Vial H Influenzae Antiserum Poly 1ML_MSDS

8/6/2019 Vial H Influenzae Antiserum Poly 1ML_MSDS

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Kit components03/09/2011

Product code Description

222371 Haemophilus Influenza Antiserum Poly

Components:

222371a Haemophilus Influenza Antiserum Poly (w/ thimerosal)

222371b Haemophilus Influenza Antiserum Poly (w/ sodium azide)

The preservative used for this product recently has changed. Two MSDSs are being provided, one for thediscontinued formulation, containing thimerosal and the other is for the new formulation, containingsodium azide. You can identify the different products by the presence or absence on the outer packageand package insert of a mercury warning associated with thimerosal.


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Safety data sheetaccording to 1907/2006/EC, Article 31

Date Prepared: 09.03.2011 Revision: 11.02.2011

Not classified as hazardous according to criteria of Australian Safety and Compensation Council

1Identification of the substance/mixture and of the company/undertaking

Product identifier

Trade name: Haemophilus Influenza Antiserum Poly (w/ thimerosal)Article number: 222371

Relevant identified uses of the substance or mixture and uses advised against Sector of UseSU3 Industrial uses: Uses of substances as such or in preparations at industrial sitesSU22 Professional uses: Public domain (administration, education, entertainment, services, craftsmen)SU20 Health servicesSU24 Scientific research and development

Application of the substance / the preparation Preparation

Details of the supplier of the safety data sheetManufacturer/Supplier:Becton Dickinson Pty Ltd

4 Research Park Drive

Macquarie University Research ParkNorth Ryde, NSW 2113AustraliaTel: 1800 656 100 (toll free)

Further information obtainable from:Regulatory Affairs Department - telephone: 02 8875 7045, email: [email protected] telephone number:Emergency Telephone (General Information Only): 1800 656 100 Business Hours: 8:30am to 5:00pm Mondaythrough Friday (EST)

2Hazards identification

Classification of the substance or mixture

The product is not classified according to the Globally Harmonized System (GHS).

Classification according to Directive 67/548/EEC or Directive 1999/45/ECThis product contains no hazardous constituents, or the concentration of all chemical constituents are below theregulatory threshold limits described by the Occupational Safety and Health Administration HazardCommunication Standard or European Directive 67/548/EEC and 1999/45/EC.

VoidInformation concerning particular hazards for human and environment:The product does not have to be labelled due to the calculation procedure of the "General Classification

guideline for preparations of the EU" in the latest valid version. Classification system:The classification is in line with current EC lists. It is extended, by information from technical literature and

company information.

Label elements

Labelling according to EU guidelines:Observe the general safety regulations when handling chemicalsThe product is not subject to identification regulations under EU Directives and the Ordinance on Hazardous

Materials (German GefStoffV).

Other hazardsResults of PBT and vPvB assessmentPBT:Not applicable.

(Contd. on page 2)

AU


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Trade name: Haemophilus Influenza Antiserum Poly (w/ thimerosal)

(Contd. of page 1)

vPvB:Not applicable.

3Composition/information on ingredients

Chemical characterization: MixturesDescription:Mixture consisting of the following components.

Dangerous components: Void

Additional information For the wording of the listed risk phrases refer to section 15.

4First aid measures

Description of first aid measures General informationNo special measures required.After inhalation Seek medical treatment in case of complaints.

After skin contactImmediately wash with water and soap and rinse thoroughly.After eye contactRinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.After swallowingIf symptoms persist consult doctor.

5Firefighting measures

Extinguishing media Suitable extinguishing agentsCO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

Advice for firefightersProtective equipment:No special measures required.

6Accidental release measures

Personal precautions, protective equipment and emergency proceduresNot required.

Environmental precautions:Damp down dust with water spray.

Methods and material for containment and cleaning up:No special measures required.

Reference to other sectionsNo dangerous substances are released.

7Handling and storage

HandlingPrecautions for safe handlingNo special measures required.

Information about fire - and explosion protection:No special measures required. Conditions for safe storage, including any incompatibilities StorageRequirements to be met by storerooms and receptacles: 2 - 8

Information about storage in one common storage facility:Not required.

