Material Safety Data Sheet

Transcription

1 1. Product identification Name Material # Size GenDx-BigDye Ready Reaction mix rxn v1.1 Part of the SBTexcellerator workflow. Part of AlleleSEQR kit catalog # : PCR/Sequencing kit RUO HLA-A 07K K38-02 HLA-B 07K K39-02 HLA-C 07K K40-04 HLA-DRB1 07K K41-02 HLA-DPB1 07K K43-02 HLA-DQB1 07K K42-02 Company information GenDx Yalelaan CM, Utrecht The Netherlands Phone: +31 (0) info@gendx.com Emergency phone +31 (0) Document M Version 1 Revision date Component description BigDye -Terminator enzymes v1.1 Recommended use Research Use Only 2. Hazards identification Classification of the substance or mixture Classification according to Regulation (EC) NO 1272/2008 [CLP]: Physical hazards Health hazards Environmental hazards Additional information Not classified Not classified Not classified Label elements Labelling according to Regulation (EC) No 1272/2008 [CLP]: Hazard pictograms Signal word Hazard statements No pictogram Precautionary statements Prevention Response Storage Disposal Other hazards This mixture does not contain any substances that are assessed to be a PBT or a vpvb. 1 of 7

2 3. Composition / Information on ingredients Component CAS-No. EINECS-No. Weight percent REACH Registration number Classification according to Regulation (EC) No 1272/2008 [CLP] (10-30) XXXX Not classified 4. First aid measures Description of first aid measures Eye contact Skin contact Inhalation Ingestion Notes to Physician Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Rinse with plenty of water. Immediate medical attention is not required. Not expected to be an inhalation hazard under anticipated conditions of normal use of this material. Consult a physician if necessary. Not expected to present a significant ingestion hazard under anticipated conditions of normal use. If you feel unwell, seek medical advice. Treat symptomatically. Most important symptoms and effects, both acute and delayed: Indication of any immediate medical attention and special treatment needed: 5. Fire-fighting measures Extinguishing media Suitable extinguishing media Water spray. Carbon dioxide (CO2). Foam. Dry chemical. Unsuitable extinguishing media No information available. Specific hazards arising from the substance or mixture: Advice for firefighters: Not known. Standard procedure for chemical fires. 6. Accidental release measures Personal precautions, protective equipment and emergency procedures Ensure adequate ventilation. Always wear recommended Personal Protective Equipment. Use personal protection equipment. See Section 8 for more detail. Environmental precautions No special environmental precautions required. Avoid discharge into drains and waterways whenever possible. Methods and material for containment and cleaning up Soak up with inert absorbent material. Reference to other sections See section 8 for more information. 2 of 7

3 7. Handling and storage Precautions for safe handling Use personal protective equipment as required. No special handling advices are necessary. Conditions for safe storage, including any incompatibilities Keep in a dry, cool and well-ventilated place. Keep in properly labelled containers. Specific end use(s) For research use only. 8. Exposure controls & personal protection Control Parameters Exposure limits Chemical name EU OEL (TWA) EU OEL (STEL) EU Skin Notation Chemical Name Austria Belgium (TWA) Denmark (TWA) Finland OEL (TWA) 10 mg/m 3 Chemical Name France OEL (VME) Germany OEL (TWA) Ireland (TWA) Italy OEL (TWA) 10 mg/m 3 10 mg/m 3 Chemical Name Sweden - Occupational Exposure Limits - TLVs (LLVs) Netherlands OEL (MAC) Spain OEL (TWA) United Kingdom 10 mg/m 3 10 mg/m 3 Chemical Name European Union France OEL (VME) Germany OEL (TWA) 10 mg/m 3 Chemical Name Italy OEL (TWA) Portugal Netherlands OEL (MAC) Finland OEL (TWA) Chemical Name Austria Denmark Poland Switzerland Chemical Name Ireland Norway Lithuania OEL (TWA) Spain OEL (TWA) 10 mg/m 3 3 of 7

