SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Simvastatin Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

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

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

2. HAZARDS IDENTIFICATIONGHS classification of chemical product
Skin sensitisation: Category 1
Specific target organ toxicity repeated exposure:

Category 2 (Liver, muscle, optic nerve, Eye)

Short-term (acute) aquatic
hazard:Category 3

Long-term (chronic) aquatic
hazard:Category 3

GHS label elements
Hazard pictograms:

Signal word:

Warning

Hazard statements:

H317 May cause an allergic skin reaction.
H373 May cause damage to organs (Liver, muscle, optic nerve,Eye) through prolonged or repeated exposure.
H412 Harmful to aquatic life with long lasting effects.
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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Precautionary statements:

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Prevention:
P260 Do not breathe dust.
P272 Contaminated work clothing should not be allowed out of
the workplace.
P273 Avoid release to the environment.
P280 Wear protective gloves.
Response:
P302 + P352 IF ON SKIN: Wash with plenty of water.
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.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification
Important symptoms and out- : Dust contact with the eyes can lead to mechanical irritation.
lines of the emergency asMay form explosive dust-air mixture during processing, hansumed
dling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Simvastatin
StarchCAS-No.
79902-63-9
9005-25-8

Concentration (% w/w)>= 2.5 - < 10>= 1 - < 10

ENCS No.

Cellulose
Ascorbic acid

9004-34-6
50-81-7>= 1 - < 10>= 1 - < 10

5-62

Citric acid monohydrate

5949-29-1>= 1 - < 10

2-1318

Titanium dioxide

13463-67-7> 0 - < 10

1-558, 5-5225

8-98

4. FIRST AID MEASURES
General advice:

If inhaled:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
Get medical attention.
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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

In case of contact, immediately flush skin with plenty of water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.
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.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides

Specific extinguishing methods:

Special protective equipment
for firefighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).

Environmental precautions

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.

:

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in 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.

Handling
Technical measures:

Local/Total ventilation
Advice on safe handling::

Avoidance of contact
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.
Oxidizing agents
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.
Contaminated work clothing should not be allowed out of theworkplace.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,

7. HANDLING AND STORAGE

4 / 22

SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.
Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Keep in properly labelled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

Simvastatin

StarchCellulose
Ascorbic acid

79902-63-9
TWA
Further information: DSEN
Wipe limit
9005-25-8
TWA
9004-34-6
TWA
50-81-7
TWA

Titanium dioxide

13463-67-7

Engineering measures

Value type
(Form ofexposure)

Control parameters / Reference
concentration /Permissible concentration
25 µg/m3 (OEB 3)

Basis

250 µg/100 cm²
10 mg/m3
10 mg/m3
5000 µg/m3 (OEB
1)
1.5 mg/m3(Titanium)

Internal
ACGIH
ACGIH
Internal

Internal

OEL-M
JP OEL(Respirable
JSOH
particulatematter)Further information: Group 2B: possibly carcinogenic to humans
OEL-M (Total 2 mg/m3
JP OELparticulate(Titanium)
JSOH
matter)Further information: Group 2B: possibly carcinogenic to humans:

All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., open-face containment devices).
Minimize open handling.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Filter type
Hand protection:

Particulates type

Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
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.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

powderColour:No data available

Odour

:

odourlessOdour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint 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

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit:

No data available

Flash point:

Not applicable

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

Not applicable
6 / 22

SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

No data available:

No data available

Relative vapour density:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

7 / 22

SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

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

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
Test atmosphere: dust/mist

Acute dermal toxicity:

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

Ascorbic acid:
Acute oral toxicity:

LD50 (Rat): 11,900 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

Titanium dioxide:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 6.82 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity

Skin corrosion/irritation
Not classified based on available information.

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Components:
Simvastatin:
Species
Remarks::

RabbitModerate skin irritation

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

Citric acid monohydrate:
SpeciesResult::RabbitNo skin irritation

Titanium dioxide:
SpeciesResult::RabbitNo skin irritation

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

Rabbitslight irritation

Starch:SpeciesResult::RabbitNo eye irritation

Ascorbic acid:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

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

Titanium dioxide:
SpeciesResult::RabbitNo eye irritation

9 / 22

SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

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

Titanium dioxide:
Test Type
Exposure routes
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
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

10 / 22

SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

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.

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

Citric acid monohydrate:
Genotoxicity in vitro:

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

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Result: negative
Genotoxicity in vivo:

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

Titanium dioxide:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Result: negative

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

Titanium dioxide:
Species:Rat
12 / 22

SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Application RouteExposure time
MethodResultRemarks:::::

inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
The mechanism or mode of action may not be relevant in
humans.

Carcinogenicity - Assessment:

Limited evidence of carcinogenicity in inhalation studies withanimals.

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
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

Cellulose:
Effects on fertility

Effects on foetal development:

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

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Ascorbic acid:
Effects on foetal development:

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

Citric acid monohydrate:
Effects on foetal development:

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 (Liver, muscle, optic nerve, Eye) through prolonged or repeatedexposure.
Components:
Simvastatin:
Target Organs
Assessment::

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

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:

RabbitRepeated dose toxicity
Components:

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

NOAEL
LOAEL
Application Route
Target Organs

:
:
:
:

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

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

Citric acid monohydrate:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
4,000 mg/kg
8,000 mg/kg
Ingestion
10 DaysTitanium dioxide:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
24,000 mg/kg
Ingestion
28 DaysSpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rat
10 mg/m3
inhalation (dust/mist/fume)
2 yr

Aspiration toxicity
Not classified based on available information.

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Experience with human exposure
Components:
Simvastatin:
Skin contact:

Remarks: May produce an allergic reaction.

Ingestion:

Target Organs: Liver
Symptoms: upper respiratory tract infection, Headache, Abdominal pain, constipation, Nausea
Target Organs: Musculo-skeletal system

12. ECOLOGICAL INFORMATION
Ecotoxicity
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

Cellulose:
Toxicity to fish:

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

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

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

Citric acid monohydrate:
Toxicity to fish:

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

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

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 (Skeletonema costatum (marine diatom)): > 10,000 mg/l
Exposure time: 72 h

Toxicity to microorganisms:

EC50: > 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

Toxicity to daphnia and otheraquatic invertebrates
Titanium dioxide:
Toxicity to fish

Persistence and degradability
Components:
Simvastatin:
Biodegradability:

Result: rapidly degradable

Stability in water:

Hydrolysis: 50 %(3.2 d)Cellulose:
Biodegradability:

Result: Readily biodegradable.

Ascorbic acid:
Biodegradability:

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

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

Citric acid monohydrate:
Biodegradability

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21:

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

Simvastatin:
Partition coefficient: noctanol/water:log Pow: > 4.07

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

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

Bioaccumulative potential
Components:

Mobility in soil
No data available
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEnvironmentally hazardous

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

IATA-DGR
UN/ID No.
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
24371-00023

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.
Special precautions for user
Not applicable
15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable

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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical nameTitanium(IV) oxide

Concentration (%)>0 - <10

Remarks-

Substances Subject to be Indicated Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Not regulated as a dangerous good

20 / 22

SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Aviation Law
Not regulated as a dangerous goodMarine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Not classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
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/

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
ACGIH / TWA
JP OEL JSOH / OEL-M::

8-hour, time-weighted average
Occupational Exposure Limit-Mean

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
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SAFETY DATA SHEET

Simvastatin Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
24371-00023

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
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.
JP / EN

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