APP201051 Antifouling paints (AFPs) · 2019-04-06 · antifouling paints (APP201051), specifically the review of HSNO hazard classifications for antifouling paints (AFPs). This report

CLASSIFICATION UPDATE REPORT

www.epa.govt.nz

APP201051 – Antifouling paints (AFPs) February 2013

2

APP201051 Classification Update Report

February 2013

Executive Summary

This document provides additional information related to the Application for the reassessment of

antifouling paints (APP201051), specifically the review of HSNO hazard classifications for antifouling

paints (AFPs). This report should be read in conjunction with the application report.1

This document summarises the process followed in reviewing the classifications of AFP substances.

EPA staff undertook a review of the classifications of AFP active ingredients, which led to some

proposed amendments to the existing HSNO classifications of AFP substances covered by this

reassessment. No proposals are made regarding classification changes to the approvals of active

ingredients themselves. The effect of the proposed classification changes in terms of the default

HSNO controls that should apply, are detailed for each AFP substance.

What happens next?

Comments on proposed classification changes for AFP substances detailed in this document are

welcomed. Please send your feedback to the email address below by 22 March 2013, and ensure

that you quote the application code APP201051. Note that feedback received on this report will not

form part of the formal submission process for this Application, but may be incorporated into the

Evaluation and Review Report that is provided to the decision-making committee.

For further information, please use the following contact details:

Email: [email protected]

Telephone: +64 4 474 2426

1 http://www.epa.govt.nz/search-

databases/HSNO%20Application%20Register%20Documents/APP201051_APP201051%20Application%20Final%20(2012.01.

22).pdf

mailto:[email protected]

http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/APP201051_APP201051%20Application%20Final%20(2012.01.22).pdf



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February 2013

Table of Contents

Executive Summary ............................................................................................................................... 2

Table of Contents ................................................................................................................................... 3

Review of the classifications of AFP substances .............................................................................. 5

Appendix A: Classification of AFP active ingredients ....................................................................... 8

Chlorothalonil ................................................................................................................................. 8

Copper (I) oxide ........................................................................................................................... 10

Copper pyrithione ......................................................................................................................... 14

Copper thiocyanate ...................................................................................................................... 17

DCOIT .......................................................................................................................................... 19

Dichlofluanid ................................................................................................................................ 21

Diuron .......................................................................................................................................... 24

Irgarol ........................................................................................................................................... 27

Mancozeb .................................................................................................................................... 29

Octhilinone ................................................................................................................................... 32

Thiram .......................................................................................................................................... 34

Tolylfluanid ................................................................................................................................... 37

Zinc pyrithione .............................................................................................................................. 40

Zineb ............................................................................................................................................ 43

Ziram ............................................................................................................................................ 45

Appendix B: Classification of AFP formulations .............................................................................. 48

3(2H)-Isothiazolone, 4,5-dichloro-2-octyl-, Copper (I) Oxide ....................................................... 49

3(2H)-Isothiazolone, 4,5-dichloro-2-octyl-, Copper Thiocyanate ................................................. 49

Chlorothalonil, Copper (I) Oxide .................................................................................................. 50

Chlorothalonil, Mancozeb, Copper (I) Oxide ............................................................................... 50

Copper (I) Oxide .......................................................................................................................... 51

Copper (I) Oxide, Copper Pyrithione ........................................................................................... 53

Dichlofluanid, Copper (I) Oxide .................................................................................................... 54

Dichlofluanid, Copper Thiocyanate .............................................................................................. 54

Diuron .......................................................................................................................................... 54

Diuron, Copper (I) Oxide .............................................................................................................. 55

Diuron, Copper Thiocyanate ........................................................................................................ 58

Irgarol 1051, Copper (I) oxide ...................................................................................................... 58

Irgarol 1051, Copper Thiocyanate ............................................................................................... 58

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February 2013

Irgarol 1051, Tolylfluanid, Zinc pyrithione, Octhilinone, Copper (I) oxide, Copper Pyrithione ..... 59

Octhilinone, Copper (I) Oxide ...................................................................................................... 61

Octhilinone, Tolylfluanid, Copper (I) Oxide .................................................................................. 61

Thiram, Copper (I) Oxide ............................................................................................................. 62

Tolyfluanid, Copper Thiocyanate ................................................................................................. 62

Zinc Pyrithione ............................................................................................................................. 63

Zinc Pyrithione, Copper (I) Oxide ................................................................................................ 65

Zinc Pyrithione, Copper Thiocyanate ........................................................................................... 65

Zineb, Copper (I) Oxide ............................................................................................................... 66

Zineb, Copper (I) Oxide, Copper Pyrithione ................................................................................ 66

Zineb, Copper Thiocyanate ......................................................................................................... 66

5


February 2013

Review of the classifications of AFP substances

EPA staff have reviewed classifications for all AFP formulations covered by the reassessment. This

review took into account the following matters which influence the classification assigned:

any changes in the classification of the components of the mixture, including AFP active

ingredients, that may have occurred since the original classification was carried out;

use of summation rules in place of additivity for derivation of ecotoxicity classifications for

mixtures; and

in the absence of formulation data, use of mixture rules to determine irritancy/corrosivity

classifications.

Active ingredients

EPA staff reviewed the HSNO classification for each of the active ingredients used in AFPs, as they

are the primary biocidal ingredient in the substances. Reviews of the active ingredient classifications

by European, US and Australian authorities were considered.

A summary of the classification changes for the active ingredients is provided in the following table:

Table 2: Proposed classification changes for the active ingredients

Active Changes

Chlorothalonil Change 9.2B to 9.2C

Copper (I) oxide None

Copper pyrithione Remove 6.3A, add 6.8B and 6.9A oral and inhalation, add 9.3B

Copper thiocyanate Remove 6.9B

DCOIT Add 6.1D oral 567 mg/kg, add 9.3C

Dichlofluanid Remove 6.1D oral, add 9.4C

Diuron Remove 6.4A, add 6.7B, change 9.3C to 9.3B

Irgarol Remove 6.4A

Mancozeb None

Octhilinone None

Thiram Change 6.1C to 6.1B value 0.5mg/L.

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February 2013

Active Changes

Delete 6.3B, add 6.8B

Tolyfluanid Remove 6.1C oral

Zinc pyrithione Remove 6.3A, add 6.9A inhalation

Zineb Remove 9.2C

Ziram Remove 6.3B

A summary table was prepared for each active ingredient that identifies when a change in

classification should apply and a brief indication of the data and source that justified the change.

These summary tables active are provided in Appendix A.

