: A /50 Blend SORBITOL SPECIAL / Glycerin Dry Basis

Transcription

1 A /50 Blend SORBITOL SPECIAL / Glycerin Dry Basis Revision date: 01/05/2015 Supersedes: 11/01/2012 Version: 3.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form Trade name SDS code Product group : Mixture : : E030 : Trade product 1.2. Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses Use of the substance/preparation : Food/pharmaceutical products Uses advised against 1.3. Details of the supplier of the safety data sheet SPI Pharma Chemin du Vallon du Maire Septemes - France T F CBlasquez@spipharma.com 1.4. Emergency telephone number Emergency number : (Not 24 hrs, business hours only) SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification according to Regulation (EC) No. 1272/2008 [CLP] Classification according to Directive 67/548/EEC or 1999/45/EC Adverse physicochemical, human health and environmental effects 2.2. Label elements Labelling according to Regulation (EC) No. 1272/2008 [CLP] No labelling applicable 2.3. Other hazards This substance/mixture does not meet the PBT criteria of REACH, annex XIII. This substance/mixture does not meet the vpvb criteria of REACH, annex XIII. SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable 3.2. Mixtures Name Product identifier % Classification according to Directive 67/548/EEC Glycerin (CAS No.) (EC no) D-Glucitol (CAS No.) (EC no) Proprietary Other Nonhazardous Components Proprietary Proprietary Name Product identifier % Classification according to Regulation (EC) No. 1272/2008 [CLP] Glycerin (CAS No.) (EC no) D-Glucitol (CAS No.) (EC no) Proprietary Other Nonhazardous Components Proprietary Proprietary 01/05/2015 EN (English) 1/5

2 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 : In case of accident by inhalation: remove casualty to fresh air and keep at rest. : After contact with skin, take off immediately all contaminated clothing, and wash immediately with plenty of water. : In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. : Do not induce vomiting without medical advice. In all cases of doubt, or when symptoms persist, seek medical advice Most important symptoms and effects, both acute and delayed Symptoms/injuries after inhalation Symptoms/injuries after skin contact : direct contact may cause skin irritation. Symptoms/injuries after eye contact : Direct contact with the eyes is likely irritating. Symptoms/injuries after ingestion 4.3. Indication of any immediate medical attention and special treatment needed Treat symptomatically. SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media: : carbon dioxide (CO2), water, dry chemical powder. Unsuitable extinguishing media 5.2. Special hazards arising from the substance or mixture Fire hazard : Not combustible. minimal fire hazard. On combustion forms: carbon oxides (CO and CO2). Explosion hazard. Reactivity Advice for firefighters Protective equipment for firefighters : Extra personal protection: complete protective clothing including self-contained breathing apparatus. In case of fire: Wear self-contained breathing apparatus. Refer to section 8. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures For non-emergency personnel Protective equipment For emergency responders Protective equipment : Wear suitable protective clothing gloves, and eye/face protection. : Wear suitable protective clothing, gloves and eye/face protection Environmental precautions Prevent entry to sewers and public waters. Do not allow to enter into surface water or drains Methods and material for containment and cleaning up For containment Methods for cleaning up : contain the discharged material. : Sweep or shovel spills into appropriate container for disposal. Thoroughly wash the area with water after a spill or leak clean-up Reference to other sections Refer to sections 8 and 13. SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling Hygiene measures : Avoid contact with skin, eyes and clothes. Wash hands thoroughly after handling. Do not breathe dust. : Handle in accordance with good industrial hygiene and safety practice Conditions for safe storage, including any incompatibilities Storage condition(s) : Keep container tightly closed. Store in well ventilated area. Incompatible materials : Acids. Oxidizing agent Specific end use(s) SECTION 8: Exposure controls/personal protection 8.1. Control parameters 01/05/2015 EN (English) 2/5

