Safety data sheet Label elements The product shall not be classified as hazardous according to EU classification and labelling rules.
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1 Safety data sheet Revision: Replaces: Version: 0101/EU-UK SECTION 1: Identification of the substance/mixture and of the company/undertaking 11 Product identifier Trade name: Pertussis Toxin <10000µg/ml 12 Relevant identified uses of the substance or mixture and uses advised against Recommended uses: Vaccination 13 Details of the supplier of the safety data sheet Supplier: SSI Diagnostica A/S Herredsvejen Hillerød Denmark Tel: Fax: ssidiagnostica@ssidiagnosticacom 14 Emergency telephone number Emergency telephone comments: The emergency telephone is open between 8 am and 4 pm on workdays SECTION 2: Hazards identification 21 Classification of the substance or mixture CLP-classification (Regulation (EC) No 1272/2008): Most serious harmful effects: The product shall not be classified as hazardous according to EU classification and labelling rules Potentially neurotoxic 22 Label elements The product shall not be classified as hazardous according to EU classification and labelling rules 23 Other hazards The product does not contain any PBT or vpvb substances SECTION 3: Composition/information on ingredients 32 Mixtures Registration number CAS/ EC No Substance CLP-classification (Regulation (EC) No 1272/2008) w/w% Note Pertussis Toxin Acute Tox 2; H330 Acute Tox 3; H311 Acute Tox 4; H302 <1 Please see section 16 for the full text of H-phrases SECTION 4: First aid measures 41 Description of first aid measures 1 / 5 Pertussis Toxin <10000µg/ml
2 Inhalation: Ingestion: Skin: Eyes Other information: Seek fresh air Seek medical advice in case of persistent discomfort Wash out mouth thoroughly and drink 1-2 glasses of water in small sips Seek medical advice in case of persistent discomfort Remove contaminated clothing Wash the skin thoroughly with water and continue washing for a long time Seek medical advice in case of persistent discomfort Flush with water (preferably using eye wash equipment) until irritation subsides Seek medical advice if symptoms persist When obtaining medical advice, show the safety data sheet or label 42 Most important symptoms and effects, both acute and delayed Potentially neurotoxic CX XX02# 43 Indication of any immediate medical attention and special treatment needed No special immediate treatment required SECTION 5: Firefighting measures 51 Extinguishing media Suitable extinguishing media Unsuitable extinguishing media Extinguish with powder, foam, carbon dioxide or water mist Use water or water mist to cool non-ignited stock Do not use water stream, as it may spread the fire 52 Special hazards arising from the substance or mixture The product is not directly flammable Avoid inhalation of vapour and fumes seek fresh air Can generate harmful flue gases containing carbon monoxide in the event of fire 53 Advice for firefighters If there is a risk of exposure to vapour and flue gases, a self-contained breathing apparatus must be worn Move containers from danger area if it can be done without risk Avoid inhalation of vapour and flue gases seek fresh air SECTION 6: Accidental release measures 61 Personal precautions, protective equipment and emergency procedures For non-emergency personnel: Wear gloves For emergency responders: Normal protective clothing equivalent to EN 469 is recommended 62 Environmental precautions Prevent spillage from entering drains and/or surface water 63 Methods and material for containment and cleaning up Wipe up spills with a cloth 64 Reference to other sections See section 8 for type of protective equipment See section 13 for instructions on disposal SECTION 7: Handling and storage 71 Precautions for safe handling Running water and eye wash equipment should be available 72 Conditions for safe storage, including any incompatibilities Store in a dry, cool, well-ventilated area Store at temperatures between 2-8 C The product should be stored safely, out of reach of children and away from food, animal feeding stuffs, etc 73 Specific end use(s) None SECTION 8: Exposure controls/personal protection 81 Control parameters Legal basis: 82 Exposure controls Appropriate engineering controls: Commission Directive 2000/39/EC (Occupational Exposure Limits) Last amended by Commission Directive 2009/161/EU Contains no substances subject to reporting requirements Wash hands before breaks, before using restroom facilities, and at the end of work Wear the personal protective equipment specified below 2 / 5 Pertussis Toxin <10000µg/ml
