SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

SECTION 1. IDENTIFICATION
Product name:

Estradiol Formulation

Manufacturer or supplier's details
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
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Flammable liquids: Category 3
Carcinogenicity:

Category 1A

Reproductive toxicity:

Category 1ASpecific target organ toxicity- repeated exposure:

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

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H226 Flammable liquid and vapor.
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.

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, sparks, open flame and hot surfaces. No smoking.
P233 Keep container tightly closed.
1 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

P241 Use explosion-proof electrical, ventilating and lighting
equipment.
P242 Use only non-sparking tools.
P243 Take precautionary measures against static discharge.
P260 Do not breathe vapors.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately
all contaminated clothing. Rinse skin with water.
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
P403 + P235 Store in a well-ventilated place. Keep cool.
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
Vapors may form explosive mixture with air.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Ethanol#
Estradiol# Voluntarily-disclosed substance

CAS-No.
64-17-550-28-2

Concentration (% w/w)>= 40 - <= 45
0.06

SECTION 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.

If inhaled:

In case of skin contact:

In case of eye contact:

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.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
2 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

If swallowed:

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

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
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.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemicalHigh volume water jet

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Do not use a solid water stream as it may scatter and spread
fire.
Flash back possible over considerable distance.
Vapors 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 fire-fighters:

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.

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

Remove all sources of ignition.
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
oil barriers).
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials for:

Non-sparking tools should be used.
3 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

containment and cleaning up

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

Soak up with inert absorbent material.
Suppress (knock down) gases/vapors/mists with a water sprayjet.
For large spills, provide diking or other appropriate
containment to keep material from spreading. If diked material
can be pumped, store recovered material in appropriate
container.
Clean up remaining materials from spill with suitable
absorbent.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

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 vapors.
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
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.
Keep in properly labeled 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:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Flammable solids
Pyrophoric liquids
Pyrophoric solids
4 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

Self-heating substances and mixtures
Substances and mixtures which in contact with water emit
flammable gases
Explosives
Gases
Very acutely toxic substances and mixtures
SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
Components

CAS-No.

Ethanol

64-17-5

Value type
(Form ofexposure)
STEL
TWA
TWA

Estradiol50-28-2

TWA

Further information: Skin
Wipe limit
Engineering measures:

Control parameters / Permissible
concentration
1,000 ppm
1,000 ppm
1,900 mg/m³
1,000 ppm
1,900 mg/m³
0.05 µg/m3 (OEB
5)

Basis

0.5 µg/100 cm²Internal

ACGIH
NIOSH REL
OSHA Z-1
Internal

Minimize workplace exposure concentrations.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Use explosion-proof electrical, ventilating and lighting
equipment.

Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Choose gloves to protect hands against chemicals dependingon the concentration specific to place of work. Breakthroughtime is not determined for the product. Change gloves often!
For special applications, we recommend clarifying theresistance to chemicals of the aforementioned protective
gloves with the glove manufacturer. Take note that the
5 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Eye protection:

Skin and body protection:

Hygiene measures:

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

product is flammable, which may impact the selection of handprotection. Wash hands before breaks and at the end of
workday.
Wear the following personal protective equipment:
Safety glasses
Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
Wear the following personal protective equipment:
If assessment demonstrates that there is a risk of explosive
atmospheres or flash fires, use flame retardant antistatic
protective clothing.
Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

gel

Color

:

clear, colorless

Odor

:

No data available

Odor Threshold:

No data available

pH:

6.6 - 6.8

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

81 - 86 °F / 27 - 30 °C
Method: closed cup

Evaporation rate:

No data available

Flammability (solid, gas):

No data available

Flammability (liquids):

Ignitable (see flash point)

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available
6 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

60000 - 85000 mm²/s

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:Not applicable

Particle size:

No data available

SECTION 10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Flammable liquid and vapor.
Vapors 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.

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.

