SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Estradiol Gel 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
Flammable liquids: Category 2
Serious eye damage/eye irritation:

Category 2ACarcinogenicity:

Category 1A

Reproductive toxicity:

Category 1ASpecific target organ toxicity repeated exposure:

Category 1 (Liver, Bone, Blood, Endocrine system)

Long-term (chronic) aquatic
hazard:Category 1

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H225 Highly flammable liquid and vapour.
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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

H319 Causes serious eye irritation.
H350 May cause cancer.
H360FD May damage fertility. May damage the unborn child.
H372 Causes damage to organs (Liver, Bone, Blood, Endocrine system) through prolonged or repeated exposure.
H410 Very toxic to aquatic life with long lasting effects.
Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P210 Keep away from heat, hot surfaces, sparks, open flames
and other ignition sources. No smoking.
P233 Keep container tightly closed.
P241 Use explosion-proof electrical/ ventilating/ lighting equipment.
P242 Use non-sparking tools.
P243 Take action to prevent static discharges.
P260 Do not breathe vapours.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact lenses, if present andeasy to do. Continue rinsing.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P337 + P313 If eye irritation persists: Get medical advice/ attention.
P391 Collect spillage.
Storage:
P403 + P235 Store in a well-ventilated place. Keep cool.
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- : Vapours may form explosive mixture with air.
lines of the emergency assumed
3. COMPOSITION/INFORMATION ON INGREDIENTS
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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

Substance / Mixture

SDS Number:
10608785-00007:

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

MixtureComponents
Chemical name
Ethanol#

CAS-No.
64-17-5

Concentration (% w/w)
58.5

ENCS No.
2-202

Propylene glycol

57-55-6

12.5

2-234

Polyacrylic acid9003-01-4

1.5

6-898

2,2',2''-Nitrilotriethanol

102-71-6

0.28

2-308, 2-353

Estradiol# Voluntarily-disclosed substance

50-28-2

0.1

4. FIRST AID MEASURES
General advice:

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:

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.
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.
In case of contact, immediately flush eyes with plenty of water
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Causes serious eye irritation.
May cause cancer.
May damage fertility. May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
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
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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

Unsuitable extinguishingmedia
Specific hazards during firefighting:High volume water jet:

Do not use a solid water stream as it may scatter and spread
fire.
Flash back possible over considerable distance.
Vapours may form explosive mixtures with air.
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

Remove all sources of ignition.
Ventilate the area.
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.
Prevent spreading over a wide area (e.g. by containment or oilbarriers).
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:

Non-sparking tools should be used.
Soak up with inert absorbent material.
Suppress (knock down) gases/vapours/mists with a water
spray jet.
For large spills, provide dyking or other appropriate containment to keep material from spreading. If dyked material canbe pumped, store recovered material in appropriate container.
Clean up remaining materials from spill with suitable absorbent.
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.

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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

7. HANDLING AND STORAGE
Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Use explosion-proof electrical, ventilating and lighting equipment.
Do not get on skin or clothing.
Do not breathe vapours.
Do not swallow.
Do not get in 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
Non-sparking tools should be used.
Keep container tightly closed.
Keep away from heat, hot surfaces, sparks, open flames andother ignition sources. No smoking.
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.
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.
Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
Keep away from heat and sources of ignition.
Do not store with the following product types:
Oxidizing solids
Oxidizing liquids
Unsuitable material: None known.

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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

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)

Ethanol
2,2',2''-Nitrilotriethanol
Estradiol64-17-5
102-71-6
50-28-2

STEL
TWA
TWA

Further information: Skin
Wipe limit
Engineering measures:

Control parameters / Reference
concentration /Permissible concentration
1,000 ppm
5 mg/m3
0.05 µg/m3 (OEB
5)

Basis

0.5 µg/100 cm²Internal

ACGIH
ACGIH
Internal

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.
Use explosion-proof electrical, ventilating and lighting equipment.

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
: Combined particulates and organic vapour type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body protection:

Consider double gloving. Take note that the product is flammable, which may impact the selection of hand 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.
Work uniform or laboratory coat.
Additional body garments should be used based upon the
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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

task 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:gelColour:opalescent

Odour

:

aromatic

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

Ignitable (see flash point)

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
Flash point:

No data available

:

22 °C
Method: closed cup

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

No data available
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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Density and / or relative density
Relative density:
Density

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

No data available:

No data available

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

Not applicable

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Highly flammable liquid and vapour.
Vapours may form explosive mixture with air.
Can react with strong oxidizing agents.

Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

Heat, flames and sparks.
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.
Components:
Ethanol:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Method: OECD Test Guideline 401

Acute inhalation toxicity:

LC50 (Rat): 124.7 mg/l
Exposure time: 4 h
Test atmosphere: vapour
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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Assessment: The substance or mixture has no acute dermal
toxicity

Polyacrylic acid:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Remarks: Based on data from similar materials

2,2',2''-Nitrilotriethanol:
Acute oral toxicity:

LD50 (Rat): 6,400 mg/kg

Acute dermal toxicity:

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

Estradiol:
Acute oral toxicity:

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

Acute toxicity (other routes of :administration)

LD50 (Rat): > 300 mg/kg
Application Route: Subcutaneous

Skin corrosion/irritation
Not classified based on available information.
Components:
Ethanol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Propylene glycol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Polyacrylic acid:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

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Estradiol Gel Formulation
Version
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Revision Date:
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2,2',2''-Nitrilotriethanol:
Species
MethodResultSDS Number:
10608785-00007:::

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

RabbitOECD Test Guideline 404
No skin irritation

Serious eye damage/eye irritation
Causes serious eye irritation.
Components:
Ethanol:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

Propylene glycol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

Polyacrylic acid:
SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

2,2',2''-Nitrilotriethanol:
SpeciesResult::RabbitNo eye irritation

Estradiol:
Result:No eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Ethanol:
Test Type
Exposure routes
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative

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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
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Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

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

2,2',2''-Nitrilotriethanol:
Test Type
Exposure routes
Species
MethodResult:::::Maximisation Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

Estradiol:
Exposure routes
Species
Assessment
Result::::Skin contact
Guinea pig
Does not cause skin sensitisation.
negative

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

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

Genotoxicity in vivo:

Test Type: Rodent dominant lethal test (germ cell) (in vivo)
Species: Mouse
Application Route: Ingestion
Result: equivocal

Propylene glycol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Result: negative
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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
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Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

2,2',2''-Nitrilotriethanol:
Genotoxicity in vitro:

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

Estradiol:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Test system: mammalian cells
Result: positive
Test Type: Chromosome aberration test in vitro
Test system: mammalian cells
Result: positive
Test Type: Chromosomal aberration
Test system: mammalian cells
Result: positive

Genotoxicity in vivo:

Test Type: Chromosomal aberration
Species: Rat
Cell type: Bone marrow
Result: negative
Test Type: Chromosomal aberration
Species: Mouse
Cell type: Bone marrow
Result: negative

Carcinogenicity
May cause cancer.
Components:
Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

2,2',2''-Nitrilotriethanol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Skin contact
103 weeks
negative

Estradiol:
Species
Application RouteExposure time
LOAEL

:
:
:
:

Mouse
Ingestion
24 Months
100 µg/kg
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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

ResultTarget Organs::

positive
female reproductive organs

Species
Application RouteExposure time
LOAEL
ResultTarget Organs

:
:
:
:
:
:

Rat
Subcutaneous
13 weeks
20 mg/kg body weight
positive
Endocrine system

Carcinogenicity - Assessment:

Positive evidence from human epidemiological studies

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

Test Type: Two-generation reproduction toxicity study
Species: Mouse
Application Route: Ingestion
Result: negative

Propylene glycol:
Effects on fertility:

Test Type: Two-generation reproduction toxicity study
Species: Mouse
Application Route: Ingestion
Result: negative:

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

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 416
Result: negative:

Test Type: Reproduction/Developmental toxicity screening
test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 421
Result: negative:

Test Type: One-generation reproduction toxicity study

Effects on foetal development

2,2',2''-Nitrilotriethanol:
Effects on fertility

Effects on foetal development

Estradiol:
Effects on fertility

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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
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Revision Date:
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SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

