Section 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE  
  Product identifiers  
 : 6α-Methylprednisolone 21-hemisuccinate sodium 
 Product name 
 salt 
 CAS-No. : 2375-03-3 
   
 
  Section 2. HAZARDS IDENTIFICATION  
  Classification of the substance or mixture  
  Classification according to Regulation (EC) No 1272/2008 [EU-GHS/CLP]  
 Carcinogenicity (Category 2) 
 Reproductive toxicity (Category 1B) 
  Classification according to EU Directives 67/548/EEC or 1999/45/EC  
 May cause harm to the unborn child. Limited evidence of a carcinogenic effect. 
  Label elements  
  Labelling according Regulation (EC) No 1272/2008 [CLP]  
 Pictogram 
 Signal word Danger 
 Hazard statement(s) 
 Suspected of causing cancer. 
 May damage fertility or the unborn child. 
 Precautionary statement(s) 
 Obtain special instructions before use. 
 Use personal protective equipment as required. 
 P308 + P313 IF exposed or concerned: Get medical advice/ attention. 
 Supplemental Hazard none 
 Statements 
  According to European Directive 67/548/EEC as amended.  
 Hazard symbol(s) 
 R-phrase(s) 
 R61 May cause harm to the unborn child. 
 R40 Limited evidence of a carcinogenic effect. 
 S-phrase(s) 
 S53 Avoid exposure - obtain special instructions before use. 
 S22 Do not breathe dust. 
 S36/37/39 Wear suitable protective clothing, gloves and eye/face protection. 
 S45 In case of accident or if you feel unwell, seek medical advice immediately 
 (show the label where possible). 
 Restricted to professional users. 
  Other hazards - none  
 
  Section 3. COMPOSITION/INFORMATION ON INGREDIENTS  
  Substances  
 : 6α-Methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione 21- 
 Synonyms 
 hemisuccinate 
 Formula : C26H33NaO8 
 Molecular Weight : 496,53 g/mol 
 Component Concentration 
  Pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-,  
  monosodium salt, (6α,11β)-  
 CAS-No. 2375-03-3 - 
 EC-No. 219-156-8 
 
  Section 4. FIRST AID MEASURES  
  Description of 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  
 Flush eyes with water as a precaution. 
  If swallowed  
 Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 
  Most important symptoms and effects, both acute and delayed  
  Indication of any immediate medical attention and special treatment needed  
 no data available 
 
  Section 5. FIREFIGHTING MEASURES  
  Extinguishing media  
  Suitable extinguishing media  
 Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. 
  Special hazards arising from the substance or mixture  
 Carbon oxides, Sodium oxides 
  Advice for firefighters  
 Wear self contained breathing apparatus for fire fighting if necessary. 
  Further information  
 no data available 
 
  Section 6. ACCIDENTAL RELEASE MEASURES  
  Personal precautions, protective equipment and emergency procedures  
 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  
 Prevent further leakage or spillage if safe to do so. 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. 
  Reference to other sections  
 For disposal see section 13. 
 
  Section 7. HANDLING AND STORAGE  
  Precautions for safe handling  
 Avoid exposure - obtain special instructions before use.Avoid contact with skin and eyes. 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, including any incompatibilities  
 Store in cool place. Keep container tightly closed in a dry and well-ventilated place. 
  Specific end uses  
 no data available 
 
  Section 8. EXPOSURE CONTROLS/PERSONAL PROTECTION  
  Control parameters  
  Components with workplace control parameters  
  Exposure controls  
  Appropriate engineering controls  
 Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and 
 at the end of workday. 
  Personal protective equipment  
  Eye/face protection  
 Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested 
 and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). 
  Skin 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. 
  Body Protection  
 impervious clothing, The type of protective equipment must be selected according to the 
 concentration and amount of the dangerous substance at the specific workplace. 
  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). 
 
  Section 9. PHYSICAL AND CHEMICAL PROPERTIES  
  Information on basic physical and chemical properties  
 a) Appearance Form: powder, lyophilized 
 b) Odour no data available 
 c) Odour Threshold no data available 
 d) pH no data available 
 e) Melting point/freezing no data available 
 point 
 f) Initial boiling point and no data available 
 boiling range 
 g) Flash point no data available 
 h) Evaporation rate no data available 
 i) Flammability (solid, gas) no data available 
 j) Upper/lower no data available 
 flammability or 
 explosive limits 
 k) Vapour pressure no data available 
 l) Vapour density no data available 
 m) Relative density no data available 
 n) Water solubility no data available 
 o) Partition coefficient: n- no data available 
 octanol/water 
 p) Autoignition no data available 
 temperature 
 q) Decomposition no data available 
 temperature 
 r) Viscosity no data available 
 s) Explosive properties no data available 
 t) Oxidizing properties no data available 
  Other safety information  
 no data available 
 
  Section 10. STABILITY AND REACTIVITY  
  Reactivity  
 no data available 
  Chemical stability  
 no data available 
  Possibility of hazardous reactions  
 no data available 
  Conditions to avoid  
 no data available 
  Incompatible materials  
 no data available 
  Hazardous decomposition products  
 Other decomposition products - no data available 
 
  Section 11. TOXICOLOGICAL INFORMATION  
  Information on toxicological effects  
  Acute toxicity  
 LD50 Oral - rat - > 5.000 mg/kg 
 Remarks: Lungs, Thorax, or Respiration:Respiratory stimulation. Skin and Appendages: Other: Hair. 
  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  
 Limited evidence of carcinogenicity in animal studies 
 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  
 May cause congenital malformation in the fetus. 
 Presumed human reproductive toxicant 
  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 swallowed. 
  Skin  May be harmful if absorbed through skin. May cause skin irritation. 
  Eyes  May cause eye irritation. 
  Additional Information  
 RTECS: TU4154060 
 
  Section 12. ECOLOGICAL INFORMATION  
  Toxicity  
 no data available 
  Persistence and degradability  
 no data available 
  Bioaccumulative potential  
 no data available 
  Mobility in soil  
 no data available 
  Results of PBT and vPvB assessment  
 no data available 
  Other adverse effects  
 no data available 
 
  Section 13. DISPOSAL CONSIDERATIONS  
  Waste treatment methods  
  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. 
 
  Section 14. TRANSPORT INFORMATION  
  UN number  
 ADR/RID: - IMDG: - IATA: - 
  UN proper shipping name  
 ADR/RID: Not dangerous goods 
 IMDG: Not dangerous goods 
 IATA: Not dangerous goods 
  Transport hazard class(es)  
 ADR/RID: - IMDG: - IATA: - 
  Packaging group  
 ADR/RID: - IMDG: - IATA: - 
  Environmental hazards  
 ADR/RID: no IMDG Marine pollutant: no IATA: no 
  Special precautions for user  
 no data available 
 
  Section 15. REGULATORY INFORMATION  
 This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. 
  Safety, health and environmental regulations/legislation specific for the substance or mixture  
 no data available 
  Chemical Safety Assessment  
 
 
  SECTION 16 - ADDITIONAL INFORMATION  
 N/A