SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:Finasteride (1%) 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 productReproductive toxicity: Category 1BSpecific target organ toxicity repeated exposure (Oral):

Category 2 (Testis)Long-term (chronic) aquatic
hazard:Category 3

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360D May damage the unborn child.
H373 May cause damage to organs (Testis) through prolonged
or repeated exposure if swallowed.
H412 Harmful to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
P405 Store locked up.
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 asContact with dust can cause mechanical irritation or drying ofsumed
the skin.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
StarchCAS-No.
9004-34-6
9005-25-8

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

ENCS No.

Finasteride
Titanium dioxide

98319-26-7
13463-67-7>= 1 - < 2.5> 0 - < 10

1-558, 5-5225

Diiron trioxide

1309-37-1> 0 - < 101-357, 5-5188

Iron oxide1332-37-2> 0 - < 10

1-357

Sodium bis(2ethylhexyl)sulfosuccinate577-11-7> 0 - < 10

2-1623, 2-1620

8-98

4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

If inhaled:

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: 2023/09/30
Date of first issue: 2015/01/26

If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
May damage the unborn child.
May cause damage to organs through prolonged or repeatedexposure if swallowed.
Contact with dust can cause mechanical irritation or drying of
the skin.
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
Metal 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 emer-

Use personal protective equipment.
Follow safe handling advice (see section 7) and personal pro3 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

gency procedures

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

tective equipment recommendations (see section 8).

Environmental precautions:

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

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in 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.
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.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working

7. HANDLING AND STORAGE

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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

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.
Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
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.

Value type
(Form ofexposure)

Cellulose
StarchFinasteride

9004-34-6
9005-25-8
98319-26-7

TWA
TWA
TWA

Titanium dioxide

Iron oxide

Control parameters / Reference
concentration /Permissible concentration
10 mg/m3
10 mg/m3
0.5 µg/m3 (OEB
5)
5 µg/100 cm²
1.5 mg/m3(Titanium)

Basis

ACGIH
ACGIH
Internal

Wipe limit
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
TWA (Res2.5 mg/m3
ACGIH
pirable par(Titanium dioxide)
ticulate matter)
1332-37-2
OEL-M
1 mg/m3
JP OEL(Respirable(Iron)JSOH
dust)
OEL-M (Total 4 mg/m3
JP OEL
dust)(Iron)
JSOH
13463-67-7

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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Diiron trioxide

1309-37-1

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

OEL-M(Respirable
dust)
OEL-M (Total
dust)
TWA (Respirable particulate matter)

1 mg/m3(Iron)JP OEL
JSOH

4 mg/m3(Iron)
5 mg/m3

JP OEL
JSOH
ACGIH

This substance(s) is not bioavailable and therefore does not contribute to a dust inhalation
hazard.
Titanium dioxide
Engineering measures:

Use closed processing systems or containment technologies
to control at source (e.g., glove boxes/isolators) and to prevent leakage of compounds into the workplace.
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
No open handling permitted.
Totally enclosed processes and materials transport systems
are required.
Operations require the use of appropriate containment technology designed to prevent leakage of compounds into theworkplace.

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.
Filter type
: Particulates type
Hand protection
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

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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

Physical state:

powderColour

:

tan

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 applicableAuto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:log Pow: 3.5
pH: 7
Active ingredient

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density:

No data available
No data available

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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

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

Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

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

Cellulose:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

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

Components:

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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

Starch:Acute oral toxicity:

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

Acute dermal toxicity:

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

Finasteride:
Acute oral toxicity:

LD50 (Rat): 373 - 828 mg/kg
LD50 (Mouse): 486 mg/kg

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

Diiron trioxide:
Acute oral toxicity:

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

Iron oxide:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Remarks: Based on data from similar materials

Sodium bis(2-ethylhexyl)sulfosuccinate:
Acute oral toxicity: LD50 (Rat): 3,080 mg/kg
Acute dermal toxicity:

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

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

Titanium dioxide:
SpeciesResult::RabbitNo skin irritation

Diiron trioxide:
Species:

Rabbit9 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

MethodResult::OECD Test Guideline 404
No skin irritation

Iron oxide:
Species
MethodResultRemarks::::

RabbitOECD Test Guideline 404
No skin irritation
Based on data from similar materials

