: Ibuprofen impurity B CRS

Transcription

1 Date of issue: 30/05/2017 Revision date: 30/05/2017 Supersedes: 07/07/2015 Version: 10.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form Trade name : Mixtures Product code : : Ibuprofen impurity B CRS 1.2. Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses Main use category Use of the substance/mixture Function or use category : The product is intended for research, analysis and scientific education. : For professional use only : Laboratory chemicals Uses advised against Restrictions on use 1.3. Details of the supplier of the safety data sheet European Directorate for the Quality of Medicines & Healthcare EDQM, Council of Europe Strasbourg - France T +33(0) F +33(0) sds@edqm.eu Emergency telephone number Emergency number : +33(0) SECTION 2: Hazards identification 2.1. Classification of the substance or mixture : Do not use : Ingestion, Inhalation, Dermal Classification according to Regulation (EC) No. 1272/2008 [CLP]Mixtures/Substances: SDS EU 2015: According to Regulation (EU) 2015/830 (REACH Annex II) Flammable liquids, Category 2 Acute toxicity (oral), Category 4 Acute toxicity (dermal), Category 4 H225 H302 H312 Acute toxicity (inhalation:dust,mist) Category 4 H332 Serious eye damage/eye irritation, Category 2 H319 Full text of H statements : see section 16 Adverse physicochemical, human health and environmental effects Expert judgement and weight of evidence determination Label elements Labelling according to Regulation (EC) No. 1272/2008 [CLP] Extra labelling to displayextra classification(s) to display Hazard pictograms (CLP) : Signal word (CLP) Hazard statements (CLP) Precautionary statements (CLP) : Danger GHS02 GHS07 : H225 - Highly flammable liquid and vapour H302+H312+H332 - Harmful if swallowed, in contact with skin or if inhaled H319 - Causes serious eye irritation : P261 - Avoid breathing vapours P280 - Wear protective gloves P301+P312 - IF SWALLOWED: Call a POISON CENTER if you feel unwell Labelling according to: exemption for inner packaging where the contents do not exceed 10ml No labelling required 23/05/2017 EN (English) 1/6

2 2.3. Other hazards SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable 3.2. Mixtures Name Product identifier % Classification according to Regulation (EC) No. 1272/2008 [CLP] Acetonitrile (CAS-No.) (EC-No.) (EC Index-No.) <= 100 Flam. Liq. 2, H225 Acute Tox. 4 (Inhalation), H332 Acute Tox. 4 (Dermal), H312 Acute Tox. 4 (Oral), H302 Eye Irrit. 2, H319 IBUPROFEN IMPURITY B (CAS-No.) <= 0,1 Acute Tox. 4 (Oral), H302 Eye Irrit. 2, H319 STOT SE 3, H335 Full text of H-statements: see section 16 SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures after inhalation First-aid measures after skin contact First-aid measures after eye contact First-aid measures after ingestion : Move to fresh air. Assure fresh air breathing. : Wipe off as much as possible (using a clean, soft, absorbent material). Wash with plenty of soap and water. : Rinse with water while holding the eyes wide open. : Rinse mouth Most important symptoms and effects, both acute and delayed Symptoms/effects after inhalation : Insufficient data available. Symptoms/effects after skin contact : Insufficient data available. Symptoms/effects after eye contact : Insufficient data available Indication of any immediate medical attention and special treatment needed Get medical advice/attention. If possible show this sheet, if not available show packaging or label. SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media : Extinguishing blanket Special hazards arising from the substance or mixture Fire hazard : See Heading Advice for firefighters Firefighting instructions : Use extinguishing media appropriate for surrounding fire. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures General measures : Avoid any direct contact with the product. Do not breathe dust/fume/gas/mist/vapours/spray For non-emergency personnel For emergency responders 6.2. Environmental precautions 6.3. Methods and material for containment and cleaning up Methods for cleaning up : Ensure waste is collected and contained. Clean thoroughly Reference to other sections 23/05/2017 EN (English) 2/6

3 SECTION 7: Handling and storage 7.1. Precautions for safe handling Additional hazards when processed Precautions for safe handling Hygiene measures : The attention of the user is drawn to the risks possibly incurred by using the product for any other purpose than that for which it was intended. : Material should be handled with caution. Avoid any direct contact with the product. : Handle in accordance with good industrial hygiene and safety procedures Conditions for safe storage, including any incompatibilities Technical measures : Comply with applicable regulations. Storage conditions : Store locked up Specific end use(s) See Heading 1. SECTION 8: Exposure controls/personal protection 8.1. Control parameters 8.2. Exposure controls Appropriate engineering controls: Keep in a well-ventilated room. Use only in a exhaust booth with integrated air filter. High efficiency particulate air filter (HEPA filter). Hand protection: Chemically resistant protective gloves. EN 374 Eye protection: Safety glasses. DIN EN 166 Skin and body protection: Use chemically protective clothing. DIN EN Respiratory protection: Dust production: dust mask with filter type P3. DIN EN 140 & 149. Liquid product : Aerosol mask. Wear breathing apparatus if exposed to vapours/dusts/aerosols SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state Colour Odour Odour threshold ph Relative evaporation rate (butylacetate=1) Melting point Freezing point Boiling point Flash point Auto-ignition temperature Decomposition temperature Flammability (solid, gas) Vapour pressure Relative vapour density at 20 C Relative density Solubility Log Pow Viscosity, kinematic Viscosity, dynamic Explosive properties Oxidising properties : Liquid : See Heading 2, 4.2, 8. Not applicable. 23/05/2017 EN (English) 3/6

