Insulin Glargine Formulation

MSD

Revision date : 2024-09-28

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GHS08 GHS05
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

203-577-9/108-39-4

Name of the chemical

m-cresol

Concentration

>=3-<5

General Information

Version

5.0

Revision date

2024-09-28

Product name

Insulin Glargine Formulation

1.2.1 Relevant identified uses

Pharmaceutical

Emergency telephone

353-51-601000, +1-908-423-6000

Icons in SDS

GHS05 GHS08

Company Information

company name

MSD

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

EHSDATASTEWARD@msd.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H315, H318, H373

Hazard statements

Code

Statements

H315

Causes skin irritation

Section 2

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture

Signal word

Danger

Hazard statements

H315 Causes skin irritation. H318 Causes serious eye damage. H373 May cause damage to organs through prolonged or repeated exposure.

Prevention

P260 Do not breathe dust. P264 Wash skin thoroughly after handling. P280 Wear protective gloves/ eye protection/ face protection.

Response

P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre- sent and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor. P314 Get medical advice/ attention if you feel unwell. P332 + P313 If skin irritation occurs: Get medical advice/ attention.

Hazardous Ingredients

Insulin Glargine m-Cresol

Other hazards

This substance/mixture contains no components considered to be either persistent, bioaccumula- tive and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher

ECOLOGICAL INFORMATION

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regu- lation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

TOXICOLOGICAL INFORMATION

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher. May form explosive dust-air mixture during processing, handling or other means.

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008) Skin irritation, Category 2 H315: Causes skin irritation. Serious eye damage, Category 1 H318: Causes serious eye damage. Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2 longed or repeated exposure.

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