SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product name: Synonyms: doxium EC number: 243-531-5 CAS number: 20123-80-2 (anhydrous substance) REACH registration number: a REACH registration number is not available for this substance as this substance or its uses are exempted from registration, the annual tonnage does not require a registration or the registration is envisaged for a later registration deadline 1.2. Relevant identified uses of the substance or mixture and uses advised against Manufacture of medicinal products. 1.3. Details of the supplier of the safety data sheet FSP Galena Krucza 62 50-984 Wrocław, Poland tel.: (48) 71 7106316, (48) 71 7106205 email: info@galena.pl 1.4. Emergency telephone number 112 SECTION 2: HAZARDS IDENTIFICATION 2.1. Classification of the substance or mixture This product is not classified as hazardous according to Regulation (EC) No 1272/2008. 2.2. Label elements The product does not need to be labelled in accordance with EC directives or respective national laws. 2.3. Other hazards The substance does not meet the criteria for PBT or vpvb. No other hazards. Page 1 / 8
SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS 3.1. Substances Ingredient Content EC number CAS number Molecular formula Molecular weight Classification Calcium dobesilate monohydrate > 99% 243-531-5 20123-80-2 (anhydrous substance) C 12H 10CaO 10S 2, H 2O 436.4-3.2 Mixtures Not applicable. SECTION 4: FIRST AID MEASURES 4.1. Description of first aid measures If inhaled: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical advice. In case of skin contact: Wash with plenty of soap and water. If skin irritation occurs get medical advice. In case of eye contact: Rinse cautiously with water for several minutes. If eye irritation occurs get medical advice. If swallowed: Rinse mouth with water. Do not induce vomiting. Get medical advice. 4.2. Most important symptoms and effects, both acute and delayed If inhaled: Dust may cause mild allergy and/or irritation of mucous membrane. In case of skin contact: Prolonged contact with skin may cause slight irritation. In case of eye contact: Direct contact with eyes may cause slight irritation. If swallowed: Swallowing may cause mild irritation of oral cavity and upper alimentary tract. 4.3. Indication of any immediate medical attention and special treatment needed Not available. Page 2 / 8
SECTION 5: FIREFIGHTING MEASURES 5.1. Extinguishing media Suitable extinguishing media: water, dry chemical powder, foam, carbon dioxide. 5.2. Special hazards arising from the substance or mixture Non-flammable substance. Under fire conditions it emits toxic fumes (CO, SO 2). 5.3. Advice for firefighters Wear self contained breathing apparatus for fire fighting if necessary. SECTION 6: ACCIDENTAL RELEASE MEASURES 6.1. Personal precautions, protective equipment and emergency procedures For non-emergency personnel Wear suitable protective equipment as described in Section 8. Avoid dust formation. Avoid breathing dust. Handle and store in a well-ventilated area. For emergency personnel Wear suitable protective equipment as described in Section 8. Suitable fabric for personal protective clothing: cotton, polyester. 6.2. Environmental precautions Do not allow to enter ground waters and sewage. Collect substance into appropriate container, dispose according to local regulations. 6.3. Methods and material for containment and cleaning up Avoid dust formation during collecting and disposal. Wash contaminated area with water. During cleaning wear suitable protective equipment as described in Section 8. 6.4. Reference to other sections For description of suitable protective equipment refer to Section 8. For disposal considerations refer to Section 13. SECTION 7: HANDLING AND STORAGE 7.1. Precautions for safe handling Handle with care. Avoid dust formation. Handle and store in a well-ventilated area. Do not allow to enter ground waters and sewage. Do not eat, drink or smoke when handling the substance. Do not get in eyes, on skin, or on clothing. Page 3 / 8
Wash hands and face thoroughly after handling. Contaminated work clothing should not be allowed out of the workplace. Take off contaminated clothing and wash before reuse. 7.2. Conditions for safe storage, including any incompatibilities Store indoors below 25 C in tightly closed original containers. Store in a well-ventilated area. Protect from light and moisture. Incompatibilities: iron salts. 7.3. Specific end use(s) When using the substance for manufacture of medicinal products according to the specific end use described in subsection 1.2 ensure appropriate transportation, storage, sampling and usage according to the rules of Good Manufacturing Practice (GMP). SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1. Control parameters Occupational exposure limit values are not defined for the substance. 8.2. Exposure controls Appropriate engineering controls Store and handle indoors. Store in a well-ventilated area. Protect from light and moisture. Appropriate personal protective equipment Eye/face protection: Skin protection: Respiratory protection: Environmental exposure controls use safety glasses use latex protective gloves of minimal thickness 0.20 mm. Use work clothing made of cotton or polyester use dust masks such as two-layer medical masks. Do not allow to enter ground waters and sewage. Collect substance into appropriate container, dispose according to local regulations. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES 9.1. Information on basic physical and chemical properties a) Appearance: solid substance, white crystalline powder b) Odour: no odour c) Odour threshold: does not apply d) ph: 4,5 6,0 (10% w/v solution in water) e) Melting point/freezing point: no data available f) Initial boiling point and boiling range: no data available g) Flash point: no data available Page 4 / 8
