SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

SECTION 1. IDENTIFICATION
Product name:

Etonogestrel Formulation (Implanon)

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
Reproductive toxicity:

Category 1A

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
H360F May damage fertility.

Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
P405 Store locked up.
Disposal:
1 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
(17α)-13-Ethyl-17-hydroxy-1154048-10-1
methylene-18,19-dinorpregn-4-en-20yn-3-one
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 50 - < 70

SECTION 4. FIRST AID MEASURES
General advice:

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

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

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.
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
2 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

None known.

:

Exposure to combustion products may be a hazard to health.

:

Carbon oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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

SECTION 6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

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

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitablecontainer for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on
surfaces, as these may form an explosive mixture if they are
released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need 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:

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 breathe vapors.
3 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

Conditions for safe storage:

Materials to avoid:

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

Do not swallow.
Avoid contact with eyes.
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.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

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

CAS-No.

(17α)-13-Ethyl-17-hydroxy-11methylene-18,19-dinorpregn-4en-20-yn-3-one

54048-10-1

Engineering measures:

Value type
(Form ofexposure)
TWA

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

Basis

Wipe limit

0.5 µg/100 cm²Internal

Internal

Use closed processing systems or containment technologies
to control at source (e.g., glove boxes/isolators) and toprevent leakage of compounds into the workplace.
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
No open handling permitted.
Totally enclosed processes and materials transport systems
are required.
Operations require the use of appropriate containment
technology designed to prevent leakage of compounds into
the workplace.

Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
4 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Hygiene measures:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets,
disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

Solid form

Color

:

No data available

Odor

:

No data available

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
5 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

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: noctanol/water
Autoignition temperature:

No data available:

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 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.
6 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

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

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: 4,744 mg/kg
Method: Calculation method

Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Acute oral toxicity: LD50 (Rat): > 2,000 mg/kg
LD50 (Mouse): > 2,000 mg/kg
Skin corrosion/irritation
Not classified based on available information.
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Species: MouseResult: No skin irritation
SpeciesResult::Guinea pig
No skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.

7 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

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

Test Type: In vivo micronucleus test
Species: Mouse
Application Route: Oral
Result: negative

Germ cell mutagenicity Assessment:

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

Carcinogenicity
Not classified based on available information.
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Species: Rat
Application Route: OralActivity duration: 2y: 0.5 mg/kg body weight
Result: negative
Species
Application RouteActivity duration
ResultCarcinogenicity - Assessment

:
:
:
:
:

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

Weight of evidence does not support classification as a carcinogen

IARC

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.

OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as a known or anticipated carcinogen by NTP.

8 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

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

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

Reproductive toxicity - Assessment:

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

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Species: Rat
LOAEL: 0.5 mg/kg
Application Route: OralExposure time
: 1yTarget Organs: Reproductive organs, Endocrine system
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

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

Aspiration toxicity
Not classified based on available information.

9 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

Experience with human exposure
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Inhalation: Symptoms: Headache, Dizziness, Abdominal pain, Nausea,
Skin disorders, effects on menstruation, vaginitis, breast tenderness, mood swings, male reproductive effects, Sweating
SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Toxicity to fish
: LC50 (Oncorhynchus mykiss (rainbow trout)): 4.0 mg/l
Exposure time: 96 h
Method: FDA 4.11
LC50 (Lepomis macrochirus (Bluegill sunfish)): > 1.3 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: No toxicity at the limit of solubility.
Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to fish (Chronic toxicity):

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

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

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

10 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

Persistence and degradability
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Stability in water: Hydrolysis: < 10 %(5 d)Method: FDA 3.09
Bioaccumulative potential
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Bioaccumulation: Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): 128
Method: OECD Test Guideline 305
Partition coefficient: noctanol/water:log Pow: 3.5

Mobility in soil
Components:(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one:
Distribution among environ: log Koc: 2.84
mental compartments
Method: FDA 3.08
Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
Labels:::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
((17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn4-en-20-yn-3-one)
9III
911 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

Environmentally hazardous:

yes

IATA-DGR
UN/ID No.
Proper shipping name

:
:

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
((17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn4-en-20-yn-3-one)
9
III
Miscellaneous
956

:

956

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
((17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4en-20-yn-3-one)
9III
9
F-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.
((17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn4-en-20-yn-3-one)
9
III
CLASS 9171
yes((17α)-13-Ethyl-17-hydroxy-11-methylene-18,19dinorpregn-4-en-20-yn-3-one)
Above applies only to containers over 119 gallons or 450
liters.
Shipment by ground under DOT is non-regulated; however it
may be shipped per the applicable hazard classification tofacilitate multi-modal transport involving ICAO (IATA) or IMO.

Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, andvariations in regional or country regulations.

12 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

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

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
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(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4en-20-yn-3-one
Vinylacetate copolymer with ethene

54048-10-1

California List of Hazardous Substances(17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4en-20-yn-3-one

54048-10-1

24937-78-8

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

NFPA 704:

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

Flammability

HEALTH1
Health00Special hazard*

1

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Etonogestrel Formulation (Implanon)
Version
6.11

Revision Date:
09/26/2023

SDS Number:
16561-00025

Date of last issue: 03/20/2023
Date of first issue: 09/29/2014(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

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

Revision Date:

09/26/2023

The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release andshall not be considered a warranty or quality specification of any type. The information provided
relates only to the specific material identified at the top of this SDS and may not be valid when the
SDS material is used in combination with any other materials or in any process, unless specified
in the text. Material users should review the information and recommendations in the specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
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