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1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

Product name: Orlistat
CAS-No.: 96829-58-2

2. HAZARDS IDENTIFICATION

Classification of the substance or mixture

Not a hazardous substance or mixture according to Regulation (EC) No 1272/2008
This substance is not classified as dangerous according to Directive 67/548/EEC.

3. COMPOSITION/INFORMATION ON INGREDIENTS

Synonyms: ( − )-Tetrahydrolipstatin; N-Formyl-L-leucine (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester
Formula: C₂₉H₅₃NO₅C₂₉H₅₃NO₅
Molecular Weight: 495,73 g/mol

4. FIRST AID MEASURES

Description of first aid measures

If inhaled
If breathed in, move person into fresh air. If not breathing, give artificial respiration.
In case of skin contact
Wash off with soap and plenty of water.
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.

5. FIRE-FIGHTING 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, nitrogen oxides (NOx)
Precautions for fire-fighters
Wear self contained breathing apparatus for fire fighting if necessary.
Further information
no data available

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures
Avoid dust formation. Avoid breathing vapors, mist or gas.
Environmental precautions
Do not let product enter drains.
Methods and materials for containment and cleaning up
Sweep up and shovel. Keep in suitable, closed containers for disposal.

7. HANDLING AND STORAGE

Precautions for safe handling
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.
Recommended storage temperature: 2 - 8 °C
Specific end uses
no data available

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Control parameters
Components with workplace control parameters
Exposure controls
Appropriate engineering controls
General industrial hygiene practice.
Personal protective equipment
Eye/face protection
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
Choose body protection in relation to its type, to the concentration and amount of dangerous substances, and to the specific work-place., The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Respiratory protection
Respiratory protection is not required. Where protection from nuisance levels of dusts are desired, use type N95 (US) or type P1 (EN 143) dust masks. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).

9. PHYSICAL AND CHEMICAL PROPERTIES

Form: solid
Melting point/range: < 50 °C
Flammability (solid, gas) no data available

10. STABILITY AND REACTIVITY

Incompatible materials
Strong oxidizing agents
Hazardous decomposition products
Other decomposition products - no data available

11. TOXICOLOGICAL INFORMATION

Information on toxicological effects
Acute toxicity
TDLo Oral - mouse - 560 mg/kg
Remarks: Blood:Changes in serum composition (e.g., TP, bilirubin, cholesterol). Biochemical:Metabolism
(intermediary):Lipids including transport.
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.

Potential health effects

Inhalation
Ingestion
Skin
Eyes
May be harmful if inhaled. May cause respiratory tract irritation.
May be harmful if swallowed.
May be harmful if absorbed through skin. May cause skin irritation.
May cause eye irritation.
 

12. ECOLOGICAL INFORMATION

Toxicity
no data available
Persistence and degradability
no data available
Bioaccumulative potential
no data available

13. DISPOSAL CONSIDERATIONS

Waste treatment methods
Product
Offer surplus and non-recyclable solutions to a licensed disposal company.
Contaminated packaging
Dispose of as unused product.