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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

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

Simvastatin 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)
Skin sensitisation, Category 1
Specific target organ toxicity - repeatedexposure, Category 2
Long-term (chronic) aquatic hazard, Category 3

H317: May cause an allergic skin reaction.
H373: May cause damage to organs through prolonged or repeated exposure.
H412: Harmful to aquatic life with long lasting effects.

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)

1 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Hazard pictograms:

Signal word:

Warning

Hazard statements:

H317 May cause an allergic skin reaction.
H373 May cause damage to organs through prolonged orrepeated exposure.
H412 Harmful to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
P260 Do not breathe dust.
P273 Avoid release to the environment.
P280 Wear protective gloves.
Response:
P314 Get medical advice/ attention if you feel unwell.
P333 + P313 If skin irritation or rash occurs: Get medical
advice/ attention.
P362 + P364 Take off contaminated clothing and wash it
before reuse.

Hazardous components which must be listed on the label:
Simvastatin
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

Simvastatin

CAS-No.
EC-No.
Index-No.
Registration number
79902-63-9

Citric acid monohydrate

5949-29-1

2 / 22

Classification

Concentration(% w/w)

Skin Irrit. 2; H315
Skin Sens. 1; H317
STOT RE 1; H372
(Liver, muscle,
optic nerve, Eye)
Aquatic Chronic 2;
H411
Eye Irrit. 2; H319
STOT SE 3; H335>= 2.5 - < 10>= 1 - < 10

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Substances with a workplace exposure limit :Starch
9005-25-8
232-679-6
Cellulose
9004-34-6
232-674-9
Ascorbic acid50-81-7200-066-2>= 1 - < 10>= 1 - < 10>= 1 - < 10

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
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 if symptoms occur.
Rinse mouth thoroughly with water.

4.2 Most important symptoms and effects, both acute and delayed
Risks: May cause an allergic skin reaction.
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.

3 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

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

Carbon 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.
4 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

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.

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 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
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. Contaminatedwork clothing should not be allowed out of the workplace.
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.
5 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Advice on common storage

7.3 Specific end use(s)Specific use(s)Date of last issue: 20.03.2023
Date of first issue: 12.10.2021:

Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

:

No data available

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
Simvastatin

StarchCellulose

Ascorbic acid

CAS-No.

Value type (Formof exposure)79902-63-9
TWA
Further information: DSEN
Wipe limit
9005-25-8
TWA (inhalable
dust)
TWA (Respirable
dust)
9004-34-6
TWA (inhalable
dust)
TWA (Respirable
dust)
STEL (inhalable
dust)
50-81-7
TWA

Control parametersBasis

25 µg/m3 (OEB 3)

Internal

250 µg/100 cm²
10 mg/m3

Internal
GB EH40

4 mg/m3

GB EH40

10 mg/m3

GB EH40

4 mg/m3

GB EH40

20 mg/m3

GB EH40

5000 µg/m3 (OEB 1)

Internal

Predicted No Effect Concentration (PNEC):
Substance name
Citric acid monohydrate

Environmental Compartment
Fresh water
Marine water
Sewage treatment plant
Fresh water sediment
Marine sediment
6 / 22Value
0.44 mg/l
0.044 mg/l
1000 mg/l
34.6 mg/kg dryweight (d.w.)
3.46 mg/kg dry

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021
weight (d.w.)
33.1 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: No data available
Odour: odourless
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
7 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

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:

No data available

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

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, han8 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

dling 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.
Components:
Simvastatin:
Acute oral toxicity:

LD50 (Rat): 5,000 mg/kg
LD50 (Mouse): 3,800 mg/kg

Citric acid monohydrate:
Acute oral toxicity:

LD50 (Mouse): 5,400 mg/kg

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 402
Assessment: The substance or mixture has no acute dermal
toxicity

Starch:Acute oral toxicity:

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

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

Cellulose:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
9 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Test atmosphere: dust/mist
Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

Ascorbic acid:
Acute oral toxicity:

LD50 (Rat): 11,900 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Components:
Simvastatin:
Species
Remarks::

RabbitModerate skin irritation

Citric acid monohydrate:
SpeciesResult::RabbitNo skin irritation

Ascorbic acid:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Simvastatin:
Species
Remarks::

Rabbitslight irritation

Citric acid monohydrate:
SpeciesResult::RabbitIrritation to eyes, reversing within 21 days

Starch:SpeciesResult::RabbitNo eye irritation

Ascorbic acid:
Species
MethodResult:::RabbitOECD Test Guideline 405
No eye irritation

10 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Respiratory or skin sensitisation
Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
Not classified based on available information.
Components:
Simvastatin:
Assessment
Result::Probability or evidence of skin sensitisation in humans
positive

Starch:Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Ascorbic acid:
Test Type
Exposure routes
SpeciesResult::::Maurer optimisation test
Skin contact
Guinea pig
negative

Germ cell mutagenicity
Not classified based on available information.
Components:
Simvastatin:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Alkaline elution assay
Result: negative
Test Type: Chromosomal aberration
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Application Route: Oral
Result: negative

Germ cell mutagenicity- Assessment:

Weight of evidence does not support classification as a germ
cell mutagen.

11 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

Citric acid monohydrate:
Genotoxicity in vitro

SDS Number:
9825298-00007:

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: in vitro micronucleus test
Result: positive
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Genotoxicity in vivo:

Test Type: Mutagenicity (in vivo mammalian bone-marrowcytogenetic test, chromosomal analysis)
Species: Rat
Application Route: Ingestion
Result: negative

Starch:Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
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

Ascorbic acid:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative

12 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Carcinogenicity
Not classified based on available information.
Components:
Simvastatin:
Species
Application RouteExposure timeTarget Organs
Tumor Type
Remarks

:
:
:
:
:
:

Mouse
Oral
< 92 weeks
Harderian gland
Liver, Lungs
The significance of these findings for humans is not certain.

