Note: Ingredients listed on restricted chemical lists
EC/CAS
238-877-9/14807-96-6
Name of the chemical
Talc
Concentration
>=1-<10
EC/CAS
232-679-6/9005-25-8
Name of the chemical
Starch
Concentration
>=1-<10
EC/CAS
200-334-9/57-50-1
Name of the chemical
Sucrose, pure C12H22O11
Concentration
>=1-<10
EC/CAS
201-550-6/84-66-2
Name of the chemical
Diethyl phthalate (DEP),5
Concentration
>=1-<10
General Information
Version
3.3
Revision date
2023-09-30
Product name
Pancrelipase (High / Low Lipase) Formulation
1.2.1 Relevant identified uses
Pharmaceutical
Emergency telephone
+44 1 670 59 32 05, +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. May form combustible dust concentrations in air.
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK SI 2019/720, and UK SI 2020/1567) 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.
