SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

SECTION 1. IDENTIFICATION
Product name:

Progesterone 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 2

Reproductive toxicity:

Category 1A

Effects on or via lactation
GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

May form combustible dust concentrations in air.
H351 Suspected of causing cancer.
H360FD May damage fertility. May damage the unborn child.
H362 May cause harm to breast-fed children.

Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P263 Avoid contact during pregnancy and while nursing.
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
1 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

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
Sunflower oil
Progesterone
Glycerine
Titanium dioxide

CAS-No.
8001-21-6
57-83-0
56-81-513463-67-7

Concentration (% w/w)
41.38727.7778.337
0.4475SECTION 4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayed: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.
Suspected of causing cancer.
May damage fertility. May damage the unborn child.
May cause harm to breast-fed children.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
2 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Protection of first-aiders:

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Do not use a solid water stream as it may scatter and spread
fire.
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
released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to
3 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Avoid contact during pregnancy and while nursing.
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.
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:
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
Value type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
5 mg/m³
Value type (Form of exposure): TWA (respirable fraction)
4 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

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.

Sunflower oil

8001-21-6

Progesterone

57-83-0

Titanium dioxide

13463-67-7

Value type
(Form ofexposure)
TWA (mist total)
TWA (mist respirable)
TWA
Wipe limit
TWA (total
dust)
TWA (Respirable particulate matter)

Control parameters / Permissible
concentration
10 mg/m³

Basis

5 mg/m³

NIOSH REL

6 μg/m3 (OEB 4)
60 μg/100 cm2
15 mg/m³

Internal
Internal
OSHA Z-1

2.5 mg/m³(Titanium dioxide)

ACGIH

NIOSH RELThis substance(s) is not bioavailable and therefore does not contribute to a dust inhalation
hazard.
Titanium dioxide
Engineering measures:

Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., vacuum conveying
from a closed system, packout head with inflatable seal fromstationary container, ventilated enclosure, etc.).
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Essentially no open handling permitted.
Use closed processing systems or containment technologies.

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
5 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

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:

Crystalline powder

Color

:

white to off-white

Odor

:

odorless

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

259 °F / 126 °C

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

Not applicable

6 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

Flammability (solid, gas):

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:

No data available

Solubility(ies)
Water solubility:

practically insoluble

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.

Molecular weight:

No data available

Particle size:

No data available

SECTION 10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Dust can form an explosive mixture in air.

:::

Avoid dust formation.
None.
No hazardous decomposition products are known.

7 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

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:
Sunflower oil:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 401
Remarks: Based on data from similar materials

Progesterone:
Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Remarks: Based on data from similar materials

Glycerine:
Acute oral toxicity:

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

Acute dermal toxicity:

LD50 (Guinea pig): > 5,000 mg/kg

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:
Sunflower oil:SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

Progesterone:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials
8 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Glycerine:
SpeciesResult::RabbitNo skin irritation

Titanium dioxide:
SpeciesResult::RabbitNo skin irritation

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Sunflower oil:SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

Progesterone:
SpeciesResult
MethodRemarks::::

RabbitNo eye irritation
OECD Test Guideline 405
Based on data from similar materials

Glycerine:
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:
Sunflower oil:
Test Type
Routes of exposure
SpeciesResultRemarks:::::

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

9 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

Progesterone:
Test Type
Routes of exposure
Species
MethodResultRemarks

:
:
:
:
:
:

Maximization Test
Skin contact
RabbitOECD Test Guideline 406
negative
Based on data from similar materials

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:
Sunflower oil:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative
Remarks: Based on data from similar materials

Progesterone:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Remarks: Based on data from similar materials
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Method: OECD Test Guideline 482
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Monkey
Application Route: Subcutaneous
Result: negative
Test Type: Unscheduled DNA synthesis (UDS) test withmammalian liver cells in vivo
Species: Rat
Application Route: Ingestion
Result: negative

Glycerine:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
10 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

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

:
:
:
:

Mouse, female
Subcutaneous
104 weeks
positive:

Limited evidence of carcinogenicity in animal studies

Glycerine:
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.
This substance(s) is not bioavailable and therefore does notcontribute to a dust inhalation hazard.

