the following table has been reported the PECs calculated using the default values (worst-case).

Local PEC (OECD ESD)

Scenario 1: Dipping treatment during application

Annual average local PEC in air 4.56 x 10-7 mg/m3 Scenario 3: Vacuum pressure treatment during application Annual average local PEC in air 1.14 x 10-5 mg/m3



46

2.2.2.5 Risk characterisation

Aquatic Compartment

Scenario PEC/PNEC values

Water compartment

Sediment compartment

Sewage treatment

plant

Scenario 1 (dipping treatment during application) 11.3 75.9 3.05

Scenario 2 (dipping treatment during storage) 5.54 37.3 - Scenario 3 (Vacuum pressure treatment during

application) 3.37 23.1 0.92

Scenario 4 (Vacuum pressure treatment during storage) 4.09 27.5 -

Scenario 6 (Noise Barrier)

Time1 6.02 40.6 0.26

Time2 0.05 0.34 0.0025

The PEC/PNEC ratios for the water and sediment compartments in the scenario 1, 2, 3 and 4 (dipping treatment during application and storage, vacuum pressure treatment during application and storage) are higher than 1. For the use scenario 1, the PEC/PNEC value is higher than the trigger value of 1 also for the sediment and sewage treatment plant. For the water and sediment compartments in the scenario 6 (Noise barrier) the PEC/PNEC ratio is higher than 1 in the short term whilst the long term use does not pose any risk.

In conclusion, in order to reduce emissions from the application and storage phases for aquatic compartment, the dipping and vacuum pressure treatment must be performed only by those plants where significant losses can be contained (e.g., no drain connections to storm drains or STP) and appropriately recycled/disposed.



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Terrestrial Compartment including Groundwater

Summary of PEC/PNEC values for terrestrial compartment

Scenario PEC/PNEC values Terrestrial compartment

Scenario 2: Storage of dipped/ immersed wood After 30 days 10.9

After 15 years 19.6

Scenario 4: Storage of vacuum-pressure-treated wood: After 30 days 10.9

After 20 years 26.2

Scenario 6: Treated wood in service: Noise barrier After 30 days After 20 years*

4.36

1.8

Scenario 7: Treated wood in service: Fence After 30 days After 20 years

9.5

1.2

Scenario 8: Treated wood in service: House After 30 days After 20 years

11.3

1.5

Scenario 9: Treated wood in service: Transmission pole After 30 days After 20 years

1.45

0.2

Scenario 10: Treated wood in service: Fence post After 30 days After 20 years

3.64

0.15

Thus, for scenarios 2, 4, 6, 7 and 8 the PEC/PNEC values are higher than 1 suggesting that there is unacceptable for the terrestrial compartment.

For scenarios 2 and 4 the PEC/PNEC values are higher than 1 suggesting that there is unacceptable risk for the terrestrial compartment. Furthermore, an increasing risk over time has been predicted for both the scenarios. Therefore, all timber treated by dipping and vacuum pressure applications should be stored on impermeable hard standing surfaces so as to prevent direct losses to soil and allow losses to be collected for re-use or disposal.

For scenarios 6, 7, and 8 the PEC/PNEC values are higher than 1 in the short-term whilst for the long-term use the PEC/PNEC values are round 1.

For scenario 9 and 10 the PEC/PNEC values are higher than 1 in the short-term whilst the long-term use does not pose any risk.



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Being a potential risk identified for a number of the terrestrial compartments, the use products should be restricted to prevent the use for treatment of wood in contact with fresh water or used for outdoor constructions near or above water, or for treatment of wood that will be continually exposed to the weather or subject to frequent wetting. Therefore, the product should be restricted to prevent use on wood in use class 3 unless, a safe use of the product is also demonstrated by providing data such as an additional leaching study at product authorization stage. In fact, the leaching data currently used for the derivation of the PEC values were generated with a worst-case leaching value. Particularly, the leaching study simulates worst-case conditions being the wooden blocks continuously submerged in water, for a period of 14 days, taking into account the high water solubility for DDAC, that was accepted at TM level (TMI 09 and TMII 09).

Summary of PEC/PNEC values for groundwater

As an indication for potential groundwater levels, the concentration in porewater of agricultural soil is taken, according to the TGD equations 67 and 68. It should be noted that this is a worst-case assumption, neglecting transformation and dilution in deeper soil layers.

Scenario PEC Limit value PEC/PNEC values

mg/l Scenario 2: Storage of dipped/ immersed wood

0.00017 mg/l

0.0001

1.7

Scenario 4: Storage of vacuum-pressure-treated wood:

0.00023 mg/l 2.3

Scenario 6: Treated wood in service: Noise barrier

0.00003 mg/l 0.3

Scenario 7: Treated wood in service: Fence 0.00006 mg/l 0.6 Scenario 8: Treated wood in service: House 0.00007 mg/l

0.7

Scenario 9: Treated wood in service: Transmission pole

0.00001 mg/l

0.1

Scenario 10:Treated wood in service: Fence post

0.00001 mg/l 0. 1

For scenarios 2 and 4, PEC/PNEC ratios higher than 1 are indicating a potential risk for groundwater. However, in order to reduce emissions from the storage phases for aquatic compartment, the dipping and vacuum pressure treatment must be performed only by those plants where significant losses can be contained (e.g no drain connections to storm drains or STP) and appropriately recycled/disposed.



49

Environmental risk in the atmosphere

For the atmosphere compartment no PNEC values are available. However, for all scenarios, the PEC in air is considered to be negligible (≤ 1E-05) suggesting that there is no concern for this compartment.

Primary and secondary poisoning (non-compartment specific effects relevant to the food chain)

Scenario PEC/PNEC values

Fish-eating mammals Fish-eating birds

Scenario 1: Dipping application 0.046 <0.751

Scenario 2 Storage of dipping/immersed wood 0.01 <0.222

Scenario 3 Vacuum pressure application 0.014 <0.222

Scenario 4 Storage of Vacuum pressure treated wood 0.010 <0.163

Thus, as all PEC/PNEC values are < 1 for all scenarios, there is no concern with regard to non compartment specific effects relevant to the food chain (secondary poisoning via aquatic food chain)



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3. DECISION

3.1. Background to the Proposed Decision

On the basis of the proposed and supported uses and the evaluation conducted as summarised in chapter 2 of this document, it can be concluded that under the conditions listed in chapter 3.2 Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) fulfils the requirements laid down in Article 5(1) (b), (c), and (d) of Directive 98/8/EC, apart from those corresponding to the list in chapter 3.4 below. C12-16-ADBAC is proposed to be included in Annex I of the Directive pending on the submission of the data/information required by RMS under chapter 3.4.

The overall conclusion from the human health evaluation of C12-16-ADBAC, for use in product type 8 (wood preservatives) is that the active substance in biocidal products containing 2% w/w C12-16-ADBAC will not present an unacceptable risk to humans during the proposed normal use. This conclusion relies on the fact that users will be applying the basic principles of good practice and using appropriate and obligatory PPE (as identified in Document II-C and below); in particular for the vacuum pressure treatment where considerable contamination of the operator can be anticipated, a higher degree of protection than typical work clothing is warranted. Consequently, it is assumed impermeable coveralls will be worn. Also, to reduce exposure via the hands, operators would be required to wear new protective gloves at the start of each daily dipping session.

For the secondary exposure assessment risks have been identified for the exposed populations. Therefore, mitigation measure is proposed in order to prevent that children enter in direct contact with treated wood.

As regards the environmental risk assessment, unacceptable risks have been identified for the aquatic compartment due to the industrial or professional applications (dipping and vacuum pressure treatments) and storage of products containing 2% w/w C12-16-ADBAC. The wood preservative products containing C12-16-ADBAC at 2% w/w must not be used to treat wooden structures located where direct losses to water cannot be prevented. For the water and sediment compartments in the Noise barrier scenario the PEC/PNEC values are higher than 1 in the short-term use whilst the long-term use does not pose any risk. For the scenarios presenting a concern risk mitigation measures are proposed.

For the terrestrial compartment unacceptable risks have been identified following storage on site and wood in service. For the Noise Barrier, Fence and House scenarios the PEC/PNEC values are higher than 1 in the short-term whilst for the long-term use the PEC/PNEC values are round 1. Therefore the product should be restricted to prevent use for treatment of wood in Use Class 3. For Transmission Pole and Fence Post scenarios the PEC/PNEC values are higher than 1 in the short-term whilst the long-term use does not pose any risk.

For these scenarios risk reduction measures are proposed in order to prevent the direct losses to the soil.



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For the groundwater compartment, unacceptable risks have been identified following storage on site. Therefore, risk reduction measure is proposed in order to prevent losses which would be collected for re-use or disposal.

C12-16-ADBAC is proposed to be included in Annex I of the Directive.

The Annex I – entry should, however, only include the intended uses with the conditions and restrictions proposed in this report.



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3.2. Proposed Decision regarding Inclusion in Annex I

The Italian CA recommends that Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) is included in Annex I to Directive 98/8/EC as an active substance for use in wood preservative products (Product-type 8), subject to the following specific provisions:

Common name: Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC)

IUPAC name: Not applicable

CAS No.: 68424-85-1

EC No.: 270-325-2

Minimum degree of purity of the active substance:

The active substance as manufactured shall have a minimum purity of 94% (w/w) dry weight.

Identity and maximum content of impurities:

The identity and maximum content of impurities must not differ in such a way as to invalidate the assessment for the inclusion of the active substance on to Annex I.

Product types:

Wood preservative (product-type 8)

Specific provisions:

Member States shall ensure that authorisations are subject to the following condition:

1. For industrial or professional users safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.

2. Products shall not be used for treatment of wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.

3. Labels and, where provided, safety data sheets of products authorised shall indicate that industrial or professional application shall be conducted within a contained area or on impermeable hard standing with bunding, and that freshly treated timber shall be stored after treatment on impermeable hard standing to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.



53

4. Products shall not be authorised for treatment of wood that will be in contact with fresh water or used for outdoor constructions near or above water, continually exposed to the weather or subject to frequent wetting, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures.

