SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

SECTION 1. IDENTIFICATION
Product name:

Etonogestrel / Ethinyl 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)
Combustible dust
Carcinogenicity:

Category 1A

Reproductive toxicity:

Category 1ASpecific target organ toxicity- repeated exposure:

Category 1 (Liver, Blood)

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
H350 May cause cancer.
H360FD May damage fertility. May damage the unborn child.
H372 Causes damage to organs (Liver, Blood) 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.
P260 Do not breathe dust, fume, gas, mist, vapors or spray.
1 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

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:
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
(17α)-13-Ethyl-17-hydroxy-1154048-10-1
methylene-18,19-dinorpregn-4-en-20yn-3-one
Ethinylestradiol
57-63-6
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 0.1 - < 1>= 0.1 - < 1

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 swallowed:

Most important symptoms
and effects, both acute and:

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 cause cancer.
May damage fertility. May damage the unborn child.
2 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

delayedProtection of first-aiders:

Notes to physician:

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

Causes damage to organs through prolonged or repeatedexposure.
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.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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

:

Exposure to combustion products may be a hazard to health.

:

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

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

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
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 suitablecontainer 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 anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to
3 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

determine 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:

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, fume, gas, mist, vapors or spray.
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.
Keep in properly labeled 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
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
Components

CAS-No.

Control parameters / Permissible
concentration
0.05 µg/m3 (OEB
5)

Basis

54048-10-1

Value type
(Form ofexposure)TWA(17α)-13-Ethyl-17-hydroxy-11methylene-18,19-dinorpregn-4en-20-yn-3-one
Ethinylestradiol

57-63-6

Wipe limit
TWA

0.5 µg/100 cm²
0.01 µg/m3 (OEB
5)

Internal
Internal

4 / 18Internal

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014
Wipe limit

Engineering measures:

0.1 µg/100 cm²Internal

Use closed processing systems or containment technologies
to control at source (e.g., glove boxes/isolators) and toprevent 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
the workplace.

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
Eye protection::

Skin and body protection:

Hygiene measures:

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.
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.
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 the
5 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

use of administrative controls.
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

solid

Color

:

white

Odor

:

odorless

Odor Threshold:

No data available

pH:

Not applicable

Melting point/freezing point:

Not applicable

Initial boiling point and boiling
range

:

Not applicableFlash point:

Not applicable

Evaporation rate:

Not applicable

Flammability (solid, gas):

May form explosive dust-air mixture during processing,handling or other means.

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

Not applicable

Lower explosion limit / Lower
flammability limit:

Not applicable

Vapor pressure:

Not applicable

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

1 g/cm³

Solubility(ies)
Water solubility:

insoluble

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

6 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

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.
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.

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Acute oral toxicity: LD50 (Rat): > 2,000 mg/kg
LD50 (Mouse): > 2,000 mg/kg
Ethinylestradiol:
Acute oral toxicity:

LD50 (Rat): 1,200 mg/kg
LD50 (Mouse): 1,737 mg/kg

Acute inhalation toxicity:

Remarks: No data available

Acute dermal toxicity:

Remarks: No data available

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

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

Skin corrosion/irritation
Not classified based on available information.
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Species: MouseResult: No skin irritation
SpeciesResult::Guinea pig
No skin irritation

Ethinylestradiol:
Remarks:

No data available

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

No data available

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Ethinylestradiol:
Remarks:

No data available

Germ cell mutagenicity
Not classified based on available information.
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Genotoxicity in vitro: Test Type: reverse mutation assay
Test system: Salmonella typhimurium
Result: negative
Test Type: in vitro test
Test system: Chinese hamster ovary cells
Result: negative
Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Application Route: Oral
8 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

Result: negative
Germ cell mutagenicity Assessment
Ethinylestradiol:
Genotoxicity in vitro:

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

:

Test Type: Bacterial reverse mutation assay (AMES)
Test system: Salmonella typhimurium
Result: negative
Test Type: Bacterial reverse mutation assay (AMES)
Test system: Escherichia coli
Result: negative
Test Type: Chromosome aberration test in vitro
Test system: Human lymphocytes
Result: equivocal

Genotoxicity in vivo:

Test Type: Chromosomal aberration
Species: Mouse
Cell type: Bone marrow
Application Route: Oral
Result: positive
Test Type: Micronucleus test
Species: Mouse
Cell type: Bone marrow
Application Route: Oral
Result: negative

Germ cell mutagenicity Assessment:

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

Carcinogenicity
May cause cancer.
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Species: Rat
Application Route: OralActivity duration: 2y: 0.5 mg/kg body weight
Result: negative
Species
Application RouteActivity duration
ResultCarcinogenicity - Assessment

:
:
:
:
:

Rat
Subcutaneous
2y0.02 mg/kg body weight
negative:

Weight of evidence does not support classification as a carcinogen9 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

Ethinylestradiol:
Species
Application RouteExposure time
Result::::Rat, male and female
Oral
2 Years
negative

Species
Application RouteExposure time
Result::::Monkey, female
Oral
10 Years
negative

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

Known to be human carcinogen
Ethinylestradiol(Estrogens, Steroidal)

57-63-6

Reproductive toxicity
May damage fertility. May damage the unborn child.
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Effects on fertility: Test Type: Fertility
Species: Rat, female
Application Route: Oral
Fertility: LOAEL: 0.012 mg/kg body weight
Result: Effects on fertility.
Test Type: Fertility
Species: Rabbit, female
Application Route: Oral
Dose: 0.05 milligram per kilogram
Result: Effects on fertility.
Effects on fetal development:

Species: Rat, female
Duration of Single Treatment: 14 dGeneral Toxicity Maternal: NOAEL: 1.8 mg/kg body weight
Result: No teratogenic effects.

Reproductive toxicity - Assessment:

Positive evidence of adverse effects on sexual function andfertility from human epidemiological studies.

:

Species: Hamster

Ethinylestradiol:
Effects on fertility

10 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

Fertility: LOAEL: 6.3 mg/kg body weight
Result: Effects on fertility.
Effects on fetal development:

Test Type: Four-generation reproduction toxicity study
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: > 0.006 mg/kg body weight
Result: Specific developmental abnormalities.
Test Type: Two-generation reproduction toxicity study
Species: Rat, male and female
Application Route: Oral
Developmental Toxicity: LOAEL: 0.005 mg/kg body weight
Result: Specific developmental abnormalities.

Reproductive toxicity - Assessment:

Clear evidence of adverse effects on sexual function andfertility, based on animal experiments., Clear evidence ofadverse effects on development, based on animal
experiments.

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Causes damage to organs (Liver, Blood) through prolonged or repeated exposure.
Components:
Ethinylestradiol:
Target Organs
Assessment::

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

Repeated dose toxicity
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Species: Rat
LOAEL: 0.5 mg/kg
Application Route: OralExposure time
: 1yTarget Organs: Reproductive organs, Endocrine system
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.625 mg/kg
Oral
26 Weeks
Reproductive organs, Endocrine system

Ethinylestradiol:
Species
NOAEL

:
:

Rat
0.25 mg/kg
11 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:

0.5 mg/kg
Oral
2 Weeks
Liver

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rabbit0.015 mg/kg
Oral
20 Weeks
Liver

Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Dog
0.04 mg/kg
0.2 mg/kg
Oral
95 d
Blood

Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat, male and female
0.0015 mg/kg
0.005 mg/kg
Oral
2y
Reproductive organs, Mammary gland, Liver, Uterus (including cervix)

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Inhalation: Symptoms: Headache, Dizziness, Abdominal pain, Nausea,
Skin disorders, effects on menstruation, vaginitis, breast tenderness, mood swings, male reproductive effects, Sweating
Ethinylestradiol:
Ingestion:

Symptoms: Abdominal pain, Nausea, Vomiting, Diarrhea,
Headache, Dizziness, mood swings, Edema, liver functionchange, water retention, hair loss, gynecomastia, effects on
menstruation

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Toxicity to fish
: LC50 (Oncorhynchus mykiss (rainbow trout)): 4.0 mg/l
Exposure time: 96 h
Method: FDA 4.11
12 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

LC50 (Lepomis macrochirus (Bluegill sunfish)): > 1.3 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: No toxicity at the limit of solubility.
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 3.9 mg/l
Exposure time: 48 h
Method: FDA 4.08
Remarks: No toxicity at the limit of solubility.

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.059 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210
NOEC (Oryzias latipes (Japanese medaka)): 0.0000027 mg/l
Exposure time: 183 d
Method: OECD Test Guideline 229

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

NOEC (Daphnia magna (Water flea)): 1.2 mg/l
Exposure time: 21 d
NOEC: 70.8 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
EC50: > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

Ethinylestradiol:
Toxicity to fish

Toxicity to algae/aquaticplants:LC50 (Lepomis macrochirus (Bluegill sunfish)): 1.6 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 6.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 6.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.01 µg/l
Exposure time: 35 d
Method: OECD Test Guideline 210
NOEC (Zebrafish): 0.00031 µg/l
Exposure time: 339 d
13 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

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

NOEC (Daphnia magna (Water flea)): 0.75 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Toxicity to microorganisms

EC50: > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209:

NOEC: 24.9 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Persistence and degradability
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Stability in water: Hydrolysis: < 10 %(5 d)Method: FDA 3.09
Bioaccumulative potential
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Bioaccumulation: Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): 128
Method: OECD Test Guideline 305
Partition coefficient: noctanol/water
Ethinylestradiol:
Bioaccumulation

Partition coefficient: noctanol/water:log Pow: 3.5:

Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): 264
Method: OECD Test Guideline 305:

log Pow: 4.15

Mobility in soil
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Distribution among environ: log Koc: 2.84
mental compartments
Method: FDA 3.08
Ethinylestradiol:
Distribution among environ-:log Koc: 3.86
14 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

mental 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.
If not otherwise specified: Dispose of as unused product.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ethinylestradiol, (17α)-13-Ethyl-17-hydroxy-11-methylene18,19-dinorpregn-4-en-20-yn-3-one)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Ethinylestradiol, (17α)-13-Ethyl-17-hydroxy-11-methylene18,19-dinorpregn-4-en-20-yn-3-one)
9
III
Miscellaneous
956

:

956

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Ethinylestradiol, (17α)-13-Ethyl-17-hydroxy-11-methylene18,19-dinorpregn-4-en-20-yn-3-one)
9III
9
F-A, S-F
yes

Class
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
Environmentally hazardous

15 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

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 name

:
:

Class
Packing group
LabelsERG Code
Marine pollutant

:
:
:
:
:

Remarks:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Ethinylestradiol, (17α)-13-Ethyl-17-hydroxy-11-methylene18,19-dinorpregn-4-en-20-yn-3-one)
9
III
CLASS 9171
yes(Ethinylestradiol, (17α)-13-Ethyl-17-hydroxy-11-methylene18,19-dinorpregn-4-en-20-yn-3-one)
Above applies only to containers over 119 gallons or 450
liters.
Shipment by ground under DOT is non-regulated; however it
may be shipped per the applicable hazard classification tofacilitate multi-modal transport involving ICAO (IATA) or IMO.

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:

Combustible dust
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
Vinylacetate copolymer with ethene
Ethinylestradiol

16 / 1824937-78-8
57-63-6

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

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

HEALTH1
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
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
17 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel / Ethinyl Estradiol Formulation
Version
8.10

Revision Date:
09/26/2023

SDS Number:
16799-00024

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014

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:

09/26/2023

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.
US / Z8

18 / 18