Microsoft word - sdb3000ac5e00102.rtf

EC safety data sheet
Trade name: Bicalutamide 50 mg Film-coated tablets / Bicalutamide 150 mg Film Identification of the substance/preparation and of the
company/undertaking
Identification of the substance or preparation
Trade name
Bicalutamide 50 mg Film-coated tablets / Bicalutamide 150 mg Film
coated tablets
Use of the substance/preparation
Company/undertaking identification
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3 20354 Information provided by / telephone
Wedel site: Tel: +49 (4103)-8006-0; Fax: +49 (4103)-8006-100 Emergency telephone
+49(0)551 / 19240 {Giftinformationszentrum Nord (GIZ-Nord)} (Service in english) Advice on Safety Data Sheet
Hazards identification
Hazard symbols
Particular information pertaining specific risk for human / environment
The product does not require a hazard warning label in accordance with Directive 1999/45/EC. No special hazards have to be mentioned. But please observe the information given in this safety data sheet. Composition / information on ingredients
Chemical characterization
Additional ingredients:
bicalutamide (INN)
First aid measures
General information
In case of persisting adverse effects, consult a physician. Change contaminated, saturated clothing. After inhalation
Remove affected person from the immediate area. Ensure supply of fresh air. After skin contact
Wash off immediately with soap and water. After eye contact
Separate eyelids, wash the eyes thoroughly with water (15 min.). After ingestion
Seek medical advice immediately. Rinse mouth thoroughly with water. Never give anything by mouth to an unconscious person. Fire-fighting measures
Suitable extinguishing media
Foam; Carbon dioxide; extinguishing powder; Water spray jet Special exposure hazards arising from the substance or preparation itself, combustion products, resulting gases
In the event of fire, the following can be released: Carbon dioxide (CO2) Carbon monoxide (CO) Fire gas of organic material has to be classed invariably as respiratory poison. EC safety data sheet
Trade name: Bicalutamide 50 mg Film-coated tablets / Bicalutamide 150 mg Film Special protective equipment for fire-fighters
Use self-contained breathing apparatus. Wear protective clothing. Accidental release measures
Personal precautions
Refer to protective measures listed in sections 7 and 8. Ensure adequate ventilation. Avoid dust formation. Keep away sources of ignition. Environmental precautions
Do not discharge into the drains/surface waters/groundwater. Methods for cleaning up/taking up
Pick up mechanically. When picked up, treat material as prescribed under heading "Disposal considerations". Handling and storage
Handling
Advice on safe handling
No special measures necessary if stored and handled as prescribed. Avoid the formation and deposition of dust. Provide good ventilation of working area (local exhaust ventilation, if necessary). Advice on protection against fire and explosion
Dust can form an explosive mixture with air. Take precautionary measures against static charges. Keep away from sources of heat and ignition. Requirements for storage rooms and vessels
Advice on storage assembly
Further information on storage conditions
Keep container tightly closed and dry in a cool, well-ventilated place. Exposure controls / personal protection
Exposure limit values
Personal protective equipment
Respiratory protection
If workplace exposure limits are exceeded, a respiration protection approved for this particular job must be worn. Hand protection
In case of intensive contact, wear protective gloves (EN 374). Sufficient protection is given wearing suitable protective gloves checked according to i.e. EN 374, in the event of risk of skin contact with the product . Before use, the protective glove should be tested in any case for its specific work-station suitability (i.e. mechanical resistance, product compatibility and antistatic properties). Adhere to the manufacturer’s instructions and information relating to the use, storage, care and replacement of protective gloves. Protective gloves shall be replaced immediately when physically damaged or worn. Design operations thus to avoid permanent use of protective gloves. Eye protection
Skin protection
Clothing as usual in the chemical industry. General protective and hygiene measures
Do not eat, drink or smoke during work time. Keep away from foodstuffs and beverages. Wash hands before breaks and after work. Have eye wash fountain available. Do not inhale dust. Physical and chemical properties
General information
Important health, safety and environmental information
Solubility in water
Octanol/water partition coefficient (log Pow)
EC safety data sheet
Trade name: Bicalutamide 50 mg Film-coated tablets / Bicalutamide 150 mg Film Stability and reactivity
Conditions to avoid
Materials to avoid
Hazardous decomposition products
No hazardous decomposition products known. Thermal decomposition
Toxicological information
Acute toxicity
Acute oral toxicity
Acute dermal toxicity
Acute inhalational toxicity
Effects after repeated or prolonged exposition (subacute, subchronic, chronic)
Mutagenicity
In vitro mammalian cell gene mutation test Reproduction toxicity
Indications of toxic effects are available from reproduction studies in animals. Carcinogenicity
Indications of possible carcinogenic effects in animal studies are available. Experience in practice
Other information (chapter 11.)
The values mentioned are those of the active ingredient. Ecological information
Ecotoxicity
Fish toxicity
Daphnia toxicity
Persistence and degradability
Biodegradability
Bioaccumulative potential
Other adverse effects
Do not discharge product unmonitored into the environment. The ecological data given are those of the active ingredient. Disposal considerations
Allocation of a waste code number, according to the European Waste Catalogue, should be carried out in agreement with the EC safety data sheet
Trade name: Bicalutamide 50 mg Film-coated tablets / Bicalutamide 150 mg Film Packaging
Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste removal. Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer. Transport information
Other information (chapter 14.)
The product is not defined under national/international road, rail, sea and air transport regulations as a hazardous material. Regulatory information
Labelling in accordance with EC directives
The product does not require a hazard warning label in accordance with EC Directive 1999/45/EC. Hazard symbols
Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances
Annex I, part 1 + 2: not mentioned. With regard to possibly appropriate decomposition products see Chapter 10. Other information
Sources of key data used to compile the data sheet:
EC Directive 67/548/EC resp. 99/45/EC as amended in each case. Regulation (EC) No 1907/2006 (REACH) as amended in each case. EC Directives 2000/39/EC, 2006/15/EC as amended in each case. National Threshold Limit Values of the corresponding countries as amended in each case. Transport regulations according to ADR, RID, IMDG, IATA as amended in each case. The data sources used to determine physical, toxic and ecotoxic data, are indicated directly in the corresponding chapter. Department issuing safety data sheet
UMCO Umwelt Consult GmbH Georg-Wilhelm-Str. 183 b, D-21107 Hamburg Tel.: +49 40 / 41 92 13 00 Fax: +49 40 / 41 92 13 57 e-mail: [email protected] This information is based on our present state of knowledge. However, it should not constitute a guarantee for any specific product properties and shall not establish a legally valid relationship.

Source: http://www.basistherapie.com/medac_international/data/SDS/bicalutamid_E.pdf