SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

SECTION 1. IDENTIFICATION
Product name:

Ezetimibe / Rosuvastatin Formulation

Manufacturer or supplier's details
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
Emergency telephone: 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
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Combustible dust
Carcinogenicity:

Category 1B

Reproductive toxicity:

Category 1BSpecific target organ toxicity- single exposure (Oral):

Category 1 (Liver, Kidney, muscle)

Specific target organ toxicity- repeated exposure (Oral):

Category 1 (Eye)GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
H350 May cause cancer.
H360FD May damage fertility. May damage the unborn child.
H370 Causes damage to organs (Liver, Kidney, muscle) if swallowed.
H372 Causes damage to organs (Eye) through prolonged orrepeated exposure if swallowed.

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

Precautionary Statements

SDS Number:
3177581-00014:

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P307 + P311 IF exposed: Call a doctor.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.

Other hazards
Dust contact with the eyes can lead to mechanical irritation.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
Cellulose
9004-34-6
Ezetimibe
163222-33-1
Rosuvastatin
147098-20-2
Sodium n-dodecyl sulfate
151-21-3
Magnesium stearate557-04-0
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 10 - < 20>= 5 - < 10>= 1 - < 5>= 1 - < 5>= 1 - < 5

SECTION 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 inhaled, remove to fresh air.
Get medical attention.
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.
2 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

If swallowed:

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

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.
May cause cancer.
May damage fertility. May damage the unborn child.
Causes damage to organs if swallowed.
Causes damage to organs through prolonged or repeatedexposure if swallowed.
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
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING 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
Fluorine compounds
Nitrogen oxides (NOx)
Sulfur oxides
Metal oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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.

SECTION 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.

:

3 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

Methods and materials forcontainment and cleaning up

SDS Number:
3177581-00014:

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Sweep up or vacuum up spillage and collect in suitablecontainer 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 anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Avoid contact with 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.
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.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

4 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
inert or nuisance dust
50 Million particles per cubic footValue type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
15 mg/m³
Value type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
5 mg/m³
Value type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
15 Million particles per cubic footValue type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
Dust, nuisance dust and particulates

10 mg/m³
Value type (Form of exposure): PEL (Total dust)
Basis: CAL PEL
5 mg/m³
Value type (Form of exposure): PEL (respirable dust fraction)
Basis: CAL PEL

Components

CAS-No.

Cellulose

9004-34-6

Ezetimibe

163222-33-1

Rosuvastatin

147098-20-2

Magnesium stearate557-04-0

Engineering measures:

Value type
(Form ofexposure)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA
Wipe limit
TWA
Wipe limit
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)

Control parameters / Permissible
concentration
10 mg/m³
5 mg/m³

Basis

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

25 µg/m3 (OEB 3)
250 µg/100 cm²
20 µg/m3 (OEB 3)
200 µg/100 cm²
10 mg/m³

Internal
Internal
Internal
Internal
ACGIH

3 mg/m³

ACGIH

ACGIH
NIOSH RELAll engineering controls should be implemented by facility
5 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

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-facecontainment devices).
Minimize open handling.
Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
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 theworking 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.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColor:white to off-white
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Odor

:

No data available

Odor 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

Evaporation rate:

Not applicable

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

Vapor pressure:

Not applicable

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

7 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Particle size:

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

No data available

SECTION 10. STABILITY AND REACTIVITY
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.

SECTION 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: > 5,000 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
8 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

Acute dermal toxicity

SDS Number:
3177581-00014:

Acute toxicity (other routes of :administration)

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Remarks: No data available
LD50 (Rat): > 2,000 mg/kg
Application Route: Intraperitoneal
LD50 (Mouse): > 1,000 - < 2,000 mg/kg
Application Route: Intraperitoneal

Rosuvastatin:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Target Organs: Liver, Stomach, muscle, Kidney

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

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

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

9 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

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

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

Sodium n-dodecyl sulfate:
Test Type
Routes of exposure
SpeciesResultRemarks:::::

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

Magnesium stearate:
Test Type
Routes of exposure
Species
MethodResultRemarks

:
:
:
:
:
:

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

10 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

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

Rosuvastatin:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Test system: Escherichia coli
Result: negative
Test Type: Chromosomal aberration
Test system: Chinese hamster lung cells
Result: negative

