Gentamicin (8%) Injection Formulation

Organon & Co

Revision date : 2021-04-09

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GHS08 GHS09
Health risk rating 5
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

100-51-6

Name of the chemical

Benzyl Alcohol

Concentration

N/A

EC/CAS

202-859-9

Name of the chemical

Benzyl alcohol (38)

Concentration

N/A

General Information

Revision date

2021-04-09

Product name

Gentamicin (8%) Injection Formulation

1.2.1 Relevant identified uses

Pharmaceutical

Emergency telephone

215-631-6999

Icons in SDS

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)

H360D, H373, H400, H410, H411

Hazard statements

Code

Statements

H360D

May damage the unborn child

Section 2

CLP CLASSIFICATION

Reproductive toxicity, Category 1A H360D: May damage the unborn child. Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2 longed or repeated exposure. Short-term (acute) aquatic hazard, Cate- H400: Very toxic to aquatic life. gory 1 Long-term (chronic) aquatic hazard, Cat- H411: Toxic to aquatic life with long lasting effects. egory 2

2.2 Label elements

REGULATION (EC) No 1272/2008)

Signal word

Danger

Hazard statements

H360D May damage the unborn child. H373 May cause damage to organs through prolonged or repeated exposure. H410 Very toxic to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.

Response

P308 + P313 IF exposed or concerned: Get medical advice/ attention. P391 Collect spillage.

Storage

P405 Store locked up.

Hazardous Ingredients

Gentamicin

2.3 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.

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