SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Ezetimibe / Atorvastatin 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 productSpecific target organ toxicity - : Category 2 (Liver, muscle)
repeated exposure (Oral)
Long-term (chronic) aquatic
hazard:Category 2

GHS label elements
Hazard pictograms:

Signal word:

Warning

Hazard statements:

H373 May cause damage to organs (Liver, muscle) throughprolonged or repeated exposure if swallowed.
H411 Toxic to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
P260 Do not breathe dust.
P273 Avoid release to the environment.
Response:
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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

P314 Get medical advice/ attention if you feel unwell.
P391 Collect spillage.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
Other hazards which do not result in classification
Important symptoms and out- : Dust contact with the eyes can lead to mechanical irritation.
lines of the emergency asContact with dust can cause mechanical irritation or drying ofsumed
the skin.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Atorvastatin
Ezetimibe
Magnesium stearate

CAS-No.
9004-34-6
134523-03-8
163222-33-1
557-04-0

Sodium n-dodecyl sulfate

151-21-3

Concentration (% w/w)>= 20 - < 30>= 10 - < 20>= 2.5 - < 10
> 0 - < 10>= 0.25 - < 1

ENCS No.

2-611
2-16794. 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:

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.
Get medical attention if symptoms occur.
Wash with water and soap.
Get medical attention if symptoms occur.
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.
May cause damage to organs through prolonged or repeatedexposure if swallowed.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

Notes to physician

SDS Number:
26493-00022:

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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 chemical
None known.

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

Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)
Fluorine compounds
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 deter3 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

mine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
7. HANDLING AND STORAGE
Handling
Technical measures:

Local/Total ventilation
Advice on safe handling::

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

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 breathe dust.
Do not swallow.
Avoid contact with eyes.
Avoid prolonged or repeated contact with skin.
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.
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.
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
4 / 25Control parame-

Basis

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29(Form ofexposure)

Cellulose
Atorvastatin

9004-34-6
134523-03-8

Ezetimibe

163222-33-1

Magnesium stearate557-04-0

Engineering measures

:

TWA
TWA
Wipe limit
TWA
Wipe limit
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)ters / Reference
concentration /Permissible concentration
10 mg/m3
0.05 mg/m3 (OEB
3)
0.5 mg/100 cm²
25 µg/m3 (OEB 3)
250 µg/100 cm²
10 mg/m3

3 mg/m3

ACGIH
Internal
Internal
Internal
Internal
ACGIH

ACGIH

All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., open-face containment devices).
Minimize open handling.

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

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

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

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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Physical state:

powderColour:off-white

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

Flammability (liquids):

No data available

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:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

0.01 g/l

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Density
Relative vapour density:

No data available:

No data available
6 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available

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:

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:
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

Atorvastatin:
Acute oral toxicity:

LD50 (Rat, male and female): > 5,000 mg/kg
LD50 (Mouse, male and female): > 5,000 mg/kg
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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

Ezetimibe:
Acute oral toxicity

SDS Number:
26493-00022:

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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

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

Sodium n-dodecyl sulfate:
Acute oral toxicity:

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

Acute dermal toxicity:

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

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

Ezetimibe:
SpeciesResult::RabbitNo skin irritation

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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

Sodium n-dodecyl sulfate:SpeciesResult::RabbitSkin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Atorvastatin:
SpeciesResult
Method:::RabbitNo eye irritation
Draize Test

Ezetimibe:
SpeciesResult::RabbitNo eye irritation

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

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

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Atorvastatin:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Ezetimibe:
Test TypeSpeciesResult:::Maximisation Test
Guinea pig
negative

Magnesium stearate:
Test Type
Exposure routes
Species
MethodResultRemarks

:
:
:
:
:
:

Maximisation Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative
Based on data from similar materials

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

Maximisation Test
Skin contact
Guinea pig
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

Atorvastatin:
Genotoxicity in vitro:

Test Type: reverse mutation assay
Test system: Salmonella typhimurium
Result: negative
Test Type: reverse mutation assay
Test system: Escherichia coli
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Test system: Chinese hamster lung cells
Result: negative
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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Test Type: sister chromatid exchange assay
Test system: Chinese hamster lung cells
Result: negative
Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Cell type: Bone marrow
Application Route: Oral
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

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

Sodium n-dodecyl sulfate:
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
Result: negative

Genotoxicity in vivo:

Test Type: Rodent dominant lethal test (germ cell) (in vivo)
Species: Mouse
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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Application Route: Ingestion
Result: negative
Carcinogenicity
Not classified based on available information.
Components:
Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

Atorvastatin:
Species
Application RouteExposure time
NOAEL
LOAEL
ResultTarget Organs

