SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

SECTION 1. IDENTIFICATION
Manufacturer or supplier's details
Company: 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
Carcinogenicity:

Category 1A

Reproductive toxicity:

Category 1ASpecific target organ toxicity repeated exposure:

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

Short-term (acute) aquatic
hazard:Category 3

Long-term (chronic) aquatic
hazard:Category 1

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

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.
H402 Harmful to aquatic life.
H410 Very toxic to aquatic life with long lasting effects.
1 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Precautionary Statements:

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P391 Collect spillage.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
May form explosive dust-air mixture during processing, handling or other means.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Estradiol
17-Hydroxy-6-methyl-19-norpregna-4,6-diene3,20-dione 17-acetate
Talc
Titanium dioxide

CAS-No.
9004-34-6
50-28-2
58652-20-3
14807-96-6
13463-67-7

Concentration (% w/w)>= 10 -< 20>= 2,5 -< 5>= 1 -< 2,5>= 1 -< 5>= 0,1 -< 1

SECTION 4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
2 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

In case of eye contact:

If swallowed:

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

Notes to physician:

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

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.
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:

3 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

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 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

4 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

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

CAS-No.

Cellulose

9004-34-6

Estradiol50-28-2

Further information: Skin
Wipe limit
58652-20-3
TWA

17-Hydroxy-6-methyl-19norpregna-4,6-diene-3,20dione 17-acetate

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

Basis

0.5 µg/100 cm²
0,2 µg/m³

Internal
Internal

AR OELACGIHInternal

Wipe limit
2 µg/100 cm²Internal
CMP (Res2 mg/m³
AR OELpirable fraction)
TWA
2 mg/m³
ACGIH(Respirable
particulatematter)13463-67-7
CMP
10 mg/m³
AR OEL
Further information: A4 - Not classifiable as a human carcinogenTalc

14807-96-6

Titanium dioxide

Engineering measures

Value type
(Form ofexposure)
CMP
TWA
TWA

:

Minimize workplace exposure concentrations.
Apply measures to prevent dust explosions.
Ensure that dust-handling systems (such as exhaust ducts,
dust collectors, vessels, and processing equipment) aredesigned in a manner to prevent the escape of dust into thework area (i.e., there is no leakage from the equipment).
If sufficient ventilation is unavailable, use with local exhaust
ventilation.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or
exposure assessment demonstrates exposures outside therecommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

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. Wash hands before
breaks and at the end of workday.
Wear the following personal protective equipment:
Safety goggles
5 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Skin and body protection:

Hygiene measures:

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
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:

powder

Color

:

white

Odor

:

odorless

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

No data available

Evaporation rate:

No data available

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:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

1 g/cm³

Solubility(ies)
Water solubility:

No data available

Partition coefficient: n-:

No data available
6 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

octanol/water
Autoignition temperature:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, dynamic:

No data available

Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

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.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 5.000 mg/kg
Method: Calculation method:

LD50 (Rat): > 5.000 mg/kg

Components:
Cellulose:
Acute oral toxicity

7 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Acute inhalation toxicity:

LC50 (Rat): > 5,8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2.000 mg/kg

Estradiol:
Acute oral toxicity:

LD50 (Rat): > 2.000 mg/kg

Acute toxicity (other routes of :administration)

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

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Acute oral toxicity: LD50 (Rat): > 2.000 mg/kg
LD50 (Mouse): > 2.000 mg/kg
Acute toxicity (other routes of :administration)

LD50 (Rat): > 2.000 mg/kg
Application Route: Intraperitoneal

Talc:
Acute oral toxicity:

LD50 (Rat): > 5.000 mg/kg
Remarks: Based on data from similar materials

Titanium dioxide:
Acute oral toxicity:

LD50 (Rat): > 5.000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 6,82 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity

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

Titanium dioxide:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.

8 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Components:
Estradiol:
Result:No eye irritation

Talc:
SpeciesResult::RabbitNo eye irritation

Titanium dioxide:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Estradiol:
Routes of exposure
Species
Assessment
Result::::Skin contact
Guinea pig
Does not cause skin sensitization.
negative

Talc:
Routes of exposure
SpeciesResult:::Skin contact
Humansnegative

Titanium dioxide:
Test Type
Routes of exposure
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative

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

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

9 / 20SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Genotoxicity in vivo:

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

Estradiol:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

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

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Genotoxicity in vitro: Test Type: Ames test
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Rat
Application Route: Oral
Result: negative
Test Type: In vivo micronucleus test
Species: Mouse
Application Route: Oral
Result: negative
10 / 20

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Talc:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

Test Type: Chromosome aberration test in vitro
Species: Rat
Application Route: Ingestion
Result: negative

Titanium dioxide:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Result: negative

Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

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 - Assessment:

Positive evidence from human epidemiological studies

Carcinogenicity
May cause cancer.
Components:

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Species: Rat
Application Route: oral (feed)
Activity duration: 52 Weeks: 10 mg/kg body weight
Result: negative
11 / 20

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

Species
Application RouteSDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

:
:
:
:
:

Mouse
oral (feed)
20 mg/kg body weight
positive
Mammary gland, Pituitary gland:

Weight of evidence does not support classification as a carcinogen

Talc:
Species
Application RouteExposure time
Result

:
:
:
:

Mouse
inhalation (dust/mist/fume)
2 Years
negative

Titanium dioxide:
Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
The mechanism or mode of action may not be relevant in humans.

