SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

Section 1: Identification
Product identifier:

Pancrelipase (High / Low Lipase) Formulation

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
Manufacturer or supplier's details
Company: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

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

E-mail address

EHSSTEWARD@organon.com:

Section 2: Hazard identification
Classification of the substance or mixture
Skin corrosion/irritation: Category 2
Serious eye damage/eye irritation:

Category 2

Respiratory sensitisation:

Category 1

GHS Label elements, including precautionary statements
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.
1 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

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.
Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical name
Pancrelipase
Talc
StarchSucrose
Diethyl phthalate

CAS-No.
53608-75-6
14807-96-6
9005-25-8
57-50-1
84-66-2

Concentration (% w/w)>= 70 -< 90>= 1 -< 10>= 1 -< 10>= 1 -< 10>= 1 -< 10Section 4: First-aid measures
Description of necessary 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: If inhaled, remove to fresh air.
If not breathing, give artificial respiration.
If breathing is difficult, give oxygen.
Get medical attention.
In case of skin contact: In case of contact, immediately flush skin with plenty of water
2 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

In case of eye contact:

If swallowed:

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

for at least 15 minutes while removing contaminated clothing
and shoes.
Get medical attention.
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.

Most important symptoms and effects, both acute and delayed
Risks: 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).
Protection of first-aiders: 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).
Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.
Section 5: Fire-fighting measures
Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

:

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

Special hazards arising from the substance or mixture
Specific hazards during fire- : Avoid generating dust; fine dust dispersed in air in sufficient
fighting
concentrations, 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

Special protective actions for fire-fighters
Special protective equipment : In the event of fire, wear self-contained breathing apparatus.
3 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

for firefighters
Specific extinguishing methods

SDS Number:
5322087-00010:

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

Use personal protective equipment.
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.

Section 6: Accidental release measures
Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
Environmental precautions
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 for containment and cleaning up
Methods for 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.
Section 7: Handling and storage
Precautions for safe handlingTechnical 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.
4 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

Hygiene measures

SDS Number:
5322087-00010:

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

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 theenvironment.
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.

Conditions for safe storage, including any incompatibilities
Conditions for safe storage: Keep in properly labelled containers.
Keep tightly closed.
Store in accordance with the particular national regulations.
Materials to avoid: Do not store with the following product types:
Strong oxidizing agents
Section 8: Exposure controls/personal protection
Control parameters
Occupational Exposure Limits
Components

CAS-No.

Pancrelipase

53608-75-6

Talc

14807-96-6

5 / 17

Value type
(Form ofexposure)TWA
PEL (longterm)
TWA (Respirable particulate mat-Control parameters / Permissible
concentration
OEB 3 (>= 10 <100 µg/m3)
2 mg/m3Basis

2 mg/m3

ACGIH

Internal
SG OELSAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Starch

9005-25-8

Sucrose57-50-1

Diethyl phthalate

84-66-2

Appropriate engineering
control measures:

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

ter)
PEL (longterm)
TWA
PEL (longterm)
TWA
PEL (long
term)
TWA

10 mg/m3

SG OEL

10 mg/m3
10 mg/m3

ACGIH
SG OEL

10 mg/m3
5 mg/m3

ACGIH
SG OEL

5 mg/m3

ACGIH

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.

Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: 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.
Skin protection: Work uniform or laboratory coat.
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.
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Combined particulates and organic vapour type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Consider double gloving.

Section 9: Physical and chemical properties
Appearance

:

solid

Colour:No data available

Odour

:

No data available

Odour Threshold:

No data available
6 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

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

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 characteristics
Particle size:

No data available

7 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

Section 10: Stability and reactivity
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.

Section 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

Talc:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Remarks: Based on data from similar materials

Starch:Acute oral toxicity:

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

Acute dermal toxicity:

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

Sucrose:Acute oral toxicity:

LD50 (Rat): 29,700 mg/kg

Diethyl phthalate:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 4.64 mg/l
Exposure time: 6 h
Test atmosphere: vapour

Acute dermal toxicity:

LD50 (Rat): > 11,181 mg/kg
8 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

Skin corrosion/irritation
Causes skin irritation.
Components:
Pancrelipase:
Species
MethodResultRemarks::::

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

Talc:
SpeciesResult::RabbitNo skin irritation

Diethyl phthalate:SpeciesResult::RabbitNo skin irritation

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

Talc:
SpeciesResult::RabbitNo eye irritation

Starch:SpeciesResult::RabbitNo eye irritation

Diethyl phthalate:SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.