3.3. Elements to be taken into account by Member States when authorising products

Products containing C12-16-ADBAC are intended to be used in the treatment of wood by Dipping/immersion process and vacuum pressure application by industrial/professional users only. Indeed in consideration of the potential risk derived for the in-situ treatment scenarios this application shall not be authorised.

Human Health and Environmental Risk Assessment has been performed on the knowledge that the wood treatment solution employed contains 2% a.s. Therefore any deviation from the value of 2% increasing the concentration of the substance in the final treatment solution, must undergo through a specific risk assessment.

When authorising the product use Member States Authorities should ensure that the Risk Reduction Measure described in Sections 3.2 and 3.5 are applied. In particular, due to the irritant/corrosive properties, labels and/or safety data sheets of products authorised for industrial or professional use should indicate the need of specific Personal Protective Equipments in according to the following characteristics:

Hygiene measures

Avoid contact with skin, eyes and clothing. Wash hands before breaks and immediately after handling the product.

Respiratory protection

In the case of vapour formation, use a respirator with an approved filter. Respirator with a vapour filter of the following type should be used: EN 141.

Hand protection for long-term exposure

Suitable material for gloves: Nitrile rubber

Break through time / glove: > 480 min

Minimal thickness / glove: 0.7 mm

Take note of the information given by the producer concerning permeability and break through times, and of special workplace conditions (mechanical strain, duration of contact).

Hand protection for short-term exposure (e.g. accidental aerosols from splashing etc.)

Suitable material for gloves: Nitrile rubber



54

Break through time / glove: > 30 min

Minimal thickness / glove: 0.4 mm

Take note of the information given by the producer concerning permeability and break through times, and of special workplace conditions (mechanical strain, duration of contact).

Eye protection

Tightly fitting safety goggles; Face-shield.

Skin and body protection

Choose body protection according to the amount and concentration of the dangerous substance at the work place, Rubber or plastic apron, Rubber or plastic boots.

Moreover due to the possibility of systemic effects the use new gloves on each working day in order to benefit of an extra protection, is strongly recommended.

At the product authorisation stage, efficacy should be demonstrated according to uses claimed

As the assessment should not be considered as comprehensive of the overall exposure pathways, additional exposure scenarios covering overall exposure pathways should be estimated at Product Authorization stage when the guidelines on the risk characterization for the local effects are finalized, depending on the use patterns.

Additional leaching data should be submitted at the product authorisation stage in order to demonstrate that use class 3 (treatment of wood exposed to weathering) can be acceptable.

3.4. Requirement for further information

The need for the following studies should in particular be considered:

• Five-batch analysis data supporting each source of C12-16-ADBAC are required prior to product authorization. These data must be generated on representative batches of the technical concentrate and quantify the active substance, significant and relevant impurities. The batch analysis data must be supported by fully validated methods of analysis. Though valid analytical methods were concerned for Annex I inclusion for the active substance, impurities and process solvents in the technical concentrate, additional information/clarification must be provided for these methods if they are used to support the new batch analysis data (please refer to the RMS specific requests in the evaluation box of the relevant study summaries under Doc. IIIA). Such data should be submitted to the RMS (Italy) within 6 months from the endorsement of the Assessment Report at the Standing Committee on Biocidal Product (21st September 2012).



55

• Additional highly-specific confirmatory methods for C12-16-ADBAC residues in soil and water (both drinking- and surface-water) are required. These methods can be provided at the product authorization stage at national level.

• For the risk characterization of the local effects, sufficient data on inhalation toxicity for ADBAC should be submitted at Product Authorization stage depending on the scenarios of the biocidal product.

3.5. Updating this Assessment Report

This assessment report may need to be updated periodically in order to take account of scientific developments and results from the examination of any of the information referred to in Articles 7, 10.4 and 14 of Directive 98/8/EC. Such adaptations will be examined and finalised in connection with any amendment of the conditions for the inclusion of C12-16-ADBAC in Annex I to the Directive.



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Appendix I: List of end points

Chapter 1: Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Proposed Classification and Labelling

Active substance (ISO Common Name) Not available

Registered in EINECS as Quaternary ammonium compounds, benzyl-(C12-16)-alkyldimethyl, chlorides

Function (e.g. fungicide) Fungistatic and insecticide

Rapporteur Member State Italy

Identity (Annex IIA, point II.)

Chemical name (IUPAC) Not applicable

Chemical name (CA) Quaternary ammonium compounds, benzyl-(C12-16)-alkyldimethyl, chlorides

CAS No 68424-85-1

EC No 270-325-2

Other substance No. None

Minimum purity of the active substance as manufactured (g/kg or g/l)

>940 g/kg

Identity of relevant impurities and additives (substances of concern) in the active substance as manufactured (g/kg)

None

Molecular formula C9 H13 N Cl R where R = C12 H25, C14 H29 or C16 H33

Alkyl chain lengths distribution:

Chain Length

Specification for 68424-85-1

Typical Analysis of a Commercial Product

C12 39 - 75% 41.82% C14 20 - 52% 48.43% C16 < 12% 9.51%

Molecular mass 340.0 – 396.1 g/mol (Avg. = 359.6 g/mol)

Structural formula

N+

RCl-

R = C12H25 C14H29 C16H33



57

Physical and chemical properties (Annex IIA, point III., unless otherwise indicated)

Melting point (state purity) The substance does not melt, but was observed to decompose starting at approximately 150°C (96.6%)

Boiling point (state purity) The substance decomposed before melting (96.6%) Temperature of decomposition > 150°C Appearance (state purity) Light beige solid (96.6%) Relative density (state purity) 0.96 at 20°C (96.6%) Surface tension 31.3 mN/m at 20°C (test solution: 1 g/l aqueous

solution) Vapour pressure (in Pa, state temperature) 6.03E-04Pa@ 20°C

8.57E-04 Pa @ 25°C 4.22E-03 Pa @ 50°C

Henry’s law constant (Pa m3 mol -1) 5.03E-07 Pa m3 mol -1 at 20°C Solubility in water (g/l or mg/l, state temperature) pH 5.5: 409 g/l at 20°C

pH 6.5: 431 g/l at 20°C pH 8.2: 379 g/l at 20°C

Solubility in organic solvents (in g/l or mg/l, state temperature) (Annex IIIA, point III.1)

Ethanol: > 250 g/l at 20°C Isopropanol: >250 g/l at 20°C Octanol: > 250 g/l at 20°C

Stability in organic solvents used in biocidal products including relevant breakdown products (IIIA, point III.2)

Ethanol: Stable – < 5% loss over 2 weeks at 55 °C (not acceptable but, due to the supporting information provided, no new study is required) Isopropanol: Stable – < 5% loss over 2 weeks at 55°C (not acceptable but, due to the supporting information provided, no new study is required)

Partition coefficient (log POW) (state temperature) Not determined (EC methods A.8 not applicable for surfactants). Assessment by KOWWIN is inaccurate (software database very limited for surfactants). Log Pow could be roughly obtained from solubility in n-octanol and water. However, this calculation is of no use with regard to environmental fate and behaviour and secondary poisoning risk assessment (experimental BCF available)

Dissociation constant (not stated in Annex IIA or IIIA; additional data requirement from TNsG)

Not applicable: the substance is irreversibly ionized

UV/VIS absorption (max.) (if absorption > 290 nm state ε at wavelength)

The ultraviolet/visible absorption spectra were consistent with the assigned structure of the active substance

Flammability Not highly flammable Explosive properties Not explosive

Classification and proposed labelling (Annex IIA, point IX.)

with regard to physical/chemical data No classification with regard to toxicological data C- Corrosive

R22; R34; S26, S28; S36/37/39; S45 with regard to fate and behaviour data No classification with regard to ecotoxicological data N- Dangerous for the environment

R50; S60; S61 Specific concentration limits for the environmental classification

Cn ≥ 0.25 %: N; R50



58

Classification and proposed labeling based on Regulation EC 1272/2008

GHS Pictogram GHS05, GHS07, GHS09

Signal Word Danger

Hazard Statement H302; H314; H400

Specific concentration limits for the environmental classification

M= 100



59

Chapter 2: Methods of Analysis

Analytical methods for the active substance

Technical active substance (principle of method) (Annex IIA, point 4.1)

HPLC with evaporative light scattering detection (ELSD). Confirmation by LC-MS 5-batch analysis supporting each source of C12-16-ADBAC should be provided prior to product authorization

Impurities in technical active substance (principle of method) (Annex IIA, point 4.1)

HPLC-ELSD (identification by LC-MS) Titration method IC coupled with conductivity detector (additional validation necessary) Karl-Fischer titration and GFC/FID for process solvents

Analytical methods for residues

Soil (principle of method and LOQ) (Annex IIA, point 4.2)

Extraction with methanol:water (90:10 v/v) containing 0.01 M ammonium formate and 0.1% formic acid. Analysis by LC-MS (m/z = 304.3 for C12-ADBAC). LOQ = 0.01 mg/kg (total C12-16-ADBAC) Confirmatory method should be provided for the product authorization phase at national level

Air (principle of method and LOQ) (Annex IIA, point 4.2)

Not required. The a.s. is non-volatile; it will not be used by spray application; measurable concentrations in the air under normal use will not occur and are highly unlikely even under unusual circumstances (e.g. accidental release)

Water (principle of method and LOQ) (Annex IIA, point 4.2)

Partition with 0.1 M heptanesulfonic acid and dichloromethane. Concentration by rotary evaporation and re-dissolution in 0.1% formic acid in methanol. Analysis by LC-MS (m/z 304.3= for C12-ADBAC). LOQ = 0.1 µg/l (total C12-16-ADBAC) Confirmatory method should be provided for the product authorization phase at national level

Body fluids and tissues (principle of method and LOQ) (Annex IIA, point 4.2)

Not required. The a.s. is neither toxic nor highly toxic

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) (Annex IIIA, point IV.1)

Not required. Wood treated with C12-16-ADBAC-containing biocidal product is not intended for and contains label restrictions against use in areas where food for human consumption is prepared, consumed or stored, or where the feedingstuff for livestock is prepared, consumed or stored

Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) (Annex IIIA, point IV.1)

Not required. Wood treated with C12-16-ADBAC-containing biocidal product is not intended for and contains label restrictions against use in areas where food for human consumption is prepared, consumed or stored, or where the feedingstuff for livestock is prepared, consumed or stored



60

Chapter 3: Impact on Human Health

Absorption, distribution, metabolism and excretion in mammals (Annex IIA, point 6.2)

Rate and extent of oral absorption: Based on data on urine excretion (5-8%) and tissue residues (<1%), and on the highly ionic nature of the a.s., it is expected that its oral absorption is limited (about 10%). The majority (>90% ) of orally administered Alkyldimethyl-benzylammonium Chloride is excreted very likely unabsorbed via the faeces.

