SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

SECTION 1. IDENTIFICATION
Product name:

Ganirelix 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)
Reproductive toxicity: Category 1BSpecific target organ toxicity- repeated exposure:

Category 1 (Bone marrow, Liver, Adrenal gland, spleen, Ovary)

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H360Fd May damage fertility. Suspected of damaging the unborn child.
H372 Causes damage to organs (Bone marrow, Liver, Adrenal
gland, spleen, Ovary) through prolonged or repeated exposure.

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 mist or vapors.
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
and face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical attention.
1 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
Ganirelix
124904-93-4
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 0.01 - < 0.1

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.
Flush eyes with water as a precaution.
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.
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
2 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

Carbon dioxide (CO2)
Dry chemical
None known.

:

Exposure to combustion products may be a hazard to health.

:No hazardous combustion products are known

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.
Prevent spreading over a wide area (e.g., by containment or
oil barriers).
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:

Soak up with inert absorbent material.
For large spills, provide diking or other appropriate
containment to keep material from spreading. If diked material
can be pumped, store recovered material in appropriate
container.
Clean up remaining materials from spill with suitable
absorbent.
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:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
3 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Conditions for safe storage:

Materials to avoid:

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

Do not breathe mist or vapors.
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.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

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

CAS-No.

Ganirelix

124904-93-4

Value type
(Form ofexposure)
TWA
Wipe limit

Engineering measures:

Control parameters / Permissible
concentration
0.2 µg/m3 (OEB
5)
2 µg/100 cm²

Basis

Internal
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: No personal respiratory protective equipment normallyrequired.
Hand protection
Material:

Chemical-resistant gloves

4 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Remarks
Eye protection::

Skin and body protection:

Hygiene measures:

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

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:

Aqueous solution

Color

:

No data available

Odor

:

No data available

Odor Threshold:

No data available

pH

:

5

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

212 °F / 100 °C

Flash point:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

5 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

Vapor pressure:

23 hPa (68 °F / 20 °C)

Relative vapor density:

No data available

Relative density:

1

Solubility(ies)
Water solubility:

completely miscible

Partition coefficient: noctanol/water
Autoignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
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
Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Can react with strong oxidizing agents.

:::

None known.
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.

6 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

Components:
Ganirelix:
Acute toxicity (other routes of :administration)

LD50 (Rat): 40 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Serious eye damage/eye irritation
Not classified based on available information.
Components:
Ganirelix:SpeciesResult
Method:::RabbitMild eye irritation
Draize Test

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Ganirelix:
Test TypeSpeciesResult:::Maximization Test
Guinea pig
negative

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

Test Type: reverse mutation assay
Test system: Salmonella typhimurium
Result: negative
Test Type: reverse mutation assay
Test system: Escherichia coli
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: Intravenous
7 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

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.
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.

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

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Subcutaneous
Duration of Single Treatment: 13 Weeks
Fertility: LOAEL: 0.1 µg/kg
Result: Effects on fertility.
Test Type: Fertility/early embryonic development
Species: Rat, female
Application Route: Subcutaneous
Duration of Single Treatment: 8 Weeks
Fertility: LOAEL: 10 µg/kg
Result: No effects on mating performance., Effects on fertility.
Test Type: Fertility
Species: Monkey
Application Route: Subcutaneous
Fertility: NOAEL: 0.02 mg/kg body weight
Result: Effects on fertility.

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat, female
Application Route: Subcutaneous
Embryo-fetal toxicity.: LOAEL: 10 µg/kg
Result: Embryo-fetal toxicity.
Test Type: Embryo-fetal development
Species: Rabbit, female
Application Route: Subcutaneous
Embryo-fetal toxicity.: LOAEL: 30 µg/kg
Result: Embryo-fetal toxicity.
8 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

Reproductive toxicity - Assessment

SDS Number:
22224-00022:

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

Clear evidence of adverse effects on sexual function andfertility, based on animal experiments., Some evidence ofadverse effects on development, based on animal
experiments.

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Causes damage to organs (Bone marrow, Liver, Adrenal gland, spleen, Ovary) through prolonged
or repeated exposure.
Components:
Ganirelix:
Routes of exposure
Target Organs
Assessment:::

Ingestion
Bone marrow, Liver, Adrenal gland, spleen, Ovary
Causes damage to organs through prolonged or repeatedexposure.

Ganirelix:Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
0.02 mg/kg
2 mg/kg
Subcutaneous
6 Months
Bone marrow

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Mouse, female
0.3 mg/kg
Subcutaneous
3 Months
Liver, Adrenal gland, spleen, Ovary

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Mouse, male
3 mg/kg
Subcutaneous
3 Months
Liver, Adrenal gland, spleenSpecies
NOAEL
Application RouteExposure time
Remarks:::::

Monkey2.5 mg/kg
Subcutaneous
6 Months
No significant adverse effects were reported

Repeated dose toxicity
Components:

Aspiration toxicity
Not classified based on available information.
9 / 13

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

Experience with human exposure
Components:
Ganirelix:
Inhalation:

Symptoms: The most common side effects are:, vaginal
bleeding, Headache, Abdominal pain, Nausea, ectopic pregnancy, miscarriage

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Ganirelix:
Ecotoxicology Assessment
Acute aquatic toxicity:

No data available

Chronic aquatic toxicity

No data available:

Persistence and degradability
No data available
Bioaccumulative potential
No data available
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
UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-Code
10 / 13SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014

Not regulated as a dangerous goodTransport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
Not regulated as a dangerous goodSpecial precautions for user
Not applicable
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:

Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

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
Water

7732-18-5

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

11 / 13SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

NFPA 704:

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014
HMIS® IV:

Flammability

HEALTH1
Health00Special hazard*

3

FLAMMABILITY

1

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

12 / 13SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Ganirelix Formulation
Version
7.9

Revision Date:
09/26/2023

SDS Number:
22224-00022

Date of last issue: 03/20/2023
Date of first issue: 10/15/2014(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.
US / Z8

13 / 13