: HEPATITIS B SURFACE ANTIGEN (HBsAg) AY SUBTYPE

Transcription

1 HEPATITIS B SURFACE ANTIGEN (HBsAg) AY SUBTYPE Date of issue: 15/07/2015 Revision date: 15/07/2015 Supersedes: 27/09/2006 Version: 4.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code : / : HEPATITIS B SURFACE ANTIGEN (HBsAg) AY SUBTYPE Type of product : Purified HBsAg from human plasma in a phosphate buffered saline. Thermal inactivated 10 hours at 60ºC Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses Industrial/Professional use spec Use of the substance/mixture : For professional use only : For In Vitro Diagnostic use Uses advised against 1.3. Details of the supplier of the safety data sheet BIOKIT, S.A. Can Malé s/n Lliçà d'amunt - Spain T F infosds@biokit.com Emergency telephone number Emergency number : +44 (0) ( USA & Canada) SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification according to Regulation (EC) No. 1272/2008 [CLP] Not classified 2.2. Label elements Labelling according to Regulation (EC) No. 1272/2008 [CLP] Extra labelling to displayextra classification(s) to display Precautionary statements (CLP) : P280 - Wear eye protection, protective gloves, protective clothing P305+P351+P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing 2.3. Other hazards Adverse physicochemical, human health and environmental effects : To our knowledge, this product does not present any particular risk, provided it is handled in accordance with good occupational hygiene and safety practice. SECTION 3: Composition/information on ingredients 3.1. Substance Not applicable 3.2. Mixture This mixture does not contain any substances to be mentioned according to the criteria of section 3.2 of REACH annex II SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures general First-aid measures after inhalation First-aid measures after skin contact First-aid measures after eye contact : Never give anything by mouth to an unconscious person. If you feel unwell, seek medical advice (show the label where possible). : Allow breathing of fresh air. Allow the victim to rest. : Remove affected clothing and wash all exposed skin area with mild soap and water, followed by warm water rinse. : Rinse immediately with plenty of water. Obtain medical attention if pain, blinking or redness persist. 17/07/2015 EN (English) Document: DRC-731 Edition 4 [P-853] 1/6

2 First-aid measures after ingestion : Rinse mouth. Do NOT induce vomiting. Obtain emergency medical attention Most important symptoms and effects, both acute and delayed Symptoms/injuries : Not expected to present a significant hazard under anticipated conditions of normal use Indication of any immediate medical attention and special treatment needed Treat symptomatically. SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media : Foam. Dry powder. Carbon dioxide. Water spray. Sand. : Do not use a heavy water stream Special hazards arising from the substance or mixture Fire hazard Explosion hazard Hazardous decomposition products in case of fire : Not flammable. : Product is not explosive. : Carbon oxydes (CO, CO2). Nitrogen oxides (NOx) and sulphur oxides Advice for firefighters Firefighting instructions Protection during firefighting : Use water spray or fog for cooling exposed containers. Exercise caution when fighting any chemical fire. Prevent fire-fighting water from entering environment. : Do not enter fire area without proper protective equipment, including respiratory protection. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures For non-emergency personnel Emergency procedures For emergency responders Protective equipment Emergency procedures : Evacuate unnecessary personnel. : Equip cleanup crew with proper protection. : Ventilate area Environmental precautions Prevent entry to sewers and public waters. Notify authorities if liquid enters sewers or public waters Methods and material for containment and cleaning up Methods for cleaning up 6.4. Reference to other sections See Heading 8. Exposure controls and personal protection. : Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Collect spillage. Store away from other materials. SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling : Wash hands and other exposed areas with mild soap and water before eating, drinking or smoking and when leaving work. Provide good ventilation in process area to prevent formation of vapour Conditions for safe storage, including any incompatibilities Storage conditions Incompatible products Incompatible materials Storage temperature : -20 C Heat and ignition sources Prohibitions on mixed storage Special rules on packaging 7.3. Specific end use(s) : Keep container closed when not in use. Keep only in original container. Keep cool. Protect from sunlight. : Strong bases. Strong acids. : Sources of ignition. Direct sunlight. : conditions to be avoided. : Heat sources. Direct sunlight. : Keep only in original container. This device is intended for In Vitro Diagnostic use. Use the product in accordance with the Good Laboratory Practice. SECTION 8: Exposure controls/personal protection 8.1. Control parameters 8.2. Exposure controls Personal protective equipment : Avoid all unnecessary exposure. 17/07/2015 EN (English) Document: DRC-731 Edition 4 [P-853] 2/6