EPA staff note: No formal amendment can be made to the approvals for the active ingredients used in

AFPs under this application, as the active ingredient approvals do not form part of this reassessment.

The review of the HSNO classification of the active ingredients used in AFPs was carried out in order

to inform the review of hazard classifications of AFP substances. Any modifications to the

classifications of the active ingredient substances will need to be carried out as part of a separate

application process, such as the EPA’s Yearly Chemical Review. EPA staff note that modifications to

classifications of active ingredients used in AFPs could have wider ranging implications, given that the

same active ingredients are used in many non-AFP pesticide substances which have not been

reviewed in this application.

AFP Formulations

The review of AFP classifications highlights a number of instances where proposed classifications are

not appropriate for all substances approved under a given approval. In such instances, EPA staff

propose the introduction of additional approvals for those substances where the amended original

approval is no longer considered appropriate. Classifications for AFP formulations are provided in

Appendix B, highlighting proposed changes to classifications for each substance. Additionally, AFPs

that contain hydrocarbon solvents that are aspiration hazards, and present at concentrations of 10%

or greater, will also be classified as acutely toxic via aspiration. The affected substances are detailed

in Appendix B.

EPA staff urge importers and manufacturers of AFPs, and other interested parties, to review the

proposed revised classifications for the formulations. Interested parties should contact the EPA if they

require additional assistance in determining which approval relates to a given trade name product. If

formulation data can be provided that would alter the proposed classification, EPA staff request that

this is submitted for review.

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February 2013

Impact of revised classifications on default HSNO controls

Default HSNO controls that apply to a substance are largely based on the controls that are triggered

for a given hazard classification. The effect of EPA staff’s proposed classification changes on default

controls for AFP substances are detailed in Appendix B, highlighting where controls have been added

or removed.

Staff note: In some circumstances, a change in hazard classification is proposed for a formulation but

the default controls triggered may not change. However, the measures required to comply with the

control may change, such as the secondary identifiers required to be specified on a product

label. Approvals may contain variations to controls, which are not listed here but may still be relevant

despite a change of classification. EPA staff consider that variations to controls and additional

controls previously applied to the existing approvals should remain in place, unless the proposed

classification changes mean that a particular classification and associated controls and variations are

no longer relevant.

EPA staff consider that implementation of the modified controls should come into force after a

transitional period of 2 years to allow manufacturers and importers to make the necessary changes

required to comply with the revised controls. EPA staff propose that classification changes should

come into force immediately should such a decision be made.

The most significant changes to default controls would arise when a substance that is currently

classified as a eye irritant is reclassified as a eye corrosive substance. Product labels and safety data

sheets of affected products will need to be updated to reflect the corrosive nature of the substance

(i.e. pictograms, priority and secondary identifiers, precautionary statements (including the PPE

requirements), etc.). The EPA’s labelling guide2 can be used to assist in determining the effects of

proposed classification changes.

All AFPs are classified as 9.1A substances. The packing group requirements for class 8.3A

substances are the same as for 9.1A substances, so the proposed corrosivity classification for some

AFPs does not alter the existing packing group requirements.

Introduction of a corrosive classification also imposes a requirement that advertising must include an

indication of the corrosive nature of the substance, and that access to the substance by children must

be restricted under certain circumstances.

2 http://www.epa.govt.nz/Publications/hsnogen-labelling-guide.pdf .

http://www.epa.govt.nz/Publications/hsnogen-labelling-guide.pdf

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February 2013

Appendix A: Classification of AFP active ingredients

Abbreviations used in this appendix are explained in the glossary of the main application report.3

In this appendix the following abbreviations are used:

ND: No Data or poor quality data (according to Klimisch criteria).

No: Data are available for the formulation, or for all components and classification is not triggered.

Chlorothalonil

Hazard

Current

HSNO

classification

Proposed

changes to the

classification

Reference, Rationale

Subclass 6.1 Acute

toxicity (oral)

No -

Subclass 6.1 Acute

toxicity (dermal)

No -

Subclass 6.1 Acute

toxicity (inhalation)

6.1B -

Subclass 6.1

Aspiration hazard

ND -

Subclass 6.3/8.2 Skin

irritancy/corrosion

No -

3 http://www.epa.govt.nz/search-databases/Pages/applications-details.aspx?appID=APP201051

http://www.epa.govt.nz/search-databases/Pages/applications-details.aspx?appID=APP201051

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February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.4/8.3 Eye

irritancy/corrosion

8.3A -

Subclass 6.5A

Respiratory

sensitisation

ND -

Subclass 6.5B

Contact sensitisation

6.5B -

Subclass 6.6

Mutagenicity

No -

Subclass 6.7

Carcinogenicity

6.7B -

Subclass 6.8

Reproductive/

developmental toxicity

No -

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target

organ systemic

toxicity

6.9A (Oral) -

Subclass 9.1 Aquatic 9.1A - Current classification is based on an acute endpoint of 96-h EC50 = 0.0076

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February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


ecotoxicity mg/L for the rainbow trout. The proposed change corresponds to a higher

quality (fulfils USEPA-guideline criteria and is listed in a trustworthy

regulatory source) fish study for the fathead minnow with a 96-h EC50 =

0.023 mg/L listed in the USEPA RED for chlorothalonil. The same

rationale for change applies to the crustacean (from a 48-h EC50 of 0.059

mg/L to 0.068 mg/L for Daphnia magna) and algal (from a 72-h EC50 of

0.17 mg/L to 0.19 mg/L for Selenastrum capricornutum) endpoints obtained

from the same data source.

Subclass 9.2 Soil

ecotoxicity

9.2B -

Subclass 9.3

Terrestrial vertebrate

ecotoxicity

9.3B -

Subclass 9.4

Terrestrial

invertebrate

ecotoxicity

No -

Copper (I) oxide

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


11


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute

toxicity (oral) 6.1D -

Subclass 6.1 Acute

toxicity (dermal) No -

Subclass 6.1 Acute

toxicity (inhalation) 6.1D -

Subclass 6.1 Aspiration

hazard ND -


irritancy/corrosion No -


irritancy/corrosion 6.4A -

Subclass 6.5A

Respiratory sensitisation 6.5A -

Subclass 6.5B Contact

sensitisation No -

Subclass 6.6 ND No Changing the classification would be consistent with the conclusions of the EU4 and

US5 cited reviews. Both documents indicate that via routes which do not pass

4 http://echa.europa.eu/documents/10162/13630/scher_opinion_hh_en.pdf

http://echa.europa.eu/documents/10162/13630/scher_opinion_hh_en.pdf

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February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Mutagenicity normal homeostatic mechanisms i.e. oral, dermal and inhalation, there is no

identified risk of mutagenicity.

