General Information
Revision date
2013-05-23
Product name
ZYTIGA (ABIRATERONE ACETATE)
Substance name
ZYTIGA (ABIRATERONE ACETATE)
CAS No.
154229-18-2
1.2.1 Relevant identified uses
Finished Pharmaceutical Product, Pharmacotherapeutic
Emergency telephone
+32 14 602444
Icons in SDS
Company Information
company name
Janssen Pharmaceutica NV
e-mail address of the competent person responsible for the Safety Data Sheet
RA-JANBE-SAFETYDA@JANBE.JNJ.COM
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H360FD, H373, H400, H410
Hazard statements
Code
Statements
H360FD
May damage fertility; May damage the unborn child
Section 2
CLP CLASSIFICATION
Reproductive toxicity, Category 1B H360FD: May damage fertility. May damage the unborn child. Specific target organ toxicity - repeated H373: May cause damage to organs through exposure, Category 2 prolonged or repeated exposure if swallowed. Acute aquatic toxicity, Category 1 H400: Very toxic to aquatic life. Chronic aquatic toxicity, Category 1 H410: Very toxic to aquatic life with long lasting effects.
2.1 Classification of the substance or mixture
67/548/EEC, 1999/45/EC) Toxic to Reproduction Category 1 R60: May impair fertility. Toxic to Reproduction Category 1 R61: May cause harm to the unborn child. Harmful R48/22 Harmful danger of serious damage to health by prolonged exposure if swallowed. Dangerous for the environment R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
2.2 Label elements
REGULATION (EC) No 1272/2008)
Signal word
Danger
Hazard statements
H360FD May damage fertility. May damage the unborn child. H373 May cause damage to organs through prolonged or repeated exposure if swallowed. H410 Very toxic to aquatic life with long lasting effects.
Prevention
P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust or mist. P281 Use personal protective equipment as required.
Response
P308 + P313 IF exposed or concerned: Get medical advice/ attention.
Storage
P405 Store locked up.
Disposal
P501 Dispose of contents/ container to an approved waste disposal plant. Medicinal products in the finished state, intended for the final user, are not subject to GHS labeling.
Hazardous Ingredients
154229‐18‐2 ABIRATERONE ACETATE
2.3 Other hazards
May be absorbed via the skin. Refer to the pharmacotherapeutic group (section 1.2) and the patient packaging insert to evaluate the possible workplace hazards when this Finished Pharmaceutical Product is accidently leaking, broken or crushed.