4 Engineering measures: Exposure controls Personal protection equipment Respiratory protection Hand Protection Eye Protection Skin and body protection Hygiene measures Ensure adequate ventilation, especially in confined areas In case of insufficient ventilation wear respirators and components tested and approved under appropriate government standards. Wear suitable gloves. Glove material: Compatible chemical-resistant gloves. Tight sealing safety goggles. Wear suitable protective clothing. Handle in accordance with good industrial hygiene and safety practice. Environmental exposure controls: No special environmental precautions required. Avoid discharge into drains and waterways whenever possible. 9. Physical and chemical properties Information on basic physical and chemical properties Appearance Liquid Odor ph Melting point/melting range C >0 F >32 Boiling point/boiling range C >100 F >212 Flash point C>90 F >160 Autoignition temperature C F Decomposition temperature C F Evaporation rate Flammability (solid, gas) Upper explosion limit Lower explosion limit Vapour pressure Relative density Specific gravity Solubility Soluble in water Partition coefficient n-octanol/water Explosive properties Other information No further relevant information available 10. Stability and reactivity Reactivity Chemical stability Possibility of hazardous reactions Conditions to avoid Incompatible materials Hazardous decomposition products known Stable under normal conditions Hazardous reaction has not been reported under normal processing. Strong acids. Oxidizing agents. Acetic anhydride. Isocyanates. Ammonia. Bases. Carbon oxides. 4 of 7

5 11. Toxicological information Information on toxicological effects Chemical name LD50 (oral,rat/mouse) LD50 (dermal,rat/rabbit) LC50 (inhalation,rat/mouse) = mg/kg Oral no data available >570mg/m 3 (Rat) Principle Routes of Exposure, Potential Health Effects Irritation Corrosivity Sensitisation STOT - Single Exposure STOT - Repeated Exposure Carcinogenicity Mutagenicity Reproductive toxicity Aspiration Hazard 12. Ecological information Toxicity Contains no substances known to be hazardous to the environment or not degradable in waste water treatment plants. Chemical name Freshwater Algae Data Water Flea Data no data available Daphnia magna EC50>500 mg/l (24h) Freshwater Fish Microtox Data Iog Pow Species Data no data available no data available IogPow-1.76 Persistence and degradability Bioaccumulative potential Inherently biodegradable. Material does not bioaccumulate. Results of PBT and vpvb assessment This mixture does not contain any substances that are assessed to be a PBT or a vpvb. Other adverse effects No further relevant information available. 13. Disposal considerations Waste treatment methods The generation of waste should be avoided or minimized wherever possible. Empty containers or liners may retain some product residues. This material and its container must be disposed of in according to approved disposal technique. Disposal of this product, its solutions or of any by-products, shall comply with the requirements of all applicable local, regional or national/federal regulations. 14. Transport information IATA / ADR / DOT-US / IMDG Not classified as dangerous in the meaning of transport regulations. UN Number UN proper shipping name Transport hazard class(es) Packing group 5 of 7

6 Environmental Hazards Special precautions for user Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code 15. Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture Substances of Very High Concern Restricted substances under EC 1907/2006, Annex XVII Substances listed under Annex I of Regulation (EC) No 689/2008 Restricted substances under Annex V of Regulation (EC) No 689/2008 Substances under Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC German Water hazard classes (Wassergefährdungsklassen) Chemical name Weight percent Germany - Water Classification (VwVwS) - Annex 1 Germany - Water Classification (VwVwS) - Annex 2 - Water Hazard Classes hazard class 1 - low hazard to waters Germany - Water Classification (VwVwS) - Annex 3 no data available Other International Inventories Chemical name EINECS (European Union) ELINCS (European List of Notified Chemical Substances) ENCS (Japan) PICCS (Philippines) Listed - Listed Listed Chemical name AICS (Australia) South Korea (KECL) Canada (DSL) NDSL Listed Listed Listed - Chemical Safety Assessment No chemical safety assessment has been carried out. 6 of 7

7 16. Other information References ECHA: TOXNET: echemportal: LOLI database: Classification and procedure used to derive the classification for mixtures according to Regulation (EC) 1272/2008 [CLP]: "The above information was acquired by diligent search and/or investigation and the recommendations are based on prudent application of professional judgment. The information shall not be taken as being all inclusive and is to be used only as a guide. All materials and mixtures may present unknown hazards and should be used with caution. Since the Company cannot control the actual methods, volumes, or conditions of use, the Company shall not be held liable for any damages or losses resulting from the handling or from contact with the product as described herein. THE INFORMATION IN THIS SDS DOES NOT CONSTITUTE A WARRENTY, EXPRESSED OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PUPOSE" 7 of 7