Species: Rat
Application Route: Ingestion
Fertility: LOAEL: 0.5 mg/kg body weight
Result: Effects on fertility
Test Type: One-generation reproduction toxicity study
Species: Rat
Duration of Single Treatment: 90 d
Fertility: LOAEL: 0.69 mg/kg body weight
Result: Effects on fertility
Test Type: Two-generation study
Species: Mouse
Application Route: Oral
Fertility: LOAEL: 0.1 mg/kg body weight
Result: Effects on fertility
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Mouse, female
Application Route: Subcutaneous
Teratogenicity: LOAEL: 4 mg/kg body weight
Symptoms: Malformations were observed.
Result: positive, Teratogenic effects
Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Subcutaneous
Teratogenicity: LOAEL: 2.5 µg/kg body weight
Symptoms: Reduced body weight
Result: positive, Embryotoxic effects and adverse effects on
the offspring were detected.
Test Type: Embryo-foetal development
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.2 mg/kg body weight
Symptoms: Early Resorptions / resorption rate, Reduced
number of viable fetuses, Reduced body weight
Result: Embryotoxic effects and adverse effects on the offspring were detected only at high maternally toxic doses

Reproductive toxicity - Assessment:

May damage fertility. May damage the unborn child.

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Causes damage to organs (Liver, Bone, Blood, Endocrine system) through prolonged or repeatedexposure.

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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
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Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

Components:
2,2',2''-Nitrilotriethanol:
Assessment:

No significant health effects observed in animals at concentrations of 200 mg/kg bw or less.
No significant health effects observed in animals at concentrations of 0.2 mg/l/6h/d or less.

Estradiol:
Target Organs
Assessment::

Liver, Bone, Blood, Endocrine system
Causes damage to organs through prolonged or repeatedexposure.

Ethanol:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
1,280 mg/kg
3,156 mg/kg
Ingestion
90 Days

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat, male>= 1,700 mg/kg
Ingestion
2 yr2,2',2''-Nitrilotriethanol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 1,000 mg/kg
Ingestion
90 DaysSpecies
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 0.5 mg/l
inhalation (dust/mist/fume)
28 Days
OECD Test Guideline 412

Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
125 mg/kg
Skin contact
90 Days

Estradiol:
Species:Rat

Repeated dose toxicity
Components:

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LOAEL
Application RouteExposure timeTarget Organs

SDS Number:
10608785-00007

:
:
:
:

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08>= 0.17 mg/kg
Ingestion
90 d
Mammary gland, Ovary, Uterus (including cervix), Liver, Bone,
Endocrine system, Blood, Testis

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Estradiol:
Inhalation:

Symptoms: tingling, Nose bleeding

Skin contact:

Symptoms: Skin irritation, Redness, pruritis

Ingestion:

Symptoms: Headache, Gastrointestinal disturbance, Dizziness, Vomiting, Diarrhoea, water retention, liver functionchange, changes in libido, breast tenderness, menstrual irregularities:

LC50 (Pimephales promelas (fathead minnow)): > 1,000 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia (water flea)): > 1,000 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Chlorella vulgaris (Fresh water algae)): 275 mg/l
Exposure time: 72 h

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Ethanol:
Toxicity to fish

EC10 (Chlorella vulgaris (Fresh water algae)): 11.5 mg/l
Exposure time: 72 h
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

Propylene glycol:
Toxicity to fish:

NOEC (Daphnia magna (Water flea)): 9.6 mg/l
Exposure time: 9 d
EC50 (Pseudomonas putida): 6,500 mg/l
Exposure time: 16 h

LC50 (Oncorhynchus mykiss (rainbow trout)): 40,613 mg/l
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Version
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Revision Date:
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SDS Number:
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Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

Exposure time: 96 h
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 18,340 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Skeletonema costatum (marine diatom)): 19,300 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

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

Polyacrylic acid:
Toxicity to fish

NOEC (Ceriodaphnia dubia (water flea)): 13,020 mg/l
Exposure time: 7 d
NOEC (Pseudomonas putida): > 20,000 mg/l
Exposure time: 18 h:

LC50 (Brachydanio rerio (zebrafish)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: Based on data from similar materials

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): > 1 mg/l
Exposure time: 32 d
Remarks: Based on data from similar materials

Toxicity to microorganisms:

EC50 (activated sludge): > 100 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209
Remarks: Based on data from similar materials

