SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Desogestrel Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

Emergency telephone number :+1-215-631-6999

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

2. HAZARDS IDENTIFICATIONGHS classification of chemical productReproductive toxicity: Category 1BSpecific target organ toxicity repeated exposure:

Category 1 (Pituitary gland, Uterus (including cervix), Ovary,
Mammary gland, Prostate)Long-term (chronic) aquatic
hazard:Category 1

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360Fd May damage fertility. Suspected of damaging the unborn child.
H372 Causes damage to organs (Pituitary gland, Uterus (including cervix), Ovary, Mammary gland, Prostate) through prolonged or repeated exposure.
H410 Very toxic to aquatic life with long lasting effects.

1 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Precautionary statements:

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

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
Important symptoms and out- : Dust contact with the eyes can lead to mechanical irritation.
lines of the emergency asContact with dust can cause mechanical irritation or drying ofsumed
the skin.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical nameStarch, oxidized

CAS-No.
65996-62-5

Concentration (% w/w)>= 1 - < 10

Propylene glycol

57-55-6

Titanium dioxide

13463-67-7> 0 - < 10

Desogestrel

54024-22-5>= 0.1 - < 0.25>= 0.1 - < 1

ENCS No.
8-99
2-234
1-558, 5-5225

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.
2 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

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 damage fertility. Suspected of damaging 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.

5. FIREFIGHTING 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 firefighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :Use personal protective equipment.
3 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

tive equipment and emergency procedures

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

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 suitable container 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 and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

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.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye

7. HANDLING AND STORAGE

4 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.
Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Keep in properly labelled 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
Unsuitable material: None known.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

Starch, oxidized

65996-62-5

Control parameters / Reference
concentration /Permissible concentration
0.5 mg/m3

Basis

TWA (inhalACGIH
able dust)
13463-67-7
OEL-M
1.5 mg/m3
JP OEL(Respirable(Titanium)
JSOH
particulatematter)Further information: Group 2B: possibly carcinogenic to humans
OEL-M (Total 2 mg/m3
JP OELparticulate(Titanium)
JSOH
matter)Further information: Group 2B: possibly carcinogenic to humans
54024-22-5
TWA
0.04 µg/m3 (OEB Internal
5)
Wipe limit
0.4 µg/100 cm²Internal

Titanium dioxide

Desogestrel

Engineering measures

Value type
(Form ofexposure):

Use closed processing systems or containment technologies
to control at source (e.g., glove boxes/isolators) and to prevent leakage of compounds into the workplace.
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
No open handling permitted.
5 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

Totally enclosed processes and materials transport systems
are required.
Operations require the use of appropriate containment technology designed to prevent leakage of compounds into theworkplace.
Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

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.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

powderColour

:

white

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

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

Flammability (liquids):

No data available

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
6 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

Lower explosion limit /Lower flammability limit

SDS Number:
21976-00026:

No data available

Flash point:

Not applicable

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

Not applicableAuto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

No data available:

No data available

Relative vapour density:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle characteristics
Particle size:

No data available

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:

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents

10. STABILITY AND REACTIVITY

7 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Hazardous decomposition
products:

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

No hazardous decomposition products are known.

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

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

Acute dermal toxicity:

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

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

Desogestrel:
Acute oral toxicity:

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

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

8 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

Titanium dioxide:
SpeciesResultSDS Number:
21976-00026::

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Propylene glycol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

Titanium dioxide:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Propylene glycol:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Titanium dioxide:
Test Type
Exposure routes
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative

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

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
9 / 20SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

Method: OECD Test Guideline 473
Result: negative
Genotoxicity in vivo:

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

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

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

Carcinogenicity
Not classified based on available information.
Components:
Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
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.

Carcinogenicity - Assessment

10 / 20

SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Desogestrel:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Oral
104 weeks
negative

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Oral
81 weeks
negative

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

Reproductive toxicity
May damage fertility. Suspected of damaging the unborn child.
Components:
Propylene glycol:
Effects on fertility

Effects on foetal development

Desogestrel:
Effects on fertility:

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

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

Test Type: 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 foetal development:

Test Type: Embryo-foetal development
Species: Rabbit, female
Application Route: Oral
Developmental Toxicity: NOAEL F1: 1 mg/kg body weight
Result: Embryotoxic effects and adverse effects on the offspring were detected., No teratogenic effects
Test Type: Embryo-foetal development
Species: Rat, female
Application Route: Oral
Embryo-foetal toxicity: LOAEC Parent: 0.125 mg/kg bodyweightResult: No teratogenic effects
11 / 20

SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

Reproductive toxicity - Assessment

SDS Number:
21976-00026:

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

Clear evidence of adverse effects on sexual function and fertility, based on animal experiments., Some evidence of adverse
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) through prolonged or repeated exposure.
Components:
Desogestrel:
Target Organs:

Assessment:

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

Repeated dose toxicity
Components:
Starch, oxidized:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
22,500 mg/kg
Ingestion
90 Days

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat, male>= 1,700 mg/kg
Ingestion
2 yr

Titanium dioxide:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
24,000 mg/kg
Ingestion
28 DaysSpecies
NOAEL
Application RouteExposure time

:
:
:
:

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

Desogestrel:
Species
LOAEL::

Rat, female
0.00625 mg/kg
12 / 20

SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

Application RouteExposure timeTarget Organs

:
:
:

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

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Desogestrel:
Ingestion:

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

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Propylene glycol:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 40,613 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to algae/aquaticplants:

ErC50 (Skeletonema costatum (marine diatom)): 19,300 mg/l
Exposure time: 72 h
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SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

Method: OECD Test Guideline 201
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

Titanium dioxide:
Toxicity to fish

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

LC50 (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

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
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SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
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SDS Number:
21976-00026

aquatic invertebrates (Chronic toxicity)
M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

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

10,000: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

Persistence and degradability
Components:
Propylene glycol:
Biodegradability:

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

Desogestrel:
Stability in water:

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

log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8:

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

log Pow: 3.5

Bioaccumulative potential
Components:
Propylene glycol:
Partition coefficient: noctanol/water
Desogestrel:
Bioaccumulation

Partition coefficient: noctanol/water
Mobility in soil
Components:
Desogestrel:

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SAFETY DATA SHEET

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Revision Date:
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Distribution among environmental compartments

SDS Number:
21976-00026:

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

log Koc: 2.84

Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

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.
(Desogestrel)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Desogestrel)
9
III
Miscellaneous
956

:

956

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
Labels:::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Desogestrel)
9
III
9

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

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SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
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EmS Code
Marine pollutant

SDS Number:
21976-00026::

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

F-A, S-F
yes

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.
Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
ERG Code:171

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical namePropane-1,2-diol

Number106

Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical nameTitanium(IV) oxide

Concentration (%)>0 - <10

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Remarks-

SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

Substances Subject to be Indicated Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Miscellaneous dangerous substances and articles (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Miscellaneous dangerous substances and articles (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
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SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
Further information
Sources of key data used tocompile the Safety Data
Sheet

:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
ACGIH / TWA
JP OEL JSOH / OEL-M::

8-hour, time-weighted average
Occupational Exposure Limit-Mean

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal 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;
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SAFETY DATA SHEET

Desogestrel Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
21976-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/10/15

n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
JP / EN

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