SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:

Ganirelix Formulation

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub: Pharmaceuticalstance/Mixture
Recommended restrictions
on use:Not applicable

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
Shotton Lane
NE23 3JU Cramlington NU - Great Britain
Telephone:+44 1 670 59 32 05

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK
SI 2019/720, and UK SI 2020/1567)
Reproductive toxicity, Category 1BSpecific target organ toxicity - repeatedexposure, Category 1

H360Fd: May damage fertility. Suspected of damaging the unborn child.
H372: Causes damage to organs through prolonged or repeated exposure.

2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK SI
2019/720, and UK SI 2020/1567)
Hazard pictograms:

1 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Signal word:

DangerHazard statements:

H360FdH372

Precautionary statements:

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

May damage fertility. Suspected of damaging theunborn child.
Causes damage to organs through prolonged orrepeated exposure.

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/ eyeprotection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
P405

Store locked up.

Hazardous components which must be listed on the label:
Ganirelix
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.

SECTION 3: Composition/information on ingredients
3.2 Mixtures
Components
Chemical name

Ganirelix

CAS-No.
EC-No.
Index-No.
Registration number
124904-93-4

Classification

Concentration(% w/w)

Repr. 1B; H360Fd
STOT RE 1; H372
(Bone marrow,
Liver, Adrenal
gland, spleen, Ovary)>= 0.01 - < 0.1

specific concentration limit
Repr. 1B; H360Fd>= 0.01 %STOT RE 1; H372>= 0.01 %2 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021
Repr. 1B; H360Fd>= 0.01 %STOT RE 1; H372>= 0.01 %For explanation of abbreviations see section 16.

SECTION 4: First aid measures
4.1 Description of 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.
Protection of first-aiders:

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).

If inhaled:

If inhaled, remove to fresh air.
Get medical attention.

In case of skin contact:

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.

In case of eye contact:

Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.

If swallowed:

If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.

4.2 Most important symptoms and effects, both acute and delayed
Risks: May damage fertility. Suspected of damaging the unborn
child.
Causes damage to organs through prolonged or repeatedexposure.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

3 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:

None known.

5.2 Special hazards arising from the substance or mixture
Specific hazards during fire- : Exposure to combustion products may be a hazard to health.
fighting
Hazardous combustion products
5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods:

No hazardous combustion products are known:

In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

:

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.

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
6.2 Environmental precautions
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.
If spillage enters rivers or watercourses, inform the Environment Agency (emergency telephone number 0800 807060).

6.3 Methods and material for containment and cleaning up
Methods for cleaning up: Soak up with inert absorbent material.
For large spills, provide dyking or other appropriate contain4 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

ment 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.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handlingTechnical measures:
Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

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.
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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Keepareas and containers
tightly closed. Store in accordance with the particular national
regulations.
Advice on common storage:

Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
5 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Explosives
Gases
7.3 Specific end use(s)Specific use(s):No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
Components

CAS-No.

Ganirelix

124904-934

Value type (Formof exposure)
TWA

Control parameters

Basis

0.2 µg/m3 (OEB 5)Internal

Wipe limit

2 µg/100 cm²Internal

8.2 Exposure controls
Engineering measures
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 accordancewith GMP principles to protect 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 ofcompounds into the workplace.
Personal protective equipment
Eye/face protection: 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.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Skin and body protection::

Respiratory protection:

Consider double gloving.
Work uniform or laboratory coat.
Additional body garments should be used based upon the task
being performed (e.g., sleevelets, apron, gauntlets, disposable
suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
No personal respiratory protective equipment normally required.

6 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: Aqueous solution
Colour: No data available
Odour: No data available
Odour Threshold: No data available
pH

:

5

Melting point/freezing point:

No data available

Initial boiling point and boiling
range
Flash point:

100 °C:No data available

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

23 hPa (20 °C)

Relative vapour density:

No data available

Relative density

:

1

:
:

completely miscible
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.

9.2 Other information
Flammability (liquids):

No data available

Molecular weight:

No data available

Solubility(ies)
Water solubility
Partition coefficient: noctanol/water
Auto-ignition temperature

7 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Particle size:

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

No data available

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

None known.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on toxicological effects
Information on likely routes of : Inhalation
exposure
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:
8 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

Species
MethodResultSDS Number:
9371307-00007:::

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

RabbitDraize Test
Mild eye irritation

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

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.

9 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

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 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 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.

10 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Repeated dose toxicity
Components:
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

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

SECTION 12: Ecological information
12.1 Toxicity
Components:
Ganirelix:
Ecotoxicology Assessment
Acute aquatic toxicity:

No data available

11 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

Chronic aquatic toxicity

SDS Number:
9371307-00007:

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

No data available

12.2 Persistence and degradability
No data available
12.3 Bioaccumulative potential
No data available
12.4 Mobility in soil
No data available
12.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.

:

This substance/mixture does not contain components considered to have endocrine disrupting properties for environment
according to UK REACH Article 57(f).

12.6 Other adverse effects
Product:
Endocrine disrupting potential

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
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 information
14.1 UN number
ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous good
12 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

14.2 UN proper shipping nameADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

14.3 Transport hazard class(es)14.4 Packing group

14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Not applicable
14.7 Transport in bulk according to Annex II of Marpol and the IBC CodeRemarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
Relevant EU provisions transposed through retained EU law
UK REACH List of restrictions (Annex 17):

13 / 16

Conditions of restriction for the following entries should be considered:
Number on list 3
Substance(s) or mixture(s) are listed
here according to their appearance
in the regulation, irrespective of theiruse/purpose or the conditions of therestriction. Please refer to the condi-

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021
tions in corresponding Regulation todetermine whether an entry is applicable to the placing on the market ornot.

UK REACH Candidate list of substances of very high: Not applicableconcern (SVHC) for Authorisation
The Persistent Organic Pollutants Regulations (retained : Not applicable
Regulation (EU) 2019/1021 as amended for Great Britain)
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
UK REACH List of substances subject to authorisation: Not applicable(Annex XIV)GB Export and import of hazardous chemicals - Prior: Not applicable
Informed Consent (PIC) Regulation
Control of Major Accident Hazards Regulations 2015 (COMAH)
Not applicable
Other regulations:
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to new and expectant mothers at work contained in Regulation 16 to 18) and of thePregnant Workers Directive 92/85/EEC.
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to protection of young people at work contained in Regulation 19) and of Directive
94/33/EC on the protection of young people at work.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined15.2 Chemical safety assessment
A Chemical Safety Assessment has not been carried out.

SECTION 16: Other information
Other information:

Items where changes have been made to the previous version
are highlighted in the body of this document by two verticallines.

Full text of H-Statements
H360Fd:

H372:

May damage fertility. Suspected of damaging the unborn
child.
Causes damage to organs through prolonged or repeatedexposure if swallowed.

Full text of other abbreviations
Repr.
: Reproductive toxicity
14 / 16

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

STOT RE:

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Specific target organ toxicity - repeated exposure

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; 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; 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 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; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; 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; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of very high concern; TCSI - Taiwan Chemical Substance Inventory; 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
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/

Classification of the mixture:

Classification procedure:

Repr. 1B

H360FdCalculation method

STOT RE 1

H372

Calculation method

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
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Ganirelix Formulation
Version
3.3

Revision Date:
06.04.2024

SDS Number:
9371307-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

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.
GB / EN

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