2,2',2''-Nitrilotriethanol:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): 11,800 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 609.88 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Desmodesmus subspicatus (green algae)): 512 mg/l
Exposure time: 72 h
Test substance: Neutralised product
EC10 (Desmodesmus subspicatus (green algae)): 26 mg/l
Exposure time: 72 h
Test substance: Neutralised productToxicity to daphnia and other:

NOEC (Daphnia magna (Water flea)): 16 mg/l
17 / 24

SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

Estradiol:
Toxicity to fish

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

Exposure time: 21 d
IC50: > 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209:

LC50 (Oryzias latipes (Japanese medaka)): 3.9 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 2.7 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:NOEC (Pseudokirchneriella subcapitata (green algae)): 1.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
EC50 (Pseudokirchneriella subcapitata (green algae)): > 1.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
M-Factor (Chronic aquatic:
toxicity)
Toxicity to microorganisms:

NOEC (Oryzias latipes (Japanese medaka)): 0.000003 mg/l
Exposure time: 160 d
Method: OECD Test Guideline 210
NOEC (Daphnia magna (Water flea)): 0.2 mg/l
Exposure time: 21 d
1,000
EC50: > 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
NOEC: 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

Persistence and degradability
Components:
Ethanol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 84 %Exposure time: 20 d

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SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

Propylene glycol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 98.3 %Exposure time: 28 d
Method: OECD Test Guideline 301F

Polyacrylic acid:
Biodegradability:

Result: Not readily biodegradable.
Remarks: Based on data from similar materials

2,2',2''-Nitrilotriethanol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 96 %Exposure time: 19 d

Estradiol:
Biodegradability:

Result: rapidly degradable
Biodegradation: 84 %Exposure time: 24 hrs

Ethanol:
Partition coefficient: noctanol/water:log Pow: -0.35

Propylene glycol:
Partition coefficient: noctanol/water:log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8:

Species: Cyprinus carpio (Carp)
Bioconcentration factor (BCF): < 3.9:

log Pow: -1.9:

log Pow: 4.01:

log Koc: 3.81

Bioaccumulative potential
Components:

2,2',2''-Nitrilotriethanol:
Bioaccumulation

Partition coefficient: noctanol/water
Estradiol:
Partition coefficient: noctanol/water
Mobility in soil
Components:
Estradiol:
Distribution among environmental compartments

19 / 24

SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

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.
Empty containers retain residue and can be dangerous.
Do not pressurize, cut, weld, braze, solder, drill, grind, or expose such containers to heat, flame, sparks, or other sourcesof ignition. They may explode and cause injury and/or death.
If not otherwise specified: Dispose of as unused product.

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

:
:
:
:
:
:

UN 1170
ETHANOL SOLUTION
3
II
3
yes

:
:
:
:
:
:

UN 1170
Ethanol solution
3IIFlammable Liquids
364

:

353

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 1170
ETHANOL SOLUTION(Estradiol)
3II
3F-E, S-D
yes

IATA-DGR
UN/ID No.
Proper shipping nameClass
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

20 / 24

SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

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
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
ERG Code:127

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Group 4, Type 2 petroleums, Water insoluble liquid, (1000 litre), Hazardous rank III
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical namePropane-1,2-diol
Acrylic acid polymer
Triethanolamine

Number106
234
108

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 name
Ethanol
propane-1,2-diol
Triethanolamine

Concentration (%)>=50 - <60>=10 - <20>0 - <10

21 / 24

Remarks
From April 1st, 2025-

SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical name
Ethanol
propane-1,2-diol

Remarks
From April 1st, 2025

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)
Inflammable Substance
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 ThereofClass I Designated Chemical Substances
Chemical name
Polymer of acrylic acid

Administration number
565

Concentration (%)
1.5

High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Flammable liquids (Article 2 and 3 of rules on shipping and storage of dangerous goods and its
Attached Table 1)
Aviation Law
Flammable liquid (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table
1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Noxious liquid substance(Category Z)

Pack transportation:

Classified as marine pollutant

22 / 24

SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

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
Specially Controlled 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)
ACGIH / TWA
ACGIH / STEL::

8-hour, time-weighted average
Short-term exposure limit

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 Con23 / 24

SAFETY DATA SHEET

Estradiol Gel Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
10608785-00007

Date of last issue: 2023/09/30
Date of first issue: 2022/02/08

centration 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

24 / 24