Subclass 6.7

Carcinogenicity ND ND

ND classification consistent with the conclusions of the EU4 and US

5 cited reviews.

Both documents indicate that there is insufficient animal or human data to give a

carcinogenic classification.

Subclass 6.8

Reproductive/


No -

Subclass 6.8

Reproductive/


(via lactation)

NC -

Subclass 6.9 Target

organ systemic toxicity

6.9B (Oral and

inhalation) -

Subclass 9.1 Aquatic

ecotoxicity 9.1A -

Current classification is based on a fish study of unknown quality and an

undetermined form of copper for the Thymallus arcticus with a 96-h LC50 of 0.003

mg/L. The proposed change is a specific endpoint for copper oxide (96-h flow

through EC50 = 0.0344 mg/L dissolved) from a trustworthy regulatory source that

uses validated methodology (EFSA6, 2008).

5 http://www.epa.gov/oppsrrd1/REDs/copper_red_amend.pdf

6 http://www.efsa.europa.eu/en/efsajournal/doc/187r.pdf

http://www.epa.gov/oppsrrd1/REDs/copper_red_amend.pdf

http://www.efsa.europa.eu/en/efsajournal/doc/187r.pdf

13


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


The same rationale as mentioned above justifies the changes proposed for

crustaceans (48-h EC50 for Daphnia magna from 0.005 mg/L to 0.45 mg/L) and

algae (from a 4-day EC50 for Selenastrum capricornutum of 0.03 mg/L to a 72-h

EC50 for Pseudokirchneriella subcapitata of 0.133 mg/L) from the same data

source.

Subclass 9.2 Soil

ecotoxicity No -

There is currently no available soil ecotoxicity data in the Substance Database.

EFSA6 data on Eisenia fetida (14-day LC50 > 862 mg Cu/kg d.w. soil based on

Copper oxide WP) is therefore recommended for inclusion in the Substance

Database.

Subclass 9.3 Terrestrial

vertebrate ecotoxicity 9.3B -

Current classification based on a rat LD50 of 470 mg/kg bw should be updated to

an LD50 of 261 mg Cu/kg bw from the EFSA6 report


invertebrate ecotoxicity No -

Current classification is based on an contact toxicity LD50 for Apis mellifera of >25

μg/bee. This information should be modified slightly to >22 µg/bee, from the EFSA6

report.

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February 2013

Copper pyrithione

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute


Subclass 6.1 Acute

toxicity (dermal) ND No

Data from the UK7 cite a dermal LD50 of > 2.0 g/kg from a rabbit study along with

data indicating that dermal absorption of copper pyrithione is low. On this basis

EPA staff agree with the UK report in that a dermal toxicity classification is not

appropriate for copper pyrithione.

Subclass 6.1 Acute

toxicity (inhalation) 6.1A -


hazard ND -



The UK7 assessment concluded negative results on a study for this endpoint with

copper pyrithione in rabbits. The EU CLP8 inventory lists copper pyrithione as

“Causes skin irritation” from 28 notifiers, but not classified by 6 notifiers. APVMA9

reports are consistent in their view that copper pyrithione is not a skin irritant and

thus classification is not warranted.

7 http://www.pesticides.gov.uk/Resources/CRD/ACP/223_CuP.pdf

8 http://clp-inventory.echa.europa.eu/ (CAS# 238-984-0)

9 http://www.apvma.gov.au/registration/assessment/docs/prs_zinc_pyrithione.pdf

http://www.pesticides.gov.uk/Resources/CRD/ACP/223_CuP.pdf

http://clp-inventory.echa.europa.eu/

http://www.apvma.gov.au/registration/assessment/docs/prs_zinc_pyrithione.pdf

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February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification




Subclass 6.5A

Respiratory sensitisation ND -


sensitisation ND No

The UK 7 and APVMA

7 assessment reported that no classification for contact

sensitisation is necessary.

Subclass 6.6

Mutagenicity ND No

The UK 7 and APVMA



Subclass 6.7

Carcinogenicity ND No

The UK 7 and APVMA



Subclass 6.8

Reproductive/


ND 6.8B

The UK7 concluded a possible developmental risk at the same dose as

maternotoxicity based on the precautionary approach as causality cannot be

established using read-across studies from zinc pyrithione and sodium pyrithione.

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target

organ systemic toxicity ND 6.9A (Oral)

According to the UK7 report, repeat dose oral studies in rats using sodium, copper

or zinc pyrithione consistently resulted in loss of hindlimb function. The lowest

adverse effect level cited was 2 mg/kg bw/day.

Similar effects were not apparent in a repeat dose investigative study in monkeys.

However due to the lack of information as to whether the results from the rat or

16


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


monkey are more relevant to humans, the UK adopted a precautionary approach

and allocated a target organ toxicity classification. The EPA staff agrees with the

UK regulator in the approach for assigning this hazard classification.


ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity ND 9.2D

Change proposed on the basis of consistency with read-across done for similar

compounds (sodium and zinc pyrithione).


vertebrate ecotoxicity ND 9.3B

Change proposed on the basis of a 28-day LD50 = 126 mg/kg bw on Colinus

virginianus from a UK10

report


invertebrate ecotoxicity ND -

10 The Health and Safety Executive, 2005. Evaluation on: Copper Pyrithione as a New Active Ingredient in Professional Antifouling Products.

17


February 2013

Copper thiocyanate

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute


Subclass 6.1 Acute

toxicity (dermal) 6.1D -

Subclass 6.1 Acute



hazard ND -


irritancy/corrosion ND -



Subclass 6.5A



sensitisation ND -

Subclass 6.6

Mutagenicity ND -

Subclass 6.7 ND -

18


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Carcinogenicity

Subclass 6.8

Reproductive/


ND -

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target

organ systemic toxicity 6.9B ND

No information on target organ toxicity has been found in the public domain

including reviews by other regulatory bodies. The 6.9B classification has been

based on other copper compounds. To ensure a consistent approach with other

classifications for this active, an ND classification is proposed.


ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity ND 9.2D


vertebrate ecotoxicity 9.3C -


invertebrate ecotoxicity No ND Change proposed on the basis of no available information for this endpoint.

19


February 2013

DCOIT

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute

toxicity (oral) ND 6.1D

Based on the EU11

Competent Authority Report citing validated rat and mouse

studies with LD50s of 1636 and 567 mg/kg bw, respectively.

