SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Ganirelix Formulation

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

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

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

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

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

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

Category 1 (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 vapours.
1 / 14

SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

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/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
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
None known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Ganirelix

CAS-No.
124904-93-4

Concentration (% w/w)>= 0.01 - < 0.1

ENCS No.

4. FIRST AID MEASURES
General 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:

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.
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
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SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

Notes to physician

SDS Number:
22213-00023:

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

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.

:No hazardous combustion products are known

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.
Prevent spreading over a wide area (e.g. by containment or oilbarriers).
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 dyking or other appropriate containment to keep material from spreading. If dyked material canbe pumped, store recovered material in appropriate container.
Clean up remaining materials from spill with suitable absorbent.
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.

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SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

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:

Packaging material:

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.
Do not breathe mist or vapours.
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.
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
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)

Ganirelix

124904-93-4

TWA

4 / 14Control parameters / Reference
concentration /Permissible concentration
0.2 µg/m3 (OEB

BasisInternal

SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

Wipe limit
Engineering measures:

5)
2 µg/100 cm²Internal

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: No personal respiratory protective equipment normally required.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

Aqueous solution

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:

100 °C

5 / 14

SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

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

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

:

5

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

completely miscible

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

23 hPa (20 °C)

Density and / or relative density
Relative density:

1

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::

Not classified as a reactivity hazard.
Stable under normal conditions.

10. STABILITY AND REACTIVITY
Reactivity
Chemical stability

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SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products

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

Can react with strong oxidizing agents.

:::

None known.
Oxidizing agents
No hazardous decomposition products are known.

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
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 sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Ganirelix:
Test TypeSpeciesResult:::Maximisation Test
Guinea pig
negative

7 / 14

SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

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 assay
Test system: Chinese hamster ovary cells
Result: negative

Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Application Route: Intravenous
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.
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
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SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

Result: Effects on fertility
Effects on foetal development:

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

Reproductive toxicity - Assessment:

Clear evidence of adverse effects on sexual function and fertility, based on animal experiments., Some evidence of adverse
effects on development, based on animal experiments.

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

Mouse, male

Repeated dose toxicity
Components:

9 / 14

SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:

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

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Ganirelix:
Inhalation:

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

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
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available

10 / 14

SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

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.

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

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
Not applicable

11 / 14

SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

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
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable

12 / 14

SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
22213-00023

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

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
Not regulated as a dangerous good
Aviation Law
Not regulated as a dangerous goodMarine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Not 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:

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

16. OTHER INFORMATION
Further information
Sources of key data used tocompile the Safety Data
Sheet

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
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SAFETY DATA SHEET

Ganirelix Formulation
Version
8.0

Revision Date:
2024/04/06

Date format

SDS Number:
22213-00023:

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

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.
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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