Note: Ingredients listed on restricted chemical lists
EC/CAS
13463-67-7
Name of the chemical
Reaction mass of titanium dioxide and silver chloride
Concentration
N/A
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
EC/CAS
69-65-8
Name of the chemical
D-mannitol C6H14O6
Concentration
N/A
EC/CAS
25322-68-3
Name of the chemical
polyethyleneglycol
Concentration
N/A
EC/CAS
236-675-5
Name of the chemical
Titandioxid; [in Pulverform mit mindestens 1 % Partikel mit aerodynamischem Durchmesser ≤ 10 μm] (2020/217)
Concentration
N/A
EC/CAS
200-711-8
Name of the chemical
D-mannitol C6H14O6
Concentration
N/A
General Information
Revision date
2021-07-09
Product name
TIVICAY TABLETS
Product Synonyms
DOLUTEGRAVIR SODIUM TABLETS * GSK1349572A 10 MG TABLETS * DOLUTEGRAVIR 10
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)
H400, H410
Hazard statements
Code
Statements
H400
Very toxic to aquatic life
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
Environmental hazards
Hazardous to the aquatic environment, acute Category 1 H400 - Very toxic to aquatic life. aquatic hazard Hazardous to the aquatic environment, Category 1 H410 - Very toxic to aquatic life long-term aquatic hazard with long lasting effects. Hazard summary Caution - Pharmaceutical agent. Not classified for health hazards. However, occupational exposure to the mixture or substance(s) may cause adverse health effects. 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
CROSCARMELLOSE SODIUM, DOLUTEGRAVIR SODIUM, MANNITOL, MICROCRYSTALLINE CELLULOSE, Polyethylene glycol, Polyvinylpyrrolidone, Titanium dioxide
Signal word
Warning
Hazard statements
H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects.
Prevention
P273 Avoid release to the environment.
Response
P391 Collect spillage.
Storage
Not available.
Disposal
P501 Dispose of contents/container in accordance with local/regional/national/international regulations.
Supplemental label elements
33.58 % of the mixture consists of component(s) of unknown acute oral toxicity. 71.88 % of the mixture consists of component(s) of unknown acute dermal toxicity. 53.88 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 37.8 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.
2.3 Other hazards
Assume that this material is capable of sustaining combustion. Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
