Simvastatin Formulation

Organon & Co

Revision date : 2024-04-06

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GHS08 GHS07
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

9005-25-8

Name of the chemical

Starch

Concentration

>=5-<10

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

>=1-<5

EC/CAS

50-81-7

Name of the chemical

Ascorbic acid C6H8O6

Concentration

>=1-<5

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

>=0.1-<1

General Information

Version

11.2

Revision date

2024-04-06

Product name

Simvastatin Formulation

1.2.1 Relevant identified uses

Pharmaceutical

supplier name

Organon & Co

Emergency telephone

1-551-430-6000, 1-215-631-6999

Icons in SDS

GHS07 GHS08 M004 M009 M010 M011 M013 M059

Company Information

company name

Organon & Co

e-mail address of the competent person responsible for the Safety Data Sheet

EHSSTEWARD@organon.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H317, H351, H372

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

SECTION 2: Hazards identification

Signal word

Danger

Hazard statements

If small particles are generated during further processing, han- dling or by other means, may form combustible dust concentra- tions in air. H317 May cause an allergic skin reaction. H351 Suspected of causing cancer if inhaled. H372 Causes damage to organs (Liver, muscle, optic nerve, Eye) through prolonged or repeated exposure.

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. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P272 Contaminated work clothing must not be allowed out of the workplace. P280 Wear protective gloves, protective clothing, eye protection and face protection.

Response

P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P308 + P313 IF exposed or concerned: Get medical attention. P333 + P313 If skin irritation or rash occurs: Get medical atten- tion. P363 Wash contaminated clothing before reuse.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents and container to an approved waste disposal plant.

Other hazards

Dust contact with the eyes can lead to mechanical irritation.

2.1 Classification of the substance or mixture

1910.1200) Combustible dust Skin sensitization : Category 1 Carcinogenicity (Inhalation) : Category 2 Specific target organ toxicity : Category 1 (Liver, muscle, optic nerve, Eye) - repeated exposure

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