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Safety Data Sheet Oxybutynin Hydrochloride Revision date : 2011/09/28 1. Product and Company Identification 2. Hazards Identification Emergency overview WARNING: HARMFUL IF SWALLOWED. May cause eye damage. Possible risk of harm to the unborn child. KEEP OUT OF REACH OF CHILDREN. INGESTION MAY CAUSE GASTRIC DISTURBANCES. CAN FORM EXPLOSIVE DUST-AIR MIXTURES. Avoid contact with the skin, eyes and clothing. Avoid inhalation of dusts. Use with local exhaust ventilation. Wear a NIOSH-certified (or equivalent) particulate respirator. Wear NIOSH-certified chemical goggles. Wear chemical resistant protective gloves. Wear protective clothing. Eye wash fountains and safety showers must be easily accessible. State of matter: solid Colour: white Odour: odourless Potential health effects
Primary routes of exposure: Routes of entry for solids and liquids include eye and skin contact, ingestion and inhalation. Routes of entry for gases include inhalation and eye contact. Skin contact may be a route of entry for liquified gases. Acute toxicity: Of moderate toxicity after single ingestion. Irritation / corrosion: Skin contact causes irritation. May cause severe damage to the eyes. Sensitization: No data available concerning sensitizing effects. The chemical structure suggests a sensitizing effect. Chronic toxicity:
Safety Data Sheet Oxybutynin Hydrochloride Revision date : 2011/09/28
Teratogenicity: Indications of possible developmental toxicity/teratogenicity were seen in animal studies. Genotoxicity: Mutagenicity tests revealed no genotoxic potential. Signs and symptoms of overexposure: The most important known symptoms and effects are described in the labelling (see section 2) and/or in section 11. Potential environmental effects
Aquatic toxicity: The inhibition of the degradation activity of activated sludge is not anticipated when introduced to biological treatment plants in appropriate low concentrations. Acutely toxic for aquatic organisms. 3. Composition / Information on Ingredients CAS Number Content (W/W) Chemical name
Benzeneacetic acid,.alpha.-cyclohexyl-.alpha.-hydroxy-, 4-(diethylamino)-2-butynyl ester, hydrochloride
4. First-Aid Measures General advice: Remove contaminated clothing. If inhaled: Keep patient calm, remove to fresh air, seek medical attention. After inhalation of decomposition products: Immediately inhale corticosteroid dose aerosol. If on skin: Wash thoroughly with soap and water. If irritation develops, seek medical attention. If in eyes: Wash affected eyes for at least 15 minutes under running water with eyelids held open. Seek medical attention. If swallowed: Rinse mouth immediately and then drink plenty of water, seek medical attention. Never induce vomiting or give anything by mouth if the victim is unconscious or having convulsions. Note to physician
Treat according to symptoms (decontamination, vital functions), no known specific antidote. Administer corticosteroids (e.g. Prednisolon) in case of toxic lung oedema.
5. Fire-Fighting Measures Suitable extinguishing media: carbon dioxide, dry powder, alcohol-resistant foam, water spray
Safety Data Sheet Oxybutynin Hydrochloride Revision date : 2011/09/28
Unsuitable extinguishing media for safety reasons: water jet Hazards during fire-fighting: carbon monoxide, carbon dioxide, Hydrogen chloride, nitrogen oxides Under special fire conditions traces of other toxic substances are possible. Dust explosion hazard. Protective equipment for fire-fighting: Firefighters should be equipped with self-contained breathing apparatus and turn-out gear. Further information: Dispose of fire debris and contaminated extinguishing water in accordance with official regulations. In case of fire and/or explosion do not breathe fumes. 6. Accidental release measures Personal precautions: Do not breathe dust. Avoid dust formation. Avoid contact with the skin, eyes and clothing. Ensure adequate ventilation. Information regarding personal protective measures see, chapter 8. Environmental precautions: Do not discharge into drains/surface waters/groundwater. Discharge into the environment must be avoided. If the product enters drains or sewers, the local water company should be contacted immediately; in the case of contamination of streams, rivers or lakes, the Environment Agency. Cleanup: For small amounts: Pick up with suitable appliance and dispose of. For large amounts: Sweep/shovel up. Dispose of absorbed material in accordance with regulations. 7. Handling and Storage Handling General advice: Avoid dust formation. Avoid inhalation of dusts/mists/vapours. Avoid contact with the skin, eyes and clothing. Ensure thorough ventilation of stores and work areas. In case of insufficient ventilation, wear suitable respiratory equipment. Product should be worked up in closed equipment as far as possible. Keep away from food, drink and animal feeding stuffs. Protection against fire and explosion: Prevent electrostatic charge - sources of ignition should be kept well clear - fire extinguishers should be kept handy. The product is capable of dust explosion. Avoid dust formation. General advice: Keep container tightly closed and dry. 8. Exposure Controls and Personal Protection
Advice on system design: Provide local exhaust ventilation to control dust.