Carcinogenicity - Assess-:

Limited evidence of carcinogenicity in inhalation studies with

Carcinogenicity
Suspected of causing cancer.
Components:
Progesterone:
Species
Application RouteExposure time
ResultCarcinogenicity - Assessment

11 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

ment

animals.

IARC

Group 2B: Possibly carcinogenic to humans
Titanium dioxide

13463-67-7

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

Reasonably anticipated to be a human carcinogen
Progesterone

57-83-0

Reproductive toxicity
May damage fertility. May damage the unborn child.
May cause harm to breast-fed children.
Components:
Progesterone:
Effects on fertility:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Subcutaneous
Result: positive

Effects on fetal development:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Subcutaneous
Result: positive

Reproductive toxicity - Assessment:

Positive evidence of adverse effects on sexual function andfertility from human epidemiological studies., Clear evidenceof adverse effects on development, based on animal
experiments., Studies indicating a hazard to babies during thelactation period

Glycerine:
Effects on fertility:

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

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Not classified based on available information.

12 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

Repeated dose toxicity
Components:
Glycerine:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
0.167 mg/l
0.622 mg/l
inhalation (dust/mist/fume)
13 Weeks

Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
8,000 - 10,000 mg/kg
Ingestion
2ySpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rabbit
5,040 mg/kg
Skin contact
45 Weeks

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)
2yAspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Progesterone:
General Information:

Target Organs: Endocrine system
Symptoms: Effects on fertility.

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Sunflower oil:
Toxicity to fish:

LC50 (Leuciscus idus (Golden orfe)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials
13 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 32 mg/l
Exposure time: 48 h
Method: Directive 67/548/EEC, Annex V, C.2.
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
Remarks: Based on data from similar materials

Progesterone:
Toxicity to fish:

LC50 (Danio rerio (zebra fish)): > 1 - 10 mg/l
Exposure time: 96 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 1 mg/l
Exposure time: 48 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.000010
mg/l
Exposure time: 21 d

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

NOEC (Daphnia magna (Water flea)): 0.1 mg/l
Exposure time: 26 d:

LC50 (Oncorhynchus mykiss (rainbow trout)): 54,000 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 1,955 mg/l
Exposure time: 48 h

Toxicity to microorganisms:

NOEC (Pseudomonas putida): > 10,000 mg/l
Exposure time: 16 h
Method: DIN 38 412 Part 8

Titanium dioxide:
Toxicity to fish:

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

14 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

Toxicity to microorganisms

SDS Number:
5155504-00010:

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

EC50: > 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

Persistence and degradability
Components:
Progesterone:
Biodegradability:

Result: Readily biodegradable.
Remarks: Based on data from similar materials

Glycerine:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 92 %Exposure time: 30 d
Method: OECD Test Guideline 301D

Progesterone:
Partition coefficient: noctanol/water:

Pow: 3.65
Method: OECD Test Guideline 117

Glycerine:
Partition coefficient: noctanol/water:log Pow: -1.75

Bioaccumulative potential
Components:

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

Contaminated packaging:

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

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number:

UN 3077
15 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Proper shipping name

:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Progesterone)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Progesterone)
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.
(Progesterone)
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

:
:

Class
Packing group
LabelsERG Code
Marine pollutant
Remarks

:
:
:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Progesterone)
9
III
CLASS 9171
yes(Progesterone)
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

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

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

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
Sunflower oil
Progesterone
Gelatins
Glycerine

8001-21-6
57-83-0
9000-70-8
56-81-5

California Prop. 65
WARNING: This product can expose you to chemicals including Progesterone, 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
Progesterone

57-83-0

California Permissible Exposure Limits for Chemical Contaminants
Sunflower oil
Glycerine

8001-21-6
56-81-5

The ingredients of this product are reported in the following inventories:
IECSC: not determinedAICS:

not determinedDSL:

not determined

SECTION 16. OTHER INFORMATION
Further information
17 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

NFPA 704:

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019
HMIS® IV:

Flammability

HEALTH

3
Health00Special hazard*

4

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
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 Pre18 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Progesterone Formulation
Version
3.1

Revision Date:
09/30/2023

SDS Number:
5155504-00010

Date of last issue: 04/04/2023
Date of first issue: 10/17/2019

vention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

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

Revision Date:

09/30/2023

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

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