Rate and extent of dermal absorption: Based on data from an in vitro study on human skin, the % absorbable was almost identical for the 2 different dilutions (0.03% and 0.3%) tested Summing up the radioactivity present in the receptor fluid, in the skin at the application site (after stratum corneum removal)and in the tape strips 6-20 the value for dermal absorption of the a.s. to be considered in risk characterization is 8.3%.

Distribution: Following i.v. administration in rats: 45 – 55% in faeces, 20 – 30% in urine, 30 – 35% in tissues. One week after oral administration tissue residues were <1% .

Potential for accumulation: None noted Metabolism Four major metabolites of ADBAC were identified, as

the product of alkyl chain hydroxylation. It can be hypothesized that ADBAC metabolism is carried out by gut microflora.

Rate and extent of excretion: Following oral administration in rats: 87 – 99% excreted in faecesas unabsorbed material, 5 – 8% excreted in urine

Toxicologically significant metabolite None

Acute toxicity (Annex IIA, point 6.1)

Rat LD50 oral 344 mg/kg bw

Rabbit LD50 dermal 2848 mg/kg bw

Rat LC50 inhalation Study not conducted

Skin irritation Corrosive

NOAEL/NOAEC = 0.3% in water at 2.0 ml/kg body weight per day (2 week-treatment)

Eye irritation Corrosive

Skin sensitisation (test method used and result) Buehler Test guinea pig – Not sensitising

Maximization test with Didecyldimethylammonium Chloride (chemical and structural analog) – Not sensitising



61

Repeated dose toxicity (Annex IIA, point 6.3)

Species/ target / critical effect Gastrointestinal symptoms (due to irritation of GI mucosa) in all species tested.

Lowest relevant oral NOAEL NOEL = 13.1 mg/kg/day (1 year Dog)

Lowest relevant dermal NOAEL NOEL = 20 mg/kg bw/day (highest dose tested and achievable without relevant irritation effects)

Lowest relevant inhalation NOAEL Not conducted

Genotoxicity (Annex IIA, point 6.6)

In-vitro:

In-vivo:

Ames test – negative (with and without metabolic activity)

Chromosomal aberration test – negative (with and without metabolic activity)

Mammalian cell gene mutation assay – negative (with and without metabolic activity)

Micronucleus assay - negative

Carcinogenicity (Annex IIA, point 6.4)

Species/type of tumour Rat/none, Mouse/none

lowest dose with tumours Negative

Reproductive toxicity (Annex IIA, point 6.8)

Species/ Reproduction target / critical effect Rat / NOEL / reduced weight gain and food consumption in parental and F1 animals

Lowest relevant reproductive NOAEL / LOAEL LOEL/NOEL parental = 2000 / 1000 mg/kg food (> 100 mg/kg bw/day / > 50 mg/kg bw/day )

LOEL/NOEL F1 offspring = 2000 / 1000 mg/kg food (> 100 mg/kg bw/day / > 50 mg/kg bw/day)

NOEL F2 offspring = 1000 mg/kg food (> 50 mg/kg b.w)

Species/Developmental target / critical effect Rat /NOEL / maternal toxicity

Lowest relevant developmental NOAEL / LOAEL LOEL/NOEL maternal = 30 mg/kg bw/day / 10 mg/kg bw/day

NOEL developmental ≥ 100 mg/kg bw/day

Species/Developmental target / critical effect Rabbit / NOEL / maternal toxicity



62

Lowest relevant developmental NOAEL / LOAEL LOEL/NOEL maternal = 9,0 mg/kg bw/day / 3.0 mg/kg bw/day

NOEL developmental ≥ 9.0 mg/kg bw/day

Neurotoxicity / Delayed neurotoxicity (Annex IIIA, point VI.1)

Species/ target/critical effect

Lowest relevant developmental NOAEL / LOAEL Study not conducted/ not relevant

Other toxicological studies (Annex IIIA, VI/XI)

............................................................................... None required

Medical data (Annex IIA, point 6.9)

............................................................................... No substance-specific effects have been noted. No specific observations or sensitivity/allergenicity have been reported.



63

Summary for local effects

Value Study Safety factor

Non-Professional users

ADI (if residues in food or feed)

Not applicable

Professional users

AEC (Acceptable Exposure Concentration)

0.014 mg/cm2 2-week skin irritation study in rats

3.2

Reference value for dermal absorption

Not applicable

Drinking water limit Not applicable

ARfD (acute reference dose)

Not applicable

Acceptable exposure scenarios for local effects (including method of calculation)

Industrial/Professional users Hands: 0.000275 mg/cm2 (MIXING&LOADING Riskofderm Connecting lines); 0.077mg/cm2 (Vacuum pressure treatment - Handling Model1)

Body: 0.005mg/cm2 (Dipping treatment - Handling Model1) - 0.009mg/cm2 (Vacuum pressure treatment - Handling Model1)

Feet: 0.027mg/cm2 (Vacuum pressure treatment - Handling Model1) - 0.036mg/cm2 (Dipping treatment - Handling Model1)

Production of active substance:

Formulation of biocidal product

Intended uses Dipping and Vacuum pressure industrial/professional applications

Secondary exposure Dermal: 0.22% ADBAC

Non-professional users

Indirect exposure as a result of use



64

Summary for systemic effects (Annex IIA, point 6.10)

Value Study Safety factor

Non-Professional users

ADI (if residues in food or feed)

Not applicable

Industrial/Professional users

AEL (Operator/Worker Exposure)

0.13 mg/kg/day 1 year oral study on dogs 100

Reference value for dermal absorption

8.3% In vitro on human skin

Drinking water limit 0.1 µg/l As set by EU drinking water Directive 98/83/EC

ARfD (acute reference dose)

Not applicable.



65

Acceptable exposure scenarios for systemic effects (including method of calculation)

Industrial/Professional users AEL% = 2.38 – 153% of the AEL

Production of active substance: Not applicable

Formulation of biocidal product Not applicable

Secondary exposure Not applicable

Non-professional users Not applicable

Indirect exposure as a result of use MOE(dermal) = 29– 188

MOE(inhalation) = 3226 – 19230

MOE(oral) = 31 - 655



66

Chapter 4: Fate and Behaviour in the Environment

Route and rate of degradation in water (Annex IIA, point 7.6, IIIA, point XII.2.1, 2.2)

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

pH___5___: >30 days at 25°C

pH___7___: >30 days at 25°C

pH___9___: >30 days at 25°C

Photolytic / photo-oxidative degradation of active substance and resulting relevant metabolites

The photolysis data available for DDAC are adequate for ATMAC. The test substance is photolytically stable in absence of a photosensitising agent.

Readily biodegradable (yes/no) Yes

Biodegradation in seawater Not used in seawater

Non-extractable residues Not applicable

Distribution in water / sediment systems (active substance)

A biodegradation study in two water/sediment systems has been performed on DDAC and shoed that the substance easily migrates from the aqueous phase to the sediment phase and is also easily adsorbed to sediments (high Koc). The degradation in the sediment phase did not increase very much after the first month and the DT50 of the total system was not reached within the 120 days test duration

Distribution in water / sediment systems (metabolites)

Not applicable

Route and rate of degradation in soil (Annex IIIA, point VII.4, XII.1.1, XII.1.4; Annex VI, para. 85)

Mineralization (aerobic) No data available

Laboratory studies (range or median, with number of measurements, with regression coefficient)

No data available

Field studies (state location, range or median with number of measurements)

Not applicable:

Anaerobic degradation Active substance is readily biodegradable

Soil photolysis Stable, not subject to photogradation in soil

Non-extractable residues No data available

Relevant metabolites - name and/or code, % of applied a.i. (range and maximum)

Not measured

Soil accumulation and plateau concentration No data available



67

Adsorption/desorption (Annex IIA, point XII.7.7; Annex IIIA, point XII.1.2)

Ka , Kd

Kaoc , Kdoc

pH dependence (yes / no) (if yes type of dependence)

Ka (Kaoc) values for four soil types: Sand: 6’172 (6’171’657) Sandy loam: 5’123 (640’389) Clay loam: 32’429 (1’663’039) Silt loam: 10’797 (2’159’346) Kd (Kdoc) values for four soil types: Sand: 7173 (7’137’310) Sandy loam: 965’401 (12’067’457) Clay loam: 65’556 (84’900’622) Silt loam: 14’083 (2’816’590) No pH dependence

Fate and behaviour in air (Annex IIIA, point VII.3, VII.5)

Direct photolysis in air Atmospheric t½ = 3 hr (AOPWIN Model)

Quantum yield of direct photolysis Not specified

Photo-oxidative degradation in air Latitude: ............. Season: ................. DT50 ..............

Volatilization Not volatile [vapour pressure <1E-05 hPa (<1E-03 Pa) at 50°C]

Monitoring data, if available (Annex VI, para. 44)

Soil (indicate location and type of study) No data available

Surface water (indicate location and type of study) No data available

Ground water (indicate location and type of study) No data available

Air (indicate location and type of study) No data available



68

Chapter 5: Effects on Non-target Species

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2)

Species Time-scale Endpoint Toxicity (a.s.)