Subclass 6.1 Acute

toxicity (dermal) ND -

Subclass 6.1 Acute

toxicity (inhalation) 6.1B -


hazard ND -


irritancy/corrosion 8.2C -



Subclass 6.5A



sensitisation 6.5B -

Subclass 6.6 ND -

11 http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/review_programme/ca_reports/antifouling_products/doc_pt_publicpdf/_EN_1.0_&a=d

http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/review_programme/ca_reports/antifouling_products/doc_pt_publicpdf/_EN_1.0_&a=d

20


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Mutagenicity

Subclass 6.7

Carcinogenicity ND -

Subclass 6.8

Reproductive/


ND -

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target

organ systemic toxicity ND -


ecotoxicity 9.1A -

Same classification remains, but it is based on 120-h ErEC50 of 0.00048 mg/L for

Skeletonema costatum obtained from the EU11

Competent Authority Report.

Subclass 9.2 Soil

ecotoxicity ND No

Change proposed on the basis of data from the EU11

Competent Authority Report

for Eisenia fetida, citing an LC50 = 250 mg/kg bw soil.


vertebrate ecotoxicity ND 9.3C


invertebrate ecotoxicity ND ND

21


February 2013

Dichlofluanid

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute

toxicity (oral) 6.1D No

A UK12

and EU13

indicate the oral rat LD50 using recognised regulatory methods

and GLP is >5000 mg/kg bw. On the basis of data from a commonly used species

for LD50 testing (current classification is based on a guinea pig study) and

consistency with other international regulators a change to a “No” classification is

proposed.

Subclass 6.1 Acute


Subclass 6.1 Acute



hazard ND -


irritancy/corrosion 6.3B -



Subclass 6.5A ND -

12 http://www.fluoridealert.org/pesticides/dichlofluanid.evaluation.03.pdf

13 http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/assessement_directive/dichlofluanid_assessment/_EN_1.0_&a=d

http://www.fluoridealert.org/pesticides/dichlofluanid.evaluation.03.pdf

http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/assessement_directive/dichlofluanid_assessment/_EN_1.0_&a=d

22


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Respiratory sensitisation



Subclass 6.6

Mutagenicity ND No

The UKError! Bookmark not defined.

report concludes that in spite of positive results for

bacterial point mutation and mutations at the TK locus in eukaryotic cells (in vitro),

the weight of evidence (negative in 6 in vivo assays) was that dichlofluanid was

unlikely to be a genotoxic hazard.

Subclass 6.7


According to the study cited in the UKError! Bookmark not defined.

and EU13

an increased

incidence of thyroid tumours was noted in rats, however further investigative studies

provided sufficient data to indicate that this was a rat-specific event and not relevant

to humans.

Subclass 6.8

Reproductive/


No ND

According to the study cited in the UKError! Bookmark not defined.

and EU13

effects seen in

the offspring occurred at maternally toxic doses. In the absence of any information

which provides sufficient evidence that the effects seen were a result of maternal

toxicity and not a direct effect of treatment, an “ND” classification is proposed.

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target

organ systemic toxicity 6.9B (Oral) 6.9B (Oral)

Subclass 9.1 Aquatic 9.1A - Classification remains the same but the lowest endpoint for fish is updated on the

basis of the UKError! Bookmark not defined.

report data for Oncorhynchus mykiss changing

23


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


ecotoxicity from the current 96-h EC50 of 0.05 mg/L to 0.01 mg/L.

Subclass 9.2 Soil

ecotoxicity ND No

Change proposed on the basis of data from the Pesticides Properties Database

(PPDB14

) for Eisenia fetida, with a 14-day LC50 = 890 mg/kg.




invertebrate ecotoxicity ND 9.4C


(PPDB14

) for Apis mellifera, with a 48-h acute contact toxicity LD50 = 16 µg/bee.

14 http://sitem.herts.ac.uk/aeru/footprint/en/index.htm

24


February 2013

Diuron

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute


Subclass 6.1 Acute


Reports from other regulators, e.g. US EPA15

RED on diuron conclude the dermal

LD50 as determined in a valid rat study is >2000 mg/kg. For consistency with

international regulators a “No” classification is proposed.

Subclass 6.1 Acute

toxicity (inhalation) No -


hazard ND -




irritancy/corrosion 6.4A No


RED on diuron conclude diuron is not

an eye irritant. For consistency with international regulators a “No” classification is

proposed.

Subclass 6.5A



sensitisation No -

15 http://www.epa.gov/oppsrrd1/REDs/diuron_red.pdf

http://www.epa.gov/oppsrrd1/REDs/diuron_red.pdf

25


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.6

Mutagenicity ND No


RED on diuron conclude that a

classification for mutagenicity is not required. The approach or classification also

took into account conflicting data mentioned in the EPA Substance Database, but

on a weight-of-evidence approach have still concluded a “No” classification.

Subclass 6.7

Carcinogenicity ND 6.7B


RED on diuron present rat and mouse

studies that clearly showed an increased incidence of tumours in these animals.

The relevance to humans remains uncertain despite investigative/mechanistic type

studies performed. Due to the uncertainty on relevance to humans and the HSNO

criteria for carcinogenicity classifications a 6.7B classification is proposed.

Subclass 6.8

Reproductive/


6.8B No

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target

organ systemic toxicity 6.9A (Oral) -


ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity 9.2A -

26


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification



vertebrate ecotoxicity 9.3C 9.3B


(PPDB14

) for the rat, with an acute toxicity LD50 = 437 mg/kg bw.



27


February 2013

Irgarol

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute

toxicity (oral) 6.1E -

Subclass 6.1 Acute


Subclass 6.1 Acute



hazard ND -




irritancy/corrosion 6.4A No

Based on a UK16

report on diuron were adequate data was provided to classify

diuron as non-irritant to the eyes a removal of the eye irritancy classification is

proposed.

Subclass 6.5A




16 http://www.pesticides.gov.uk/Resources/CRD/ACP/218_Irgarol.pdf

http://www.pesticides.gov.uk/Resources/CRD/ACP/218_Irgarol.pdf

28


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.6

Mutagenicity ND No

No classification required on the basis of five in vitro and one in vivo study as

“negative” cited in the UKError! Bookmark not defined.

and the EU Competent Authority

Report17

, 2011.

