SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Etonogestrel Formulation (Implanon)

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 1A
Short-term (acute) aquatic
hazard:Category 2

Long-term (chronic) aquatic
hazard:Category 1

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360F May damage fertility.
H401 Toxic to aquatic life.
H410 Very toxic to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been read1 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

and understood.
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 name(17α)-13-Ethyl-17-hydroxy-11methylene-18,19-dinorpregn-4-en20-yn-3-one

CAS-No.
54048-10-1

Concentration (% w/w)>= 50 - < 60

ENCS No.

4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
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.
2 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

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: 2014/09/29

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.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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

:

Exposure to combustion products may be a hazard to health.

:

Carbon oxides

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- :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 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.
3 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

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.
7. HANDLING AND STORAGE
Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust.
Do not breathe vapours.
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.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
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.
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

4 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Packaging material:

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

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.

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

54048-10-1

TWA

Wipe limit
Engineering measures:

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

Basis

0.5 µg/100 cm²Internal

Internal

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.
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.
5 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

Solid form

Colour:No data available

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
Lower explosion limit /Lower flammability limit:

No data available

Flash point:

No data available

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, dynamic:

No data available

Viscosity, kinematic:

No data available:

No data available

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Solubility(ies)
Water solubility

6 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Density

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29:

1 g/cm³

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
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.

7 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

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 sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
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 assay
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: 2 yr
: 0.5 mg/kg body weight
Result: negative
8 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

Species
Application RouteActivity duration
ResultCarcinogenicity - Assessment

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

:
:
:
:
:

Rat
Subcutaneous
2 yr
0.02 mg/kg body weight
negative:

Weight of evidence does not support classification as a carcinogen

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 foetal 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
: 1 yrTarget Organs: Reproductive organs, Endocrine system
9 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

Species
LOAEL
Application RouteExposure timeTarget Organs

SDS Number:
16550-00026

:
:
:
:
:

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

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

Aspiration toxicity
Not classified based on available information.
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
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)

NOEC (Daphnia magna (Water flea)): 1.2 mg/l
Exposure time: 21 d

10 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29:

10,000:

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

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

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
11 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

Contaminated packaging

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29:

Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

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
9
yes

IATA-DGR
UN/ID No.
Proper shipping name::

14. TRANSPORT INFORMATIONInternational Regulations

:
:
:
:

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.
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
12 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

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
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
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
Not applicable
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

13 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

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)
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

14 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

16. OTHER INFORMATION
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

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;
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.
15 / 16

SAFETY DATA SHEET

Etonogestrel Formulation (Implanon)
Version
8.0

Revision Date:
2024/04/06

SDS Number:
16550-00026

Date of last issue: 2023/09/26
Date of first issue: 2014/09/29

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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