SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Ezetimibe Formulation

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

Telephone:+1-551-430-6000

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

E-mail address

EHSSTEWARD@organon.com:

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

2. HAZARDS IDENTIFICATIONGHS Classification
Long-term (chronic) aquatic
hazard:GHS label elements
Hazard pictograms:

Signal word
Hazard statements::

Precautionary statements:

Category 2

None
H411 Toxic to aquatic life with long lasting effects.
Prevention:
P273 Avoid release to the environment.
Response:
P391 Collect spillage.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Other hazards which do not result in classification
Dust contact with the eyes can lead to mechanical irritation.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Ezetimibe
Sodium n-dodecyl sulfate
Magnesium stearate
2-Pyrrolidone

CAS-No.
9004-34-6
163222-33-1
151-21-3
557-04-0
616-45-5

Concentration (% w/w)>= 10 -< 30>= 10 -< 25>= 1 -< 2.5
< 10
< 0.3

4. FIRST AID MEASURES
General advice:

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

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

If inhaled, remove to fresh air.
Get medical attention if symptoms occur.
In case of contact, immediately flush skin with plenty of water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.
Dust contact with the eyes can lead to mechanical irritation.

Notes to physician::

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:

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

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.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)
Fluorine compounds
Sulphur oxides
Metal oxides

Specific extinguishing methods:

Special protective equipment
for firefighters:

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

6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :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:

Sweep up or vacuum up spillage and collect in suitable container for disposal.
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.
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.

:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.

7. HANDLING AND STORAGE
Technical measures

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Local/Total ventilation
Advice on safe handling::

Conditions for safe storage:

Materials to avoid:

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Use only with adequate ventilation.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Avoid contact with eyes.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
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.
Keep in properly labelled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

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

CAS-No.

Value type
Control parameBasis(Form ofters / Permissible
exposure)
concentration
9004-34-6NAB
10 mg/m3
ID OELTWA
10 mg/m3
ACGIH
163222-33-1 TWA
25 µg/m3 (OEB 3) Internal
Wipe limit
250 µg/100 cm²Internal
557-04-0NAB
10 mg/m3
ID OEL
Further information: Not classified as carcinogenic to humans. Not
enough data to classify these materials as carcinogenic to humans or animals
TWA (Inhal10 mg/m3
ACGIH
able particulate matter)
TWA (Res3 mg/m3
ACGIH
pirable particulate matter)

Cellulose
Ezetimibe
Magnesium stearate

Engineering measures:

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.

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

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:

Hygiene measures:

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.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to the working place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColour:off-white

Odour

:

No data available

Odour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

5 / 22

SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Evaporation rate:

No data available

Flammability (solid, gas):

May form explosive dust-air mixture during processing, handling or other means.

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

No data available

Relative vapour density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Heat, flames and sparks.

10. STABILITY AND REACTIVITY

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Incompatible materials
Hazardous decomposition
products::

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 2,000 mg/kg
Method: Calculation method

Cellulose:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

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

Ezetimibe:
Acute oral toxicity:

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

Components:

LD50 (Mouse): > 5,000 mg/kg
LD50 (Dog): > 3,000 mg/kg
Acute inhalation toxicity:

Remarks: No data available

Acute dermal toxicity:

Remarks: No data available

Acute toxicity (other routes of :administration)

LD50 (Rat): > 2,000 mg/kg
Application Route: Intraperitoneal
LD50 (Mouse): > 1,000 - < 2,000 mg/kg
Application Route: Intraperitoneal

Sodium n-dodecyl sulfate:
Acute oral toxicity:

LD50 (Rat): 1,200 mg/kg
Method: OECD Test Guideline 401

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 402
Remarks: Based on data from similar materials

Magnesium stearate:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 423
Assessment: The substance or mixture has no acute oral toxicity
Remarks: Based on data from similar materials

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Remarks: Based on data from similar materials

2-Pyrrolidone:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 401
Assessment: The substance or mixture has no acute oral toxicity

Acute dermal toxicity:

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

Skin corrosion/irritation
Not classified based on available information.
Components:
Ezetimibe:
SpeciesResult::RabbitNo skin irritation

Sodium n-dodecyl sulfate:SpeciesResult::RabbitSkin irritation

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

2-Pyrrolidone:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Ezetimibe:
SpeciesResult::RabbitNo eye irritation

Sodium n-dodecyl sulfate:SpeciesResult
Method:::RabbitIrreversible effects on the eyeOECD Test Guideline 405

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

2-Pyrrolidone:
SpeciesResult::RabbitIrritation to eyes, reversing within 7 days

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Ezetimibe:
Test TypeSpeciesResult:::Maximisation Test
Guinea pig
negative

Sodium n-dodecyl sulfate:
Test Type
Exposure routes
SpeciesResultRemarks:::::