Subclass 6.7


Subclass 6.8

Reproductive/


ND -

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target



ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity ND -

Subclass 9.3 Terrestrial No -

17 http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/review_programme/ca_reports/antifouling_products/version_reference/_EN_1.0_&a=d

http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/review_programme/ca_reports/antifouling_products/version_reference/_EN_1.0_&a=d

29


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


vertebrate ecotoxicity



Mancozeb

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute

toxicity (oral) No -

Subclass 6.1 Acute


Subclass 6.1 Acute



hazard ND -





30


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.5A




Subclass 6.6

Mutagenicity No -

Subclass 6.7


Subclass 6.8

Reproductive/


ND -

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target

organ systemic toxicity 6.9B (Oral) -


ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity No -

31


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification



vertebrate ecotoxicity No -



32


February 2013

Octhilinone

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute


Subclass 6.1 Acute

toxicity (dermal) 6.1C -

Subclass 6.1 Acute

toxicity (inhalation) 6.1C -


hazard ND -


irritancy/corrosion 8.2C -



Subclass 6.5A




Subclass 6.6

Mutagenicity ND No

Subclass 6.7


33


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.8

Reproductive/


ND -

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target



ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity ND -





34


February 2013

Thiram

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute

toxicity (oral) 6.1C -

Subclass 6.1 Acute


US EPA18

and ECHA19

database information indicate that classification for acute

dermal toxicity is not triggered citing a rat dermal LD50 > 2000 mg/kg bw. A “No”

classification is therefore proposed.

Subclass 6.1 Acute

toxicity (inhalation) 6.1C 6.1B

The change is proposed based on current available data in the EPA Substance

Database indicating a rat LC50 = 0.5 mg/L. This is consistent with information from

the EPA18

report.


hazard ND -


irritancy/corrosion 6.3B No

A removal of the skin irritancy classification is proposed on the basis of conclusions

reached in the US EPA18

report and ECHA19

database where classification for skin

irritation is not met. Other general summary type literature available in the public

domain indicate thiram is a skin irritant but do not cite the data this was based

upon. The change is proposed, therefore, to achieve consistency with other

international regulators.

Subclass 6.4/8.3 Eye 6.4A -

18 http://www.epa.gov/opp00001/chem_search/reg_actions/reregistration/red_PC-079801_1-Sep-04.pdf

19 http://echa.europa.eu/information-on-chemicals (CAS# 137-26-8)

http://www.epa.gov/opp00001/chem_search/reg_actions/reregistration/red_PC-079801_1-Sep-04.pdf

http://echa.europa.eu/information-on-chemicals

35


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


irritancy/corrosion

Subclass 6.5A




Subclass 6.6

Mutagenicity ND No

A change to a “No” classification is proposed on the basis of insufficient evidence to

classify. A similar conclusion has been reached by other regulators (US EPA18

and

ECHA19

database).

Subclass 6.7


The US EPA18

report concluded that thiram is “not likely to be a carcinogen” whilst

the ECHA19

database reports that classification is not triggered. For consistency

with other regulators a change to “No” in the carcinogenicity classification is

proposed.

Subclass 6.8

Reproductive/


ND 6.8B

A more recent report from the US EPA, 2007 (found in docket EPA-HQ-OPP-2007-

0020-0009) notes that the study in which serious malformations were seen initially

is considered unacceptable due to technical deficiencies that compromised the

evaluation of the study. Additionally, the findings weren’t reproduced in a more

recent study at similar doses. Classification should be based on a more recent

developmental neurotoxicity study (offspring systemic and neurotoxicity LOAEL: 3.7

mg/kg bw/day based on increased locomotor activity in females; NOAEL: 1.4 mg/kg

bw/day). A 6.8B classification for reproductive/developmental toxicity is therefore

proposed.

Subclass 6.8

Reproductive/ ND -

36


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification



(via lactation)

Subclass 6.9 Target



ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity ND -





37


February 2013

Tolylfluanid

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute

toxicity (oral) 6.1C No

Current classification is based on toxicity studies on guinea pigs/rabbits. A more

consistent approach with other intentional regulators would be to use data obtained

from rats/mice. This data is available in the EPA Substance Database and its use is

proposed in favour of a “No” classification.

Subclass 6.1 Acute


Subclass 6.1 Acute



hazard ND -





Subclass 6.5A




Subclass 6.6

Mutagenicity No -

38


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.7


Subclass 6.8

Reproductive/


No -

Subclass 6.8

Reproductive/


(via lactation)

ND No

Currently the EPA Substance Database does not include any reference to data on

this endpoint. A US EPA20

factsheet and other regulatory reports such as EFSA’s21

mention the endpoint and conclude that classification is not met. Based on a

weight-of-evidence approach, the staff therefore consider relevant to classify it as

“No” in order to achieve consistency with other regulators.

Subclass 6.9 Target


6.9A

(Inhalation)

6.9B (Oral)

-


ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity No -

20 http://www.epa.gov/opp00001/chem_search/reg_actions/registration/fs_PC-309200_01-Sep-02.pdf

21 http://www.efsa.europa.eu/en/scdocs/doc/praper_sr29_conclusion_tolylfluanid_summary_en1.pdf

http://www.epa.gov/opp00001/chem_search/reg_actions/registration/fs_PC-309200_01-Sep-02.pdf

http://www.efsa.europa.eu/en/scdocs/doc/praper_sr29_conclusion_tolylfluanid_summary_en1.pdf

39


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification






40


February 2013

Zinc pyrithione

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute


Subclass 6.1 Acute


In the absence of any specific data on zinc pyrithione and on the basis that the

acute dermal toxicity of both copper and sodium pyrithione salts is considered to be

low, a “No” classification has been recommended for copper pyrithione as part of

this review. To achieve consistency within the EPA Substance database the same

change is proposed for zinc pyrithione.

Subclass 6.1 Acute



hazard ND -


irritancy/corrosion 6.3A No Same rationale as cited for the 6.1 acute toxicity (dermal) subclass.



Subclass 6.5A



sensitisation No -

Subclass 6.6 ND No See comments on this endpoint for copper pyrithione.

41


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Mutagenicity

Subclass 6.7

Carcinogenicity ND No See comments on this endpoint for copper pyrithione.

Subclass 6.8

Reproductive/


6.8B -

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target

organ systemic toxicity 6.9A (Oral)

6.9A (Oral)

6.9A (Inhalation)

Little data available suggest lung as possible target after single and repeated

exposure (LOAEC = 2.5 mg/m3). Sources are from a UK

22 report and information

found in a US EPA docket (EPA-HQ-OPP-2004-0147-0023) support this view and

in order to achieve consistency with other regulators, the addition of a 6.9A

(Inhalation) classification is proposed.


ecotoxicity 9.1A -

Subclass 9.2 Soil

ecotoxicity ND -

22 http://www.pesticides.gov.uk/Resources/CRD/ACP/208_zinc_pyrithione.pdf

http://www.pesticides.gov.uk/Resources/CRD/ACP/208_zinc_pyrithione.pdf

42


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification






43


February 2013

Zineb

Hazard Current HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute

toxicity (oral) No -

Subclass 6.1 Acute


Subclass 6.1 Acute

toxicity (inhalation) ND -


hazard ND -





Subclass 6.5A




Subclass 6.6

Mutagenicity No -

Subclass 6.7


44


February 2013

Hazard Current HSNO

classification

Proposed

changes to the

classification


Subclass 6.8

Reproductive/


ND -

Subclass 6.8

Reproductive/


(via lactation)

ND -

Subclass 6.9 Target


No (Oral)

ND

(Dermal/Inhalation)

-


ecotoxicity 9.1A -

Although the classification for aquatic ecotoxicity remains the same, a new lowest

endpoint in which the 9.1A classification will be based on is proposed. The data

was sourced from a EU23

Competent Authority Report, citing a 72-h EC50 for algae

Skeletonema costatum = 0.036 mg/L.

