General Information
Version
4.11
Revision date
2024-04-06
Product name
Ganirelix Formulation
1.2.1 Relevant identified uses
Pharmaceutical
Emergency telephone
+1-551-430-6000, +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)
H360Fd, H372
Hazard statements
Code
Statements
H360Fd
May damage fertility; Suspected of damaging the unborn child
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
Danger
Hazard statements
H360Fd May damage fertility. Suspected of damaging the unborn child. H372 Causes damage to organs through prolonged or re- peated exposure.
Prevention
P201 Obtain special instructions before use. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. 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
Ganirelix
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.
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Reproductive toxicity, Category 1B H360Fd: May damage fertility. Suspected of dam- aging the unborn child. Specific target organ toxicity - repeated H372: Causes damage to organs through pro- exposure, Category 1 longed or repeated exposure.
