SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

SECTION 1. IDENTIFICATION
Product name:

Desogestrel / 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 1BSpecific target organ toxicity- repeated exposure:

Category 1 (Pituitary gland, Uterus (including cervix), Ovary,
Mammary gland, Prostate, 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 (Pituitary gland, Uterus (including cervix), Ovary, Mammary gland, Prostate, 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.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

P260 Do not breathe dust.
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.
Starch
9005-25-8
Stearic acid57-11-4
Desogestrel
54024-22-5
Ethinylestradiol
57-63-6
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 20 - < 30>= 5 - < 10>= 0.1 - < 1>= 0.01 - < 0.1

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:

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.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

and effects, both acute anddelayedProtection of first-aiders:

Notes to physician:

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

May damage fertility. May damage the unborn child.
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:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

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

Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)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
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

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 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:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Avoid contact with eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure
assessment
Keep container tightly closed.
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
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
inert or nuisance dust
50 Million particles per cubic footValue type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
15 mg/m³
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

Value type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
5 mg/m³
Value type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
15 Million particles per cubic footValue type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
Dust, nuisance dust and particulates

10 mg/m³
Value type (Form of exposure): PEL (Total dust)
Basis: CAL PEL
5 mg/m³
Value type (Form of exposure): PEL (respirable dust fraction)
Basis: CAL PEL

Components

CAS-No.

Desogestrel

54024-22-5

Value type
(Form ofexposure)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)
TWA

Starch

9005-25-8

Ethinylestradiol

57-63-6

Wipe limit
TWA

Stearic acid57-11-4

Wipe limit
Engineering measures:

Control parameters / Permissible
concentration
10 mg/m³
5 mg/m³

Basis

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

10 mg/m³

ACGIH

3 mg/m³

ACGIH0.04 µg/m3 (OEB
5)
0.4 µg/100 cm²
0.01 µg/m3 (OEB
5)
0.1 µg/100 cm²Internal

ACGIH
NIOSH RELInternal
Internal
Internal

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.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

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 theuse of administrative controls.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColor:

White to light yellow

Odor

:

No data available

Odor Threshold:

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

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash 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:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

Not applicable

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

1 g/cm³

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle size:

No data available

SECTION 10. STABILITY AND REACTIVITY

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

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:
Starch:Acute oral toxicity:

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

Acute dermal toxicity:

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

Stearic acid:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 2 mg/l
Exposure time: 1 h
Test atmosphere: vapor
Remarks: Based on data from similar materials

Acute dermal toxicity:

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

Desogestrel:
Acute oral toxicity:

LD50 (Rat, male and female): > 2,000 mg/kg
LD50 (Mouse, male and female): > 2,000 mg/kg

Ethinylestradiol:
Acute oral toxicity:

LD50 (Rat): 1,200 mg/kg
LD50 (Mouse): 1,737 mg/kg
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

Acute inhalation toxicity:

Remarks: No data available

Acute dermal toxicity:

Remarks: No data available

Skin corrosion/irritation
Not classified based on available information.
Components:
Stearic acid:
Species
MethodResult:::RabbitPatch Test 24 Hrs.
No skin irritation

Ethinylestradiol:
Remarks:

No data available

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Starch:SpeciesResult::RabbitNo eye irritation

Stearic acid:
SpeciesResult::RabbitNo eye irritation

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:
Starch:Test Type
Routes of exposure
SpeciesResult::::Maximization Test
Skin contact
Guinea pig
negative

9 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

Stearic acid:
Test Type
Routes of exposure
SpeciesResultRemarks:::::

Maximization Test
Skin contact
Guinea pig
negative
Based on data from similar materials

Ethinylestradiol:
Remarks:

No data available

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

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

Stearic acid:
Genotoxicity in vitro:

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

Desogestrel:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Rat
Application Route: Intraperitoneal
Result: negative

Ethinylestradiol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Test system: Salmonella typhimurium
Result: negative
Test Type: Bacterial reverse mutation assay (AMES)
Test system: Escherichia coli
10 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

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.

Desogestrel:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Oral
104 weeks
negative

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Oral
81 weeks
negative

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
May cause cancer.
Components:

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.

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

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:
Stearic acid:
Effects on fertility:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials

Effects on fetal development:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials

Desogestrel:
Effects on fertility:

Test Type: Fertility/early embryonic development
Species: Rabbit, female
Fertility: LOAEL Parent: 2 mg/kg body weight
Result: Effects on fertility.
Test Type: Fertility/early embryonic development
Species: Rat, female
Fertility: NOAEL Parent: 0.5 mg/kg body weight
Result: No effects on fertility.

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rabbit, female
Application Route: Oral
Developmental Toxicity: NOAEL F1: 1 mg/kg body weight
Result: Embryotoxic effects and adverse effects on theoffspring were detected., No teratogenic effects.
Test Type: Embryo-fetal development
Species: Rat, female
Application Route: Oral
Embryo-fetal toxicity.: LOAEC Parent: 0.125 mg/kg bodyweightResult: No teratogenic effects.

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

Reproductive toxicity - Assessment

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014:

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

Ethinylestradiol:
Effects on fertility:

Species: Hamster
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 (Pituitary gland, Uterus (including cervix), Ovary, Mammary gland,
Prostate, Liver, Blood) through prolonged or repeated exposure.
Components:
Desogestrel:
Target Organs:

Assessment:

Ethinylestradiol:
Target Organs
Assessment::

Pituitary gland, Uterus (including cervix), Ovary, Mammary
gland, Prostate
Causes damage to organs through prolonged or repeatedexposure.