Subclass 9.2 Soil

ecotoxicity ND -


vertebrate ecotoxicity No -

Subclass 9.4 Terrestrial ND -

23 http://circa.europa.eu/Public/irc/env/bio_reports/library?l=/review_programme/ca_reports/antifouling_products/bpd_car_03-2011pdf/_EN_1.0_&a=d

45


February 2013

Hazard Current HSNO

classification

Proposed

changes to the

classification


invertebrate ecotoxicity

Ziram

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


Subclass 6.1 Acute


Subclass 6.1 Acute


A “No” classification is proposed with the purpose of achieving consistency with

other regulators and based on a weight of evidence approach, as it was concluded

by a US EPA24

RED and information found in the EU25

Pesticide Database that this

classification is not triggered due to the acute dermal toxicity LD50 > 2000 mg/kg.

Subclass 6.1 Acute



hazard ND -


irritancy/corrosion 6.3B No Considering both, the US EPA

24 RED and EU

25 Pesticide Database information

concluding that the skin irritancy endpoint is not triggered and that the data cited

24 http://www.epa.gov/opp00001/chem_search/reg_actions/reregistration/red_PC-034805_12-Jul-04.pdf

46


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification


refers to GLP and regulatory compliant studies which indicate no irritation, a

removal of this classification is proposed.



Subclass 6.5A




Subclass 6.6

Mutagenicity No -

Subclass 6.7

Carcinogenicity No -

Subclass 6.8

Reproductive/


No -

Subclass 6.8

Reproductive/


(via lactation)

No -

Subclass 6.9 Target


47


February 2013

Hazard

Current

HSNO

classification

Proposed

changes to the

classification



ecotoxicity 9.1A -

Although the classification for aquatic ecotoxicity remains the same, a new lowest

endpoint in which the 9.1A classification will be based on is proposed. The data

was sourced from the EU25

Pesticide Database , citing a 96-h LC50 for the fish

Lepomis macrochirus = 0.00097 mg/L.

Subclass 9.2 Soil

ecotoxicity No -



Using data from the same report mentioned above from the EU25

Pesticide

Database, a change of endpoint is proposed, using an LD50 for the bird Colinus

virginianus = 97 mg/kg bw.



25 http://ec.europa.eu/food/plant/protection/evaluation/database_act_subs_en.htm (CAS# 137-30-4)

http://ec.europa.eu/food/plant/protection/evaluation/database_act_subs_en.htm

48


February 2013

Appendix B: Classification of AFP formulations

Approval numbers marked with an asterisk have been proposed for phase-out (e.g. HSR000912*) – refer to application document26

for further information.

Where an approval has been assigned an acute toxicity classification that is denoted with the superscript A (e.g. 6.1DA), the substance will also be an

aspiration hazard if it contains hydrocarbons that are aspiration hazards at concentrations of 10% or greater.

The following table provides descriptions of the controls referred to by the codes in the substance classification tables.

Control

code Regulation Description

Hazardous Substances (Emergency Management) Regulations 2001

EM2 8(a) Information requirements for corrosive substances

Hazardous Substances (Identification) Regulations 2001

I2 8 Priority identifiers for corrosive substances

I10 19 Secondary identifiers for corrosive substances

I20 36(8) Durability of information for class 6.1 substances

I22 40 Specific documentation requirements for corrosive substances

I30 53 Advertising corrosive and toxic substances

Hazardous Substances (Packaging) Regulations 2001

P14 20 Packaging requirements for corrosive substances

26 http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/APP201051_APP201051%20Application%20Final%20(2012.01.22).pdf


49


February 2013

The following tables contain the proposed changes to the classifications of the AFP substances that are the subject of this application.

3(2H)-Isothiazolone, 4,5-dichloro-2-octyl-, Copper (I) Oxide

Substance Description HSNO Approval

Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Hempel's Antifouling Globic

HSR000112* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A

3.1C, 6.3B, 6.4A, 6.5B, 6.6A,

6.8B, 6.9B, 9.1A

Remove:

I20, I30

ABC7 ANTIFOULING

HSR001748* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3C

3.1C, 6.1D, 6.3A, 8.3A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3C

Add:

EM2, I2, I10, I22, P14

3(2H)-Isothiazolone, 4,5-dichloro-2-octyl-, Copper Thiocyanate


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

SeaSafe Ultra

HSR100427* 3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.9B, 9.1A, 9.3C

3.1C, 6.1DA, 6.3A, 6.4A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.3C

No change

50


February 2013

Chlorothalonil, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Antifouling paint containing 138

g/L chlorothalonil and 722 g/L

cuprous oxide

HSR000912* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B,

6.7B, 6.9B, 9.1A, 9.2C, 9.3B

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B,

6.7B, 6.9B, 9.1A, 9.3B

No change

Antifouling paint containing 84-

138 g/L chlorothalonil and 517-

690 g/L cuprous oxide

HSR000913* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.2C, 9.3B

3.1C, 6.1D, 6.3A, 6.4A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.3B

No change

Chlorothalonil, Mancozeb, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Antifouling paint containing

chlorothalonil 62 g/L and 518 g/L

cuprous oxide and 82 g/L

mancozeb

HSR000914* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B,

6.7B, 6.8A, 6.9B, 9.1A, 9.2C, 9.3B

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B,

6.7B, 6.8A, 6.9B, 9.1A, 9.3B

No change

51


February 2013

Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Waterbased Antifouling Range HSR000041 6.1D, 6.3B, 6.4A, 6.8A, 6.9B, 9.1A,

9.3C

6.1D, 6.3B, 6.4A, 6.8A, 6.9B, 9.1A,

9.3B

No change


g/litre cuprous oxide

HSR000919 6.1E, 6.4A, 6.9B, 9.1A, 9.3C No change No change



HSR000920 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3C

3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3C

No change



HSR000921 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3B

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3B

No change


g/kg cuprous oxide (Part B)

