Note: Ingredients listed on restricted chemical lists
General Information
Revision date
2021-04-22
Product name
DABRAFENIB 50 MG AND 75 MG CAPSULES
Product Synonyms
DABRAFENIB MESYLATE, FORMULATED PRODUCT
1.2.1 Relevant identified uses
Bulk Formulated Product
Emergency telephone
VERISK 3E GLOBAL INCIDENT RESPONSE
Icons in SDS
Company Information
company name
GlaxoSmithKline UK
e-mail address of the competent person responsible for the Safety Data Sheet
msds@gsk.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H351, H373, H400, H411
Hazard statements
Code
Statements
H351
Suspected of causing cancer
Section 2
2.1 Classification of the substance or mixture
The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies.
EU Classification
Regulation (EC) No 1272/2008 as amended
Health hazards
Carcinogenicity Category 2 H351 - Suspected of causing cancer. Specific target organ toxicity - repeated Category 2 H373 - May cause damage to exposure organs through prolonged or repeated exposure.
Environmental hazards
Hazardous to the aquatic environment, acute Category 1 H400 - Very toxic to aquatic life. aquatic hazard Hazardous to the aquatic environment, Category 2 H411 - Toxic to aquatic life with long-term aquatic hazard long lasting effects. Hazard summary May cause damage to organs through prolonged or repeated exposure. Suspected of causing cancer. Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards. Dangerous for the environment if discharged into watercourses.
2.2 Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains
DABRAFENIB MESYLATE, MICROCRYSTALLINE CELLULOSE
Signal word
Warning
Hazard statements
H351 Suspected of causing cancer. H373 May cause damage to organs through prolonged or repeated exposure. H400 Very toxic to aquatic life. H411 Toxic to aquatic life with long lasting effects.
Prevention
P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust/fume/gas/mist/vapours/spray. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.
Response
P308 + P313 IF exposed or concerned: Get medical advice/attention. P391 Collect spillage.
Storage
P405 Store locked up.
Disposal
P501 Dispose of contents/container in accordance with local/regional/national/international regulations.
Supplemental label elements
98.7 % of the mixture consists of component(s) of unknown acute oral toxicity. 99.7 % of the mixture consists of component(s) of unknown acute dermal toxicity. 66.8 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 66.8 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.
2.3 Other hazards
Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