Sodium bis(2-ethylhexyl)sulfosuccinate:
Species: RabbitMethod: OECD Test Guideline 404
Result: Skin irritation
Serious eye damage/eye irritation
Not classified based on available information.
Components:
Starch:SpeciesResult::RabbitNo eye irritation

Finasteride:
Species
Remarks::

Rabbitslight irritation

Titanium dioxide:
SpeciesResult::RabbitNo eye irritation

Diiron trioxide:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

Iron oxide:
SpeciesResult
MethodRemarks::::

RabbitNo eye irritation
OECD Test Guideline 405
Based on data from similar materials

Sodium bis(2-ethylhexyl)sulfosuccinate:
Species: Rabbit
Result: Irreversible effects on the eye
Method: OECD Test Guideline 405

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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Starch:Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

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

Diiron trioxide:
Exposure routes
SpeciesResult:::Skin contact
Guinea pig
negative

Iron oxide:
Exposure routes
SpeciesResultRemarks::::

Skin contact
Guinea pig
negative
Based on data from similar materials

Sodium bis(2-ethylhexyl)sulfosuccinate:
Test Type: Human repeat insult patch test (HRIPT)
Exposure routes: Skin contact
Species: HumansResult: negative
Germ cell mutagenicity
Not classified based on available information.
Components:
Cellulose:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative
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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

Genotoxicity in vivo:

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

Starch:Genotoxicity in vitro:

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

Finasteride:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: Mutagenicity (in vivo mammalian bone-marrowcytogenetic test, chromosomal analysis)
Application Route: Oral
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

Diiron trioxide:
Genotoxicity in vitro:

Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

Iron oxide:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Based on data from similar materials

Sodium bis(2-ethylhexyl)sulfosuccinate:
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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
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Genotoxicity in vitro

SDS Number:
49649-00024:

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: equivocal
Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative
Remarks: Based on data from similar materials

Carcinogenicity
Not classified based on available information.
Components:
Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

ResultTarget Organs
Remarks

:
:
:
:
:
:
:

Rat
Ingestion
2 Years
160 mg/kg body weight
negative
TestesBenign tumor(s)Species
Application RouteExposure time
ResultTarget Organs
Remarks

:
:
:
:
:
:

Mouse
Ingestion
19 month(s)negative
TestesBenign tumor(s)Titanium dioxide:
Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
The mechanism or mode of action may not be relevant in
humans.
This substance(s) is not bioavailable and therefore does notcontribute to a dust inhalation hazard.

Finasteride:
Species
Application RouteExposure time

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Finasteride (1%) Formulation
Version
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Revision Date:
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Carcinogenicity - Assessment

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26:

Limited evidence of carcinogenicity in inhalation studies withanimals.

Diiron trioxide:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Intraperitoneal injection
790 - 914 days
negative

Iron oxide:
Species
Application RouteExposure time
ResultRemarks

:
:
:
:
:

Rat
Intraperitoneal injection
790 - 914 days
negative
Based on data from similar materials:

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: Fertility/early embryonic development
Species: Rabbit
Application Route: Oral
Fertility: NOAEL: 80 mg/kg body weight
Result: No effects on fertility

Reproductive toxicity
May damage the unborn child.
Components:
Cellulose:
Effects on fertility

Effects on foetal development

Finasteride:
Effects on fertility

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Fertility: LOAEL: 80 mg/kg body weight
Result: positive
Remarks: There is no evidence that these findings are relevant to humans.
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

Developmental Toxicity: LOAEL: 0.003 mg/kg body weight
Result: Teratogenic effects, Embryotoxic effects.
Test Type: Embryo-foetal development
Species: Monkey
Application Route: Ingestion
Developmental Toxicity: LOAEL: 2 mg/kg body weight
Result: Teratogenic effects
Reproductive toxicity - Assessment:

Clear evidence of adverse effects on development, based onanimal experiments.

Sodium bis(2-ethylhexyl)sulfosuccinate:
Effects on fertility: Test Type: Three-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative
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.
STOT - repeated exposure
May cause damage to organs (Testis) through prolonged or repeated exposure if swallowed.
Components:
Finasteride:
Exposure routes
Target Organs
Assessment:::

Ingestion
Testis
Causes damage to organs through prolonged or repeatedexposure.