Maximisation Test
Skin contact
Guinea pig
negative
Based on data from similar materials

Magnesium stearate:
Test Type
Exposure routes
Species:::

Maximisation Test
Skin contact
Guinea pig
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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

MethodResultRemarks:::

OECD Test Guideline 406
negative
Based on data from similar materials

2-Pyrrolidone:
Test Type
Exposure routes
Species
MethodResultRemarks

:
:
:
:
:
:

Local lymph node assay (LLNA)
Skin contact
Mouse
OECD Test Guideline 429
negative
Based on data from similar materials

Germ cell mutagenicity
Not classified based on available information.
Components:
Cellulose:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative

Ezetimibe:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Metabolic activation: with and without metabolic activation
Result: negative
Test Type: Chromosomal aberration
Test system: Human lymphocytes
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Cell type: Bone marrow
Application Route: Oral
Result: negative

Sodium n-dodecyl sulfate:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

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

Test Type: Rodent dominant lethal test (germ cell) (in vivo)
Species: Mouse
Application Route: Ingestion
Result: negative

Magnesium stearate:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
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
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Based on data from similar materials

2-Pyrrolidone:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Method: OECD Test Guideline 474
Result: negative

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

:
:
:

Rat
Ingestion
72 weeks
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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Result:negative

Ezetimibe:
Species
Application RouteExposure time
Result::::Rat, female
oral (feed)
104 weeks
negative

Species
Application RouteExposure time
Result::::Rat, maleoral (feed)
104 weeks
negative

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
oral (feed)
104 weeks
negative

Sodium n-dodecyl sulfate:Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
Ingestion
2 Years
OECD Test Guideline 453
negative
Based on data from similar materials

2-Pyrrolidone:
Species
Application RouteExposure time
ResultRemarks

:
:
:
:
:

Mouse
Ingestion
18 month(s)negative
Based on data from similar materials

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

Effects on foetal development:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

Ezetimibe:
Effects on fertility

Effects on foetal development

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21:

Test Type: Fertility/early embryonic development
Species: Rat, male and female
Fertility: NOAEL: > 1,000 mg/kg body weight
Result: No effects on fertility, No fetotoxicity:

Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: NOAEL: > 1,000 mg/kg body weight
Result: No adverse effects
Test Type: Development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: NOAEL: > 1,000 mg/kg body weight
Result: No adverse effects

Sodium n-dodecyl sulfate:
Effects on fertility

Effects on foetal development

Magnesium stearate:
Effects on fertility

Effects on foetal development

2-Pyrrolidone:
Effects on fertility:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 416
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: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
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: One-generation reproduction toxicity study
Species: Rat
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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Application Route: Ingestion
Result: positive
Remarks: Based on data from similar materials
Effects on foetal development:

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

Reproductive toxicity - Assessment:

Clear evidence of adverse effects on sexual function and fertility, based on animal experiments., Clear evidence of adverse
effects on development, based on animal experiments.

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

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 DaysEzetimibe:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Dog
1,000 mg/kg
Oral
90 d
No significant adverse effects were reported

Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
1,500 mg/kg
Oral
90 d
No significant adverse effects were reported

Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Mouse
500 mg/kg
Oral
90 d
No significant adverse effects were reported

Species
NOAEL
Application RouteExposure time

:
:
:
:

Dog
300 mg/kg
Oral
1 yr
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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Remarks:

No significant adverse effects were reported

Sodium n-dodecyl sulfate:Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
488 mg/kg
Ingestion
90 DaysBased on data from similar materials

Magnesium stearate:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
> 100 mg/kg
Ingestion
90 DaysBased on data from similar materials

2-Pyrrolidone:
Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
207 mg/kg
Ingestion
3 Months
OECD Test Guideline 408

Aspiration toxicity
Not classified based on available information.
Components:
Ezetimibe:
Not applicable
Experience with human exposure
Components:
Ezetimibe:Ingestion:

Symptoms: Headache, Nausea, Vomiting, Diarrhoea, flatulence, muscle pain, upper respiratory tract infection, Backpain, joint pain:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
Exposure time: 48 h

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Cellulose:
Toxicity to fish

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Remarks: Based on data from similar materials
Ezetimibe:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 0.125 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: No toxicity at the limit of solubility

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 4 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): >0.317 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility
NOEC (Pseudokirchneriella subcapitata (green algae)): 0.317
mg/l
Exposure time: 96 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.051 mg/l
Exposure time: 33 d
Method: OECD Test Guideline 210
NOEC (Cyprinodon variegatus (sheepshead minnow)): 4 mg/l
Exposure time: 7 dRemarks: No toxicity at the limit of solubility