HSR000922 6.1D, 6.4A, 6.9B, 9.1A, 9.3B No change No change


g/litre cuprous oxide and 550

g/litre zinc oxide

HSR000929 This substance was erroneously

identified in the application

document with the following

classifications:

6.1E, 6.4A, 6.9B, 9.1A, 9.3C

The correct current hazard

classification for this substance

are:

3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.9B,

9.1A, 9.3B

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B, 6.9B,

9.1A, 9.3B

No change



g/litre zinc oxide

HSR000930 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3B

3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3B

No change

52


February 2013


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls



g/litre zinc oxide

HSR000931 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3B

Split approval into 2 approvals

1. Antifouling paint containing

840 g/litre cuprous oxide and 350

g/litre zinc oxide HSR000931

Antifouling Seaguardian

3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3B

No change

2. Antifouling Seavictor 50

Assign new approval name and

approval number

3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3B

No change

Hempel's Antifouling Olympic

86901 colour range

HSR002484 3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.9B, 9.1A, 9.3B


1. Hempel's Antifouling Olympic

86901 colour range HSR002484

3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.9B, 9.1A, 9.3B

No change

2. Reduced Copper Antifouling

Range (Range C)


approval number

3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3B

No change

Hempel's Antifouling Olympic

86951 colour range

HSR002698 3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.9B, 9.1A, 9.3B

No change No change

53


February 2013


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Antifouling paint containing 640-

655g/L cuprous oxide

HSR100080 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.9B,

9.1A, 9.3B

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B, 6.9B,

9.1A, 9.3B

No change

Copper (I) Oxide, Copper Pyrithione


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Micron 77 Red HSR100057 3.1C, 6.1D, 6.3A, 6.7B, 6.8B,

6.8C, 6.9B, 8.3A, 9.1A, 9.3B

No change No change

Micron 77 Blue HSR100058 3.1C, 6.1D, 6.3A, 6.7B, 6.8B, 6.8C,

6.9B, 8.3A, 9.1A, 9.3B

No change No change

Micron 77 Black HSR100059 3.1C, 6.1D, 6.3A, 6.7B, 6.8B, 6.8C,

6.9B, 8.3A, 9.1A, 9.3B

No change No change

Micron 77 Navy HSR100060 3.1C, 6.1D, 6.3A, 6.7B, 6.8B, 6.8C,

6.9B, 8.3A, 9.1A, 9.3B

No change No change

54


February 2013

Dichlofluanid, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Antifouling paint containing 408 -

494 g/litre cuprous oxide and 34 -

42 g/litre dichlofluanid

HSR000923 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3B

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3B

No change

Dichlofluanid, Copper Thiocyanate


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls


g/litre copper thiocyanate and 36

g/litre dichlofluanid

HSR000889 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3C

3.1C, 6.1EA, 6.3B, 6.4A, 6.5B,

6.8B, 6.9B, 9.1A

Remove:

I20

Diuron


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls


g/litre diuron (Part A)

HSR000934* 3.1C, 6.1E, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.2B, 9.3C

3.1C, 6.1D, 6.3A, 6.4A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.2B,

9.3C

No change

55


February 2013

Diuron, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Antifouling paint containing 450 -

849 g/litre cuprous oxide and 40 -

70 g/litre diuron

HSR000924* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.2A, 9.3B



450 - 849 g/litre cuprous oxide

and 40 - 70 g/litre diuron

HSR000924

Interspeed 642 BQA 407

Red/BQA 412 Blue

Micron Extra

Intercleane 165 BWA 900 Bright

Red

Interspeed 642 BQA 405 Dark

Red

3.1C, 6.1D, 6.3A, 6.4A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.2A,

9.3B

No change




(aspiration hazard)

(Substance A)

If approval is not revoked,

assign new approval name and

approval number

No change

56


February 2013


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Micron CSC (Black, Blue,

Burgundy & White)

Longlife (Black, Blue & White)

3.1C, 6.1DA, 6.3A, 6.4A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.2A,

9.3B




(aspiration hazard)

(Substance B)



approval number

Coppercoat Extra

Longlife Extra (Blue, Red &

Black)

Micron Extra Dover White

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.2A,

9.3B

No change


g/litre cuprous oxide, 65 g/litre

diuron and 320 g/litre zinc oxide

HSR000925* 3.1C, 6.1D, 6.4A, 6.8B, 6.9B, 9.1A,

9.2A, 9.3B

3.1C, 6.1D, 6.4A, 6.7B, 6.8B,

6.9B, 9.1A, 9.2A, 9.3B

No change

Antifouling paint containing 760 HSR000926* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B, 3.1C, 6.1D, 6.3A, 6.4A, 6.5B, No change

57


February 2013


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls


diuron and 165 g/litre zinc oxide

6.9B, 9.1A, 9.2A, 9.3B 6.7B, 6.8B, 6.9B, 9.1A, 9.2A,

9.3B

58


February 2013

Diuron, Copper Thiocyanate


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Alloy Antifouling Range HSR000038* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9A, 9.1A, 9.3C

3.1C, 6.1D, 6.3A, 8.3A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.2A,

9.3C

Add:

EM2, I2, I10, I22, P14



g/litre diuron

HSR000916* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.2A, 9.3C

3.1C, 6.1DA, 6.3A, 6.4A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.2A,

9.3C

No change

Irgarol 1051, Copper (I) oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Ablative B Antifouling Range HSR000037* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.9B,

9.1A, 9.3C

3.1C, 6.1D, 6.3A, 8.3A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3B

Add:

EM2, I2, I10, I22, P14

Hard A Antifouling Range HSR000039* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8A,

6.9B, 9.1A, 9.3C

3.1C, 6.1D, 6.4A, 6.5B, 6.8A,

6.9B, 9.1A, 9.3B

No change



g/litre irgarol

HSR000927* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.9B,

9.1A, 9.3B

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B,

6.9B, 9.1A, 9.3B

No change

Irgarol 1051, Copper Thiocyanate


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

59


February 2013



g/litre irgarol

HSR000917* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.9B,

9.1A, 9.3C

3.1C, 6.1DA, 6.3B, 6.5B, 9.1A,

9.3C

No change

Irgarol 1051, Tolylfluanid, Zinc pyrithione, Octhilinone, Copper (I) oxide, Copper Pyrithione


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Ablative A1 Antifouling Range