:

Limited evidence of carcinogenicity in inhalation studies withanimals.

ResultTarget Organs
Carcinogenicity - Assessment

Carcinogenicity - Assessment

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

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative

Effects on fetal development:

Test Type: Fertility/early embryonic development
Species: Rat
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
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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Species: Rat
Duration of Single Treatment: 90 d
Fertility: LOAEL: 0,69 mg/kg body weight
Result: Effects on fertility.
Test Type: Two-generation study
Species: Mouse
Application Route: Oral
Fertility: LOAEL: 0,1 mg/kg body weight
Result: Effects on fertility.
Effects on 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 the offspring were detected only at high maternally toxic doses

Reproductive toxicity - Assessment:

May damage fertility. May damage the unborn child.

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Effects on fetal development : Test Type: Development
Species: Rat
Application Route: Oral
Result: negative
Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Oral
Result: negative, No teratogenic effects.
Reproductive toxicity - Assessment
Talc:
Effects on fetal development:

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

:

Test Type: Embryo-fetal development
Species: Rat
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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Application Route: Ingestion
Result: negative
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.

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 9.000 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

Repeated dose toxicity
Components:

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Species: MouseNOAEL: 20 mg/kg
Application Route: OralExposure time
: 52 Weeks
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
20 mg/kg
Oral
52 Weeks

Titanium dioxide:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
24.000 mg/kg
Ingestion
28 Days

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Nomegestrol / Estradiol Formulation
Version
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Revision Date:
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Species
NOAEL
Application RouteExposure timeSDS Number:
17201-00023::::

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Rat
10 mg/m³
inhalation (dust/mist/fume)
2yAspiration 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

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:Ingestion: Symptoms: acne, amenorhea, Headache, Dizziness, Nausea,
breast tenderness, changes in libido, insomnia, musculoskeletal pain, mood swings, muscle pain, muscle twitching
SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Cellulose:
Toxicity to fish:

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

Estradiol:
Toxicity to fish:

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 tox-:

NOEC (Oryzias latipes (Japanese medaka)): 0,000003 mg/l
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Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
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SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

icity)

Exposure time: 160 d
Method: OECD Test Guideline 210

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

NOEC (Daphnia magna (Water flea)): 0,2 mg/l
Exposure time: 21 d
1.000
EC50: > 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
NOEC: 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Toxicity to algae/aquatic: EC50 (Pseudokirchneriella subcapitata (green algae)): > 3,07
plantsmg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 0,69
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Toxicity to fish (Chronic toxicity):

NOEC (Zebrafish): 0,0013 mg/l
Exposure time: 27 d

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

NOEC (Daphnia magna (Water flea)): 3,65 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility.

M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

:

10

:

EC50 (Natural microorganism): > 2,8 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
NOEC (Natural microorganism): 2,8 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility.

Talc:
Toxicity to fish:

LC50 (Brachydanio rerio (zebrafish)): > 100.000 mg/l
Exposure time: 24 h
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SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

Titanium dioxide:
Toxicity to fish

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014:

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

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 (Skeletonema costatum (marine diatom)): > 10.000 mg/l
Exposure time: 72 h

Toxicity to microorganisms:

EC50: > 1.000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Estradiol:
Biodegradability:

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

log Pow: 4,01

Bioaccumulative potential
Components:
Estradiol:
Partition coefficient: noctanol/water

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Bioaccumulation: Species: Zebrafish
Bioconcentration factor (BCF): 44
Partition coefficient: noctanol/water:log Pow: 3,7:log Koc: 3,81

Mobility in soil
Components:
Estradiol:
Distribution among environmental compartments

17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate:
Distribution among environ: log Koc: 3,35
mental compartments
Method: OECD Test Guideline 106

17 / 20

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
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.
(Estradiol, 17-Hydroxy-6-methyl-19-norpregna-4,6-diene3,20-dione 17-acetate)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Estradiol, 17-Hydroxy-6-methyl-19-norpregna-4,6-diene3,20-dione 17-acetate)
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.
(Estradiol, 17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20dione 17-acetate)
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.
18 / 20

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

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 INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or
mixtureArgentina. Carcinogenic Substances and Agents: Not applicable
Registry.
Control of precursors and essential chemicals for the
preparation of drugs.

:

Not applicable

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Revision Date
Date format::

06.04.2024
dd.mm.yyyy

Further information
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/

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
AR OEL: Argentina. Occupational Exposure Limits
ACGIH / TWA
AR OEL / CMP::

8-hour, time-weighted average
TLV (Threshold Limit Value)

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemi19 / 20

SAFETY DATA SHEET

Nomegestrol / Estradiol Formulation
Version
8.2

Revision Date:
06.04.2024

SDS Number:
17201-00023

Date of last issue: 26.09.2023
Date of first issue: 30.09.2014

cal Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information is designed only as a
guidance for 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.
AR / Z8

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