Iron oxide:
Exposure routes
Assessment::

inhalation (dust/mist/fume)No significant health effects observed in animals at concentrations of 0.2 mg/l/6h/d or less.

:
:
:

Rat
>= 9,000 mg/kg
Ingestion

Repeated dose toxicity
Components:
Cellulose:
Species
NOAEL
Application Route15 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

Exposure time:

90 Days

Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

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

Finasteride:
Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
20 mg/kg
40 mg/kg
Oral
1 yr
TestisSpecies
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
45 mg/kg
Oral
1 yr
TestisTitanium 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 yrIron oxide:
Species
NOAEL
Application RouteExposure time
MethodRemarks

:
:
:
:
:
:

Rat
4.7 mg/m3
inhalation (dust/mist/fume)
90 Days
OECD Test Guideline 413
Based on data from similar materials

Sodium bis(2-ethylhexyl)sulfosuccinate:
Species: Rat
NOAEL: 750 mg/kg
Application Route: Ingestion
Exposure time
: 90 Days

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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

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

Symptoms: breast tenderness, breast enlargement, impotence, lip swelling, skin rash

Cellulose:
Toxicity to fish:

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

Finasteride:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 20.4 mg/l
Exposure time: 96 h
Method: FDA 4.11

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 17.8 mg/l
Exposure time: 48 h
Method: FDA 4.08

Toxicity to algae/aquaticplants:NOEC (Pseudokirchneriella subcapitata (green algae)): 49
mg/l
Exposure time: 14 h
Method: FDA 4.01

Toxicity to fish (Chronic toxicity):

NOEC (Oryzias latipes (Orange-red killifish)): 0.05 mg/l
Exposure time: 105 d

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:

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

NOEC (Daphnia magna (Water flea)): 0.12 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

M-Factor (Chronic aquatic
toxicity):1:

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

Titanium dioxide:
Toxicity to fish

17 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

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

Diiron trioxide:
Toxicity to fish:

LC50 (Danio rerio (zebra fish)): > 50,000 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to microorganisms:

EC50: > 10,000 mg/l
Exposure time: 3 hIron oxide:
Toxicity to fish:

LC50 (Danio rerio (zebra fish)): > 10,000 mg/l
Exposure time: 96 h
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 10,000 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Toxicity to microorganisms:

EC50: >= 10,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209
Remarks: Based on data from similar materials

Sodium bis(2-ethylhexyl)sulfosuccinate:
Toxicity to fish
: LC50 (Danio rerio (zebra fish)): 49 mg/l
Exposure time: 96 h
Method: Directive 67/548/EEC, Annex V, C.1.
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 6.6 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Desmodesmus subspicatus (green algae)): 82.5 mg/l
Exposure time: 72 h
EC10 (Desmodesmus subspicatus (green algae)): 22 mg/l
Exposure time: 72 h

Toxicity to daphnia and other:

EC10 (Daphnia magna (Water flea)): 9 mg/l
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SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

Exposure time: 21 d
Method: OECD Test Guideline 211:

EC50 (Pseudomonas putida): 164 mg/l
Exposure time: 16 h

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Finasteride:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 0 %Exposure time: 7 dMethod: FDA 3.11

Stability in water:

Hydrolysis: 0 %(5 d)Method: FDA 3.09

Sodium bis(2-ethylhexyl)sulfosuccinate:
Biodegradability: Result: Readily biodegradable.
Biodegradation: 91.2 %Exposure time: 28 d
Bioaccumulative potential
Components:
Finasteride:
Partition coefficient: noctanol/water:log Pow: 3.57

Sodium bis(2-ethylhexyl)sulfosuccinate:
Partition coefficient: n: log Pow: 1.998
octanol/water
Remarks: Calculation
Mobility in soil
No data available
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available

19 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

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
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
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

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

20 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical name
Sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate

Number213

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
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
docusate sodium
Iron oxide

Concentration (%)>0 - <10>0 - <10>=1 - <10

Remarks
From April 1st, 2026-

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical nameIron oxide

Remarks-

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

21 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

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
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.
22 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

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

SDS Number:
49649-00024:

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

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;
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 for
23 / 24

SAFETY DATA SHEET

Finasteride (1%) Formulation
Version
14.0

Revision Date:
2024/04/06

SDS Number:
49649-00024

Date of last issue: 2023/09/30
Date of first issue: 2015/01/26

safe 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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