Fish

Fathead minnow (Pimephales promelas)

96 h Mortality LC50 0.28 mg/l

Fathead minnow (Pimephales promelas)

34 d Growth and survival NOEC 0.0322 mg/l (survival)

Invertebrates

Daphnia magna 48 h Immobilisation EC50 0.0058 mg/l

Daphnia magna 21 d Reproduction NOEC≥ 0.00415 mg/l

Chironomus tentans 28d Mortality and growth NOEC 520 mg/kg dw (survival/emergence)

Algae 1

Selenastrum capricornutum 72 hr Growth inhibition ErC50 = 0.049 mg/l

ErC10 0.009 mg/l

Plants

Lemna gibba 7d Growth inhibition ErC50 = 0.25 (frond number)

Microorganisms

Activated sewage sludge 3 hr Respiration inhibition EC50 7.75 mg/l 1 Algae are target organisms for DDAC.

Effects on earthworms or other soil non-target organisms

Acute toxicity to Eisenia foetida(Annex IIIA, point XIII.3.2)

LC50 7070 mg a.s./kg dw, in artificial soil

NOEC 953 mg a.s./kg dw, in artificial soil

Reproductive toxicity to …………………………(Annex IIIA, point XIII.3.2)

No data available.

Acute toxicity to plants

(Annex Point IIA 7.5.1.3

EC50 Mustard: 277 mg a.s./kg dw

Effects on soil micro-organisms (Annex IIA, point 7.4)

Nitrogen mineralization EC50 > 1000 mg a.s./kg dw

Carbon mineralization EC50 > 1000 mg a.s./kg dw



69

Effects on terrestrial vertebrates

Dose-related reduction in body weight gain - mammals

(Annex Point IIA6.8.2)

NOEC 400 mg a.s. /kg food (52 weeks, dog)

Acute toxicity to birds(Annex IIIA, point XIII.1.1)

Northern bobwhite quail

LD50 = 164 mg a.s./kg bw

Dietary toxicity to birds(Annex IIIA, point XIII.1.2)

Northern bobwhite quail

LC50 = >3813 mg a.s. /kg food

Dietary toxicity to birds(Annex IIIA, point XIII.1.2)

Mallard duck

LC50 = >2463 mg a.s. /kg food

Reproductive toxicity to birds(Annex IIIA, point XIII.1.3)

Not available

Effects on honeybees (Annex IIIA, point XIII.3.1)

Acute oral toxicity Not appropriate

Acute contact toxicity Not appropriate

Effects on other beneficial arthropods (Annex IIIA, point XIII.3.1)

Acute oral toxicity Not appropriate

Acute contact toxicity Not appropriate

Acute toxicity to ………………………………….. Not appropriate

Bioconcentration (Annex IIA, point 7.5)

Bioconcentration factor (BCF) Measured BCFfish whole body = 79

BCF edible tissues = 33

BCF non edible tissues = 160

BCFearthworm not available

Depuration time (DT50)

(DT90)

14-21 d ( non edible tissues)

>21d (edible tissues and whole body)

Level of metabolites (%) in organisms accounting for > 10 % of residues

No data available



70

Chapter 6: Other End Points



71

Appendix II: List of Intended Uses

Summary of intended uses The biocidal product containing the active substance is used in two wood preservative treatment applications: dipping and vacuum pressure processes.

For both processes the preservative is delivered to the processing plant by tanker in the form of a concentrate. The concentrate contains 25% of the active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride. It is diluted to a suitable working strength with water. The degree of dilution varies depending on the wood species, type of wood product and anticipated use. The requirements for Alkyldimethylbenzylammonium Chloride concentration in both processes vary between 0.4% and 2%.

Dipping/ immersion process Application rate: 2 kg a.s./m3 (worst case site-specific information)

Total amount of a.s. processed per site per day: 4 kg

Total tonnage of a.s. processed per site per year: Confidential (Reference B) (worst case)

Total tonnage of a.s. used in region: Confidential (Reference C) (widespread use, 10% of tonnage used in default region)

Vacuum pressure process Application rate: 2 kg a.s./m3 (worst-case site-specific information)

Total amount of a.s. processed per day: Confidential (Refernce E)

Total tonnage of a.s. processed per site per year: Confidential (Reference F) (worst case)

Total tonnage of a.s. used in region: Confidential (Reference C) (widespread use, 10% of tonnage used in default region)

Organisms to be controlled Wood destroying basidiomycetes (Coniophora puteana / Coniophora spec., Coriolus versicolor, Gloephyllum trabeum, Poria vaillantii / Poria spec., Fomes spec., Trametes spec., etc.)

Wood staining molds (Aureobasidium pullulans, Sclerophoma pityopila, Ophistostoma piliferum, Aspergillus niger, Aspergillus terreus, Chaetomium globosum, Paecilomyces variotii, Penicillium funicolosum, Trichoderma viridae, etc.)

Wood boring insects (Hylotrupes bajulus, Anobium punctatum, Lyctus brunneus, termites, etc.)

Products to be protected Wood, use classes 1 to 4A according to ISO draft standard (see Document IIIA Section 2 Table 2.10.2.2.2-1)

Use concentration The use concentration depends on the type of application technique, use class required and on additional formulation components. For details see exposure-scenarios in the Risk Assessments.



72

Appendix III: List of Studies

Document IIIA

Endpoint Reference No.

Reference Non-Key Studies are italicized.

3.1.1 – Melting point

A39 (LON 3391)

Fischer, A. (2001) Determination of the melting point of Barquat MB AS in accordance with OECD-Guideline 102. Clariant GmbH, Frankfurt, Germany. Report No. B 013/2001 (unpublished).

3.1.3 – Density

A40 (LON 3380)

Fischer, A. (2001) Determination of the relative density of Barquat MBAS in accordance with OECD-Guideline 109. Clariant GmbH, Frankfurt, Germany. Report No. B 011/2001 (unpublished).

3.2 – Vapour pressure

A41 (LON 3385)

Franke, J. (2001) Barquat MB AS, KP01/03 - Vapour pressure. Siemens Axiva GmbH & Co. KG for Clariant GmbH, Frankfurt, Germany. Report No. 20010308.01 (unpublished).

3.4.1 – UV/Vis

A121 (LON 3996)

Sydney, P. (2006) N-Alkyl(C12-C16)-N,N-dimethyl-Nbenzylammonium chloride (ADBAC) (Supplied as Barquat MB 80): Ultraviolet/visible absorption spectrum. Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England. Report No. ADB0030/062227 (unpublished).

3.4.2 – IR 3.4.3 – NMR

A78 (LON 3386)

Petrovic, P. (2001) Characterization of the structure of Barquat MB AS. Clariant GmbH, Frankfurt, Germany. Report No. B 016/2001 (unpublished).

3.4.4 – MS

A93 (LON 3791)

Young, S. (2004) N-Alkyl(C12-16)-N,N-dimethyl-Nbenzylammonium chloride (ADBAC): Mass spectrum. Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England. Report No. ADB/022 042073 (unpublished).

3.5 – Solubility in water

A42 (LON 3383)

Fischer, A. (2001) Determination of the water solubility of Barquat MB AS. Clariant GmbH, Frankfurt, Germany. Report No. B015/2001 (unpublished).

3.7(1) – Solubility in organic solvents

A91 (LON 3792)

Young, S. (2004) N-Alkyl(C12-16)-N,N-dimethyl-Nbenzylammonium chloride (ADBAC): Solubility in ethanol and isopropanol. Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England. Report No. ADB/021 042021 (unpublished).

3.7(2) – Solubility in organic solvents

A90 (LON 3826)

Young, S. (2004) N-Alkyl(C12-16)-N,N-dimethyl-Nbenzylammonium chloride (ADBAC): Solubility in octanol. Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England. Report No. ADB/020 042020 (unpublished).

3.8 – Stability in organic solvents

A92 (LON 3793)

Young, S. (2004) N-Alkyl(C12-16)-N,N-dimethyl-Nbenzylammonium chloride (ADBAC): Stability in ethanol and isopropanol. Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England. Report No. ADB/025 042266



73

(unpublished). 3.9 – Partition Coefficient

A111

Nixon, W.B. (1998) DDAC octanol/water partition coefficient test. Unpublished letter report dated August 14, 1998; from Wildlife International Ltd., Easton, MD, USA. (unpublished).

3.10 – Thermal stability, identity of relevant breakdown product

A73 (LON 3390)

Keipert, W. (2001) Determination of the thermal stability and stability in air of Barquat MB AS in accordance with OECDGuideline 113. Clariant GmbH, Frankfurt, Germany. Report No. B 017/2001 (unpublished).

3.11(1) – Flammability (solids) & Autoflammability

A75 (LON 3389)

Keipert, W. (2001) Determination of the relative self-ignition temperature of Barquat MB AS in accordance with EECGuideline A.16. Clariant GmbH, Frankfurt, Germany. Report No. B 019/2001 (unpublished).

3.11(2) – Flammability (solids) & Autoflammability

A74 (LON 3384)

Keipert, W. (2001) Determination of the flammability of Barquat MB AS in accordance with EEC-Guideline A.10. Clariant GmbH, Frankfurt, Germany. Report No. B 018/2001 (unpublished).

3.13 – Surface tension

A76 (LON 3537)

Schneider, S. (2001) Determination of the surface tension of an aqueous solution (1 g/L) of Barquat MB AS in accordance with OECD-Guideline 115 [and according to EEC-Guideline A.5]. Clariant GmbH, Germany. Report No. B 082/2001 (unpublished).

3.15 – Explosive properties

A77 (LON 3392)

Keipert, W. (2001) Determination of the explosive properties of Barquat MB AS in accordance with EEC-Guideline A.14. Clariant GmbH, Frankfurt, Germany. Report No. B 020/2001 (unpublished)

4.1 – Analytical methods for purity/impurity

A70 (LON 4007)

Wells, D.F. (1996) Chemical characterization of alkyl dimethyl benzyl ammonium chloride (ADBAC, Lot 7293K). Springborn Laboratories, Inc., Wareham, MA, USA. Report No. 95-8-6025 (unpublished).

4.1(2) – Analytical methods for purity/impurity (new submission)

Lonza Report No. 4134

Kurz M. and Ranft V. (2007) Determination of quaternary ammonium compounds and related quaternary impurities by HPLC-ELSD. Study No.CSPE-44/BS-07-70. Lonza AG. (Unpublished).

