SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Pancrelipase Formulation

Manufacturer or supplier's details
Company: Organon & Co.
Address:JL Raya Pandaan KM. 48
Pandaan, Jawa Timur - Indonesia

Telephone:+1-551-430-6000

Emergency telephone number :+1-215-631-6999

E-mail address

EHSSTEWARD@organon.com:

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

2. HAZARDS IDENTIFICATIONGHS Classification
Skin corrosion/irritation:

Category 2

Serious eye damage/eye irritation:

Category 2A

Respiratory sensitisation:

Category 1

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H315 Causes skin irritation.
H319 Causes serious eye irritation.
H334 May cause allergy or asthma symptoms or breathingdifficulties if inhaled.

Precautionary statements:

Prevention:
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P264 Wash skin thoroughly after handling.
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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

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 andkeep comfortable for breathing.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact lenses, if present andeasy to do. Continue rinsing.
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.
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.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Pancrelipase
StarchCalcium carbonate

CAS-No.
53608-75-6
9005-25-8
471-34-1

Concentration (% w/w)>= 30 -< 60>= 30 -< 60< 10

4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.

If inhaled:

In case of skin contact:

If inhaled, remove to fresh air.
If not breathing, give artificial respiration.
If breathing is difficult, give oxygen.
Get medical attention.
In case of contact, immediately flush skin with plenty of water
for at least 15 minutes while removing contaminated clothing
and shoes.
Get medical attention.
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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayed:Protection of first-aiders:

Notes to physician:

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of contact, immediately flush eyes with plenty of water
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention.
If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.
Causes skin irritation.
Causes serious eye irritation.
May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Excessive exposure may aggravate preexisting asthma andother respiratory disorders (e.g. emphysema, bronchitis, reactive airways dysfunction syndrome).
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemicalHigh volume water jet

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Do not use a solid water stream as it may scatter and spread
fire.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)Sulphur oxides
Metal oxides

Specific extinguishing methods:

Special protective equipment
for firefighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :Use personal protective equipment.
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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

tive equipment and emergency procedures

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Surround spill with absorbents and place a damp coveringover the area to minimise entry of the material into the air.
Add excess liquid to allow the material to enter into solution.
Soak up with inert absorbent material.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration.
Clean up remaining materials from spill with suitable absorbent.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

Technical measures:

Local/Total ventilation
Advice on safe handling::

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
Use only with adequate ventilation.
Do not get on skin or clothing.
Avoid breathing dust, fume, gas, mist, vapours or spray.
Do not swallow.
Do not get in eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
Already sensitised individuals, and those susceptible
to asthma, allergies, chronic or recurrent respiratory disease,should consult their physician regarding working with respiratory irritants or sensitisers.
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Take care to prevent spills, waste and minimize release to the

7. HANDLING AND STORAGE

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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Conditions for safe storage:

Materials to avoid:

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

environment.
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

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Components with workplace control parameters
Components

CAS-No.

Control parameBasisters / Permissible
concentration
53608-75-6
OEB 3 (>= 10 <Internal
100 µg/m3)
9005-25-8NAB
10 mg/m3
ID OEL
Further information: Not classified as carcinogenic to humans. Not
enough data to classify these materials as carcinogenic to humans or animals
TWA
10 mg/m3
ACGIH
471-34-1
NAB (Inhala- 10 mg/m3
ID OELble)(Calcium carbonate)

Pancrelipase
StarchCalcium carbonate

Engineering measures:

Value type
(Form ofexposure)
TWA

All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect 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 devices).
Minimize open handling.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

Hygiene measures

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to the working place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

:

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

solid

Colour:No data available

Odour

:

No data available

Odour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

Not applicable

Flammability (solid, gas):

May form combustible dust concentrations in air.

