SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

SECTION 1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Ganirelix Formulation

Manufacturer or supplier's details
Company: Organon & Co.
Address:

Rua Treze de Maio, 1161
Campinas, São Paulo, Brazil 13106-054

Telephone:+55 (19) 3758-2000

Emergency telephone:+55 (11) 3173-4931

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 ABNT NBR 14725 Standard
Reproductive toxicity: Category 1BSpecific target organ toxicity repeated exposure:

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

GHS label elements in accordance with ABNT NBR 14725 Standard
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.
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.
1 / 12

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
P405 Store locked up.
Other hazards which do not result in classification
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Ganirelix

CAS-No.
124904-93-4

Classification
Reproductive toxicity,
Category 1BSpecific target organ
toxicity - repeatedexposure (Oral) (Bonemarrow, Liver, Adrenal
gland, spleen, Ovary),
Category 1

Concentration (% 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:

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).
2 / 12

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

Notes to physician

SDS Number:
22195-00022:

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING 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 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:

See Engineering measures under EXPOSURE
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SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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 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.
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 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.
4 / 12

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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

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.

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

:

100 °CFlash 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

5 / 12

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

23 hPa (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.
Components:
Ganirelix:
6 / 12

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Acute toxicity (other routes of :administration)

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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
Result: negative

Germ cell mutagenicity Assessment:

Weight of evidence does not support classification as a germ
cell mutagen.
7 / 12

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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
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.

Reproductive toxicity - Assessment:

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.

8 / 12

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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.
Experience with human exposure
Components:
Ganirelix:
Inhalation:

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

9 / 12

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
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-CodeNot 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
ANTT
Not regulated as a dangerous good

10 / 12SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

Special precautions for user
Not applicable
SECTION 15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or
mixtureNational List of Carcinogenic Agents for Humans : Not applicable(LINACH)
Brazil. List of chemicals controlled by the Federal
Police:Not applicable

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Revision Date
Date format::

26.09.2023
dd.mm.yyyy

Further information
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/

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) Effect
11 / 12SAFETY DATA SHEET

Ganirelix Formulation
Version
6.9

Revision Date:
26.09.2023

SDS Number:
22195-00022

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

Concentration; 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 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.
BR / Z8

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