SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 NON Pancrelipase Formulation
SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name : Pancrelipase Formulation 1.2 Relevant identified uses of the substance or mixture and uses advised against Use of the Sub- Pharmaceutical : stance/Mixture : Not applicable Recommended restrictions on use 1.3 Details of the supplier of the safety data sheet Company :
:    +1-551-430-6000
EHSSTEWARD@organon.com 1.4 Emergency telephone number +1-215-631-6999 SECTION 2: Hazards identification 2.1 Classification of the substance or mixture Classification (REGULATION (EC) No 1272/2008) Skin irritation, Category 2 Eye irritation, Category 2 Respiratory sensitisation, Category 1 H315: Causes skin irritation. H319: Causes serious eye irritation. H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled. 2.2 Label elements Labelling (REGULATION (EC) No 1272/2008) Hazard pictograms
Causes skin irritation. SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878
H319 H334 Causes serious eye irritation. May cause allergy or asthma symptoms or breath- ing difficulties if inhaled. Precautionary statements : Prevention: P264 P280 Wash skin thoroughly after handling. Wear protective gloves/ eye protection/ face pro- tection. Response: P304 + P340 P332 + P313 P337 + P313 IF INHALED: Remove person to fresh air and keep comfortable for breathing. If skin irritation occurs: Get medical advice/ attention. If eye irritation persists: Get medical advice/ attention. If experiencing respiratory symptoms: Call a POISON CENTER/ doctor. P342 + P311 Hazardous components which must be listed on the label: 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. SECTION 3: Composition/information on ingredients
3.2 Mixtures

SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878

SECTION 4: First aid measures
4.3 Indication of any immediate medical attention and special treatment needed Treatment Treat symptomatically and supportively. : SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 NON
SECTION 5: Firefighting measures 5.1 Extinguishing media
6.1 Personal precautions, protective equipment and emergency procedures Personal precautions Use personal protective equipment. : Follow safe handling advice (see section 7) and personal pro- tective equipment recommendations (see section 8).
SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878
6.4 Reference to other sections See sections: 7, 8, 11, 12 and 13.
SECTION 7: Handling and storage

SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 10N
place. When using do not eat, drink or smoke. Wash contami- nated clothing before re-use. The effective operation of a facility should include review of engineering controls, proper personal protective equipment, appropriate degowning and decontamination procedures, industrial hygiene monitoring, medical surveillance and the use of administrative controls. 7.2 Conditions for safe storage, including any incompatibilities Requirements for storage : areas and containers Keep in properly labelled containers. Keep tightly closed. Store in accordance with the particular national regulations. Do not store with the following product types: .. Strong oxidizing agents Advice on common storage 7.3 Specific end use(s) Specific use(s) : No data available SECTION 8: Exposure controls/personal protection 8.1 Control parameters
Derived No Effect Level (DNEL) according to Regulation (EC) No. 1907/2006:
SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878

