Note: Ingredients listed on restricted chemical lists
EC/CAS
201-069-1/77-92-9
Name of the chemical
Citric acid
Concentration
N/A
EC/CAS
208-534-8/532-32-1
Name of the chemical
Benzoic acid and its sodium salt
Concentration
N/A
General Information
Revision date
2021-06-18
Product name
RETROVIR SYRUP
Product Synonyms
RETROVIR SYRUP 50 MG/5 ML * RETROVIR/AZT ORAL SOLUTION 10 MG/ML * RETROVIR
Emergency telephone
VERISK 3E GLOBAL INCIDENT RESPONSE
Icons in SDS
Company Information
company name
ViiV Healthcare Limited
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)
H341, H351
Hazard statements
Code
Statements
H341
Suspected of causing genetic defects
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
Germ cell mutagenicity Category 2 H341 - Suspected of causing genetic defects. Carcinogenicity Category 2 H351 - Suspected of causing cancer. Hazard summary Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
2.2 Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains
CITRIC ACID ANHYDROUS, GLYCERIN, SODIUM BENZOATE, ZIDOVUDINE
Signal word
Warning
Hazard statements
H341 Suspected of causing genetic defects. H351 Suspected of causing cancer.
Prevention
P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.
Response
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage
P405 Store locked up.
Disposal
P501 Dispose of contents/container in accordance with local/regional/national/international regulations.
Supplemental label elements
1 % of the mixture consists of component(s) of unknown acute dermal toxicity. 64 % of the mixture consists of component(s) of unknown acute inhalation toxicity. 11 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 11 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment. EUH208 - Contains ART STRAWBERRY FLAVOUR - PHL-134189. May produce an allergic reaction.
2.3 Other hazards
Caution - Pharmaceutical agent. This mixture does not contain substances assessed to be vPvB / PBT according to Regulation (EC) No 1907/2006, Annex XIII. The product does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher. See section 11 of the SDS for additional information on health hazards.
