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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier
Trade name:

Ezetimibe / Atorvastatin Formulation

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

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

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008)
Specific target organ toxicity - repeatedH373: May cause damage to organs through proexposure, Category 2
longed or repeated exposure.
Long-term (chronic) aquatic hazard, CatH411: Toxic to aquatic life with long lasting effects.
egory 22.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

Warning

Hazard statements

:

H373

May cause damage to organs through prolonged
1 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

Precautionary statements:

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

H411

or repeated exposure.
Toxic to aquatic life with long lasting effects.

Prevention:
P260
Do not breathe dust.
P273
Avoid release to the environment.
Response:
P314
Get medical advice/ attention if you feel unwell.
P391
Collect spillage.

Hazardous components which must be listed on the label:
Atorvastatin
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
Ecological information: The substance/mixture does not contain components considered to haveendocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
Toxicological information: The substance/mixture does not contain components considered tohave endocrine disrupting properties according to REACH Article 57(f) or Commission Delegatedregulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
May form explosive dust-air mixture during processing, handling or other means.

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

Atorvastatin

CAS-No.
EC-No.
Index-No.
Registration number
134523-03-8

Ezetimibe

163222-33-1

Classification

Concentration(% w/w)

STOT RE 2; H373
(Liver, muscle)
Aquatic Chronic 2;
H411
Aquatic Chronic 1;
H410>= 10 - < 20

M-Factor (Chronic
aquatic toxicity): 1
For explanation of abbreviations see section 16.
2 / 22>= 2.5 - < 10

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

SECTION 4: First aid measures
4.1 Description of first aid measures
General advice: In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
Protection of first-aiders:

First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).

If inhaled:

If inhaled, remove to fresh air.
Get medical attention if symptoms occur.

In case of skin contact:

Wash with water and soap.
Get medical attention if symptoms occur.

In case of eye contact:

If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.

If swallowed:

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

4.2 Most important symptoms and effects, both acute and delayed
Risks: May cause damage to organs through prolonged or repeatedexposure.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:

None known.

3 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

5.2 Special hazards arising from the substance or mixture
Specific hazards during fire- : Avoid generating dust; fine dust dispersed in air in sufficient
fighting
concentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.
Hazardous combustion products

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

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

In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
6.2 Environmental precautions
Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

6.3 Methods and material for containment and cleaning up
Methods for cleaning up: Sweep up or vacuum up spillage and collect in suitable container for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
4 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

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

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

Local/Total ventilation
Advice on safe handling::

Hygiene measures:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
Use only with adequate ventilation.
Do not 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.
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.

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

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

No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
5 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

dusts non-specificDate of last issue: 29.09.2023
Date of first issue: 29.10.2014

4 mg/m3
Value type (Form of exposure): OELV - 8 hrs (TWA) (Respirable
dust)
Basis: IE OEL
10 mg/m3
Value type (Form of exposure): OELV - 8 hrs (TWA) (inhalable
dust)
Basis: IE OEL

Components

CAS-No.

Cellulose

9004-34-6

Atorvastatin

134523-038

Ezetimibe

163222-331

Magnesium stearate557-04-0

Value type (Formof exposure)
OELV - 8 hrs
(TWA)
TWA

Control parameters

Basis

10 mg/m3

IE OEL0.05 mg/m3 (OEB 3)

Internal

Wipe limit
TWA

0.5 mg/100 cm²
25 µg/m3 (OEB 3)

Internal
Internal

Wipe limit
OELV - 8 hrs(TWA)

250 µg/100 cm²
10 mg/m3

Internal
IE OEL

8.2 Exposure controls
Engineering measures
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect products, workers, and the environment.
Containment technologies suitable for controlling compounds are required to control at source
and to prevent migration of the compound to uncontrolled areas (e.g., open-face containment devices).
Minimize open handling.
Personal protective equipment
Eye/face protection: Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Skin and body protection::

Respiratory protection:

Consider double gloving.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If adequate local exhaust ventilation is not available or expo6 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

Filter typeSDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

sure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to I.S. EN 143
Particulates type (P):SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: powderColour:off-white

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flammability (solid, gas):

May form 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

Flash point:

Not applicableAuto-ignition temperature:

No data available

Decomposition temperature:

No data available

pH:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

0.01 g/l:

No data available

Partition coefficient: noctanol/water

7 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Vapour pressure:

No data available

Relative density:

No data available

Density:

No data available

Relative vapour density:

No data available

Particle characteristics
Particle size:

No data available:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Evaporation rate:

No data available

Molecular weight:

No data available

9.2 Other information
Explosives

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

Heat, flames and sparks.
Avoid dust formation.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
Information on likely routes of : Inhalation
exposure
Skin contact
Ingestion
8 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Eye contact
Acute toxicity
Not classified based on available information.
Components:
Atorvastatin:
Acute oral toxicity:

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

Ezetimibe:
Acute oral toxicity:

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

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

Ezetimibe:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Atorvastatin:
Species
MethodResult:::RabbitDraize Test
No eye irritation
9 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

Ezetimibe:
SpeciesResultSDS Number:
26489-00023::

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

RabbitNo eye irritation

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

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

Germ cell mutagenicity
Not classified based on available information.
Components:
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
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
10 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

Ezetimibe:
Genotoxicity in vitro

SDS Number:
26489-00023:

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

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

Carcinogenicity
Not classified based on available information.
Components:
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
11 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

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

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

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
May cause damage to organs through prolonged or repeated exposure.