4.2 (a) – Analytical methods for determination of residues in soil

A65 (LON 3703)

Brewin, S. (2003) Alkyldimethylbenzylammonium chloride (ADBAC: CAS RN 68424-85-1): Validation of methodology for the determination of residues in soil. Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England. Report No. ADB/016 033181 (unpublished).

4.2 (c) – Analytical methods for determination of residues in drinking water

A82 (LON 3698)

Brewin, S. (2003) Alkyldimethylbenzylammonium chloride (ADBAC: CAS RN 68424-85-1): Validation of methodology for the determination of residues in drinking, ground and surface water. Huntingdon Life Sciences Ltd., Huntingdon,



74

Cambridgeshire, England. Report No. ADB/017 033171 (unpublished).

5.3.1 – Effects on Target Organisms

A104

Linfield, W.M. (1969) Chapter 2: Straight-chain alkylammonium compounds. In E. Jungermann (Ed.), Cationic Surfactants. Marcel Dekker: New York, NY, USA, pp 9-70.

A106

Wazny, J. and R. Rudniewski. (1997) Fungitoxic effect of the quaternary ammonium compounds wood preservatives against Basidiomycetes by using agar-plate and agar-block methods. International Research Group on Wood Preservation Document No. IRG/WP/96-30118.

6.1.1 – Acute oral toxicity A14 (LON 1002)

Wallace, J.M. (1975) Acute oral LD50 toxicity study. Bio- Toxicology Laboratories, Inc., Moorestown, NJ, USA. (published).

6.1.1 – Acute oral toxicity A14 (LON 1002)

Wallace, J.M. (1975) Acute oral LD50 toxicity study. Bio- Toxicology Laboratories, Inc., Moorestown, NJ, USA. (published).

6.1.2 – Acute dermal tox.

A15 (LON 3895)

Levenstein, I. (1977) Barquat MB-80: Dermal LD50. Leberco Laboratories, Roselle Park, NJ, USA. Study No. 73130 (published).

6.1.2 – Acute dermal tox.

A51 (LON 0709)

De Azevedo, J.P. (1971) Report on dermal toxicity in rabbits using Barquat MS-100. Wells Laboratories Inc., Jersey City NJ, USA. Report No. 0709 (unpublished).

6.1.4(1) – Skin irritation

A53 (LON 1003)

Wallace, J.M. (1975) Toxicity studies: Primary irritation study, Federal Hazardous Substances Labeling Act - Barquat MB-80. Bio-Toxicology Laboratories, Inc., Moorestown, NJ, USA. (published).

6.1.4 – Skin irritation

A52 (LON 0712)

De Azevedo, J.P. (1970) Report on primary skin irritation studies in rabbits using Barquat MS-100. Wells Laboratories Inc., Jersey City, NJ, USA. Report No. 0712 (unpublished).

6.1.4(2) – Eye irritation

A54 (LON 1001)

Wallace, J.M. (1975) Toxicity studies: Primary irritation study, Federal Hazardous Substances Labeling Act - Barquat MB-80. Bio-Toxicology Laboratories, Inc., Moorestown, NJ, USA. (published).

6.1.5(1) – Skin sensitisation

A55 (LON 1880)

Kreuzmann, J.J. (1988) Photoallergy study in guinea pigs with alkyldimethyl benzyl ammonium chloride (ADBAC). Hill Top Biolabs Inc., Miamiville, OH, USA. Report No. 88- 3226-21 (unpublished).


A102 (LON 1243)

Clement, C. (1992) BARDAC-22: Test to evaluate the sensitising potential by topical applications in the guinea pig. Hazleton-Institute Français de Toxicologie, L’Arbresle, France. Report No. 704323 RE (unpublished).


A112 (LON 4002)

Durando, J. (2005) Barquat MB 80: Dermal sensitization study in guinea pigs (Buehler method). Product Safety Laboratories, Dayton, NJ, USA. Study No. 17426 (unpublished).

6.2(1) – Toxicokinetics, Metabolism and Distribution

A50, A50a (LON 1872)

Salim, S. (1989) Absorption, distribution, metabolism and excretion studies of alkyl dimethyl benzyl ammonium chloride



75

(ADBAC) in the rat. Biological Test Center, Irvine, CA, USA. Study No. P01359 (unpublished).

6.2(2) – Toxicokinetics, Metabolism and Distribution

A 101809 (LON xxxx)

Roper, C. and Toner, F. (2006). The In Vitro Percutaneous Absorption of Radiolabelled Alkyl(C12-C16)dimethylbenzylammonium Chloride (ADBAC; CAS RN 68424-85-1) in Two Test Preparations Through Human Skin. Report No. 25982. Charles River Laboratories Tranent, Edinburgh, UK. (Unpublished)

6.3.2 – Repeated dose toxicity (dermal)

A81 (LON 0711)

Luy, T. (1972) Twenty day subacute dermal toxicity testing on rabbits using Barquat MS-100. Wells Laboratories, Inc. Jersey City, NJ, USA. Study No. E-594 (unpublished).

6.4.1(1) – Subchronic oral toxicity test; 90-day, rat

A17 (LON 1885)

Van Miller, J.P. and E.V. Weaver (1988) Ninety-day dietary toxicity study with alkyl dimethyl benzyl ammonium chloride (ADBAC) in rats. Bushy Run Research Center, Export, PA, USA. Report No. 51-503 (unpublished).



76

6.4.1(2) – Subchronic oral toxicity test; 8-week; dog

A19, A19a, A19b (LON 3442a, LON 3442b, LON 3442c)

Goldenthal, E.I. (1994) Evaluation of ADBAC in an eightweek dietary toxicity study in dogs. International Research and Development Corporation, Mattawan, MI, USA. Project No. 638-003 (unpublished). Goldenthal, E.I. (1993) Evaluation of ADBAC in a two-week gavage study in dogs. Project No. 638-002 (unpublished). Goldenthal, E.I. (1993) Evaluation of ADBAC in a two-week palatability study in dogs. Project No. 638-001 (unpublished).

6.4.1(3) – Subchronic oral toxicity test; 90-Day; mouse

A16 (LON 1883)

Van Miller, J.P. and Weaver, E.V. (1988) Ninety-day dietary dose range-finding study with alkyl dimethyl benzyl ammonium chloride (ADBAC) in mice. Bushy Run Research Center, Export, PA, USA. Report No. 51-504 (unpublished).

6.4.2 – Subchronic dermal toxicity test; rat

A18, A18a (LON 1884, LON 1876)

Gill, M.W. and Wagner, C.L. (1990) Ninety-day subchronic dermal toxicity study with alkyl dimethyl benzyl ammonium chloride (ADBAC) in rats. Bushy Run Research Center, Export, PA, USA. Report No. 52-623 (unpublished).

6.5(1) – Chronic toxicity; dog

A20 (LON 3443)

Goldenthal, E.I. (1994) Evaluation of ADBAC in a one-year chronic dietary toxicity study in dogs. International Research and Development Corp, Mattawan, MI, USA. Project No. 638-004 (unpublished).

6.5(2) – Chronic toxicity; rat

A21 (LON 1882)

Gill, M.W., Hermansky, S.J. and C.L. Wagner (1991) Chronic dietary toxicity/oncogenicity study with alkyl dimethyl benzyl ammonium chloride(ADBAC) in rats. Bushy Run Research Center, Export, PA, USA. Report No. 53-543 (unpublished).

6.6.1 – In-vitro gene mutation study in bacteria

A56 (LON 3342)

Thompson, P.W. (2001) LZ1392 (Alkyl(C10-C18) (Dimethylbenzylammoniumchloride): Reverse mutation assay "Ames Test" using Salmonella typhimurium. Safepharm Laboratories Ltd., Derby, UK. Project No. 102/367 (unpublished).

6.6.2 – In-vitro cytogenicity study in mammalian cells

A57 (LON 3434)

Durward, R. (2001) LZ1392 (Alkyl (C10-C18) (Dimethylbenzylammoniumchloride): Chromosomal aberrations assay in human lymphocytes in vitro. Safepharm Laboratories Ltd., Derby, UK. Project No. 102/366 (unpublished).

6.6.3 – In-vitro gene mutation assay in mammalian cells

A58 (LON 1874)

Young, R.R. (1989) Mutagenicity test on alkyl dimethyl benzyl ammonium chloride (ADBAC) in the CHO/HGPRT forward mutation assay. Hazleton Laboratories America, Inc., Kensington, MD, USA. Study No. 10238-0-435 (unpublished).

6.6.4 – In-vivo mutagenicity study (micronucleus test)

A24 (LON 1029)

Kallesen, T. (1985) Assessment of the mutagenic activity of Hyamine 3500 in the mouse micronucleus test. The Scantox Laboratories Ltd., Skensved, Denmark. Project No. LZA 10753 (unpublished).

6.7(1) – Carcinogenicity study; mouse

A83 (LON 1886)

Gill, M.W., Hermansky, S.J. and C.L. Wagner (1991) Chronic dietary oncogenicity study with alkyldimethylbenzylammonium chloride in mice. Union Carbide, Bushy Run



77

Research Center, Export, PA, USA. Report No. 53-515 (unpublished).

6.7(2) – Carcinogenicity study; rat

A21 (LON 1882)

Gill, M.W., Hermansky, S.J. and C.L. Wagner (1991) Chronic dietary toxicity/oncogenicity study with alkyl dimethyl benzyl ammonium chloride (ADBAC) in rats. Bushy Run Research Center, Export, PA, USA. Report No. 53-543 (unpublished). [REPORT FILED UNDER ENDPOINT 6.5]

6.8.1(1) – Teratogenicity test

A26, A26a (LON 3241)

Neeper-Bradley, T.L. (1992) Developmental toxicity evaluation II of alkyldimethylbenzylammonium chloride (ADBAC) administered by gavage to CD rats. Union Carbide, Bushy Run Research Center, Export, PA, USA. Project No. 91N0031 (unpublished).