Further information about storage conditions:None.AU

(Contd. on page 3)


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(Contd. of page 2)

8Exposure controls/personal protection

Additional information about design of technical facilities:No further data; see item 7.

Control parametersIngredients with limit values that require monitoring at the workplace:The product does not contain any relevant quantities of materials with critical values that have to be monitored atthe workplace.

Additional information: The lists valid during the making were used as basis.

Exposure controlsPersonal protective equipment General protective and hygienic measuresThe usual precautionary measures are to be adhered to when handling chemicals.

Respiratory protection:In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure use

self-contained respiratory protective device.Protection of hands:

Protective gloves.

Eye protection: Safety glasses

Body protection: Protective work clothing.

9Physical and chemical properties

Information on basic physical and chemical properties General InformationAppearance:

Form: Powder

Colour: Gold coloured

Odour: Characteristic

Change in conditionMelting point/Melting range:Not determined

Boiling point/Boiling range: Not determined

Flash point: Not applicable

Self-igniting: Product is not selfigniting.

Danger of explosion: Product does not present an explosion hazard.

Density: Not determined

Solubility in / Miscibility withWater: Soluble

Solvent content:

Solids content: 100.0 %

AU

(Contd. on page 4)


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(Contd. of page 3)

10 Stability and reactivity

Reactivity Chemical stability Thermal decomposition / conditions to be avoided:No decomposition if used according to specifications.Possibility of hazardous reactionsNo dangerous reactions known

Hazardous decomposition products:No dangerous decomposition products known

11 Toxicological information

Information on toxicological effectsAcute toxicity:Primary irritant effect:on the skin:No irritant effect.

on the eye:No irritating effect. Sensitization:No sensitizing effects known.

Additional toxicological information:The product is not subject to classification according to the calculation method of the General EU ClassificationGuidelines for Preparations as issued in the latest version.

When used and handled according to specifications, the product does not have any harmful effects to ourexperience and the information provided to us.

12 Ecological information

ToxicityAcquatic toxicity:No further relevant information available.Additional ecological information:

General notes: Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for water.Results of PBT and vPvB assessmentPBT:Not applicable.


13 Disposal considerations

Waste treatment methodsRecommendationMust not be disposed together with household garbage. Do not allow product to reach sewage system.Must be specially treated adhering to official regulations.

Uncleaned packaging:

Recommendation:Disposal must be made according to official regulations.Recommended cleansing agents: Water, if necessary together with cleansing agents.

14 Transport information

Land transport ADR/RID (cross-border)ADR/RID class: -

(Contd. on page 5)

AU


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(Contd. of page 4)

Maritime transport IMDG:IMDG Class: -

Marine pollutant: NoAir transport ICAO-TI and IATA-DGR:ICAO/IATA Class: -

UN "Model Regulation": - Special precautions for userNot applicable.

15 Regulatory information

Safety, health and environmental regulations/legislation specific for the substance or mixture

Australian Inventory of Chemical Substances

54-64-8 thimerosal

Chemical safety assessment:A Chemical Safety Assessment has not been carried out.

16 Other information

Disclaimer:To the best of our knowledge, the information contained herein is accurate. However, neither BD or any of itssubsidiaries assums any liabilities whatsoever for the accuracy or completeness of the information containedherein. Final determination of suitability of any material is the sole responsibility of the user. All materials may

present unknown hazards and should be used with caution. Although certain hazards described herein, we cannotguarantee that these are the only hazards that exist.

Department issuing MSDS:Environmental, Health & SafetyCreated by Michael J. Spinazzola

Contact: Technical Service RepresentativeAbbreviations and acronyms:ADR: Accord europen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International

Carriage of Dangerous Goods by Road)

RID: Rglement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the

International Transport of Dangerous Goods by Rail)IMDG: International Maritime Code for Dangerous Goods

IATA: International Air Transport Association

IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)

ICAO: International Civil Aviation OrganizationICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)

AU


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Hazardous according to criteria of Australian Safety and Compensation Council

1Identification of the substance/mixture and of the company/undertaking

Product identifier

Trade name: Haemophilus Influenza Antiserum Poly (w/ sodium azide)Article number: 222371