h) Evaporation rate: no data available i) Flammability (solid, gas): non-flammable j) Upper/lower flammability or explosive limits: no data available k) Vapour pressure: no data available l) Vapour density: no data available m) Relative density: 0.7 0.8 n) Solubility(ies): very soluble in water (133 g/l at 20 C), freely soluble in ethanol, very slightly soluble in 2-propanol, practically insoluble in methylene chloride o) Partition coefficient: n-octanol/water: no data available p) Auto-ignition temperature: no data available q) Decomposition temperature: no data available r) Viscosity: no data available s) Explosive properties: not classified as explosive t) Oxidising properties: not classified as oxidising 9.2. Other information No other information SECTION 10: STABILITY AND REACTIVITY 10.1. Reactivity No reactivity hazards of the substance are known. 10.2. Chemical stability The substance is stable under storage and handle conditions described on Section 7. 10.3. Possibility of hazardous reactions No hazardous reactions of the substance are known. 10.4. Conditions to avoid Avoid dust formation. Use personal protective equipment specified in Section 8. 10.5. Incompatible materials Iron salts may cause discoloration of the substance from white to yellow. This reaction is not dangerous. 10.6. Hazardous decomposition products Page 5 / 8
SECTION 11: TOXICOLOGICAL INFORMATION 11.1. Information on toxicological effects a) acute toxicity: rat, oral, LD 50: 7061 mg/kg (source: Toksikologicheskii Vestnik. Vol. (1), Pg. 29, 1994) mouse, oral, LD50: 7549 mg/kg (source: Toksikologicheskii Vestnik. Vol. (1), Pg. 29, 1994) b) skin corrosion/irritation: no data available c) serious eye damage/irritation: no data available d) respiratory or skin sensitisation: no data available e) germ cell mutagenicity: no data available f) carcinogenicity: no data available g) reproductive toxicity: no data available h) STOT-single exposure: no data available i) STOT-repeated exposure: no data available j) aspiration hazard: no data available Possible symptoms related to the physical, chemical and toxicological characteristics If inhaled: Dust may cause mild allergy and/or irritation of mucous membrane. In case of skin contact: Prolonged contact with skin may cause slight irritation. In case of eye contact: Direct contact with eyes may cause slight irritation. If swallowed: Swallowing may cause mild irritation of oral cavity and upper alimentary tract. SECTION 12: ECOLOGICAL INFORMATION 12.1. Toxicity 12.2. Persistence and degradability 12.3. Bioaccumulative potential Page 6 / 8
12.4. Mobility in soil 12.5. Results of PBT and vpvb assessment 12.6. Other adverse effects SECTION 13: DISPOSAL CONSIDERATIONS 13.1. Waste treatment methods Observe all national and local environmental regulations. Do not allow to enter ground waters and sewage. Avoid dust formation during collecting and disposal. Wash contaminated area with water. Product packaging must be emptied prior to disposal. Product packaging may be recycled after being thoroughly washed. If recycling of product packaging is not possible, it must be disposed of in compliance with the respective national regulations. SECTION 14: TRANSPORT INFORMATION 14.1. UN number 14.2. UN proper shipping name 14.3. Transport hazard class(es) 14.4. Packing group 14.5. Environmental hazards 14.6. Special precautions for user Transport by sheltered vehicle is recommended. 14.7. Transport in bulk according to Annex II of MARPOL and the IBC Code Page 7 / 8
SECTION 15: REGULATORY INFORMATION 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture International regulations that apply: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, 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, Commission Regulation (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); Commission Regulation (EU) 2015/830 of 28 May 2015 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). 15.2. Chemical safety assessment Chemical safety assessment has not been carried out. SECTION 16: OTHER INFORMATION Information about revision of Safety Data Sheet Most important changes in relation to edition IV dated 01.12.2010: name of sections were updated according to Regulation (EU) No. 2015/830 of 28 May 2015; information about classification according to Directive 67/548/EEC was deleted from sections 2.1 and 16. Training advice Provide adequate information, instruction and training for operators. Disclaimer The above information is based on the present state of our knowledge. The information presented in this document relate solely to the product and cannot be applied after the product has been processed. Page 8 / 8