6.8.1(2) – Teratogenicity test

A27, A27a (LON 3242)

Neeper-Bradley, T.L. and M.F. Kubena (1992) Developmental toxicity evaluation of alkyl dimethyl benzyl ammonium chloride (ADBAC) administered by gavage to New Zealand white rabbits. Union Carbide, Bushy Run Research Center, Export, PA, USA. Project No. 91N0032 (unpublished).

6.8.2 – Two generations reproduction study

A25 (LON 1881)

Neeper-Bradley, T.L. (1990) Two-generation reproduction study in Sprague-Dawley (CD) rats with alkyl dimethyl benzyl ammonium chloride (ADBAC) administered in the diet. Union Carbide, Bushy Run Research Center, Export, PA, USA. Report No. 52-524 (unpublished).

6.11 – Studies on other routes of administration (parenteral routes) – Acute IV study in rats

A79 (LON 1054)

Larson, P.S. (1958) Acute intravenous toxicity of Hyamine 3500 to rats. (unpublished).

7.1.1.1.1 – Hydrolysis

A2 (LON 1870)

Carpenter, M. and M. Fennessey (1988) Hydrolysis of ADBAC as a function of pH at 25 ºC. Analytical Bio- Chemistry Laboratories, Inc., Columbia, MO, USA. Report No. 35712 (unpublished).

7.1.1.1.2 – Phototransformation

in water

A1 (LON 1871)

Carpenter, M. and M. Fennessey (1988) Determination of the photolysis rate of ADBAC in pH 7 buffered solution at 25ºC. Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO, USA. Report No. 35713 (unpublished).

7.1.1.2.1(1) – Ready Biodegradability

A88 (LON 3796)

Bazzon, M and F. Deschamps (2002) Biotic degradation biodegradability evaluation on aqueous medium ultimate aerobia of the referenced compounds, CATIGENE T 50. INERIS, Vert-le-petit, France. Study No. 506223 (unpublished).


A44 (LON 3435)

Hirschen, M., Ziemer, M. and D. Seifert. (1997) Prüfung der biologischen Abbaubarkeit (ready biodegradability) gemäß OECD-Richtlinie 301A (DOC Die-Away Test). Clariant GmbH, Frankfurt, Germany. Report No. D0457 (unpublished).


A4 (LON 2301)

Corby, J.E. (1992) Semi-continuous activated sludge (SCAS) removability test - Hyamine 3500-80. Roy F. Weston, Inc., Lionville, PA, USA. Report No. 91-065 (unpublished).

7.1.1.2.1(4) – Ready A3 Corby, J.E. (1992) CO2 Production test - Hyamine3500-80.



78

Biodegradability

(LON 2302)

Roy F. Weston, Inc., Lionville, PA, USA. Report No.91-066 (unpublished).


A113 (LON 3960)

Van Dievoet, F. and V. Bouillon (2005) Biodegradability test report according to OECD 301 B – Modified. BfB Oil Research S.A. Report No. ST49132.01.01 (unpublished).

7.1.2.1.1(1) – Aerobic biodegradation

A101 (LON 3438)

Schaefer, E.C. (2001) Didecyldimethylammoniumchloride (DDAC): Die away in Activated Sludge. Wildlife International Inc., Easton, MA, USA. Project No. 289E-112 (unpublished).

Other Non-Key Biodegradability Report(s) Included in This Submission

A64, A64a (LON 1868)

Daly, D. and W. Cranor (1989) Anaerobic aquatic metabolism of alkyl dimethyl benzyl ammonium chloride. Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO, USA. Report No. 35714 (unpublished).

A63 (LON 1869)

Daly, D. and W. Cranor (1988) Aerobic aquatic metabolism of alkyl dimethyl benzyl ammonium chloride. Analytical Bio- Chemistry Laboratories, Inc., Columbia, MO, USA. Report No. 35715 (unpublished).

A67 (LON 3375)

de Vette, H.Q.M. and J.G. van Austen (2001) A water/ sediment degradation study of alkyldimethylbenzyl ammonium chloride (ADBAC) using [14C]ADBAC. TNO Chemistry, Department of Environmental Toxicology, Delft, The Netherlands. Report No. V99.1172 (unpublished).

A84 (LON 1102)

Fisher, J.D. (1971) Dissipation study of Hyamine 3500 in soil and its effects on microbial activity. Rohm & Haas Company, Philadelphia, PE, USA. Report No. 6 (unpublished).

7.2.3.1 – Adsorption and desorption

A43 (LON 1867)

Daly, D. and W. Cranor (1988) Soil/sediment adsorptiondesorption of alkyl dimethyl ammonium chloride. Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO, USA. Report No. 35716 (unpublished).

7.4.1.1(1)– Acute toxicity to fish (Lepomis macrochirus)

A8a (LON 1865)

Pate, H.O. and D.O. McIntyre (1991) Daily static-renewal acute 96-hour toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to bluegill sunfish. Battelle Columbus Division, Columbus, OH, USA. Study No. SC890050 (unpublished).

7.4.1.1(2)– Acute toxicity to fish (Pimephales promelas)

A6 (LON 3476)

Sword, M.C. and L. Stuerman (1994) Static-renewal acute toxicity of alkyl dimethyl benzyl ammonium chloride (ADBAC) to fathead minnow (Pimephales promelas). ABC Laboratories, Columbia, MO, USA. Report No. 41237 (unpublished).

7.4.1.1(3)– Acute toxicity to fish (Pimephales promelas)

A7 (LON 3477)

Sword, M.C. and L. Stuerman (1994) Static-renewal acute toxicity of alkyl dimethyl benzyl ammonium chloride (ADBAC) to fathead minnow (Pimephales promelas) in dilution water amended with 10 mg/L humic acid. ABC Laboratories, Columbia, MO, USA. Report No. 41236 (unpublished).

7.4.1.1(4)– Acute toxicity to A8 Sword, M.C. and L. Stuerman (1994). Static-renewal acute



79

fish (Pimephales promelas)

(LON 3478)

toxicity of alkyl dimethyl benzyl ammonium chloride (ADBAC) to fathead minnow (Pimephales promelas) in dilution water amended with 20 mg/L humic acid. ABC Laboratories, Columbia, MO, USA. Report No. 41235 (unpublished).

7.4.1.1(5)– Acute toxicity to fish (Oncorhynchus mykiss)

A8b (LON 1864)

Pate, H.O. and D.O. McIntyre (1991) Daily static-renewal acute 96-hour toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to rainbow trout. Battelle Columbus Division, Columbus, OH, USA. Study No. SC890051 (unpublished).

7.4.1.1– Acute toxicity to fish (Cyprinodon variegatus)

A5/5a (LON 3479)

Sved, D.W., Swigert, J.P. and G.J. Smith (1992) A 96-hour static-renewal acute toxicity test with alkyl dimethyl benzyl ammonium chloride (ADBAC) in the sheepshead minnow (Cyprinodon variegatus). Wildlife International Ltd., Easton, MD, USA. Project No. 350A-102 (unpublished).

7.4.1.1– Acute toxicity to fish (Lepomis macrochirus)

A46 (LON 1104)

Bevier Hasbruck Sleight III (1971) Acute toxicity of Hyamine 3500 to bluegill (Lepomis macrochirus). Bionomics Inc., Wareham, MA, USA. Report No. 350A-102 (unpublished).

7.4.1.1– Acute toxicity to fish

A47 (LON 1008)

Binns, R. and G.C. Clark (1969) The acute toxicity to fish of Hyamine 3500. Huntingdon Research Centre Ltd., Huntingdon, Cambridgeshire, England. Report No. 2938/69/364 (unpublished).

7.4.1.2– Acute toxicity to invertebrates (Daphnia magna)

A68 (LON 0097)

Pate, H.O. and D.O. McIntyre (1991) Daily static-renewal acute 48-hour toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to Daphnia magna. Battelle Columbus Division, Columbus, OH, USA. Study No. SC890052 (unpublished).

7.4.1.2– Acute toxicity to invertebrates (Mysidopsis bahia)

A10, A10a (LON 3798)

Sved, D.W., Swigert, J.P. and G.J. Smith (1992) A 96-hour static-renewal acute toxicity test with alkyl dimethyl benzyl ammoniumchloride (ADBAC) in the saltwater mysid (Mysidopsis bahia). Wildlife International Ltd., Easton, MD, USA. Project No. 350A-101A (unpublished).

7.4.1.2– Acute toxicity to invertebrates (Crassostrea virginica)

A9, A9a (LON 3797)

Sved, D.W., Swigert, J.P. and G.J. Smith (1992) A 48-hour static acute toxicity test with alkyl dimethyl benzyl ammonium chloride (ADBAC) in embryo larvae of the eastern oyster (Crassostrea virginica). Wildlife International Ltd., Easton, MD, USA. Project No. 350A-103 (unpublished).

7.4.1.3– Growth inhibition test on algae (Selenastrum capricornutum)

A48 (LON 3374)

Mayer, P., Oldersma, H. and J.A. Schoonmade (2001) Determination of the effect of alkyldimethylbenzylammonium chloride (ADBAC) on the growth of fresh water green alga Selenastrum capricornutum (OECD Guideline No. 201and EU C.3). TNO Chemistry, Delft, The Netherlands. Report No. V99.1176 (unpublished).

7.4.1.3– Growth inhibition test on algae (Skeletonema costatum)

A119 (LON 4000)

Desjardins, D., MacGregor, J.A. and H.O. Krueger (2005) A 96-hour toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC; 40% C12, 50% C14, 10% C16; CAS RN 68424-85-1) with the marine diatom (Skeletonema costatum). Wildlife International Ltd., Easton, MD, USA. Project No.



80

350A-104 (unpublished). 7.4.1.4(1) – Inhibition to microbiological activity

A49 (LON 3324)

Mayer, P.H., Schoonmade J.A. and A.O. Hanstveit (2001) Screening of the effect of alkyldimethylbenzylammonium chloride on the respiration rate of activated cludge (OECD Guideline No. 209). TNO Nutrition and Food Research, Delft, The Netherlands. Report No. V99.1151 (unpublished).