8.2 Exposure controls
Engineering measures All engineering controls should be implemented by facility design and operated in accordance with GMP principles to protect products, workers, and the environment. Containment technologies suitable for controlling compounds are required to control at source and to prevent migration of the compound to uncontrolled areas (e.g., open-face containment de- vices). Minimize open handling.
SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878
SECTION 10: Stability and reactivity 10.1 Reactivity Not classified as a reactivity hazard. SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 NON
10.2 Chemical stability Stable under normal conditions. 10.3 Possibility of hazardous reactions Hazardous reactions : May form combustible dust concentrations in air. Can react with strong oxidizing agents. 10.4 Conditions to avoid Conditions to avoid .. Heat, flames and sparks. Avoid dust formation. 10.5 Incompatible materials Materials to avoid .. Oxidizing agents 10.6 Hazardous decomposition products No hazardous decomposition products are known. SECTION 11: Toxicological information 11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008 Information on likely routes of   : Inhalation exposure Skin contact Ingestion Eye contact Acute toxicity Not classified based on available information. Components: Pancrelipase: Acute oral toxicity :    LD50 (Rat): > 10,000 mg/kg Skin corrosion/irritation Causes skin irritation. Components: Pancrelipase:
Serious eye damage/eye irritation Causes serious eye irritation. Components: Pancrelipase: Result Irritation to eyes, reversing within 21 days : SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 N ( ) N
Remarks : Based on data from similar materials Respiratory or skin sensitisation Skin sensitisation Not classified based on available information. Respiratory sensitisation May cause allergy or asthma symptoms or breathing difficulties if inhaled. Components: Pancrelipase:
: Assessment : May cause sensitisation by inhalation. Germ cell mutagenicity Not classified based on available information. Components: Pancrelipase: Genotoxicity in vitro : Test Type: Bacterial reverse mutation assay (AMES) Method: OECD Test Guideline 471 Result: negative Remarks: Based on data from similar materials Test Type: In vitro mammalian cell gene mutation test Method: OECD Test Guideline 476 Result: negative Remarks: Based on data from similar materials Test Type: Chromosome aberration test in vitro Method: OECD Test Guideline 473 Result: negative Remarks: Based on data from similar materials Carcinogenicity Not classified based on available information. Reproductive toxicity Not classified based on available information. Components: Pancrelipase: Effects on fertility : Test Type: Two-generation reproduction toxicity study Species: Rat Application Route: Ingestion SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 RGANON
STOT - single exposure Not classified based on available information. STOT - repeated exposure Not classified based on available information. Repeated dose toxicity Components: Pancrelipase:
Aspiration toxicity Not classified based on available information. 11.2 Information on other hazards Endocrine disrupting properties Product: Assessment The substance/mixture does not contain components consid- .. ered 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. SECTION 12: Ecological information 12.1 Toxicity Components: Pancrelipase: Toxicity to fish : LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l Exposure time: 96 h Method: OECD Test Guideline 203 Remarks: Based on data from similar materials SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 NON
12.2 Persistence and degradability Components: Pancrelipase: Biodegradability Result: Readily biodegradable. . 12.3 Bioaccumulative potential Components: Pancrelipase: Partition coefficient: n- octanol/water log Pow: < 4 : 12.4 Mobility in soil No data available 12.5 Results of PBT and vPvB assessment
: This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
12.6 Endocrine disrupting properties

:
SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878
12.7 Other adverse effects No data available
SECTION 13: Disposal considerations

SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 )N
14.5 Environmental hazards Not regulated as a dangerous good 14.6 Special precautions for user Not applicable 14.7 Maritime transport in bulk according to IMO instruments :    Not applicable for product as supplied. Remarks
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mix- ture
major-accident hazards involving dangerous substances. Not applicable
Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national regulations, where applicable. The components of this product are reported in the following inventories: AICS :  not determined
15.2 Chemical safety assessment A Chemical Safety Assessment has not been carried out. SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878 NON
SECTION 16: Other information
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by Road; AllC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Test- ing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regula- tion (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA - European Chemicals Agency; EC-Number - European Community number; ECx - Concentration associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergen- cy Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration as- sociated with x% growth rate response; GHS - Globally Harmonized System; GLP - Good La- boratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Code for the Construction and Equipment of Ships car- rying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - Interna- tional Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test popula- tion; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - Interna- tional Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Ef- fect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic sub- stance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quanti- tative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Re- striction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Substance Inventory; TECI - Thailand Existing Chemicals Inventory; TRGS - Technical Rule for Hazardous Substances; TSCA SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended by Commission Regulation (EU) 2020/878
- Toxic Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent and Very Bioaccumulative Further information Sources of key data used to compile the Safety Data Sheet :    Internal technical data, data from raw material SDSs, OECD eChem Portal search results and European Chemicals Agen- cy, http://echa.europa.eu/
The information provided in this Safety Data Sheet is correct to the best of our knowledge, infor- mation and belief at the date of its publication. The information is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and shall not be considered a warranty or quality specification of any type. The information provided relates only to the specific material identified at the top of this SDS and may not be valid when the SDS mate- rial is used in combination with any other materials or in any process, unless specified in the text. Material users should review the information and recommendations in the specific context of their intended manner of handling, use, processing and storage, including an assessment of the ap- propriateness of the SDS material in the user's end product, if applicable. IE / EN