SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING Product name Poly (Diisopropyl Fumarate)
Product from R&D - For R&D use only
Product Number SP-9P-0-001
SPECIFIC POLYMERS Avenue de l'Europe - Cap Alpha F-34830 CLAPIERS - France
Telephone
Emergency Phone #
E-mail address 2. HAZARDS IDENTIFICATION Classification of the substance or mixture Label elements Pictogram
Not a dangerous substance according to CLP - GHS. This substance is not classified as dangerous according to Directive 67/548/EEC And CE 1272/2008. Caution - substance not yet tested completely
Other hazards - none 3. COMPOSITION/INFORMATION ON INGREDIENTS
For the full text of the H-Statements mentioned in this Section, see Section 16.
4. FIRST AID MEASURES General advice Consult a physician. Show this safety data sheet to the doctor in attendance. If inhaled If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician. In case of skin contact Wash off with soap and plenty of water. Consult a physician. In case of eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. If swallowed Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 5. FIRE-FIGHTING MEASURES Suitable extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. Special protective equipment for fire-fighters Wear self contained breathing apparatus for fire fighting if necessary. 6. ACCIDENTAL RELEASE MEASURES Personal precautions Use personal protective equipment. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. Environmental precautions Do not let product enter drains. Methods and materials for containment and cleaning up Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal. 7. HANDLING AND STORAGE Precautions for safe handling Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed. Normal measures for preventive fire protection. Conditions for safe storage Keep container tightly closed in a dry and well-ventilated place. Store in cool place.
Store under inert gas. Moisture sensitive.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION Personal protective equipment Respiratory protection Where risk assessment shows air-purifying respirators are appropriate use a full-face particle respirator type N100 (US) or type P3 (EN 143) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Hand protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.
The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.
Eye protection Face shield and safety glasses Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Skin and body protection Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Hygiene measures Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance Safety data 10. STABILITY AND REACTIVITY Chemical stability Stable under recommended storage conditions. Conditions to avoid no data available Materials to avoid Strong oxidizing agents Hazardous decomposition products Hazardous decomposition products formed under fire conditions. - Carbon oxides, 11. TOXICOLOGICAL INFORMATION Acute toxicity no data available Skin corrosion/irritation no data available Serious eye damage/eye irritation no data available Respiratory or skin sensitization no data available Germ cell mutagenicity no data available Carcinogenicity
IARC: No component of this product present at levels greater than or equal to 0.1% is identified as
probable, possible or confirmed human carcinogen by IARC.
Reproductive toxicity no data available Specific target organ toxicity - single exposure no data available Specific target organ toxicity - repeated exposure no data available Aspiration hazard no data available Potential health effects Inhalation
May be harmful if inhaled. May cause respiratory tract irritation.
Ingestion
May be harmful if absorbed through skin. May cause skin irritation.
Signs and Symptoms of Exposure To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. Additional Information RTECS: Not available 12. ECOLOGICAL INFORMATION Toxicity Persistence and degradability Bioaccumulative potential Mobility in soil PBT and vPvB assessment Other adverse effects 13. DISPOSAL CONSIDERATIONS Product Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Contaminated packaging Dispose of as unused product. 14. TRANSPORT INFORMATION ADR/RID Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods 15. REGULATORY INFORMATION
This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.
16. OTHER INFORMATION Text of H-code(s) and R-phrase(s) mentioned in Section 3 Further information
The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Specific Polymers, shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale. The product is solely research and development purpose and not intended for food, drug or household purposes.
SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg of the active substance ferrous gluconate PHARMACEUTICAL FORM Red, circular, biconvex sugar-coated tablets CLINICAL PARTICULARS Therapeutic indications Ferrous gluconate tablets 300mg are indicated for the prevention and treatment of iron d