Buprenorphine Solid Formulation

Organon & Co

Revision date : 2021-09-04

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

Note: Ingredients listed on restricted chemical lists

EC/CAS

77-92-9

Name of the chemical

Citric acid

Concentration

N/A

General Information

Revision date

2021-09-04

Product name

Buprenorphine Solid Formulation

1.2.1 Relevant identified uses

Pharmaceutical

Emergency telephone

+1-215-631-6999

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

Hazard statements

Code

Statements

H360D

May damage the unborn child

Section 2

CLP CLASSIFICATION

Reproductive toxicity, Category 1A H360D: May damage the unborn child.

2.2 Label elements

REGULATION (EC) No 1272/2008)

Signal word

Danger

Hazard statements

H360D May damage the unborn child.

Prevention

P201 Obtain special instructions before use. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.

Response

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

Storage

P405 Store locked up.

Hazardous Ingredients

Buprenorphine Hydrochloride

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. Dust contact with the eyes can lead to mechanical irritation. Contact with dust can cause mechanical irritation or drying of the skin. May form explosive dust-air mixture during processing, handling or other means.

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