12 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Components:
Atorvastatin:
Exposure routes
Target Organs
Assessment:::

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

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

Repeated dose toxicity
Components:

13 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Aspiration toxicity
Not classified based on available information.
Components:
Ezetimibe:
Not applicable11.2 Information on other hazards
Endocrine disrupting properties
Product:
Assessment:

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

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

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

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

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
14 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Toxicity to microorganisms:

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

Toxicity to fish (Chronic toxicity):

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

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

Ezetimibe:
Toxicity to fish

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

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 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
15 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

Toxicity to fish (Chronic toxicity)

SDS Number:
26489-00023:

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

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

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

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

M-Factor (Chronic aquatic
toxicity)1:

12.2 Persistence and degradability
Components:
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:

log Pow: 1.62:

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

log Pow: 4.36

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

Partition coefficient: noctanol/water

16 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

12.4 Mobility in soil
Components:
Atorvastatin:
Distribution among environmental compartments:

log Koc: 2.84

Ezetimibe:
Distribution among environmental compartments:

log Koc: 4.35
Method: OECD Test Guideline 10612.5 Results of PBT and vPvB assessment
Product:
Assessment:

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

12.6 Endocrine disrupting properties
Product:
Assessment:

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

12.7 Other adverse effects
No data available

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

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

UN 3077
17 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

ADR:

UN 3077

RID:

UN 3077

IMDG:

UN 3077

IATA:

UN 3077ADN:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ezetimibe, Atorvastatin)

ADR:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ezetimibe, Atorvastatin)

RID:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ezetimibe, Atorvastatin)

IMDG

:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ezetimibe, Atorvastatin)

IATA

:

Environmentally hazardous substance, solid, n.o.s.
(Ezetimibe, Atorvastatin)

14.2 UN proper shipping name14.3 Transport hazard class(es)
Class
ADN

:

9

ADR

:

9

RID

:

9

IMDG

:

9

IATA

:

9

ADN
Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

III
M7
90
9

ADR
Packing groupClassification CodeHazard Identification Number
LabelsTunnel restriction code

:
:
:
:
:

III
M7
90
9
(-)

RID
Packing groupClassification Code

:
:

III
M7

Subsidiary risks

14.4 Packing group18 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Hazard Identification Number :Labels
:

90
9

IMDG
Packing group
LabelsEmS Code

:
:
:

III
9
F-A, S-F

:

956

:
:
:

Y956
III
Miscellaneous

:

956

:
:
:

Y956
III
Miscellaneous

ADN
Environmentally hazardous

:

yes

ADR
Environmentally hazardous

:

yes

RID
Environmentally hazardous

:

yes

IMDG
Marine pollutant:

yes

IATA (Passenger)
Environmentally hazardous:

yes

IATA (Cargo)
Environmentally hazardous:

yes

IATA (Cargo)
Packing instruction (cargo
aircraft)Packing instruction (LQ)
Packing group
LabelsIATA (Passenger)
Packing instruction (passenger aircraft)
Packing instruction (LQ)
Packing group
LabelsDate of last issue: 29.09.2023
Date of first issue: 29.10.2014

14.5 Environmental hazards

14.6 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.
14.7 Maritime transport in bulk according to IMO instruments
Remarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
REACH - Restrictions on the manufacture, placing on: Not applicable
19 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

the market and use of certain dangerous substances,mixtures and articles (Annex XVII)REACH - Candidate List of Substances of Very High: Not applicable
Concern for Authorisation (Article 59).
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
Regulation (EU) 2019/1021 on persistent organic pollu: Not applicabletants (recast)
Regulation (EU) No 649/2012 of the European Parlia: Not applicablement and the Council concerning the export and importof dangerous chemicals
REACH - List of substances subject to authorisation: Not applicable(Annex XIV)
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control ofmajor-accident hazards involving dangerous substances.
Quantity 1
Quantity 2
E2
ENVIRONMENTAL
200 t
500 t
HAZARDS
Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

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

SECTION 16: Other information
Other information:

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

Full text of H-Statements
H373

:

H410
H411

:
:

May cause damage to organs through prolonged or repeatedexposure if swallowed.
Very toxic to aquatic life with long lasting effects.
Toxic to aquatic life with long lasting effects.

Full text of other abbreviations
Aquatic Chronic: Long-term (chronic) aquatic hazard
STOT RE: Specific target organ toxicity - repeated exposure
IE OEL: Ireland. List of Chemical Agents and Carcinogens with Occupational Exposure Limit Values - Code of Practice, Schedule 1
and 2
20 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

IE OEL / OELV - 8 hrs (TWA) :Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Occupational exposure limit value (8-hour reference period)

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; ECx - Concentration
associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air
Transport Association; IBC - International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China;
IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL
- Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization;
KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory 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; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Substance Inventory; TECI Thailand Existing Chemicals Inventory; TRGS - Technical Rule for Hazardous Substances; TSCA
- Toxic Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent andVery Bioaccumulative
Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

Classification of the mixture:

Classification procedure:

STOT RE 2

H373

Calculation method

Aquatic Chronic 2

H411

Calculation method

The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of their
21 / 22

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

Ezetimibe / Atorvastatin Formulation
Version
3.2

Revision Date:
06.04.2024

SDS Number:
26489-00023

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

intended 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.
IE / EN

22 / 22