Relevant identified uses of the substance or mixture and uses advised against Sector of UseSU3 Industrial uses: Uses of substances as such or in preparations at industrial sitesSU22 Professional uses: Public domain (administration, education, entertainment, services, craftsmen)SU20 Health servicesSU24 Scientific research and development

Application of the substance / the preparation Preparation

Details of the supplier of the safety data sheetManufacturer/Supplier:Becton Dickinson Pty Ltd

4 Research Park Drive

Macquarie University Research ParkNorth Ryde, NSW 2113AustraliaTel: 1800 656 100 (toll free)

Further information obtainable from:Regulatory Affairs Department - telephone: 02 8875 7045, email: [email protected] telephone number:Emergency Telephone (General Information Only): 1800 656 100 Business Hours: 8:30am to 5:00pm Mondaythrough Friday (EST)

2Hazards identification

Classification of the substance or mixture

The product is not classified according to the Globally Harmonized System (GHS).

Classification according to Directive 67/548/EEC or Directive 1999/45/EC

Xn; Harmful

R22: Harmful if swallowed.Information concerning particular hazards for human and environment:The product has to be labelled due to the calculation procedure of the "General Classification guideline for

preparations of the EU" in the latest valid version. Classification system:The classification is in line with current EC lists. It is extended, by information from technical literature andcompany information.

Label elements

Labelling according to EU guidelines:The product has been classified and marked in accordance with EU Directives / Ordinance on Hazardous

Materials

Code letter and hazard designation of product:Xn Harmful

Hazard-determining components of labelling:sodium azide

(Contd. on page 2)

AU


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Trade name: Haemophilus Influenza Antiserum Poly (w/ sodium azide)

(Contd. of page 1)

Risk phrases:22 Harmful if swallowed.

Safety phrases:23 Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).36 Wear suitable protective clothing.

Information pertaining to particular dangers for man and environment Safety phrases:23 Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).36 Wear suitable protective clothing.

Other hazardsResults of PBT and vPvB assessmentPBT:Not applicable.


3Composition/information on ingredients Chemical characterization: MixturesDescription:Mixture consisting of the following components.

Dangerous components:

26628-22-8 sodium azide T+ R28; N R50/53R32

H300; H400; H410

0.1%

Additional information For the wording of the listed risk phrases refer to section 15.

4First aid measures

Description of first aid measures General informationSymptoms of poisoning may even occur after several hours; therefore medical observation for at least 48 hoursafter the accident.

After inhalation Supply fresh air; consult doctor in case of complaints.

After skin contactImmediately wash with water and soap and rinse thoroughly.

After eye contactRinse opened eye for several minutes under running water. Then consult a doctor.

After swallowing Call for a doctor immediately.

5Firefighting measures

Extinguishing media Suitable extinguishing agents

CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.Advice for firefightersProtective equipment:No special measures required.

6Accidental release measures

Personal precautions, protective equipment and emergency proceduresNot required.

Environmental precautions:Damp down dust with water spray.(Contd. on page 3)

AU


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(Contd. of page 2)

Methods and material for containment and cleaning up:Dispose contaminated material as waste according to item 13.Ensure adequate ventilation.

Reference to other sectionsSee Section 7 for information on safe handlingSee Section 8 for information on personal protection equipment.See Section 13 for disposal information.

7Handling and storage

HandlingPrecautions for safe handlingEnsure good ventilation/exhaustion at the workplace.

Prevent formation of aerosols.Information about fire - and explosion protection:No special measures required.

Conditions for safe storage, including any incompatibilities StorageRequirements to be met by storerooms and receptacles: 2 - 8

Information about storage in one common storage facility: Store away from oxidizing agents.

Further information about storage conditions: Store in cool, dry conditions in well sealed receptacles.

8Exposure controls/personal protection

Additional information about design of technical facilities:No further data; see item 7.

Control parameters

Ingredients with limit values that require monitoring at the workplace:

26628-22-8 sodium azide

NES 0.3* mg/m, 0.11 ppm*Peak limitation

Additional information: The lists valid during the making were used as basis.

Exposure controlsPersonal protective equipment General protective and hygienic measuresKeep away from foodstuffs, beverages and feed.Wash hands before breaks and at the end of work.

Respiratory protection:In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure useself-contained respiratory protective device.

Protection of hands:

Protective gloves.

