SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

SECTION 1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Ezetimibe / Rosuvastatin Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: Avenida 16 de Septiembre No. 301
Xaltocan - Xochimilco Mexico 16090
Telephone: +52 55 57284444
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
Skin corrosion/irritation:

Category 3

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:

H316 Causes mild skin irritation.
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.

Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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/
face protection.
Response:
P308 + P311 IF exposed or concerned: Call a POISONCENTER/ doctor.
P332 + P313 If skin irritation occurs: Get medical advice/ attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste disposal plant.
Other hazards
Dust contact with the eyes can lead to mechanical irritation.
May form explosive dust-air mixture during processing, handling or other means.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

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

CAS-No.
9004-34-6
163222-33-1
147098-20-2
151-21-3
557-04-0

Concentration (% w/w)>= 10 -< 20>= 5 -< 10>= 1 -< 5>= 1 -< 3>= 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 swallowed:

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.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

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: 18.09.2018

Never give anything by mouth to an unconscious person.
Causes mild skin irritation.
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.

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitablecontainer for disposal.
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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:

Hygiene measures:

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.
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 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
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

Explosives
Gases
SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
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)
VLE-PPT

Control parameters / Permissible
concentration
10 mg/m³

Basis

TWA
TWA
Wipe limit
TWA
Wipe limit
VLE-PPT

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

TWA(Inhalable
particulatematter)TWA(Respirable
particulatematter)10 mg/m³

NOM-010STPS-2014
ACGIH
Internal
Internal
Internal
Internal
NOM-010STPS-2014
ACGIH

3 mg/m³

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-facecontainment devices).
Minimize open handling.

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

Chemical-resistant gloves

Remarks
Eye 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.
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

Skin and body protection

SDS Number:
3177577-00013:

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColor:white to off-white

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
6 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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

Particle size:

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

Components:

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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

Ezetimibe:
Acute oral toxicity

SDS Number:
3177577-00013:

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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

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

Ezetimibe:
SpeciesResult::RabbitNo skin irritation

Sodium n-dodecyl sulfate:Species:

RabbitSkin corrosion/irritation
Causes mild skin irritation.
Components:

8 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

Result:Skin irritation

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

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::

Maximization Test
Skin contact
9 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

Species
MethodResultRemarks

SDS Number:
3177577-00013::::

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

Guinea pig
OECD Test Guideline 406
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

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

10 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

Sodium n-dodecyl sulfate:
Genotoxicity in vitro

SDS Number:
3177577-00013:

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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
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
11 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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

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
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
12 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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
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
13 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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.

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

Repeated dose toxicity
Components:

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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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 RouteExposure timeTarget Organs
Symptoms
Remarks

:
:
:
:
:
:
:

Dog
90 mg/kg
Oral
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

15 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

Magnesium stearate:
Species
NOAEL
Application RouteExposure time
Remarks

SDS Number:
3177577-00013

:
:
:
:
:

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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

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 other:

EC50 (Daphnia magna (Water flea)): > 4 mg/l
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

aquatic invertebrates

Toxicity to algae/aquaticplantsDate of last issue: 04.04.2023
Date of first issue: 18.09.2018

Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility.
:

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
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/aquatic:

EC50 (Microcystis aeruginosa (blue-green algae)): > 640 mg/l
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

plantsDate of last issue: 04.04.2023
Date of first issue: 18.09.2018

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
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 (Chron-

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
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

ic toxicity)
Toxicity to microorganisms:

EC50: 135 mg/l
Exposure time: 3 hMagnesium 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

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

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:
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

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

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

Bioaccumulative potential
Components:
Ezetimibe:
Bioaccumulation

Partition coefficient: noctanol/water

Mobility in soil
Components:

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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

Other adverse effects
No data available
SECTION 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.

SECTION 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, Rosuvastatin)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(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
NOM-002-SCT
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SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

UN number
Proper shipping name

:
:

Class
Packing group
Labels:::Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ezetimibe, Rosuvastatin)
9III
9Special 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 INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or
mixtureFederal Law for the control of chemical precursors,: Not applicableessential chemical products and machinery for
producing capsules, tablets and pills.
The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Revision Date
Date format::

30.09.2023
dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
NOM-010-STPS-2014: Mexico. Norm NOM-010-STPS-2014 on Chemicals Polluting
the Work Environment - Identification, Assessment and Control - Appendix 1 Occupational Exposure Limits
ACGIH / TWA: 8-hour, time-weighted average
NOM-010-STPS-2014 / VLE- : Time weighted average limit value
PPT
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 and
22 / 23

SAFETY DATA SHEET
Ezetimibe / Rosuvastatin Formulation
Version
2.1

Revision Date:
30.09.2023

SDS Number:
3177577-00013

Date of last issue: 04.04.2023
Date of first issue: 18.09.2018

Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; 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

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/

The information is considered as correct, but not exhaustive, and will be used only as a guide,
which is based in the current knowledge of the substance or mixture, and is applicable to proper
safety precautions for the product.
MX / Z8

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