Trade Names

Ablative A1 Antifouling Range

Antifouling SeaQuantum Classic

Antifouling SeaQuantum Ultra

Hempel’s A/F Globic NCT 8190M

Hempel’s A/F Globic NCT 8195M

HSR000036* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3B


1. Ablative A1 Antifouling

Range HSR000036

3.1C, 6.1D, 6.3A, 8.3A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3B

Add:

EM2, I2, I10, I22, P14

2. Hempel’s A/F Globic NCT



approval number

3.1C, 6.1D, 6.3A, 8.3A, 6.5B,

6.7B, 6.8B, 6.9B, 9.1A, 9.3B

Add:

EM2, I2, I10, I22, P14

3. Antifouling SeaQuantum

Ultra



approval number

3.1C, 6.1D, 6.3A, 8.3A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3B

Add:

EM2, I2, I10, I22, P14

4. Antifouling Seaquantum

Classic


No change

60


February 2013


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls


approval number

3.1C, 6.1D, 6.3A, 6.4A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3B

61


February 2013

Octhilinone, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Reduced Copper Antifouling

Range (Range D)

HSR007955* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.9B,

9.1A, 9.3B

3.1C, 6.1DA, 6.3A, 6.4A, 6.5B,

6.9B, 9.1A, 9.3B

No change

Octhilinone, Tolylfluanid, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Hard B Antifouling Range HSR000040* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8A,

6.9B, 9.1A, 9.3C

3.1C, 6.1DA, 6.3A, 8.3A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3B

Add:

EM2, I2, I10, I22, P14

62


February 2013

Thiram, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Ablative A Antifouling Range

HSR000035* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.6B,

6.8B, 6.9B, 9.1A, 9.3C

Split approval into 2

1. Ablative A Antifouling

Range HSR000035

3.1C, 6.1D, 6.3A, 8.3A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3B

Add:

EM2, I2, I10, I22, P14

2. AF1000



approval number

3.1C, 6.1D, 6.3A, 8.3A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3C

Add:

EM2, I2, I10, I22, P14



thiram and 260 g/litre zinc oxide

HSR000928* 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3B

No change No change

Tolyfluanid, Copper Thiocyanate


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Alloy C Antifouling Range HSR000952 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.7B,

6.8A, 6.9B, 9.1A, 9.2B, 9.3C

3.1C, 6.1DA, 6.3B, 6.4A, 6.5B,

6.8A, 6.9B, 9.1A, 9.2B, 9.3C

No change

63


February 2013

Zinc Pyrithione


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Optima Activator (Black) HSR000103

This substance was erroneously



classifications:

6.1D, 6.3B, 6.4A, 6.8A, 6.9B, 9.1A,

9.3C



are:

6.1C, 6.3A, 6.8B, 6.9A, 8.3A, 9.1A,

9.3B

6.1C, 6.8B, 6.9A, 8.3A, 9.1A,

9.3C

No change

Optima Activator (Blue) HSR000104




classifications:

6.1D, 6.3B, 6.4A, 6.8A, 6.9B, 9.1A,

9.3C



are:

6.1C, 6.3A, 6.8B, 6.9A, 8.3A, 9.1A,

9.3B

6.1C, 6.8B, 6.9A, 8.3A, 9.1A,

9.3C

No change

Optima Activator (Red) HSR000105



6.1C, 6.3B, 8.3A, 6.8B, 6.9A,

9.1A, 9.3C

No change

64


February 2013


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls


classifications:

6.1D, 6.3B, 6.4A, 6.8A, 6.9B, 9.1A,

9.3C



are:

6.1C, 6.3A, 6.5B, 6.8B, 6.9A, 8.3A,

9.1A, 9.3B

Optima Activator (White) HSR000106




classifications:

6.1D, 6.3B, 6.4A, 6.8A, 6.9B, 9.1A,

9.3C



are:

6.1C, 6.3A, 6.8B, 6.9A, 8.3A, 9.1A,

9.3B

6.1C, 6.8B, 6.9A, 8.3A, 9.1A,

9.3C

No change

65


February 2013

Zinc Pyrithione, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls



g/litre zinc pyrithione

HSR000932 3.1C, 6.1D, 6.3B, 6.4A, 6.7B, 6.8B,

6.8C, 6.9B, 9.1A, 9.3B


1:


640 g/litre cuprous oxide and

60 g/litre zinc pyrithione

HSR000932

3.1C, 6.1D, 6.3A, 8.3A, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3B

Add:

EM2, I2, I10, I22, P14

2.


cuprous oxide and zinc

pyrithione


approval number

3.1C, 6.1DA, 6.3B, 8.3A, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3B

Add:

EM2, I2, I10, I22, P14

Zinc Pyrithione, Copper Thiocyanate


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

Trilux 33 White HSR000121

3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.3C

3.1C, 6.1DA, 6.3B, 8.3A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3C

Add:

EM2, I2, I10, I22, P14

66


February 2013

Alloy B Antifouling Range HSR000951 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8A,

6.9B, 9.1A, 9.2B, 9.3C

3.1C, 6.1DA, 6.3B, 8.3A, 6.5B,

6.8A, 6.9B, 9.1A, 9.2B, 9.3C

Add:

EM2, I2, I10, I22, P14

Zineb, Copper (I) Oxide


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls



g/litre zineb

HSR000933 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.8B,

6.9B, 9.1A, 9.2D, 9.3B

3.1C, 6.1D, 6.3A, 6.4A, 6.5B,

6.8B, 6.9B, 9.1A, 9.3B

No change

Zineb, Copper (I) Oxide, Copper Pyrithione


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

SeaForce 60 HSR100411 3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.9B, 9.1A, 9.3B

No change No change

SeaForce 90 HSR100412 3.1C, 6.1D, 6.3A, 6.4A, 6.5B, 6.7B,

6.8B, 6.9B, 9.1A, 9.3B

No change No change

Zineb, Copper Thiocyanate


Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls


g/litre copper thiocyanate, 220

g/litre zinc oxide and 55 g/litre

zineb

HSR000918 3.1C, 6.1D, 6.3B, 6.4A, 6.5B, 6.7B,

6.8B, 6.8C, 6.9B, 9.1A, 9.3C

3.1C, 6.1DA, 6.3A, 6.4A, 6.5B,

6.7B, 6.8B, 6.8C, 6.9B, 9.1A,

9.3C

No change

67


February 2013

Ziram, Copper (I)

OxideSubstance

Description

HSNO Approval

Number

Current Hazard

Classifications

Proposed Hazard

Classifications

Effect on default

controls

ABC #3 Antifouling HSR007897* 3.1C, 6.1D, 6.3A, 6.5B, 6.8B, 6.9B,

8.3A, 9.1A, 9.3B

No change No change