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/ thechemical mixture.Selection of the glove material on consideration of the penetration times, rates of diffusion and the degradation

(Contd. on page 4)

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(Contd. of page 3)

Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of quality andvaries from manufacturer to manufacturer. As the product is a preparation of several substances, the resistance

of the glove material can not be calculated in advance and has therefore to be checked prior to the application.Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.

Eye protection: Safety glasses

Body protection: Protective work clothing.

9Physical and chemical properties

Information on basic physical and chemical properties General InformationAppearance:

Form: PowderColour: Gold coloured

Odour: Characteristic

Change in conditionMelting point/Melting range:Not determined

Boiling point/Boiling range: Not determined

Flash point: Not applicable

Self-igniting: Product is not selfigniting.

Danger of explosion: Product does not present an explosion hazard.

Density: Not determined

Solubility in / Miscibility with

Water: Soluble

10 Stability and reactivity

Reactivity Chemical stability Thermal decomposition / conditions to be avoided:No decomposition if used according to specifications.

Possibility of hazardous reactionsNo dangerous reactions known

Hazardous decomposition products:No dangerous decomposition products knownAdditional information:Sodium azide is present in this product. Contact with acidic solutions and metal compounds over time may form

potentially explosive metal azides. Should any of this material be introducted into a sanitary sewer system, flush

with copious amounts of water.AU

(Contd. on page 5)


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(Contd. of page 4)

11 Toxicological information

Information on toxicological effectsAcute toxicity:

LD/LC50 values relevant for classification:


Oral LD50 27 mg/kg (rat)

Primary irritant effect:on the skin:No irritant effect.on the eye:No irritating effect. Sensitization:No sensitizing effects known.Additional toxicological information:The product shows the following dangers according to the calculation method of the General EU ClassificationGuidelines for Preparations as issued in the latest version.

Harmful

12 Ecological information

ToxicityAcquatic toxicity:No further relevant information available.

Additional ecological information: General notes: Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for water.

Results of PBT and vPvB assessmentPBT:Not applicable. vPvB:Not applicable.

13 Disposal considerations

Waste treatment methodsRecommendationMust be specially treated adhering to official regulations.

Smaller quantities can be disposed of with household waste.

Uncleaned packaging:Recommendation:Disposal must be made according to official regulations.

Recommended cleansing agents: Water, if necessary together with cleansing agents.

14 Transport information

Land transport ADR/RID (cross-border)ADR/RID class: -

Maritime transport IMDG:IMDG Class: -

Marine pollutant: No

Air transport ICAO-TI and IATA-DGR:ICAO/IATA Class: -

UN "Model Regulation": -(Contd. on page 6)

AU


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(Contd. of page 5)

Special precautions for userNot applicable.

15 Regulatory information

Safety, health and environmental regulations/legislation specific for the substance or mixture

Australian Inventory of Chemical Substances

7732-18-5 water

50-99-7 dextrose

9002-18-0 agar

9000-71-9 casein

73049-73-7 meat peptone


7647-14-5 sodium chloride

9005-65-6 Tween 80 Chemical safety assessment:A Chemical Safety Assessment has not been carried out.

16 Other information

Disclaimer:

To the best of our knowledge, the information contained herein is accurate. However, neither BD or any of itssubsidiaries assums any liabilities whatsoever for the accuracy or completeness of the information containedherein. Final determination of suitability of any material is the sole responsibility of the user. All materials may

present unknown hazards and should be used with caution. Although certain hazards described herein, we cannotguarantee that these are the only hazards that exist.

Relevant phrasesH300 Fatal if swallowed.

H400 Very toxic to aquatic life.H410 Very toxic to aquatic life with long lasting effects.

R28 Very toxic if swallowed.R32 Contact with acids liberates very toxic gas.

R50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Department issuing MSDS:Environmental, Health & SafetyCreated by Michael J. Spinazzola

Contact: Technical Service RepresentativeAbbreviations and acronyms:ADR: Accord europen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)

RID: Rglement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the

International Transport of Dangerous Goods by Rail)

IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport Association

IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)

ICAO: International Civil Aviation Organization

ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)

LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percent

AU

Documents

Vial H Influenzae Antiserum Poly 1ML_MSDS