SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:

Ezetimibe / Rosuvastatin 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.
Shotton Lane
NE23 3JU Cramlington NU - Great Britain
Telephone:+44 1 670 59 32 05

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) as amended by GB-CLP Regulation, UK
SI 2019/720, and UK SI 2020/1567)
Carcinogenicity, Category 1B
Reproductive toxicity, Category 1BSpecific target organ toxicity - single exposure, Category 2
Specific target organ toxicity - repeatedexposure, Category 2
Long-term (chronic) aquatic hazard, Category 2

H350: May cause cancer.
H360FD: May damage fertility. May damage theunborn child.
H371: May cause damage to organs.
H373: May cause damage to organs through prolonged or repeated exposure.
H411: Toxic to aquatic life with long lasting effects.

1 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK SI
2019/720, and UK SI 2020/1567)
Hazard pictograms:

Signal word:

DangerHazard statements:

H350
H360FD
H371
H373
H411

Precautionary statements:

May cause cancer.
May damage fertility. May damage the unborn
child.
May cause damage to organs.
May cause damage to organs through prolonged
or repeated exposure.
Toxic to aquatic life with long lasting effects.

Prevention:
P201
Obtain special instructions before use.
P260
Do not breathe dust.
P273
Avoid release to the environment.
P280
Wear protective gloves/ protective clothing/ eyeprotection/ face protection.
Response:
P308 + P311 IF exposed or concerned: Call a POISONCENTER/ doctor.
P391
Collect spillage.

Hazardous components which must be listed on the label:
Rosuvastatin
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.
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
3.2 Mixtures
Components
Chemical name

Ezetimibe

CAS-No.
EC-No.
Index-No.
Registration number
163222-33-1
2 / 27

Classification

Concentration(% w/w)

Aquatic Chronic 1;>= 2.5 - < 10

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021
H410

Rosuvastatin

147098-20-2

Sodium n-dodecyl sulfate

151-21-3
205-788-1

M-Factor (Chronic
aquatic toxicity): 1
Carc. 1B; H350
Repr. 1B; H360FD
STOT SE 1; H370
(Liver, Kidney,muscle)
STOT RE 1; H372
(Eye)
Aquatic Chronic 1;
H410

M-Factor (Chronic
aquatic toxicity): 1
Acute Tox. 4; H302
Skin Irrit. 2; H315
Eye Dam. 1; H318
Aquatic Chronic 3;
H412>= 2.5 - < 10>= 1 - < 2.5

specific concentration limit
Eye Irrit. 2; H319
10 - < 20 %Eye Dam. 1; H318>= 20 %Eye Irrit. 2; H319
10 - < 20 %Eye Dam. 1; H318>= 20 %
Substances with a workplace exposure limit :Cellulose
9004-34-6
232-674-9>= 10 - < 20

For explanation of abbreviations see section 16.

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
3 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

when the potential for exposure exists (see section 8).
If inhaled:

If inhaled, remove to fresh air.
Get medical attention.

In case of skin contact:

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.

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.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.

4.2 Most important symptoms and effects, both acute and delayed
Risks: May cause cancer.
May damage fertility. May damage the unborn child.
May cause damage to organs.
May cause damage to organs through prolonged or repeatedexposure.
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.

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 prod-:

Carbon oxides
4 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

ucts

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

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Fluorine compounds
Nitrogen oxides (NOx)Sulphur oxides
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.
If spillage enters rivers or watercourses, inform the Environment Agency (emergency telephone number 0800 807060).

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

5 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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.
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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Keepareas and containers
tightly closed. Store in accordance with 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
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

:

No data available

6 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
dust of any kind
10 mg/m3
Value type (Form of exposure): TWA (Inhalable)
Basis: GB EH40
4 mg/m3
Value type (Form of exposure): TWA (Respirable fraction)
Basis: GB EH40
Components

CAS-No.