9 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

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.

Talc:
Exposure routes
SpeciesResult:::Skin contact
Humansnegative

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

Diethyl phthalate:
Test Type
Exposure routes
SpeciesResult::::Buehler Test
Skin contact
Guinea pig
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
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
10 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

Talc:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

Test Type: Chromosome aberration test in vitro
Species: Rat
Application Route: Ingestion
Result: negative

Starch:Genotoxicity in vitro:

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

Sucrose:Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative

Diethyl phthalate:
Genotoxicity in vitro:

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

Carcinogenicity
Not classified based on available information.
Components:
Talc:
Species
Application RouteExposure time
Result

:
:
:
:

Mouse
inhalation (dust/mist/fume)
2 Years
negative

Diethyl phthalate:Species
Application RouteExposure time
Result

:
:
:
:

Rat
Skin contact
103 weeks
negative
11 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

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

Effects on foetal development

Talc:
Effects on foetal development

Diethyl phthalate:
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:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 416
Result: negative:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Skin contact
Result: negative

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.

12 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

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

Diethyl phthalate:Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
150 mg/kg
Ingestion
16 WeeksAspiration toxicity
Not classified based on available information.
Section 12: Ecological information
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

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
13 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

NOEC (Desmodesmus subspicatus (green algae)): > 1 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
Talc:
Toxicity to fish:

LC50 (Brachydanio rerio (zebrafish)): > 100,000 mg/l
Exposure time: 24 hDiethyl phthalate:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 12 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

LC50 (Daphnia magna (Water flea)): 90 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Desmodesmus subspicatus (green algae)): 45 mg/l
Exposure time: 72 h
EC10 (Desmodesmus subspicatus (green algae)): 9 mg/l
Exposure time: 72 h

Toxicity to fish (Chronic toxicity):

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

NOEC (Cyprinus carpio (Carp)): 5 mg/l
Exposure time: 28 d
NOEC (Daphnia magna (Water flea)): 25 mg/l
Exposure time: 21 d

Persistence and degradability
Components:
Pancrelipase:
Biodegradability:

Result: Readily biodegradable.

Diethyl phthalate:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 94.6 %Exposure time: 28 d:log Pow: < 4

Bioaccumulative potential
Components:
Pancrelipase:
Partition coefficient: noctanol/water

14 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Sucrose:Partition coefficient: noctanol/water:

Pow: < 1

Diethyl phthalate:Partition coefficient: noctanol/water:log Pow: 2.2

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

Mobility in soil
No data available
Other adverse effects
No data available
Section 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.

Section 14: Transport information
International Regulations
UNRTDGUN numberUN proper shipping name
Transport hazard class(es)Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
UN proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN numberUN proper shipping nameClass
Subsidiary risk

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:

Not applicableNot applicableNot applicableNot applicable
15 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
5322087-00010

:
:
:
:

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

Not applicableNot applicableNot applicableNot applicable

Transport in bulk according to IMO instruments
Not applicable for product as supplied.
Special precautions for user
Not applicable
Section 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
Workplace Safety and Health Act and Workplace Safety and Health (General Provisions) Regulations: This product is subjected to the SDS, labelling, PEL and other requirements in the
Act/Regulations.
Environmental Protection and Management Act and: Not applicable
Environmental Protection and Management (Hazardous Substances) Regulations
Fire Safety (Petroleum and Flammable Materials)
Regulations:

Not applicable

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

not determined

IECSC

:

not determined

Revision Date:

28.03.2024

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:

dd.mm.yyyy

Section 16: Other information

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
SG OEL: Singapore. Workplace Safety and Health (General Provisions)
Regulations - First Schedule Permissible Exposure Limits of
Toxic Substances.
ACGIH / TWA
SG OEL / PEL (long term)::

8-hour, time-weighted average
Permissible Exposure Level (PEL) Long Term
16 / 17

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5322087-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019

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 Substances; (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.
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