Genotoxicity in vivo:

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

Sodium n-dodecyl sulfate:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
11 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

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

Carcinogenicity
May cause cancer.
Components:
Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
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

12 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Rosuvastatin:
Species
Application RouteExposure time
LOAEL
ResultSymptoms
Target Organs

:
:
:
:
:
:
:

Rat
Oral
104 weeks
80 mg/kg body weight
positive
Tumor
Uterus (including cervix)

Species
Application RouteExposure time
LOAEL
ResultSymptoms
Target Organs

:
:
:
:
:
:
:

Mouse
Oral
107 weeks
200 mg/kg body weight
positiveliver adenoma, carcinoma
Liver

Sodium n-dodecyl sulfate:Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

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

IARC

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.

OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as a known or anticipated carcinogen by NTP.

Reproductive toxicity
May damage fertility. May damage the unborn child.
Components:
Cellulose:
Effects on fertility:

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

Effects on fetal development:

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

Ezetimibe:
Effects on fertility:

Test Type: Fertility/early embryonic development
13 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Species: Rat, male and female
Fertility: NOAEL: > 1,000 mg/kg body weight
Result: No effects on fertility., No fetotoxicity.
Effects on fetal development:

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.

Rosuvastatin:
Effects on fertility:

Test Type: Fertility
Species: Rat
Application Route: Oral
Fertility: NOAEL: 50 mg/kg body weight
Test Type: Fertility
Species: Monkey
Application Route: Oral
Fertility: LOAEL: 30 mg/kg body weight
Result: Effects on male and female reproductive organs.

Effects on fetal development:

Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 50 mg/kg body weight
Result: Fetal mortality.
Test Type: Development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 3 mg/kg body weight
Result: Fetal mortality., Maternal toxicity observed.

Reproductive toxicity - Assessment:

May damage fertility. May damage the unborn child.

Sodium n-dodecyl sulfate:
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

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
14 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials
Magnesium stearate:
Effects on fertility:

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

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

STOT-single exposure
Causes damage to organs (Liver, Kidney, muscle) if swallowed.
Components:
Rosuvastatin:
Routes of exposure
Target Organs
Assessment

:
:
:

Oral
Liver, Kidney, muscle
Causes damage to organs.

STOT-repeated exposure
Causes damage to organs (Eye) through prolonged or repeated exposure if swallowed.
Components:
Rosuvastatin:
Routes of exposure
Target Organs
Assessment

:
:
:

Oral
Eye
Causes damage to organs through prolonged or repeatedexposure.

:
:
:
:

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

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

15 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

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
1y
No significant adverse effects were reported

Rosuvastatin:
Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms
Remarks

:
:
:
:
:
:
:

Dog
90 mg/kg
Oral
24 Days
Brain
Edema, Blood disorders, Necrosis
Based on data from similar materials

Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms
Remarks

:
:
:
:
:
:
:

Dog
6 mg/kgOral
52 Weeks
CorneaCorneal opacity
Based on data from similar materials

Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms
Remarks

:
:
:
:
:
:
:

Dog
30 mg/kg
Oral
12 Weeks
Eye
Eye disease
Based on data from similar materials

Species
LOAEL
Application Route

:
:
:

Dog
90 mg/kg
Oral
16 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Exposure timeTarget Organs
Symptoms
Remarks::::

4 Weeks
eye - retina
Eye disease
Based 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

Magnesium stearate:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
> 100 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:
Ezetimibe:Ingestion:

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

Rosuvastatin:
Ingestion:

Target Organs: Kidney
Symptoms: kidney toxicity
Remarks: Based on Human Evidence
Target Organs: muscle
Symptoms: musculoskeletal pain
Remarks: Based on Human Evidence
Target Organs: Liver
Symptoms: liver function change
Remarks: Based on Human Evidence

17 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

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

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

Toxicity to microorganisms

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
18 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility.
Rosuvastatin:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 1,000 mg/l
Exposure time: 96 hrs
Method: FDA 4.11
LC50 (Lepomis macrochirus (Bluegill sunfish)): > 1,000 mg/l
Exposure time: 96 hrs
Method: FDA 4.11

