Note: Ingredients listed on restricted chemical lists
EC/CAS
14807-96-6
Name of the chemical
Talc
Concentration
>=5-<10
EC/CAS
9005-25-8
Name of the chemical
Starch
Concentration
>=1-<5
EC/CAS
57-50-1
Name of the chemical
Sucrose, pure C12H22O11
Concentration
>=1-<5
EC/CAS
84-66-2
Name of the chemical
Diethyl phthalate (DEP),5
Concentration
>=1-<2.5
General Information
Version
1.8
Revision date
2024-03-28
Product name
Pancrelipase (High / Low Lipase) 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)
H315, H319, H334, H401
Hazard statements
Code
Statements
H315
Causes skin irritation
Section 2
SECTION 2: Hazards identification
Manufacture, Storage and Import of Hazardous Chemicals Rules 1989 Classification Not classified as hazardous according to criteria laid down in Part I of Schedule-1 GHS Classification Skin corrosion/irritation Category 2 Serious eye damage/eye irri- tation Category 2A Respiratory sensitisation Category 1 Short-term (acute) aquatic Category 2 hazard
Signal word
Danger
Hazard statements
H315 Causes skin irritation. H319 Causes serious eye irritation. H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled. H401 Toxic to aquatic life.
Prevention
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray. P264 Wash skin thoroughly after handling. P273 Avoid release to the environment. P280 Wear protective gloves/ eye protection/ face protection. P284 Wear respiratory protection.
Response
P302 + P352 IF ON SKIN: Wash with plenty of water. P304 + P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P332 + P317 If skin irritation occurs: Get medical help. P337 + P317 If eye irritation persists: Get medical help. P342 + P316 If experiencing respiratory symptoms: Get emer- gency medical help immediately. P362 + P364 Take off contaminated clothing and wash it before reuse.
Disposal
P501 Dispose of contents/ container to an approved waste disposal plant.
Other hazards which do not result in classification
May form combustible dust concentrations in air.
2.1 Classification of the substance or mixture
Not classified as hazardous according to criteria laid down in Part I of Schedule-1. GHS Classification Skin corrosion/irritation : Category 2 Serious eye damage/eye irri- : Category 2A tation Respiratory sensitisation : Category 1 Short-term (acute) aquatic : Category 2 hazard