3 Materials for protective clothing Hand protection Eye protection Respiratory protection : Wear suitable protective clothing : Wear protective gloves : Chemical goggles or safety glasses : Respiratory protection equipment not absolutely necessary Environmental exposure controls Other information : Avoid release to the environment. : Do not eat, drink or smoke during use. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Liquid Colour : Colourless. Yellowish. Odour : Odourless. Odour threshold ph Relative evaporation rate (butylacetate=1) Melting point Freezing point Boiling point Flash point Auto-ignition temperature Decomposition temperature Flammability (solid, gas) : Non flammable Vapour pressure Relative vapour density at 20 C Relative density Solubility : Completely soluble. Log Pow Viscosity, kinematic Viscosity, dynamic Explosive properties Oxidising properties Explosive limits 9.2. Other information SECTION 10: Stability and reactivity Reactivity Product is not explosive Chemical stability The product is stable at normal handling and storage conditions Possibility of hazardous reactions No dangerous reactions known under normal conditions of use Conditions to avoid Direct sunlight. Extremely high or low temperatures Incompatible materials Strong acids. Strong bases Hazardous decomposition products Under normal conditions of storage and use, hazardous decomposition products should not be produced. 17/07/2015 EN (English) Document: DRC-731 Edition 4 [P-853] 3/6

4 SECTION 11: Toxicological information Information on toxicological effects Acute toxicity Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard Potential adverse human health effects and symptoms :. SECTION 12: Ecological information Toxicity Persistence and degradability HEPATITIS B SURFACE ANTIGEN (HBsAg) AY SUBTYPE Persistence and degradability Not established Bioaccumulative potential HEPATITIS B SURFACE ANTIGEN (HBsAg) AY SUBTYPE Bioaccumulative potential Not established Mobility in soil Results of PBT and vpvb assessment Other adverse effects Additional information : Avoid release to the environment SECTION 13: Disposal considerations Waste treatment methods Waste disposal recommendations Ecology - waste materials SECTION 14: Transport information In accordance with ADR / RID / IMDG / IATA / ADN : Dispose in a safe manner in accordance with local/national regulations. : Avoid release to the environment. ADR IMDG IATA RID UN number Not regulated for transport UN proper shipping name Transport hazard class(es) 17/07/2015 EN (English) Document: DRC-731 Edition 4 [P-853] 4/6

5 ADR IMDG IATA RID Packing group Environmental hazards Dangerous for the Dangerous for the environment : No environment : No Marine pollutant : No Dangerous for the environment : No No supplementary information available Dangerous for the environment : No Special precautions for user - Overland transport No data available - Transport by sea No data available - Air transport No data available - Rail transport Carriage prohibited (RID) : No Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture EU-Regulations Contains no substances with Annex XVII restrictions Contains no substance on the REACH candidate list Contains no REACH Annex XIV substances National regulations Germany VwVwS Annex reference 12th Ordinance Implementing the Federal Immission Control Act - 12.BImSchV : Water hazard class (WGK) 3, severe hazard to waters (Classification according to VwVwS, Annex 4) : Is not subject of the 12. BlmSchV (Hazardous Incident Ordinance) Netherlands SZW-lijst van kankerverwekkende stoffen SZW-lijst van mutagene stoffen NIET-limitatieve lijst van voor de voortplanting giftige stoffen Borstvoeding NIET-limitatieve lijst van voor de voortplanting giftige stoffen Vruchtbaarheid NIET-limitatieve lijst van voor de voortplanting giftige stoffen Ontwikkeling Chemical safety assessment No chemical safety assessment has been carried out SECTION 16: Other information Data sources Other information : REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. : None. 17/07/2015 EN (English) Document: DRC-731 Edition 4 [P-853] 5/6

6 SDS EU (REACH Annex II) This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product 17/07/2015 EN (English) Document: DRC-731 Edition 4 [P-853] 6/6