SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Pancrelipase (High / Low Lipase) Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

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

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

2. HAZARDS IDENTIFICATIONGHS classification of chemical product
Skin corrosion/irritation: Category 2
Serious eye damage/eye irritation:

Category 2A

Respiratory sensitisation:

Category 1

Short-term (acute) aquatic
hazard:Category 2

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.
H401 Toxic to aquatic life.
1 / 21SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Precautionary statements:

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

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 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
Important symptoms and out- : May form combustible dust concentrations in air.
lines of the emergency assumed
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Pancrelipase
Talc

CAS-No.
53608-75-6
14807-96-6

Concentration (% w/w)>= 70 - < 80
> 0 - < 10

SucroseStarch57-50-1
9005-25-8>= 1 - < 10>= 1 - < 10

8-98

Diethyl phthalate

84-66-2

2.1

3-1301

Propylene glycol

57-55-6>= 0.1 - < 1

2-234

2 / 21

ENCS No.
1-468

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

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, 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.
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)
3 / 21SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

Sulphur 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- :tive equipment and emergency procedures

Use personal protective equipment.
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.

Handling
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.

7. HANDLING AND STORAGE

4 / 21SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

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 theenvironment.
Oxidizing agents
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.
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
Unsuitable material: None known.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

Value type
(Form ofexposure)

Pancrelipase

53608-75-6

TWA

Talc

14807-96-6

OEL-M(Respirable

5 / 21

Control parameters / Reference
concentration /Permissible concentration
OEB 3 (>= 10 <100 µg/m3)
1 mg/m3

Basis

Internal
JP OEL
JSOH

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

StarchSucrose
Diethyl phthalate

9005-25-8
57-50-1
84-66-2

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

particulatematter)OEL-M (Total
particulatematter)
TWA (Respirable particulate matter)
TWA
TWA
OEL-M
TWA

Engineering measures:

4 mg/m3

JP OEL
JSOH

2 mg/m3

ACGIH

10 mg/m3
10 mg/m3
5 mg/m3

ACGIH
ACGIH
JP OEL
JSOH
ACGIH

5 mg/m3

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
: Combined particulates and organic vapour 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.
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.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state

:

solid

Colour:No data available
6 / 21SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

May form combustible dust concentrations in air.

Flammability (liquids):

Not applicable

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit:

No data available

Flash point:

Not applicable

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

Not applicableAuto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density

No data available:

No data available

Relative vapour density:

Not applicable

Explosive properties:

Not explosive

7 / 21SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
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

Talc:
Acute oral toxicity:

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

Sucrose:Acute oral toxicity:

LD50 (Rat): 29,700 mg/kg

Starch:Acute oral toxicity:

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

Acute dermal toxicity:

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

Diethyl phthalate:
8 / 21SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

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

Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

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

Talc:
SpeciesResult::RabbitNo skin irritation

Diethyl phthalate:SpeciesResult::RabbitNo skin irritation

Propylene glycol:
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.

9 / 21SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

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

Propylene glycol:
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.

Talc:
Exposure routes
SpeciesResult:::Skin contact
Humansnegative

10 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

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

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

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

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

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

11 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

Sucrose:Genotoxicity in vitro:

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

Starch:Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
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

Propylene glycol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
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 Route

:
:

Rat
Skin contact
12 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Exposure time
Result::103 weeks
negative

Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

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

13 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

Propylene glycol:
Effects on fertility

Effects on foetal development

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22:

Test Type: Two-generation reproduction toxicity study
Species: Mouse
Application Route: Ingestion
Result: negative:

Test Type: Embryo-foetal development
Species: Mouse
Application Route: Ingestion
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

Diethyl phthalate:Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
150 mg/kg
Ingestion
16 Weeks

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat, male>= 1,700 mg/kg
Ingestion
2 yr

14 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

Aspiration toxicity
Not classified based on available information.
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

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 tox-:

NOEC (Cyprinus carpio (Carp)): 5 mg/l
15 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

icity)

Exposure time: 28 d

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

NOEC (Daphnia magna (Water flea)): 25 mg/l
Exposure time: 21 d

Propylene glycol:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 40,613 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 18,340 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Skeletonema costatum (marine diatom)): 19,300 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

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

NOEC (Ceriodaphnia dubia (water flea)): 13,020 mg/l
Exposure time: 7 d
NOEC (Pseudomonas putida): > 20,000 mg/l
Exposure time: 18 h

Persistence and degradability
Components:
Pancrelipase:
Biodegradability:

Result: Readily biodegradable.

Diethyl phthalate:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 94.6 %Exposure time: 28 d

Propylene glycol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 98.3 %Exposure time: 28 d
Method: OECD Test Guideline 301F:

log Pow: < 4:

Pow: < 1

Bioaccumulative potential
Components:
Pancrelipase:
Partition coefficient: noctanol/water
Sucrose:Partition coefficient: n-

16 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

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

Propylene glycol:
Partition coefficient: noctanol/water:log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8

Mobility in soil
No data available
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

17 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

IMDG-CodeUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
5322083-00011

:
:
:
:
:
:
:
:

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.
Special precautions for user
Not applicable
ERG Code:171

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical name
Diethyl phthalate
Propane-1,2-diol

Number
253
106

Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable

18 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical nameTalc (Mg3H2(SiO3)4) (without asbestos
and quartz)
Diethyl phthalate

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

Concentration (%)>0 - <10

Remarks
From April 1st, 2025

>0 - <10-

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical nameTalc (Mg3H2(SiO3)4)
Diethyl phthalate

Remarks
From April 1st, 2025-

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management ThereofClass II Designated Chemical Substances
Chemical name
Diethyl phthalate

Administration number
353

High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Not regulated as a dangerous good
Aviation Law
Not regulated as a dangerous good

19 / 21

Concentration (%)
2.1

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Not classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
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/

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
ACGIH / TWA
JP OEL JSOH / OEL-M::

8-hour, time-weighted average
Occupational Exposure Limit-Mean

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 Sys20 / 21

SAFETY DATA SHEET

Pancrelipase (High / Low Lipase) Formulation
Version
8.0

Revision Date:
2024/03/28

SDS Number:
5322083-00011

Date of last issue: 2023/09/30
Date of first issue: 2019/11/22

tem; 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.
JP / EN

21 / 21