Species
Application RouteExposure time
Tumor Type
Remarks

:
:
:
:
:

Rat
Oral
2 Years
Liver, Thyroid
The significance of these findings for humans is not certain.

Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

Ascorbic acid:
Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Ingestion
2 Years
negative

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

Effects on foetal development:

Test Type: Fertility
Species: Rat, male
Application Route: Oral
Fertility: LOAEL: 25 mg/kg body weight:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Embryo-foetal toxicity: NOAEL: 25 mg/kg body weight
Result: No teratogenic effects, No adverse effects
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
13 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Embryo-foetal toxicity: NOAEL: 10 mg/kg body weight
Result: No teratogenic effects, No adverse effects
Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Embryo-foetal toxicity: LOAEL: 60 mg/kg body weight
Result: Teratogenic potential
Remarks: Based on data from similar materials
Citric acid monohydrate:
Effects on foetal development

Cellulose:
Effects on fertility

Effects on foetal development

Ascorbic acid:
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative:

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

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

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative

STOT - single exposure
Not classified based on available information.
Components:
Citric acid monohydrate:
Assessment:

May cause respiratory irritation.

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

Liver, muscle, optic nerve, Eye
Causes damage to organs through prolonged or repeatedexposure.
14 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Repeated dose toxicity
Components:
Simvastatin:
Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
5 mg/kg
30 mg/kg
Oral
14 - 104 Weeks
Liver, Testis, Musculo-skeletal system, Eye

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
10 mg/kg
Oral
14 - 104 Weeks
Liver, Testis, Eye

Species
NOAEL
LOAEL
Application Route
Target Organs

:
:
:
:
:

Rabbit30 mg/kg
50 mg/kg
Oral
Liver, Kidney

Citric acid monohydrate:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
4,000 mg/kg
8,000 mg/kg
Ingestion
10 Days

Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Ascorbic acid:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat, male>= 8,100 mg/kg
Ingestion
13 Weeks
15 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Simvastatin:
Skin contact
Ingestion::

Remarks: May produce an allergic reaction.
Target Organs: Liver
Symptoms: upper respiratory tract infection, Headache, Abdominal pain, constipation, Nausea
Target Organs: Musculo-skeletal system

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

LC50 (Pimephales promelas (fathead minnow)): 2.91 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 3.5 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 25
mg/l
Exposure time: 96 h
NOEC (Pseudokirchneriella subcapitata (green algae)): 25
mg/l
Exposure time: 96 h

Toxicity to microorganisms:

EC50 : > 30 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
NOEC : 21 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

Citric acid monohydrate:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 100 mg/l
Exposure time: 96 h

16 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

Toxicity to daphnia and otheraquatic invertebrates

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021:

EC50 (Daphnia magna (Water flea)): 1,535 mg/l
Exposure time: 24 h

Cellulose:
Toxicity to fish:

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

Ascorbic acid:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 1,020 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to microorganisms:

EC50 : 140 mg/l
Exposure time: 16 h
Method: DIN 38 412 Part 8

12.2 Persistence and degradability
Components:
Simvastatin:
Biodegradability:

Result: rapidly degradable

Stability in water:

Hydrolysis: 50 %(3.2 d)Citric acid monohydrate:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 97 %Exposure time: 28 d
Method: OECD Test Guideline 301B

Cellulose:
Biodegradability:

Result: Readily biodegradable.

Ascorbic acid:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 97 %Exposure time: 5 dMethod: OECD Test Guideline 302:

log Pow: > 4.07

12.3 Bioaccumulative potential
Components:
Simvastatin:
Partition coefficient: noctanol/water

17 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Citric acid monohydrate:
Partition coefficient: noctanol/water:log Pow: -1.72

Ascorbic acid:
Partition coefficient: noctanol/water:log Pow: -1.85

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

12.4 Mobility in soil
No data available
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.

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
ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous good
18 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

RID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

14.2 UN proper shipping name14.3 Transport hazard class(es)14.4 Packing group

14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Not applicable
14.7 Transport in bulk according to Annex II of Marpol and the IBC CodeRemarks: Not applicable for product as supplied.

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)
UK REACH Candidate list of substances of very highconcern (SVHC) for Authorisation
19 / 22::

Not applicableNot applicableSAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

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)
Not applicable
Other regulations:
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
H315
H317
H319
H335
H372

:
:
:
:
:

H411

:

Causes skin irritation.
May cause an allergic skin reaction.
Causes serious eye irritation.
May cause respiratory irritation.
Causes damage to organs through prolonged or repeatedexposure.
Toxic to aquatic life with long lasting effects.

Full text of other abbreviations
Aquatic Chronic: Long-term (chronic) aquatic hazard
Eye Irrit.
: Eye irritation
Skin Irrit.
: Skin irritation
Skin Sens.
: Skin sensitisation
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)
20 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

GB EH40 / STEL:

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

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
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:

Skin Sens. 1

H317

Calculation method

STOT RE 2

H373

Calculation method

Aquatic Chronic 3

H412

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 mate21 / 22

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

Simvastatin Formulation
Version
5.1

Revision Date:
26.09.2023

SDS Number:
9825298-00007

Date of last issue: 20.03.2023
Date of first issue: 12.10.2021

rial 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

22 / 22