4 Explosive limits 9.2. Other information SECTION 10: Stability and reactivity Reactivity Stable under normal conditions Chemical stability Possibility of hazardous reactions Conditions to avoid Incompatible materials None under normal use. See Heading Hazardous decomposition products When heated to decomposition, emits dangerous fumes. SECTION 11: Toxicological information Information on toxicological effects Acute toxicity : Oral: Harmful if swallowed. Dermal: Harmful in contact with skin. Inhalation:dust,mist: Harmful if inhaled. ATE CLP (oral) ATE CLP (dermal) ATE CLP (dust,mist) Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT-single exposure STOT-repeated exposure Aspiration hazard 500,000 mg/kg bodyweight 1100,000 mg/kg bodyweight 1,500 mg/l/4h : Causes serious eye irritation. (Lack of data) (Lack of data) (Lack of data) (Further details: Acute toxicity) SECTION 12: Ecological information Toxicity Ecology - general : Hazardous waste. Use suitable disposal containers Persistence and degradability Bioaccumulative potential Acetonitrile ( ) Log Pow -0, Mobility in soil Results of PBT and vpvb assessment Other adverse effects 23/05/2017 EN (English) 4/6

5 SECTION 13: Disposal considerations Waste treatment methods Regional legislation (waste) SECTION 14: Transport information In accordance with ADR / IATA / IMDG : Dispose in a safe manner in accordance with local/national regulations. ADR IMDG IATA UN number UN proper shipping name ACETONITRILE ACETONITRILE Acetonitrile Transport document description UN 1648 ACETONITRILE, 3, II, (D/E) UN 1648 ACETONITRILE, 3, II (2 C c.c.) UN 1648 Acetonitrile, 3, II Transport hazard class(es) Packing group II II II Environmental hazards Dangerous for the environment : No Special precautions for user - Overland transport Classification code (ADR) Limited quantities (ADR) Excepted quantities (ADR) Packing instructions (ADR) Mixed packing provisions (ADR) Portable tank and bulk container instructions (ADR) Portable tank and bulk container special provisions (ADR) Tank code (ADR) Vehicle for tank carriage Dangerous for the environment : No Marine pollutant : No : F1 : 1l : E2 No supplementary information available : P001, IBC02, R001 : MP19 : T7 : TP2 : LGBF : FL Transport category (ADR) : 2 Special provisions for carriage - Operation (ADR) Hazard identification number (Kemler No.) : 33 Orange plates : : S2, S20 Dangerous for the environment : No Tunnel restriction code (ADR) - Transport by sea Limited quantities (IMDG) Excepted quantities (IMDG) Packing instructions (IMDG) IBC packing instructions (IMDG) Tank instructions (IMDG) Tank special provisions (IMDG) EmS-No. (Fire) EmS-No. (Spillage) : D/E : 1 L : E2 : P001 : IBC02 : T7 : TP2 : F-E : S-D 23/05/2017 EN (English) 5/6

6 Stowage category (IMDG) Flash point (IMDG) Properties and observations (IMDG) : B : 2 C c.c. MFAG-No : Air transport PCA Excepted quantities (IATA) PCA Limited quantities (IATA) PCA limited quantity max net quantity (IATA) : Colourless, volatile liquid. Flashpoint: 2 C c.c. Explosive limits: 3% to 16% Miscible with water.when involved in a fire, evolves toxic cyanide fumes. Harmful if swallowed, by skin contact or by inhalation. : E2 : Y341 : 1L PCA packing instructions (IATA) : 353 PCA max net quantity (IATA) : 5L CAO packing instructions (IATA) : 364 CAO max net quantity (IATA) ERG code (IATA) : 60L : 3L Transport in bulk according to Annex II of Marpol 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 REACH substances with Annex XVII restrictions Contains no substance on the REACH candidate list Contains no REACH Annex XIV substances National regulations Chemical safety assessment SECTION 16: Other information Full text of H- and EUH-statements: Acute Tox. 4 (Dermal) Acute toxicity (dermal), Category 4 Acute Tox. 4 (Inhalation) Acute toxicity (inhal.), Category 4 Acute Tox. 4 (Oral) Acute toxicity (oral), Category 4 Eye Irrit. 2 Serious eye damage/eye irritation, Category 2 Flam. Liq. 2 Flammable liquids, Category 2 STOT SE 3 Specific target organ toxicity Single exposure, Category 3, Respiratory tract irritation H225 Highly flammable liquid and vapour H302 Harmful if swallowed H312 Harmful in contact with skin H319 Causes serious eye irritation H332 Harmful if inhaled H335 May cause respiratory irritation SDS EU (REACH Annex II) DISCLAIMER OF LIABILITY The EDQM has created this SDS as a downstream user for regulatory compliance to rules applicable to chemicals only. This article is intended only for small-volume laboratory analysis and other routine testing prescribed in the pharmacopoeia or EDQM study protocol, under controlled conditions and by professionals only. Any other use of this article or the SDS information is the sole responsibility of the user. This substance is present in articles in quantities totalling under 10 kg per year. There is no human or environmental exposure under intended and foreseeable conditions of use. The user has the responsibility for handling, storage, use conditions and disposal of this article and for any use of the information in this SDS. The information has been obtained from suppliers and is without any warranty, express or implied, regarding its correctness. For this and other reasons, we do not assume responsibility and expressly disclaim liability for loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal of the article. 23/05/2017 EN (English) 6/6