3 Glycerin ( ) France VME (mg/m³) 10 mg/m³ Italy - Portugal - USA ACGIH ACGIH TWA (mg/m³) 10 mg/m³ United Kingdom WEL TWA (mg/m³) 10 mg/m³ 8.2. Exposure controls Appropriate engineering controls Personal protective equipment : Ensure adequate ventilation. Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure. Engineering controls are not usually necessary if good hygiene practices are followed. : Safety glasses. Gloves. Protective clothing. Hand protection Eye protection Skin and body protection Respiratory protection : Wear protective gloves. : safety glasses with side-shields. : Wear suitable protective clothing. Wear long sleeves. Use protective coverall. : In case of insufficient ventilation, wear suitable respiratory equipment. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Liquid Appearance : clear. Colour odour : mild. Odour threshold ph : 5-7 Melting point Solidification point Boiling point Flash point. Relative evaporation rate (butylacetate=1) Relative evaporation rate (ether=1) Flammability (solid, gas) Explosive limits Vapour pressure Relative vapour density at 20 C Relative density : g/cm³ Solubility : Soluble in water. Log Pow Log Kow Self ignition temperature Decomposition temperature Viscosity, kinematic Viscosity, dynamic Explosive properties Oxidising properties 9.2. Other information SECTION 10: Stability and reactivity Reactivity Chemical stability Stable under normal conditions Possibility of hazardous reactions Hazardous polymerization will not occur. 01/05/2015 EN (English) 3/5

4 10.4. Conditions to avoid Incompatible materials Incompatible materials Acids. Oxidizing agents Hazardous decomposition products Carbon oxides (CO, CO2). SECTION 11: Toxicological information Information on toxicological effects Acute toxicity : Glycerin ( ) LD50 dermal rat LD50 dermal rabbit LC50 inhalation rat (mg/l) D-Glucitol ( ) D-Mannitol ( ) 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 SECTION 12: Ecological information Toxicity Ecology - general mg/kg > mg/kg > mg/kg > 570 mg/m³ (1 hour) mg/kg mg/kg : (Conclusive but not sufficient for classification) ph: 5-7 : (Conclusive but not sufficient for classification) ph: 5-7 : (Conclusive but not sufficient for classification) : (No classification for mutagenicity as none of the components is classified for mutagenicity) : (No classification for carcinogenicity as none of the components is classified for carcinogenicity) : (No classification for reproduction as none of the components is toxic for reproduction) : (None of the components shows specific effects in acute toxicity studies requiring classification for Specific Target Organ Systemic Toxicity single exposure) : (None of the components shows specific effects in acute toxicity studies requiring classification for Specific Target Organ Systemic Toxicity repeated exposure) : : The ecological assessment of this material is based on an evaluation of its components. Not classified as none of the components is classified for aquatic toxicity Persistence and degradability Persistence and degradability Bioaccumulative potential Bioaccumulative potential Mobility in soil Ecology - soil Results of PBT and vpvb assessment This substance/mixture does not meet the PBT criteria of REACH, annex XIII. This substance/mixture does not meet the vpvb criteria of REACH, annex XIII Other adverse effects Other information. 01/05/2015 EN (English) 4/5

5 SECTION 13: Disposal considerations Waste treatment methods Regional legislation (waste) SECTION 14: Transport information Not a dangerous good in sense of transport regulations. SECTION 15: Regulatory information : Dispose of contents/container to comply with applicable local, national and international regulations. Disposal must be done according to official regulations Safety, health and environmental regulations/legislation specific for the substance or mixture EU-Regulations No Annex XVII restrictions Contains no REACH candidate substance Other regulations, restrictions and prohibition regulations : Compliance with following regulations: Regulation (EC) 1907/2006 as amended. Regulation (EC) 1272/2008 as amended. Directive 67/548/EEC as amended. Directive 1999/45/EC as amended National regulations Chemical safety assessment CSA has not been established SECTION 16: Other information Indication of changes Sources of Key data Abbreviations and acronyms : Product name, company address and composition of product were updated. : MSDS. : ACGIH (American Conference of Governement Industrial Hygienists). CAS - Chemical Abstracts Service. CLP - Classification, Labelling and Packaging. CSR - Chemical Safety Report. EC - European Community. EEC - European Economic Community. GHS - Globally Harmonised System. MSDS - Material. OSHA - Occupational Safety and Health Administration. Overland transport (ADR). PEL- Permissible Exposure Level. PBT - Persistent, Bioaccumulative and Toxic substance. REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals. Relat - Relative. SDS -. STEL- Short-Term Exposure Limit. TLV- Threshold Limit Value. TWA- Time Weighted Average. vpvb - Very Persistent and Very Bioaccumulative. 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. 01/05/2015 EN (English) 5/5