:
:
:
:
:
:
:

Mouse, male and female
oral (gavage)
2 Years
200 mg/kg body weight
400 mg/kg body weight
negative
Liver

Species
Application RouteExposure time
LOAEL
Target Organs

:
:
:
:
:

Rat, female
oral (gavage)
2 Years
100 mg/kg body weight
Musculo-skeletal system

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
Method

:
:
:
:

Rat
Ingestion
2 Years
OECD Test Guideline 453
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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

ResultRemarks

SDS Number:
26493-00022::

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

negative
Based on data from similar materials

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

Effects on foetal development

Atorvastatin:
Effects on fertility:

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:

Test Type: Fertility/early embryonic development
Species: Rat, female
Fertility: NOAEL: 225 mg/kg body weight
Result: No effects on fertility
Test Type: Fertility/early embryonic development
Species: Rat, maleFertility: NOAEL: 175 mg/kg body weight
Result: No effects on fertility

Effects on foetal development:

Species: Rat, female
Developmental Toxicity: NOAEL: 20 mg/kg body weight
Result: No teratogenic effects, Embryo-foetal toxicity
Remarks: Maternal toxicity observed.
Species: Rabbit, female
Application Route: Oral
Developmental Toxicity: NOAEL: 100 mg/kg body weight
Result: No embryo-foetal toxicity

Ezetimibe:
Effects on fertility

Effects on foetal development:

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
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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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

Effects on foetal development

Sodium n-dodecyl sulfate:
Effects on fertility

Effects on foetal development:

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: 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

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
May cause damage to organs (Liver, muscle) through prolonged or repeated exposure if swallowed.
Components:
Atorvastatin:
Exposure routes
Target Organs
Assessment:::

Ingestion
Liver, muscle
May cause damage to organs through prolonged or repeatedexposure.

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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Repeated dose toxicity
Components:
Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 Days

Atorvastatin:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat, male and female
70 mg/kg
oral (gavage)
52 Weeks
Liver

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
10 mg/kg
oral (gavage)
104 Weeks
Liver

Ezetimibe:
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
Remarks

:
:
:
:
:

Dog
300 mg/kg
Oral
1 yr
No significant adverse effects were reported

Magnesium stearate:
Species:Rat
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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

NOAEL
Application RouteExposure time
Remarks::::> 100 mg/kg
Ingestion
90 DaysBased on data from similar materials

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

:
:
:
:
:

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

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

Symptoms: muscle pain, Fatigue, stomach discomfort, Abdominal pain, constipation, flatulence, liver function change

Ezetimibe:Ingestion:

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

Cellulose:
Toxicity to fish:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Atorvastatin:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 92 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:

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SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 200 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 108
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 14
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.49 mg/l
Exposure time: 33 d
Method: OECD Test Guideline 210

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

NOEC (Daphnia magna (Water flea)): 0.2 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Toxicity to microorganisms:

EC50: > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition

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
17 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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

Magnesium stearate:
Toxicity to fish:

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

18 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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

Sodium n-dodecyl sulfate:Toxicity to fish:

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:

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 hPersistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Atorvastatin:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 7.7 %Exposure time: 28 d
Method: OECD Test Guideline 314

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

19 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

Magnesium stearate:
Biodegradability:

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

Sodium n-dodecyl sulfate:
Biodegradability:

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

log Pow: 1.62:

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

log Pow: 4.36

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

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

Atorvastatin:
Distribution among environmental compartments:

log Koc: 2.84

Ezetimibe:
Distribution among environmental compartments:

log Koc: 4.35
Method: OECD Test Guideline 106

Bioaccumulative potential
Components:
Atorvastatin:
Partition coefficient: noctanol/water
Ezetimibe:
Bioaccumulation

Partition coefficient: noctanol/water

Mobility in soil
Components:

Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
20 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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.

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, Atorvastatin)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Ezetimibe, Atorvastatin)
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, Atorvastatin)
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.
National Regulations
Refer to section 15 for specific national regulation.
21 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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.
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
Sodium alkyl(C=8-18) sulfate

Number214

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
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical name
Magnesium stearate

Concentration (%)>0 - <10

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical name
Magnesium stearate

Remarks-

Remarks-

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable

22 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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 Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Miscellaneous dangerous substances and articles (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Miscellaneous dangerous substances and articles (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

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
23 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

IECSC

SDS Number:
26493-00022:

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

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)
ACGIH / TWA:

8-hour, time-weighted average

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 Recom24 / 25

SAFETY DATA SHEET

Ezetimibe / Atorvastatin Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26493-00022

Date of last issue: 2023/09/29
Date of first issue: 2014/10/29

mendations 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

25 / 25