Cellulose

9004-34-6

Ezetimibe

163222-331

Rosuvastatin

147098-202

Value type (Formof exposure)
TWA (inhalable
dust)
TWA (Respirable
dust)
STEL (inhalable
dust)
TWA

Control parameters

Basis

10 mg/m3

GB EH40

4 mg/m3

GB EH40

20 mg/m3

GB EH4025 µg/m3 (OEB 3)

Internal

Wipe limit
TWA

250 µg/100 cm²
20 µg/m3 (OEB 3)

Internal
Internal

Wipe limit

200 µg/100 cm²Internal

Derived No Effect Level (DNEL):
Substance name

End UseExposure routes

Sodium n-dodecyl
sulfateWorkers

Inhalation

Workers

Skin contact

Consumers

Inhalation

Consumers

Skin contact

Consumers

Ingestion

Potential health effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effectsValue
285 mg/m3
4060 mg/kg
bw/day85 mg/m3
2440 mg/kg
bw/day24 mg/kg
bw/dayPredicted No Effect Concentration (PNEC):
Substance name
Sodium n-dodecyl sulfate

Environmental Compartment
Fresh water
Marine water
Sewage treatment plant
Fresh water sediment
Marine sediment
7 / 27Value
0.176 mg/l
0.018 mg/l
1.35 mg/l
6.97 mg/kg dryweight (d.w.)
0.697 mg/kg dry

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021
weight (d.w.)
1.29 mg/kg dryweight (d.w.)

Soil
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 the task
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 exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to BS EN 143
Particulates type (P)Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: powderColour: white to off-white
Odour: No data available
Odour Threshold: No data available
pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range
Flash point:

No data available:

Not applicable
8 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Evaporation rate:

Not applicable

Flammability (solid, gas):

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

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

Not applicable

Relative vapour density:

Not applicable

Relative density:

No data available

Density:

No data available::

No data available
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.

9.2 Other information
Flammability (liquids):

No data available

Molecular weight:

No data available

Particle size:

No data available

Solubility(ies)
Water solubility
Partition coefficient: noctanol/water
Auto-ignition temperature

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.

9 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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 toxicological effects
Information on likely routes of : Inhalation
exposure
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

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

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

Components:
Ezetimibe:
Acute oral toxicity

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:
10 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

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

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

Sodium n-dodecyl sulfate:SpeciesResult::RabbitSkin irritation

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

Sodium n-dodecyl sulfate:Species
MethodResult:::RabbitOECD Test Guideline 405
Irreversible effects on the eye

11 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

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

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

Germ cell mutagenicity
Not classified based on available information.
Components:
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
12 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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
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

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:
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

Carcinogenicity
May cause cancer.
Components:

13 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Rosuvastatin:
Species
Application RouteExposure time
LOAEL
ResultSymptoms
Target Organs

:
:
:
:
:
:
:

Rat
Oral
104 weeks
80 mg/kg body weight
positive
TumourUterus (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

Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

Reproductive toxicity
May damage fertility. May damage the unborn child.
Components:
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
14 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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 foetal development:

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

Reproductive toxicity - Assessment
Sodium n-dodecyl sulfate:
Effects on fertility

Effects on foetal development

Cellulose:
Effects on fertility:

May damage fertility. May damage the unborn child.

:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 416
Result: negative
Remarks: Based on data from similar materials:

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

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

15 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

Effects on foetal development

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021:

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

:
:
:

Oral
Liver, Kidney, muscle
Causes damage to organs.

STOT - single exposure
May cause damage to organs.
Components:
Rosuvastatin:
Exposure routes
Target Organs
Assessment

STOT - repeated exposure
May cause damage to organs through prolonged or repeated exposure.
Components:
Rosuvastatin:
Exposure routes
Target Organs
Assessment

:
:
:

Oral
Eye
Causes damage to organs through prolonged or repeatedexposure.

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 Route

:
:
:

Dog
300 mg/kg
Oral

Repeated dose toxicity
Components:

16 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Exposure time
Remarks::

1 yr
No significant adverse effects were reported

Rosuvastatin:
Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms
Remarks

:
:
:
:
:
:
:

Dog
90 mg/kg
Oral
24 DaysBrain
Oedema, 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

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

17 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

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

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
12.1 Toxicity
Components:
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
18 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

Toxicity to fish (Chronic toxicity):

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:

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

Rosuvastatin:
Toxicity to fish

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
19 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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 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

Toxicity to fish (Chronic toxicity):

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

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

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

M-Factor (Chronic aquatic
toxicity):1:

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

Sodium n-dodecyl sulfate:Toxicity to fish

NOEC (Desmodesmus subspicatus (green algae)): 30 mg/l
Exposure time: 72 h
Toxicity to microorganisms:

EC50 : 135 mg/l
Exposure time: 3 hToxicity to fish (Chronic toxicity):

NOEC: >= 1.357 mg/l
Exposure time: 42 d
20 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Species: Pimephales promelas (fathead minnow)
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Cellulose:
Toxicity to fish:

NOEC: 0.88 mg/l
Exposure time: 7 dSpecies: Ceriodaphnia dubia (water flea)

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

12.2 Persistence and degradability
Components:
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

Cellulose:
Biodegradability:

Result: Readily biodegradable.

:

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

12.3 Bioaccumulative potential
Components:
Ezetimibe:
Bioaccumulation

21 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

Partition coefficient: noctanol/water

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021:

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

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

12.4 Mobility in soil
Components:

12.5 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.

:

This substance/mixture does not contain components considered to have endocrine disrupting properties for environment
according to UK REACH Article 57(f).

12.6 Other adverse effects
Product:
Endocrine disrupting potential

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.
22 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

SECTION 14: Transport information
14.1 UN number
ADN:

UN 3077

ADR:

UN 3077

RID:

UN 3077

IMDG:

UN 3077

IATA:

UN 3077ADN:

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

ADR:

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

RID:

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

IMDG

:

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

IATA

:

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

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

:

9

ADR

:

9

RID

:

9

IMDG

:

9

IATA

:

9

:
:
:
:

III
M7
90
9

ADR
Packing group:Classification Code:Hazard Identification Number :

III
M7
90

Subsidiary risks

14.4 Packing group
ADN
Packing groupClassification CodeHazard Identification Number
Labels23 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

LabelsTunnel restriction code

:
:

9
(-)

RID
Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

III
M7
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: 30.09.2023
Date of first issue: 27.08.2021

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 Transport in bulk according to Annex II of Marpol and the IBC CodeRemarks: Not applicable for product as supplied.

24 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
Relevant EU provisions transposed through retained EU law
UK REACH List of restrictions (Annex 17): Not applicable
UK REACH Candidate list of substances of very high: Not applicableconcern (SVHC) for Authorisation
The Persistent Organic Pollutants Regulations (retained : Not applicable
Regulation (EU) 2019/1021 as amended for Great Britain)
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
UK REACH List of substances subject to authorisation: Not applicable(Annex XIV)GB Export and import of hazardous chemicals - Prior: Not applicable
Informed Consent (PIC) Regulation
Control of Major Accident Hazards Regulations 2015 (COMAH)
Quantity 1
E2
ENVIRONMENTAL
200 t
HAZARDS

Quantity 2
500 t

Other regulations:
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to new and expectant mothers at work contained in Regulation 16 to 18) and of thePregnant Workers Directive 92/85/EEC.
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to protection of young people at work contained in Regulation 19) and of Directive
94/33/EC on the protection of young people at work.
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
H302
H315

:
:

Harmful if swallowed.
Causes skin irritation.
25 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

H318
H350
H360FD
H370
H372

:
:
:
:
:

H410
H412

:
:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Causes serious eye damage.
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.
Very toxic to aquatic life with long lasting effects.
Harmful to aquatic life with long lasting effects.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Aquatic Chronic: Long-term (chronic) aquatic hazard
Carc.
: Carcinogenicity
Eye Dam.
: Serious eye damage
Repr.
: Reproductive toxicity
Skin Irrit.
: Skin irritation
STOT RE: Specific target organ toxicity - repeated exposure
STOT SE: Specific target organ toxicity - single exposure
GB EH40: UK. EH40 WEL - Workplace Exposure Limits
GB EH40 / TWA: Long-term exposure limit (8-hour TWA reference period)
GB EH40 / STEL
: Short-term exposure limit (15-minute 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; 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
26 / 27

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ezetimibe / Rosuvastatin Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9374038-00007

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

:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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:Carc. 1B

H350

Calculation method

Repr. 1B

H360FD

Calculation method

STOT SE 2

H371

Calculation method

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 theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
GB / EN

27 / 27