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

13 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

Repeated dose toxicity
Components:
Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

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

Stearic acid:
Species
NOAEL
Application RouteExposure time
MethodRemarks

:
:
:
:
:
:

Rat
1,000 mg/kg
Ingestion
42 Days
OECD Test Guideline 422
Based on data from similar materials

Desogestrel:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat, female
0.00625 mg/kg
Oral
26 Weeks
Pituitary gland, Uterus (including cervix), Ovary, Mammary
gland

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.005 mg/kg
Oral
52 Weeks
Pituitary gland, Uterus (including cervix), Ovary, Mammary
gland

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.005 mg/kg
Oral
52 Weeks
Pituitary gland, Uterus (including cervix), Ovary, Mammary
gland, Prostate

Ethinylestradiol:
Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
0.25 mg/kg
0.5 mg/kg
Oral
2 Weeks
Liver

Species
LOAEL
Application Route:::Rabbit0.015 mg/kg
Oral
14 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

Exposure timeTarget Organs::

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:
Desogestrel:
Ingestion:

Symptoms: Headache, changes in libido, Dizziness, Nausea,
Vomiting, Diarrhea, water retention, sodium retention, Gastrointestinal discomfort, mental depression, amenorhea, insomnia, impaired glucose tolerance, pulmonary embolism
Target Organs: Uterus (including cervix)
Target Organs: Mammary gland

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:
Stearic acid:
Toxicity to fish

Toxicity to daphnia and otheraquatic invertebrates:

LL50 (Leuciscus idus (Golden orfe)): > 10,000 mg/l
Exposure time: 48 h
Method: DIN 38412:

EL50 (Daphnia magna (Water flea)): > 10 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: Based on data from similar materials
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SAFETY DATA SHEET
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Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

No toxicity at the limit of solubility.
Toxicity to algae/aquaticplants:NOELR (Pseudokirchneriella subcapitata (green algae)): > 10
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
No toxicity at the limit of solubility.
EL50 (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
No toxicity at the limit of solubility.

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

NOELR (Daphnia magna (Water flea)): > 0.5 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211
Remarks: Based on data from similar materials
No toxicity at the limit of solubility.

Toxicity to microorganisms:

EC10 (Pseudomonas putida): 883 mg/l
Exposure time: 18 h

Desogestrel:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 4 mg/l
Exposure time: 96 h
Method: FDA 4.11
Remarks: Based on data from similar materials
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.
Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 3.9 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility.
Based on data from similar materials

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.059 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210
Remarks: Based on data from similar materials
NOEC (Oryzias latipes (Japanese medaka)): 0.0000027 mg/l
Exposure time: 183 d
Remarks: Based on data from similar materials

Toxicity to daphnia and other:

NOEC (Daphnia magna (Water flea)): 1.2 mg/l
16 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

Exposure time: 21 d
Remarks: Based on data from similar materials:

EC50: > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: Based on data from similar materials
NOEC: 70.8 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Remarks: Based on data from similar materials

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

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

17 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

Persistence and degradability
Components:
Stearic acid:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 71 %Exposure time: 28 d
Method: OECD Test Guideline 301B

Desogestrel:
Stability in water:

Hydrolysis: < 10 %(5 d)Remarks: Based on data from similar materials:

log Pow: 8.23:

Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): 128
Remarks: Based on data from similar materials:

log Pow: 3.5:

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

log Pow: 4.15

Desogestrel:
Distribution among environmental compartments:

log Koc: 2.84

Ethinylestradiol:
Distribution among environmental compartments:

log Koc: 3.86

Bioaccumulative potential
Components:
Stearic acid:
Partition coefficient: noctanol/water
Desogestrel:
Bioaccumulation

Partition coefficient: noctanol/water
Ethinylestradiol:
Bioaccumulation

Partition coefficient: noctanol/water
Mobility in soil
Components:

Other adverse effects
No data available

18 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

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, Desogestrel)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Ethinylestradiol, Desogestrel)
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, Desogestrel)
9III
9F-A, S-F
yes

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

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::UN 3077
Environmentally hazardous substance, solid, n.o.s.
19 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Class
Packing group
LabelsERG Code
Marine pollutant
Remarks

:
:
:
:
:
:

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014(Ethinylestradiol, Desogestrel)
9
III
CLASS 9171
yes(Ethinylestradiol, Desogestrel)
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
LactoseStarchStearic acid
Ethinylestradiol

63-42-39005-25-8
57-11-4
57-63-6

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.
California List of Hazardous Substances
Polyvinyl pyrrolidone

20 / 229003-39-8

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

California Permissible Exposure Limits for Chemical Contaminants
Starch

9005-25-8

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
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
ACGIH / TWA: 8-hour, time-weighted average
CAL PEL / PEL: Permissible exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
OSHA Z-1 / TWA: 8-hour time weighted average
OSHA Z-3 / TWA: 8-hour time weighted average

21 / 22

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desogestrel / Ethinyl Estradiol Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19077-00024

Date of last issue: 03/20/2023
Date of first issue: 10/06/2014

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:

09/26/2023

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

22 / 22