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

NOEC (Daphnia magna (Water flea)): 0.282 mg/l
Exposure time: 21 d
Remarks: No toxicity at the limit of solubility

M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

:

1

:

EC50: > 4.4 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility
NOEC: 4.4 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

Sodium n-dodecyl sulfate:Toxicity to fish

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21:

LC50 (Pimephales promelas (fathead minnow)): 29 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 5.55 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Desmodesmus subspicatus (green algae)): > 120 mg/l
Exposure time: 72 h
NOEC (Desmodesmus subspicatus (green algae)): 30 mg/l
Exposure time: 72 h

Toxicity to fish (Chronic toxicity):

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

Magnesium stearate:
Toxicity to fish

NOEC (Pimephales promelas (fathead minnow)): >= 1.357
mg/l
Exposure time: 42 d
NOEC (Ceriodaphnia dubia (water flea)): 0.88 mg/l
Exposure time: 7 d
EC50: 135 mg/l
Exposure time: 3 h:

LC50 (Leuciscus idus (Golden orfe)): > 100 mg/l
Exposure time: 48 h
Method: DIN 38412
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EL50 (Daphnia magna (Water flea)): > 1 mg/l
Exposure time: 47 h
Test substance: Water Accommodated Fraction
Method: Directive 67/548/EEC, Annex V, C.2.
Remarks: Based on data from similar materials
No toxicity at the limit of solubility

Toxicity to algae/aquaticplants:EL50 (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
No toxicity at the limit of solubility
NOELR (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Toxicity to microorganisms:

EC10 (Pseudomonas putida): > 100 mg/l
Exposure time: 16 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

2-Pyrrolidone:
Toxicity to fish:

LC50 (Danio rerio (zebra fish)): > 4,600 - 10,000 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and other :aquatic invertebrates

EC50 (Daphnia magna (Water flea)): > 500 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants

ErC50 (Desmodesmus subspicatus (green algae)): > 500 mg/l
Exposure time: 72 h:

EC10 (Desmodesmus subspicatus (green algae)): 22.2 mg/l
Exposure time: 72 h
Toxicity to microorganisms:

EC50: > 1,000 mg/l
Exposure time: 30 min
Method: OECD Test Guideline 209

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Ezetimibe:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 6.8 %Exposure time: 28 d

Stability in water:

Hydrolysis: 50 %(4.5 d)
Method: OECD Test Guideline 111

Sodium n-dodecyl sulfate:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 95 %Exposure time: 28 d
Method: OECD Test Guideline 301B

Magnesium stearate:
Biodegradability:

Result: Not biodegradable
Remarks: Based on data from similar materials

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SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

2-Pyrrolidone:
Biodegradability

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21:

Result: Readily biodegradable.
Remarks: Based on data from similar materials:

Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): 173
Exposure time: 97 d
Method: OECD Test Guideline 305:

log Pow: 4.36

Sodium n-dodecyl sulfate:Partition coefficient: noctanol/water:log Pow: 0.83

Magnesium stearate:
Partition coefficient: noctanol/water:log Pow: > 4

2-Pyrrolidone:
Partition coefficient: noctanol/water:log Pow: -0.71
Method: OECD Test Guideline 107:

log Koc: 4.35
Method: OECD Test Guideline 106

Bioaccumulative potential
Components:
Ezetimibe:
Bioaccumulation

Partition coefficient: noctanol/water

Mobility in soil
Components:
Ezetimibe:
Distribution among environmental compartments
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

19 / 22

SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ezetimibe)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Ezetimibe)
9
III
Miscellaneous
956

:

956

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ezetimibe)
9III
9F-A, S-F
yes

Class
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
Environmentally hazardous

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or mixture

20 / 22

SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

Minister of Industry Regulation No. 23/M-IND/PER/4/2013 concerning the Revision of Minister of Industry Regulation No. 87/M-IND/PER/9/2009 concerning Globally Harmonized System of Classification and Labelling of Chemicals.
Regulation of the Minister of Health No. 472 of 1996 on the Safeguarding of Substances
Hazardous to Health
Hazardous substances that must be registered: Not applicable
Government Regulation No. 74 of 2001 on the Management of Hazardous and Toxic Substances
Hazardous substances approved for use: Not applicable
Prohibited substances:

Not applicable

Restricted substances:

Not applicable

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

Not applicable

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

not determined

IECSC

:

not determined

Revision Date:

2023/09/26

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

:

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

Date format:

yyyy/mm/dd

16. OTHER INFORMATION

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

8-hour, time-weighted averageLong term exposure limit

21 / 22

SAFETY DATA SHEET

Ezetimibe Formulation
Version
7.1

Revision Date:
2023/09/26

SDS Number:
23831-00023

Date of last issue: 2023/03/20
Date of first issue: 2014/10/21

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.
ID / EN

22 / 22