Flammability (liquids):

Not applicable

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

Not applicable

Relative vapour density:

Not applicable

Relative density:

No data available

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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form combustible dust concentrations in air.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Pancrelipase:
Acute oral toxicity:

LD50 (Rat): > 10,000 mg/kg

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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Starch:Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

Calcium carbonate:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 420
Assessment: The substance or mixture has no acute oral toxicity

Acute inhalation toxicity:

LC50 (Rat): > 3 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403
Assessment: The substance or mixture has no acute inhalation toxicity

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 402
Assessment: The substance or mixture has no acute dermal
toxicity

Pancrelipase:
Species
MethodResultRemarks::::

RabbitOECD Test Guideline 404
Skin irritation
Based on data from similar materials

Calcium carbonate:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Skin corrosion/irritation
Causes skin irritation.
Components:

Serious eye damage/eye irritation
Causes serious eye irritation.
Components:
Pancrelipase:
ResultRemarks::

Irritation to eyes, reversing within 21 days
Based on data from similar materials

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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Starch:SpeciesResult::RabbitNo eye irritation

Calcium carbonate:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

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:
Exposure routes
SpeciesResultRemarks::::

Inhalation
Humanspositive
Based on data from similar materials

Assessment:

May cause sensitisation by inhalation.

Starch:Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Calcium carbonate:
Test Type
Exposure routes
Species
MethodResult:::::Local lymph node assay (LLNA)
Skin contact
Mouse
OECD Test Guideline 429
negative

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
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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

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
Starch:Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Calcium carbonate:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative

Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.
Components:
Pancrelipase:
Effects on fertility

Effects on foetal development:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Calcium carbonate:
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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Effects on fertility:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative

Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 414
Result: negative

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
Pancrelipase:
Species
NOAEL
Application RouteExposure time
MethodRemarks

:
:
:
:
:
:

Rat
> 100 mg/kg
Ingestion
13 Weeks
OECD Test Guideline 408
Based on data from similar materials

Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410

Calcium carbonate:
Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
> 1,000 mg/kg
Ingestion
28 Days
OECD Test Guideline 422

Aspiration toxicity
Not classified based on available information.

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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

12. ECOLOGICAL INFORMATION
Ecotoxicity
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

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 10 - 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: Based on data from similar materials

Toxicity to algae/aquaticplants:

ErC50 (Pseudokirchneriella subcapitata (green algae)): > 1 10 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
NOEC (Desmodesmus subspicatus (green algae)): > 1 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

Calcium carbonate:
Toxicity to fish:

LL50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EL50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:NOELR (Pseudokirchneriella subcapitata (green algae)): 50
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
EL50 (Pseudokirchneriella subcapitata (green algae)): > 100
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201

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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

Toxicity to microorganisms

SDS Number:
5322035-00010:

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

NOEC: 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209
EC50: > 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

Persistence and degradability
Components:
Pancrelipase:
Biodegradability:

Result: Readily biodegradable.

:

log Pow: < 4

Bioaccumulative potential
Components:
Pancrelipase:
Partition coefficient: noctanol/water
Mobility in soil
No data available
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
Labels

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable

IATA-DGR
UN/ID No.

:

Not applicable

14. TRANSPORT INFORMATIONInternational Regulations

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Pancrelipase Formulation
Version
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Revision Date:
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Proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
5322035-00010

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Special precautions for user
Not applicable
15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or mixture
Minister of Industry Regulation No. 23/M-IND/PER/4/2013 concerning the Revision of Minister of Industry Regulation No. 87/M-IND/PER/9/2009 concerning Globally Harmonized System of Classification and Labelling of Chemicals.
Regulation of the Minister of Health No. 472 of 1996 on the Safeguarding of Substances
Hazardous to Health
Hazardous substances that must be registered: Not applicable
Government Regulation No. 74 of 2001 on the Management of Hazardous and Toxic Substances
Hazardous substances approved for use: Not applicable
Prohibited substances:

Not applicable

Restricted substances:

Not applicable

Regulation of the Ministry of Trade No. 7 of 2022 on Distribution and Control of Hazardous
Materials
Type of hazardous materials subject to distribution and : Not applicable
control, Annex I

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SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

Type of hazardous materials subject to distribution and :control, Annex II

Not applicable

The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

Revision Date:

2023/09/30

Further information
Sources of key data used tocompile the Safety Data
Sheet

:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Date format:

yyyy/mm/dd

16. OTHER INFORMATION

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ID OEL: Indonesia. Occupational Exposure Limits
ACGIH / TWA
ID OEL / NAB::

8-hour, time-weighted averageLong term exposure limit

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International 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 population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; 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 substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc15 / 16

SAFETY DATA SHEET

Pancrelipase Formulation
Version
2.1

Revision Date:
2023/09/30

SDS Number:
5322035-00010

Date of last issue: 2023/04/04
Date of first issue: 2019/11/22

es; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe 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 material 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 theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
ID / EN

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