Note: Ingredients listed on restricted chemical lists
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
N/A
General Information
Revision date
2019-12-16
Product name
ZEJULA CAPSULES
Product Synonyms
NIRAPARIB CAPSULES 100 MG * NIRAPARIB TOSYLATE MONOHYDRATE, FORMULATED
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
Danger
Hazard Codes
Hazard statements (CLP)
H302, H341, H361, H372, H410
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
EU Classification
Regulation (EC) No 1272/2008 as amended
Health hazards
Acute toxicity, oral Category 4 H302 - Harmful if swallowed. Germ cell mutagenicity Category 2 H341 - Suspected of causing genetic defects. Reproductive toxicity Category 2 H361 - Suspected of damaging fertility or the unborn child. Specific target organ toxicity - repeated Category 1 H372 - Causes damage to organs exposure through prolonged or repeated exposure.
Environmental hazards
Hazardous to the aquatic environment, Category 1 H410 - Very toxic to aquatic life long-term aquatic hazard with long lasting effects. Hazard summary Caution - Potent pharmaceutical agent. Harmful if swallowed. Possible reproductive hazard. Suspected of causing genetic defects. Causes damage to organs through prolonged or repeated exposure. 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
MAGNESIUM STEARATE, NIRAPARIB TOSYLATE MONOHYDRATE
Signal word
Danger
Hazard statements
H302 Harmful if swallowed. H341 Suspected of causing genetic defects. H361 Suspected of damaging fertility or the unborn child. H372 Causes damage to organs through prolonged or repeated exposure. H410 Very 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. P264 Wash hands thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection.
Response
P301 + P312 IF SWALLOWED: Call a POISON CENTRE/doctor/physician if you feel unwell. P330 Rinse mouth. 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
99,5 % of the mixture consists of component(s) of unknown acute dermal toxicity. 99,5 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 61,18 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.
2.3 Other hazards
Caution - Potent pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