3 Personal protective equipment, eye/face protection: Personal protective equipment, skin protection: Personal protective equipment, respiratory protection: Environmental exposure controls: Not required Wear plastic or rubber protective gloves Gloves must conform to EN 374 Breakthrough time has not been determined for the product Change gloves often Not required Ensure compliance with local regulations for emissions SECTION 9: Physical and chemical properties 91 Information on basic physical and chemical properties State: Liquid Colour: Odour: Odour threshold: ph (solution for use): ph (concentrate): Melting point/freezing point: Initial boiling point and boiling range: Flash point: Evaporation rate: Flammability (solid, gas): Upper/lower flammability limits: Upper/lower explosive limits: Vapour pressure: Vapour density: Relative density: Solubility: Partition coefficient n-octanol/water: Auto-ignition temperature: Decomposition temperature: Viscosity: Explosive properties: Oxidising properties: 92 Other information None SECTION 10: Stability and reactivity 101 Reactivity Not reactive 102 Chemical stability The product is stable when used in accordance with the supplier s directions 103 Possibility of hazardous reactions None known 104 Conditions to avoid None known 105 Incompatible materials Avoid contact with strong oxidising agents 106 Hazardous decomposition products None known SECTION 11: Toxicological information 111 Information on toxicological effects Acute toxicity - oral: Acute toxicity - dermal: Acute toxicity - inhalation: 3 / 5 Pertussis Toxin <10000µg/ml
4 Skin corrosion/irritation: Serious eye damage/eye irritation: Respiratory sensitisation or skin sensitisation: Germ cell mutagenicity: Carcinogenic properties: Reproductive toxicity: Single STOT exposure: Repeated STOT exposure: Aspiration hazard: Other toxicological effects: Potentially neurotoxic SECTION 12: Ecological information 121 Toxicity 122 Persistence and degradability Test data are not available 123 Bioaccumulative potential 124 Mobility in soil Test data are not available Test data are not available 125 Results of PBT and vpvb assessment The mixture does not meet the criteria for PBT or vpvb 126 Other adverse effects None SECTION 13: Disposal considerations 131 Waste treatment methods Contact the local authorities Avoid discharge to drain or surface water EWC code: Depends on line of business and use, for instance medicines other than those mentioned in SECTION 14: Transport information The product is not covered by the rules for transport of dangerous goods 141 UN number UN proper shipping name Transport hazard class(es) Packing group Environmental hazards Special precautions for user Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code 4 / 5 Pertussis Toxin <10000µg/ml
5 - SECTION 15: Regulatory information 151 Safety, health and environmental regulations/legislation specific for the substance or mixture Special provisions: None 152 Chemical safety assessment Chemical safety assessment has not been performed SECTION 16: Other information Changes have been made in the following sections: Abbreviation explanations: Classification method: H-phrases: Training: Other information: 1,2,3,8,15,16 PBT: Persistent, Bioaccumulative and Toxic vpvb: Very Persistent and Very Bioaccumulative STOT: Specific Target Organ Toxicity Calculation based on the hazards of the known components H302 Harmful if swallowed H311 Toxic in contact with skin H330 Fatal if inhaled No special training is required, but a thorough knowledge of this safety data sheet should be a prerequisite condition This safety data sheet has been prepared for and applies to this product only It is based on our current knowledge and the information that the supplier was able to provide about the product at the time of preparation The safety data sheet complies with applicable law on preparation of safety data sheets in accordance with 1907/2006/EC (REACH) as subsequently changed HSV/ Bureau Veritas HSE Denmark A/S Oldenborggade 25, DK-7000 Fredericia T: , infohse@dkbureauveritascom, Web: wwwhsebureauveritasdk (Made in Toxido ) EU_UK 5 / 5 Pertussis Toxin <10000µg/ml
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