7.4.1.4(2) – Inhibition to microbiological activity

A62 Corby, J.E. (1992) Determination of the acute toxicity of chemicals and wastewaters to aquatic microorganisms. Roy F. Weston, Inc., Lionville, PA, USA. Report No. 91-062 (unpublished).

7.4.1.4 – Inhibition to microbiological activity

A85 (LON 3090)

Janßen, U. (1989) Prüfung auf Bakterientoxizität n. OECD 209 Belebtschlamm Respirationshemmtest Journal-Nr: 8.680. Dr. U.Noack-Laboratorium Für Angewandte Biologie, Technologiezentrum, Hildesheim, Germany. (unpublished).

7.4.2(1)– Bioconcentration

A45 (LON 1866)

Fackler, P.H. (1989) Bioconcentration and elimination of 14Cresidues by bluegill (Lepomis macrochirus) exposed to alkyl dimethyl benzyl ammonium chloride (ADBAC). Springborn Life Sciences, Inc., Wareham, MA, USA. Report No. 89-1- 2921 (unpublished).

7.4.2(2)– Bioconcentration

A86 (LON 1099)

Krzeminski, S.F. (1971) The accumulation and elimination of Hyamine 3500 residues by fish (bluegill). Bristol Research Laboratories, Philadelphia, PA, USA. Report No. 23-42 (unpublished).

7.4.3.2– Fish reproduction and growth rate (Pimphales promelas)

A11 (LON 3219)

McIntyre, D.O. and H.O. Pate (1992) Daily static-renewal early life stage toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to fathead minnows. Battelle Columbus Operations, Columbus, OH, USA. Study No. SC890057 (unpublished).

7.4.3.4 – Invertebrate reproduction and growth rate (Daphnia magna)

A12 (LON 3220)

McIntyre, D.O. and H.O. Pate (1992) Daily static-renewal chronic 21-day toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to Daphnia magna. Battelle Columbus Operations, Columbus, OH, USA. Study No. SC890056 (unpublished).

7.4.3.5.1– Effects on sediment dwelling organisms (Chironomus tentans)

A13 (LON 3221)

England, D.C. and T. Leak (1995) Chronic toxicity of sediment-incorporated ADBAC to Chironomus tentans. ABC Laboratories, Inc., Columbia, MO, USA. Report No. 41004 (unpublished).

7.4.3.5.2 -- Aquatic plant toxicity

A120 (LON 4001)

Desjardins, D., J.A. McGregor and H.O. Krueger. (2005) A 7- Day Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC; 40% C12, 50% C14, 10% C16; CAS RN 68424-85-1) with Duckweed (Lemna gibba G3). Study No. 350A-105. Wildlife International, Ltd. (Unpublished)

7.5.1.1 – Inhibition to microbiological activity

A87 (LON 3382)

de Vette, H.Q.M., Hanstveit, R. and J.A. Schoonmade (2001) The assessment of the ecological effects of



81

alkyldimethylbenzylammonium chloride (Guidelines OPPTS 850.5100 Soil Microbial Community Test, OECD 216 and OECD 217 and CTB Section H.4.1). TNO Chemistry, Delft, The Netherlands. Report No. V99.1170 (unpublished).

7.5.1.2 – Acute toxicity test to earthworms

A95 (LON 3799)

Rodgers, M.H. (2004) N-Alkyl (C12-16)-N,N-dimethyl-Nbenzylammonium chloride (ADBAC): Acute toxicity (LC50) to the earthworm. Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England. Report No. ADB/023 033976 (unpublished).

7.5.1.3 – Acute toxicity to plants

A94 (LON 3800)

Gray, J. (2004) N-Alkyl(C12-C16)-N,N-dimethyl-Nbenzylammonium chloride (ADBAC): Acute toxicity to terrestrial plants. Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England. Study No. ADB/024 (unpublished).

7.5.3.1.1 – Acute oral toxicity (Bobwhite quail )

A59 (LON 3801)

Campbell, S.M. and M. Jaber (1993) An acute oral toxicity study with alkyl dimethyl benzyl ammonium chloride (ADBAC) in the northern bobwhite quail. Wildlife International Ltd., Easton, MD, USA. Project No. 289-109 (unpublished)

7.5.3.1.2(1) – Short-term toxicity

A117 (LON 3997)

Gallagher, S.P., Martin, K.H. and J.B. Beavers (2005) A dietary LC50 study with alkyl dimethyl benzyl ammonium chloride (ADBAC; 40% C12, 50% C14, 10% C16; CAS RN 68424-85-1) in the northern bobwhite. Wildlife International Ltd., Easton, MD, USA. Project No. 350-101 (unpublished).

7.5.3.1.2(2) – Short-term toxicity

A118 (LON 3999)

Gallagher, S.P., Martin, K.H. and J.B. Beavers (2005) A dietary LC50 study with alkyl dimethyl benzyl ammonium chloride (ADBAC; 40% C12, 50% C14, 10% C16; CAS RN 68424-85-1) in the mallard. Wildlife International Ltd., Easton, MD, USA. Project No. 350-102 (unpublished).

Other Non-Key Report(s) Included in This Submission

A103 (LON 3815)

Bestari, K. (2001) Determination of the leachability of Bardac 2280 from treated wood. Centre for Toxicology, University of Guelph, Guelph, Ontario, Canada. Study No. 2000-CT-WL-B22 (unpublished).

References Supporting Summaries Found in Document III-A, Section 5

A104

Linfield, W.M. (1969) In E. Jungermann, Ed., “Cationic Surfactants”, Marcel Dekker, New York, N.Y. Chapter 2, “Straight-Chain Alkylammonium Compounds, pages 9-70.

A105

Preston, A.F., P.J. Walcheski, P.A. McKaig and D.D. Nicholas (1987) Recent research on alkylammonium compounds in the U.S. Proc. Am. Wood Pres. Assn. 83, 331-347 (published).

A106

Wazny, J. and R. Rudniewski (1997) Fungitoxic effect of the quaternary ammonium compounds wood preservatives against Basidiomycetes by using agar-plate and agar-block methods. International Research Group on Wood Preservation Document No. IRG/WP/96-30118.



82

A107

Tang, H. and J.N. Ruddick (1994) Evaluating the potential of amine chemicals for use as wood protecting agents. Part 1: Investigation of cation component of quaternary ammonium compounds. International Research Group on Wood Preservation Document No. IRG WP 94-30049.

A108

Tsunoda, K. (1990) Effect of alkyl chain length on the fungicidal efficacy of benzalkonium chlorides. J. Antibact. Antifung. Agents 18(4), 185-189 (published).



83

Document IIIB

Endpoint Reference No.

Reference Non-Key Studies are italicized.

3.5(1) – Acidity/alkalinity and if necessary pH value (1% in water)

A122 (LON 4004)

Sydney, P. (2006) BQ-25: Physicochemical properties. Huntingdon Life Sciences Ltd., Hungtingdon, Cambdridgeshire, England. Report No. ADB0031/062228 (unpublished).

3.6(1) – Relative Density

A122 (LON 4004)


3.8(1) – Technical characteristics of the biocidal product: Persistent foaming

A122 (LON 4004)


3.10.2(1) – Viscosity

A122 (LON 4004)


References Supporting Summaries Found in Document III-B, Section 5

A107

Tang, H. and J.N. Ruddick (1994) Evaluating the potential of amine chemicals for use as wood protecting agents. Part 1: Investigation of cation component of quaternary ammonium compounds. International Research Group on Wood Preservation Document No. IRG WP 94-30049.

A108

Tsunoda, K. (1990) Effect of alkyl chain length on the fungicidal efficacy of benzalkonium chlorides. J. Antibact. Antifung. Agents 18(4), 185-189 (published).

A109

Tsunoda, K. and K. Nishimoto (1987) Effectiveness of alkylammonium compounds as above-ground wood preservatives. Mokuzai Gakkaishi, 33 (7), 589-595 (published).

A110

Tsunoda, K. and K. Nishimoto (1983) Fungicidal and termicidal effectiveness of alkylammonium compounds. International Research Group on Wood Preservation Document No. IRG WP 3232.

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides


84

Appendix IV: List of standard terms and abbreviations

Stand. term / Abbreviation

Explanation

A Ampere ACh Acetylcholine AChE Acetylcholinesterase ADBAC Alkyldimethylbenzylammonium Chloride ADI acceptable daily intake ADME administration distribution metabolism and excretion ADP adenosine diphosphate AE acid equivalent AF assessment factor AFID alkali flame-ionisation detector or detection A/G albumin/globulin ratio ai active ingredient ALD50 approximate median lethal dose, 50% ALT alanine aminotransferase (SGPT) Ann. Annex AOEL acceptable operator exposure level AMD automatic multiple development ANOVA analysis of variance AP alkaline phosphatase approx Approximate ARC anticipated residue contribution ARfD acute reference dose as active substance AST aspartate aminotransferase (SGOT) ASV air saturation value ATP adenosine triphosphate BAF bioaccumulation factor BCF bioconcentration factor bfa body fluid assay BOD biological oxygen demand bp boiling point BPD Biocidal Products Directive BSAF biota-sediment accumulation factor BSE bovine spongiform encephalopathy BSP bromosulfophthalein BUN blood urea nitrogen bw body weight c centi- (x 10 –2 ) °C degrees Celsius (centigrade) CA controlled atmosphere CAD computer aided design cd candela CDA controlled drop(let) application cDNA complementary DANN CEC cation exchange capacity



