ENGERIX-B

GlaxoSmithKline UK

Revision date : 2021-12-15

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

21645-51-2

Name of the chemical

Aluminium hydroxide

Concentration

N/A

EC/CAS

54-64-8

Name of the chemical

Sodium o-(ethylmercurithio)benzoate

Concentration

N/A

EC/CAS

200-210-4

Name of the chemical

Thiomersal

Concentration

N/A

General Information

Revision date

2021-12-15

Product name

ENGERIX-B

Product Synonyms

ENGERIX B ADULT INJECTION 20 MCG/ML * ENGERIX B 20mcg ADULT * ENGERIX B (ADULT)

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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

None

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 This mixture does not meet the criteria for classification according to Regulation (EC) 1272/2008 as amended. 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.

2.2 Label elements

Label according to Regulation (EC) No. 1272/2008 as amended

Contains

ALUMINIUM HYDROXIDE, DISODIUM HYDROGEN PHOSPHATE, THIOMERSAL

Hazard pictograms

None.

Signal word

None.

Hazard statements

The mixture does not meet the criteria for classification.

Prevention

Not available.

Response

Not available.

Storage

Not available.

Disposal

Not available.

Supplemental label elements

3 % of the mixture consists of component(s) of unknown acute oral toxicity. 3 % of the mixture consists of component(s) of unknown acute dermal toxicity. 3 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 3 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.

2.3 Other hazards

This product is non-flammable. Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.

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