Safety Data Sheet Oxybutynin Hydrochloride Revision date : 2011/09/28 Personal protective equipment Respiratory protection: Wear a NIOSH-certified (or equivalent) particulate respirator. Observe OSHA regulations for respirator use (29 CFR 1910.134). Hand protection: Wear chemical resistant protective gloves., Consult with glove manufacturer for testing data. Eye protection: Tightly fitting safety goggles (splash goggles) (e.g. EN 166) Body protection: Body protection must be chosen depending on activity and possible exposure, e.g. head protection, apron, protective boots, chemical-protection suit. General safety and hygiene measures: Do not breathe dust. Avoid contact with the skin, eyes and clothing. Under no circumstances should the product come into contact with the skin of pregnant women or be inhaled by them. Females of childbearing age should not come into contact with the product. Remove contaminated clothing immediately and dispose of safely. Keep separated from food stuffs and feed stocks. When using, do not eat, drink or smoke. At the end of the shift the skin should be cleaned and skin-care agents applied. Employees should shower at the end of the shift. 9. Physical and Chemical Properties
n-octanol/water (log Pow): Solubility in water:
soluble solvent(s): Methanol, dichloromethane, trichloromethane, N,N-dimethylformamide
10. Stability and Reactivity
Conditions to avoid: Avoid humidity. Substances to avoid: acids, alkalies, oxidizing agents, reducing agents Hazardous reactions: Dust explosion hazard. Evolution of toxic gases/vapours. Decomposition products: Hazardous decomposition products: Hydrogen chloride, carbon monoxide, carbon dioxide, nitrogen oxides, toxic gases/vapours Thermal decomposition: No decomposition if stored and handled as prescribed/indicated. Oxidizing properties: not fire-propagating
Safety Data Sheet Oxybutynin Hydrochloride Revision date : 2011/09/28 11. Toxicological information
Acute toxicity
Oral: Type of value: LD50 Species: rat Value: 460 mg/kg Irritation / corrosion
Skin:
Result: Non corrosive. Method: Epiderm Corrosivity Test Eye: Result: Risk of serious damage to eyes. Method: HET-CAM test in vitro 12. Ecological Information
Aquatic invertebrates Acute: Screening (style of OECD 202) static Daphnia magna/EC50 (48 h): 1 - 10 mg/l The details of the toxic effect relate to the nominal concentration. Microorganisms Toxicity to microorganisms: Screening test aquatic activated sludge, domestic/EC20 (180 min): > 100 mg/l The details of the toxic effect relate to the nominal concentration. Degradability / Persistence Biological / Abiological Degradation Test method:
Screening test (style of OECD 301) (aerobic), activated sludge, domestic
Not readily biodegradable (by OECD criteria).
Bioaccumulation
No significant accumulation in organisms is expected as a result of the distribution coefficient of n-octanol/water (log Pow). 13. Disposal considerations Waste disposal of substance: Do not discharge into waterways or sewer systems without proper authorization. Empty contaminated containers/packaging must be handled according to applicable regulations for the hazardous properties of the contaminating material. Dispose of in accordance with national, state and local regulations.
Safety Data Sheet Oxybutynin Hydrochloride Revision date : 2011/09/28 Container disposal: Dispose of container and any rinsate in an environmentally safe manner. Recommend crushing, puncturing or other means to prevent unauthorized use of used containers. 14. Transport Information Land transport USDOT
Not classified as a dangerous good under transport regulations
Sea transport IMDG
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (contains OXYBUTYNINE HCL)
Air transport IATA/ICAO
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (contains OXYBUTYNINE HCL)
15. Regulatory Information
Federal Regulations Registration status: Chemical
OSHA hazard category:
Toxic - oral; Acute target organ effects reported; Skin and/or eye irritant; Chronic target organ effects reported
EPCRA 311/312 (Hazard categories): 16. Other Information
NFPA Hazard codes: Health : 2 Fire: 1 Reactivity: 0 Special: HMIS III rating
Safety Data Sheet Oxybutynin Hydrochloride Revision date : 2011/09/28
NFPA and HMIS use a numbering scale ranging from 0 to 4 to indicate the degree of hazard. A value of zero means that the substance possesses essentially no hazard; a rating of four indicates extreme danger. Although similar, the two rating systems are intended for different purposes, and use different criteria. The NFPA system was developed to provide an on-the-spot alert to the hazards of a material, and their severity, to emergency responders. The HMIS system was designed to communicate workplace hazard information to employees who handle hazardous chemicals. We support worldwide Responsible Care® initiatives. We value the health and safety of our employees, customers, suppliers and neighbors, and the protection of the environment. Our commitment to Responsible Care is integral to conducting our business and operating our facilities in a safe and environmentally responsible fashion, supporting our customers and suppliers in ensuring the safe and environmentally sound handling of our products, and minimizing the impact of our operations on society and the environment during production, storage, transport, use and disposal of our products.
MSDS Prepared by: BASF NA Product Regulations MSDS Prepared on: 2011/09/28 IMPORTANT: WHILE THE DESCRIPTIONS, DESIGNS, DATA AND INFORMATION CONTAINED HEREIN ARE PRESENTED IN GOOD FAITH AND BELIEVED TO BE ACCURATE , IT IS PROVIDED FOR YOUR GUIDANCE ONLY. BECAUSE MANY FACTORS MAY AFFECT PROCESSING OR APPLICATION/USE, WE RECOMMEND THAT YOU MAKE TESTS TO DETERMINE THE SUITABILITY OF A PRODUCT FOR YOUR PARTICULAR PURPOSE PRIOR TO USE. NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE DESCRIPTIONS, INFORMATION, DATA OR DESIGNS PROVIDED BE CONSIDERED A PART OF OUR TERMS AND CONDITIONS OF SALE. FURTHER, YOU EXPRESSLY UNDERSTAND AND AGREE THAT THE DESCRIPTIONS, DESIGNS, DATA, AND INFORMATION FURNISHED BY BASF HEREUNDER ARE GIVEN GRATIS AND BASF ASSUMES NO OBLIGATION OR LIABILITY FOR THE DESCRIPTION, DESIGNS, DATA AND INFORMATION GIVEN OR RESULTS OBTAINED, ALL SUCH BEING GIVEN AND ACCEPTED AT YOUR RISK. END OF DATA SHEET
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