85


Explanation

cf confer, compare to CFU colony forming units ChE cholinesterase CI confidence interval CL confidence limits cm centimetre CNS central nervous system COD chemical oxygen demand Conc Concentration CPK creatinine phosphatase cv coefficient of variation Cv ceiling value d day(s) DDAC Didecyldimethylammonium Chloride DES diethylstilboestrol DIS draft international standard (ISO) DMSO dimethylsulfoxide DNA deoxyribonucleic acid dna designated national authority DO dissolved oxygen DOC dissolved organic carbon dpi days post inoculation DRP detailed review paper (OECD) DT50(lab) period required for 50 percent dissipation (under laboratory conditions) (define

method of estimation) DT90(field) period required for 90 percent dissipation (under field conditions) (define

method of estimation) dw dry weight DWQG drinking water quality guidelines ε decadic molar extinction coefficient EASE Estimation and Assessment of Substance Exposure EC50 median effective concentration ECD electron capture detector ED50 median effective dose EDI estimated daily intake EINECS European inventory of existing commercial substances ELINCS European list of notified chemical substances ELISA enzyme linked immunosorbent assay e-mail electronic mail EMDI estimated maximum daily intake EN European norm EPMA electron probe micro-analysis ERL extraneous residue limit ESD Emission Scenario Document ESPE46/51 evaluation system for pesticides EUSES European Union system for the evaluation of substances F Field F0 parental generation F1 filial generation, first



86


Explanation

F2 filial generation, second FBS full base set FELS fish early-life stage FIA fluorescence immuno-assay FID flame ionisation detector Fmol fractional equivalent of the metabolite´s molecular weight compared to the

active substance FOB functional observation battery foc organic carbon factor (compartment dependent) fp freezing point FPD flame photometric detector FPLC fast protein liquid chromatography g gram(s) gd gestation day GAP good agricultural practice GC gas chromatography GC-EC gas chromatography with electron capture detector GC-FID gas chromatography with flame ionisation detector GC-MS gas chromatography-mass spectrometry GC-MSD gas chromatography with mass-selective detection GEP good experimental practice GFP good field practice GGT gamma glutamyl transferase GI gastro-intestinal GIT gastro-intestinal tract GL guideline level GLC gas liquid chromatography GLP good laboratory practice GM geometric mean GMO genetically modified organism GMM genetically modified micro-organism GPC gel-permeation chromatography GPS global positioning system GSH Glutathione GV Granulosevirus h hour(s) H Henry’s Law constant (calculated as a unitless value) ha hectare(s) Hb Haemoglobin HC5 concentration which will be harmless to at least 95 % of the species present

with a given level of confidence (usually 95 %) HCG human chorionic gonadotropin Hct Haematocrit HDT highest dose tested hL Hectolitre HEED high energy electron diffraction HID helium ionisation detector HPAEC high performance anion exchange chromatography HPLC high pressure liquid chromatography or high performance liquid



87


Explanation

chromatography HPLC-MS high pressure liquid chromatography - mass spectrometry HPPLC high pressure planar liquid chromatography HPTLC high performance thin layer chromatography HRGC high resolution gas chromatography HS Shannon-Weaver index Ht Haematocrit HUSS human and use safety standard I Indoor I50 inhibitory dose, 50% IC50 median immobilisation concentration or median inhibitory concentration 1 ICM integrated crop management ID ionisation detector IEDI international estimated daily intake IGR insect growth regulator im intramuscular inh inhalation INT 2-p-iodophenyl-3-p-nitrophenyl-5-phenyltetrazoliumchloride testing method ip intraperitoneal IPM integrated pest management IR infrared ISBN international standard book number ISSN international standard serial number IUCLID International Uniform Chemical Information Database iv intravenous IVF in vitro fertilisation k (in combination) kilo k rate constant for biodegradation K Kelvin Ka acid dissociation constant Kb base dissociation constant Kads adsorption constant Kdes apparent desorption coefficient kg kilogram KH Henry´s Law constant (in atmosphere per cubic metre per mole) Koc organic carbon adsorption coefficient Kom organic matter adsorption coefficient Kow octanol-water partition coefficient Kp solid-water partition coefficient kPa kilopascal(s) l, L litre LAN local area network LASER light amplification by stimulated emission of radiation LBC loosely bound capacity LC liquid chromatography LC-MS liquid chromatography- mass spectrometry LC50 lethal concentration, median LCA life cycle analysis LC-MS-MS liquid chromatography with tandem mass spectrometry



88


Explanation

LD50 lethal dose, median; dosis letalis media LDH lactate dehydrogenase ln natural logarithm LOAEC lowest observable adverse effect concentration LOAEL lowest observable adverse effect level LOD limit of detection LOEC lowest observable effect concentration LOEL lowest observable effect level log logarithm to the base 10 LOQ limit of quantification (determination) LPLC low pressure liquid chromatography LSC liquid scintillation counting or counter LSD least squared denominator multiple range test LSS liquid scintillation spectrometry LT lethal threshold m Metre M Molar µm micrometre (micron) MAC maximum allowable concentration MAK maximum allowable concentration MC moisture content MCH mean corpuscular haemoglobin MCHC mean corpuscular haemoglobin concentration MCV mean corpuscular volume MDL method detection limit MFO mixed function oxidase µg microgram mg milligram MHC moisture holding capacity MIC minimum inhibitory concentration min minute(s) MKC minimum killing concentration mL millilitre MLT median lethal time MLD minimum lethal dose mm millimetre MMAD mass median aerodynamic diameter mo month(s) MOE margin of exposure mol mole(s) MOS margin of safety mp melting point MRE maximum residue expected MRL maximum residue level or limit mRNA messenger ribonucleic acid MS mass spectrometry MSDS material safety data sheet MTD maximum tolerated dose MT material test



89


Explanation

MW molecular weight n.a. not applicable n- normal (defining isomeric configuration) n number of observations NAEL no adverse effect level nd not detected NEDI national estimated daily intake NEL no effect level NERL no effect residue level ng Nanogram nm Nanometre NMR nuclear magnetic resonance no, n° Number NOAEC no observed adverse effect concentration NOAEL no observed adverse effect level NOEC no observed effect concentration NOED no observed effect dose NOEL no observed effect level NOIS notice of intent to suspend NPD nitrogen-phosphorus detector or detection NPV nuclear polyhedrosis virus NR not reported NTE neurotoxic target esterase OC organic carbon content OCR optical character recognition ODP ozone-depleting potential ODS ozone-depleting substances OEL occupational exposure limit OH Hydroxide OJ Official Journal OM organic matter content Pa Pascal PAD pulsed amperometric detection 2-PAM 2-pralidoxime pc paper chromatography PCV haematocrit (packed corpuscular volume) PEC predicted environmental concentration PECA predicted environmental concentration in air PECS predicted environmental concentration in soil PECSW predicted environmental concentration in surface water PECGW predicted environmental concentration in ground water PED plasma-emissions-detector pH pH-value PHED pesticide handler’s exposure data PIC prior informed consent pic phage inhibitory capacity PIXE proton induced X-ray emission pKa negative logarithm (to the base 10) of the acid dissociation constant pKb negative logarithm (to the base 10) of the base dissociation constant



90


Explanation

PNEC predicted no effect concentration (compartment to be added as subscript) po by mouth POP persistent organic pollutants ppb parts per billion (10-9 ) PPE personal protective equipment ppm parts per million (10-6 ) PPP plant protection product ppq parts per quadrillion (10-24 ) ppt parts per trillion (10-12 ) PSP phenolsulfophthalein PrT prothrombin time PRL practical residue limit PT product type PT(CEN) project team CEN PTDI provisional tolerable daily intake PTT partial thromboplastin time QA quality assurance QAU quality assurance unit (Q)SAR quantitative structure-activity relationship r correlation coefficient r 2 coefficient of determination RA risk assessment RBC red blood cell REI restricted entry interval RENI Registry Nomenclature Information System Rf retardation factor RfD reference dose RH relative humidity RL50 median residual lifetime RNA ribonucleic acid RP reversed phase rpm revolutions per minute rRNA ribosomal ribonucleic acid RRT relative retention time RSD relative standard deviation s Second S Solubility SAC strong adsorption capacity SAP serum alkaline phosphatase SAR structure/activity relationship SBLC shallow bed liquid chromatography sc Subcutaneous sce sister chromatid exchange SCAS semi-continuous activated sludge SCTER smallest chronic toxicity exposure ratio (TER) SD standard deviation se standard error SEM standard error of the mean SEP standard evaluation procedure



91


Explanation

SF safety factor SFC supercritical fluid chromatography SFE supercritical fluid extraction SIMS secondary ion mass spectroscopy S/L short term to long term ratio SMEs small and medium sized enterprises SOP standard operating procedures sp species (only after a generic name) SPE solid phase extraction SPF specific pathogen free spp subspecies SSD sulphur specific detector SSMS spark source mass spectrometry STEL short term exposure limit STER smallest toxicity exposure ratio (TER) STMR supervised trials median residue STP sewage treatment plant t tonne(s) (metric ton) t½ half-life (define method of estimation) T3 tri-iodothyroxine T4 thyroxine T25 tumorigenic dose that causes tumours in 25% of the test animals TADI temporary acceptable daily intake TBC tightly bound capacity TCD thermal conductivity detector TG technical guideline, technical group TGD Technical guidance document TID thermionic detector, alkali flame detector TDR time domain reflectrometry TER toxicity exposure ratio TERI toxicity exposure ratio for initial exposure TERST toxicity exposure ratio following repeated exposure TERLT toxicity exposure ratio following chronic exposure tert tertiary (in a chemical name) TEP typical end-use product TGGE temperature gradient gel electrophoresis TIFF tag image file format TLC thin layer chromatography Tlm median tolerance limit TLV threshold limit value TMDI theoretical maximum daily intake TMRC theoretical maximum residue contribution TMRL temporary maximum residue limit TNsG technical notes for guidance TOC total organic carbon Tremcard transport emergency card tRNA transfer ribonucleic acid TSH thyroid stimulating hormone (thyrotropin) TTC 2,3,5-triphenylterazoliumchloride testing method



92


Explanation

TWA time weighted average UDS unscheduled DNA synthesis UF uncertainty factor (safety factor) ULV ultra low volume UR unit risk UV Ultraviolet UVC unknown or variable composition, complex reaction products UVCB undefined or variable composition, complex reaction products in biological

material v/v volume ratio (volume per volume) vis Visible WBC white blood cell wk Week wt Weight w/v weight per volume ww wet weight w/w weight per weight XRFA X-ray fluorescence analysis yr year < less than ≤ less than or equal to > greater than ≥ greater than or equal to

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