General Information
Version
1.10
Revision date
2024-03-28
Product name
Pancrelipase (High / Low Lipase) 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)
H315, H319, H334
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. H319 Causes serious eye irritation. H334 May cause allergy or asthma symptoms or breath- ing difficulties if inhaled.
Prevention
P264 Wash skin thoroughly after handling. P280 Wear protective gloves/ eye protection/ face pro- tection.
Response
P304 + P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P332 + P313 If skin irritation occurs: Get medical advice/ attention. P337 + P313 If eye irritation persists: Get medical advice/ attention. P342 + P311 If experiencing respiratory symptoms: Call a POISON CENTER/ doctor.
Hazardous Ingredients
Pancrelipase
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. May form combustible dust concentrations in air.
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Skin irritation, Category 2 H315: Causes skin irritation. Eye irritation, Category 2 H319: Causes serious eye irritation. Respiratory sensitisation, Category 1 H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
