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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:

Pancrelipase (High / Low Lipase) Formulation

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub: Pharmaceuticalstance/Mixture
Recommended restrictions
on use:Not applicable

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
30 Hudson Street, 33nd floor
07302 Jersey City, New Jersey, U.S.A
Telephone:+1-551-430-6000

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008)
Skin irritation, Category 2
H315: Causes skin irritation.
Eye irritation, Category 2
H319: Causes serious eye irritation.
Respiratory sensitisation, Category 1
H334: May cause allergy or asthma symptoms or
breathing difficulties if inhaled.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

DangerHazard statements

:

H315
H319

Causes skin irritation.
Causes serious eye irritation.
1 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

H334 May cause allergy or asthma symptoms or breathingdifficulties if inhaled.
Precautionary statements:

Prevention:
P264 Wash skin thoroughly after handling.
P280 Wear protective gloves/ eye protection/ face protection.
Response:
P304 + P340 IF INHALED: Remove person to fresh air andkeep comfortable for breathing.
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.

Hazardous components which must be listed on the label:
Pancrelipase
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
Ecological information: The substance/mixture does not contain components considered to haveendocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
Toxicological information: The substance/mixture does not contain components considered tohave endocrine disrupting properties according to REACH Article 57(f) or Commission Delegatedregulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
May form combustible dust concentrations in air.

SECTION 3: Composition/information on ingredients
3.2 Mixtures
Components
Chemical name

Pancrelipase

CAS-No.
EC-No.
Index-No.
Registration number
53608-75-6
258-659-7

For explanation of abbreviations see section 16.

2 / 16Classification

Concentration(% w/w)

Skin Irrit. 2; H315
Eye Irrit. 2; H319
Resp. Sens. 1;
H334>= 70 - < 90

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

SECTION 4: First aid measures
4.1 Description of 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.
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).

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
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 eye contact:

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:

If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.

4.2 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).
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

3 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:High volume water jet

5.2 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

5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods:

Carbon oxides
Nitrogen oxides (NOx)Sulphur oxides:

In the event of fire, wear self-contained breathing apparatus.
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
6.1 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).
6.2 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.

4 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

6.3 Methods and material 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.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handlingTechnical measures:

Local/Total ventilation
Advice on safe handling::

Hygiene measures:

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 theenvironment.
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
5 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

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.
7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Keep tightly closed.
areas and containers
Store in accordance with the particular national regulations.
Advice on common storage

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents:

No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
Components

CAS-No.

Pancrelipase

53608-75-6

Talc

14807-96-6

Diethyl phthalate

Value type (Formof exposure)
TWA
TWA (respirable
dust)
TWA (total dust)

84-66-2

TWA

Control parameters

Basis

OEB 3 (>= 10 < 100µg/m3)
2 mg/m3

Internal

6 mg/m3
3 mg/m3

FOR-201112-06-1358
FOR-201112-06-1358
FOR-201112-06-1358

Derived No Effect Level (DNEL) according to Regulation (EC) No. 1907/2006:
Substance name

End UseExposure routes

Diethyl phthalate

Workers

Inhalation

Workers

Skin contact

Consumers

Inhalation

Consumers

Skin contact

Consumers

Ingestion

Potential health effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects

Value
10,56 mg/m3
15 mg/kg
bw/day2,6 mg/m3
7,5 mg/kg
bw/day0,75 mg/kg
bw/dayPredicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:
Substance name

Environmental Compartment
6 / 16Value

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

Diethyl phthalate

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

Fresh water
Freshwater - intermittent
Marine water
Sewage treatment plant
Fresh water sediment
Marine sediment
Soil
Oral (Secondary Poisoning)

0,012 mg/l
0,120 mg/l0,0012 mg/l
2 mg/l0,137 mg/kg dryweight (d.w.)
0,0137 mg/kg dryweight (d.w.)
0,137 mg/kg dryweight (d.w.)
33 mg/kg food

8.2 Exposure controls
Engineering measures
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect products, workers, and the environment.
Containment technologies suitable for controlling compounds are required to control at source
and to prevent migration of the compound to uncontrolled areas (e.g., open-face containment devices).
Minimize open handling.
Personal protective equipment
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.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Skin and body protection::

Respiratory protection:

Consider double gloving.
Work uniform or laboratory coat.
Additional body garments should be used based upon the task
being performed (e.g., sleevelets, apron, gauntlets, disposable
suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to NS EN 14387
Combined particulates and organic vapour type (A-P)

Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: solid
Colour:No data available

7 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

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

Flash point:

Not applicableAuto-ignition temperature:

No data available

Decomposition temperature:

No data available

pH:

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

Relative density:

No data available

Density:

No data available

Relative vapour density:

Not applicable

Particle characteristics
Particle size:

No data available:

Not explosive

9.2 Other information
Explosives

8 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Evaporation rate:

Not applicable

Molecular weight:

No data available

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: May form combustible dust concentrations in air.
Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

Heat, flames and sparks.
Avoid dust formation.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
Information on likely routes of : Inhalation
exposure
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Components:
Pancrelipase:
Acute oral toxicity:

LD50 (Rat): > 10.000 mg/kg

Skin corrosion/irritation
Causes skin irritation.

9 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

Components:
Pancrelipase:
Species
MethodResultRemarks::::

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

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

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.

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
10 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

Result: negative
Remarks: Based on data from similar materials
Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.
Components:
Pancrelipase:
Effects on fertility

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

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

Aspiration toxicity
Not classified based on available information.
11.2 Information on other hazards
Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation
11 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

Date of last issue: 30.09.2023
Date of first issue: 22.11.2019(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

SECTION 12: Ecological information
12.1 Toxicity
Components:
Pancrelipase:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials

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

12.2 Persistence and degradability
Components:
Pancrelipase:
Biodegradability:

Result: Readily biodegradable.

:

log Pow: < 4

12.3 Bioaccumulative potential
Components:
Pancrelipase:
Partition coefficient: noctanol/water
12.4 Mobility in soil
No data available
12.5 Results of PBT and vPvB assessment
Product:
12 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

Assessment

SDS Number:
5325828-00010:

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

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.

12.6 Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
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.

SECTION 14: Transport information
14.1 UN number or ID number
ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous good

14.2 UN proper shipping name14.3 Transport hazard class(es)13 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

14.4 Packing group

14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Not applicable
14.7 Maritime transport in bulk according to IMO instruments
Remarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
REACH - Restrictions on the manufacture, placing on: Not applicablethe market and use of certain dangerous substances,mixtures and articles (Annex XVII)REACH - Candidate List of Substances of Very High: Not applicable
Concern for Authorisation (Article 59).
REACH - List of substances subject to authorisation: Not applicable(Annex XIV)
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
Regulation (EU) 2019/1021 on persistent organic pollu: Not applicabletants (recast)
Regulation (EU) No 649/2012 of the European Parlia: Not applicablement and the Council concerning the export and importof dangerous chemicals
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control ofmajor-accident hazards involving dangerous substances.
Not applicable
Other regulations:
Note the regulation on organization, leadership and participation, chapter 12 on the work of
14 / 16

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

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

children and young people.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined15.2 Chemical safety assessment
A Chemical Safety Assessment has not been carried out.

SECTION 16: Other information
Other information:

Items where changes have been made to the previous version
are highlighted in the body of this document by two verticallines.

Full text of H-Statements
H315
H319
H334

:
:
:

Causes skin irritation.
Causes serious eye irritation.
May cause allergy or asthma symptoms or breathing difficulties if inhaled.

Full text of other abbreviations
Eye Irrit.
: Eye irritation
Resp. Sens.
: Respiratory sensitisation
Skin Irrit.
: Skin irritation
FOR-2011-12-06-1358: Norway. Occupational Exposure limits
FOR-2011-12-06-1358 /: Long term exposure limit
TWA
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; ECx - Concentration
associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; 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 and Equipment 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;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory of
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Pancrelipase (High / Low Lipase) Formulation
Version
1.9

Revision Date:
28.03.2024

SDS Number:
5325828-00010

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

Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof 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; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of very high concern; TCSI - Taiwan Chemical Substance Inventory; TECI Thailand Existing Chemicals Inventory; 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
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/

Classification of the mixture:

Classification procedure:

Skin Irrit. 2

H315

Calculation method

Eye Irrit. 2

H319

Calculation method

Resp. Sens. 1

H334

Calculation method

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.
NO / EN

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