7 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

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: vapor

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

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Ethanol:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

Estradiol:
Result:No eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Ethanol:
Test Type
Routes of exposure::

Local lymph node assay (LLNA)
Skin contact
8 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

SpeciesResult::Mouse
negative

Estradiol:
Routes of exposure
Species
Assessment
Result::::Skin contact
Guinea pig
Does not cause skin sensitization.
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

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

9 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

Carcinogenicity
May cause cancer.
Components:
Estradiol:
Species
Application RouteExposure time
LOAEL
ResultTarget Organs

:
:
:
:
:
:

Mouse
Ingestion
24 Months
100 µg/kg
positive
female reproductive organs

Species
Application RouteExposure time
LOAEL
ResultTarget Organs

:
:
:
:
:
:

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

Carcinogenicity - Assess: Positive evidence from human epidemiological studies
ment
IARC
No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.
OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as a known or anticipated carcinogen by NTP.

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

Estradiol:
Effects on fertility:

Test Type: One-generation reproduction toxicity study
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
10 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

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 fetal development:

Test Type: Embryo-fetal 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-fetal 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 theoffspring 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.
Components:
Estradiol:
Target Organs
Assessment::

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

:

Rat

Repeated dose toxicity
Components:
Ethanol:
Species

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

NOAEL
LOAEL
Application RouteExposure time

:
:
:
:

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

Estradiol:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
>= 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
Skin contact
Ingestion:::

Symptoms: tingling, Nose bleeding
Symptoms: Skin irritation, Redness, pruritis
Symptoms: Headache, Gastrointestinal disturbance, Dizziness, Vomiting, Diarrhea, water retention, liver functionchange, changes in libido, breast tenderness, menstrual irregularities

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

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
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:

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

12 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

Estradiol:
Toxicity to fish

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018:

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)
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
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

Estradiol:
Biodegradability:

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

Bioaccumulative potential
Components:
Ethanol:
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

Partition coefficient: noctanol/water
Estradiol:
Partition coefficient: noctanol/water

SDS Number:
2678771-00017:

log Pow: -0.35:

log Pow: 4.01:

log Koc: 3.81

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

Mobility in soil
Components:
Estradiol:
Distribution among environmental compartments
Other adverse effects
No data available
SECTION 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 othersources of ignition. They may explode and cause injury and/or
death.
If not otherwise specified: Dispose of as unused product.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
Proper shipping nameClass
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

:
:
:
:
:
:

UN 1170
ETHANOL SOLUTION
3
III
3
yes

:
:
:
:
:
:

UN 1170
Ethanol solution
3
III
Flammable Liquids
366

:

355

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

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

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
UN/ID/NA number
Proper shipping nameClass
Packing group
LabelsERG Code
Marine pollutant

:
:
:
:
:
:
:

UN 1170
Ethanol solutions
3
III
FLAMMABLE LIQUID
127
yes(Estradiol)

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, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Flammable (gases, aerosols, liquids, or solids)
Carcinogenicity
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

SARA 313:

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
Water

7732-18-5
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

Ethanol
Estradiol64-17-550-28-2

California Prop. 65
WARNING: This product can expose you to chemicals including Estradiol, which is/are known to
the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
California List of Hazardous Substances
Ethanol

64-17-5

California Permissible Exposure Limits for Chemical Contaminants
Ethanol

64-17-5

The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information
NFPA 704:

HMIS® IV:
Flammability

HEALTH

3
Health00Special hazard*

3

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
ACGIH / STEL
: Short-term exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
16 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

OSHA Z-1 / TWASDS Number:
2678771-00017:

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018

8-hour time weighted average

AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; 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; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

09/30/2023

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
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 safe handling, use, processing, storage, transportation, disposal and release andshall 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 specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
17 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Formulation
Version
5.0

Revision Date:
09/30/2023

SDS Number:
2678771-00017

US / Z8

18 / 18

Date of last issue: 04/04/2023
Date of first issue: 04/12/2018