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 63 mg/l
Exposure time: 48 hrs
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Microcystis aeruginosa (blue-green algae)): > 640 mg/l
Exposure time: 96 hrs
Method: FDA 4.01
NOEC (Microcystis aeruginosa (blue-green algae)): 330 mg/l
Exposure time: 96 hrs
Method: FDA 4.01
EC50 (Pseudokirchneriella subcapitata (green algae)): > 800
mg/l
Exposure time: 96 hrs
Method: FDA 4.01
NOEC (Pseudokirchneriella subcapitata (green algae)): 350
mg/l
Exposure time: 96 hrs
Method: FDA 4.01

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 1 mg/l
Exposure time: 32 Days
Method: OECD Test Guideline 210

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

NOEC (Daphnia magna (Water flea)): 0.018 mg/l
Exposure time: 21 Days
Method: OECD Test Guideline 211

Toxicity to microorganisms

EC50: > 100 mg/l
Exposure time: 3 hrs
Test Type: Respiration inhibition
Method: OECD Test Guideline 209:

NOEC: 100 mg/l
Exposure time: 3 hrs
Test Type: Respiration inhibition
Method: OECD Test Guideline 209
19 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

Sodium n-dodecyl sulfate:Toxicity to fish

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018:

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

20 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

Toxicity to microorganisms

SDS Number:
3177581-00014:

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

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

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

Rosuvastatin:
Biodegradability:

Biodegradation: < 10 %Exposure time: 28 Days
Method: OECD Test Guideline 301F
Remarks: Not inherently biodegradable.

Stability in water:

Hydrolysis: < 10 %(5 Days)

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:

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

log Pow: 4.36

Bioaccumulative potential
Components:
Ezetimibe:
Bioaccumulation

Partition coefficient: noctanol/water

21 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

Rosuvastatin:
Partition coefficient: noctanol/water:log Pow: 0.3

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

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

Ezetimibe:
Distribution among environmental compartments:

log Koc: 4.35
Method: OECD Test Guideline 106

Rosuvastatin:
Distribution among environmental compartments:

log Koc: 2.15
Method: FDA 3.08

Mobility in soil
Components:

Other adverse effects
No data available
SECTION 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.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

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

IATA-DGR
UN/ID No.
Proper shipping name::UN 3077
Environmentally hazardous substance, solid, n.o.s.
22 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

:
:
:
:

(Ezetimibe, Rosuvastatin)
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, Rosuvastatin)
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.
Domestic regulation
49 CFR
UN/ID/NA number
Proper shipping name

:
:

Class
Packing group
LabelsERG Code
Marine pollutant
Remarks

:
:
:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Ezetimibe, Rosuvastatin)
9
III
CLASS 9171
yes(Ezetimibe, Rosuvastatin)
Above applies only to containers over 119 gallons or 450
liters.
Shipment by ground under DOT is non-regulated; however it
may be shipped per the applicable hazard classification tofacilitate multi-modal transport involving ICAO (IATA) or IMO.

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, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.

23 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Combustible dust
Carcinogenicity
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

SARA 313:

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
D-Glucose, 4-O-β-D-galactopyranosyl-, monohydrate
D-mannitol
Cellulose
Hydroxypropyl methylcellulose
Ezetimibe
Croscarmellose sodium

64044-51-5
69-65-89004-34-6
9004-65-3
163222-33-1
74811-65-7

California List of Hazardous Substances
Polyvinyl pyrrolidone

9003-39-8

California Permissible Exposure Limits for Chemical Contaminants
Cellulose
Magnesium stearate

9004-34-6
557-04-0

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information

24 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

NFPA 704:

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018
HMIS® IV:

Flammability

HEALTH1
Health10Special hazard*

4

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
ACGIH / TWA: 8-hour, time-weighted average
CAL PEL / PEL: Permissible exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
OSHA Z-1 / TWA: 8-hour time weighted average
OSHA Z-3 / TWA: 8-hour time weighted average
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; 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; HMIS - Hazardous Materials Identification System; 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 Pre25 / 26

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ezetimibe / Rosuvastatin Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
3177581-00014

Date of last issue: 04/04/2023
Date of first issue: 09/18/2018

vention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; 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; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

09/30/2023

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 for safe handling, use, processing, storage, transportation, disposal and release andshall 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 specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
US / Z8

26 / 26