SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

SECTION 1. IDENTIFICATION
Product name:Recombinant Follicle Stimulating Hormone Formulation

Manufacturer or supplier's details
Company: 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
Reproductive toxicity
Specific target organ toxicity repeated exposure:

Category 1B:

Category 1 (male reproductive organs, female reproductive
organs)GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H360FD May damage fertility. May damage the unborn child.
H372 Causes damage to organs (male reproductive organs,
female reproductive organs) through prolonged or repeatedexposure.

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.
1 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

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.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical nameSucroseBenzyl alcohol
Recombinant Follicle Stimulating Hormone

CAS-No.
57-50-1
100-51-6
146479-72-3

Concentration (% w/w)>= 5 -< 10>= 1 -< 5>= 0,1 -< 0,3

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 anddelayedProtection 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. May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
First Aid responders should pay attention to self-protection,:

2 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

Notes to physician

SDS Number:
26781-00024:

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

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:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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

:

Exposure to combustion products may be a hazard to health.

:

Carbon oxides
Metal oxides

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.

3 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

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 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.

Value type
Control parameBasis(Form ofters / Permissible
exposure)
concentration
57-50-1
CMP
10 mg/m³
AR OEL
Further information: A4 - Not classifiable as a human carcinogen
TWA
10 mg/m³
ACGIH
146479-72-3 TWA
5 μg/m3 (OEB 4)Internal

SucroseRecombinant Follicle Stimulating Hormone

Wipe limit
Engineering measures:

50 μg/100 cm²Internal

Minimize workplace exposure concentrations.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or
exposure assessment demonstrates exposures outside therecommended guidelines, use respiratory protection.
Filter type
: Combined particulates and organic vapor type
4 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body protection:

Hygiene measures:

Choose gloves to protect hands against chemicals dependingon the concentration specific to place of work. Breakthroughtime is not determined for the product. Change gloves often!
For special applications, we recommend clarifying theresistance to chemicals of the aforementioned protective
gloves with the glove manufacturer. Wash hands before
breaks and at the end of workday.
Wear the following personal protective equipment:
Safety glasses
Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).
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.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

liquidColor:

No data available

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

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 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

Vapor pressure:

No data available

Relative vapor density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, dynamic:

No data available

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.
Product:

6 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

Acute oral toxicity:

Acute toxicity estimate: > 5.000 mg/kg
Method: Calculation method

Acute inhalation toxicity:

Acute toxicity estimate: > 10 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method

Sucrose:Acute oral toxicity:

LD50 (Rat): 29.700 mg/kg

Benzyl alcohol:
Acute oral toxicity:

LD50 (Rat): 1.620 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 4,178 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403

Components:

Recombinant Follicle Stimulating Hormone:Acute toxicity (other routes of : LD50 (Rat): > 0,290 mg/kg
administration)
Application Route: Intravenous
LD50 (Monkey): > 0,290 mg/kg
Application Route: Intravenous
Skin corrosion/irritation
Not classified based on available information.
Components:
Benzyl alcohol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Benzyl alcohol:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

7 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Benzyl alcohol:
Test Type
Routes of exposure
Species
MethodResult:::::Maximization Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

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

Test Type: In vitro mammalian cell gene mutation test
Result: negative

Benzyl alcohol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Result: negative

Recombinant Follicle Stimulating Hormone:
Genotoxicity in vitro: Test Type: Ames test
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Test system: mammalian cells
Result: negative
Test Type: Chromosomal aberration
Test system: Human lymphocytes
Result: negative
Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Result: negative

8 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

Carcinogenicity
Not classified based on available information.
Components:
Benzyl alcohol:
Species
Application RouteExposure time
MethodResult

:
:
:
:
:

Mouse
Ingestion
103 weeks
OECD Test Guideline 451
negative

Reproductive toxicity
May damage fertility. May damage the unborn child.
Components:
Benzyl alcohol:
Effects on fertility:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Mouse
Application Route: Ingestion
Result: negative

Recombinant Follicle Stimulating Hormone:
Effects on fertility: Test Type: Fertility
Species: Rat
Application Route: Subcutaneous
Fertility: LOAEL: 0,11
Symptoms: Effect on estrous cycle, Increase of early resorptions., Reduced fertility
Result: positive
Test Type: Fertility
Species: Rabbit
Application Route: Subcutaneous
Fertility: LOAEL: 0,027
Symptoms: Reduced fertility, Reduced embryonic survival
Result: positive
Effects on fetal development:

Test Type: Development
Species: Rat
Application Route: Subcutaneous
Dose: 2.9 µg/kg
Result: positive, No teratogenic effects.

Reproductive toxicity - Assessment:

Clear evidence of adverse effects on sexual function andfertility, based on animal experiments., Clear evidence of
9 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

adverse effects on development, based on animal
experiments.
STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Causes damage to organs (male reproductive organs, female reproductive organs) through prolonged or repeated exposure.
Components:
Recombinant Follicle Stimulating Hormone:Target Organs: male reproductive organs, female reproductive organs
Assessment: Causes damage to organs through prolonged or repeatedexposure.
Repeated dose toxicity
Components:
Benzyl alcohol:
Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
1,072 mg/l
inhalation (dust/mist/fume)
28 Days
OECD Test Guideline 412

Recombinant Follicle Stimulating Hormone:
Species: Monkey
NOAEL: 0,17 mg/kg
LOAEL: 0,86 mg/kg
Application Route: Subcutaneous
Exposure time: 13 Weeks
Number of exposures: daily
Target Organs: Reproductive organs
Remarks: No significant adverse effects were reported
Species
LOAEL
Exposure timeTarget Organs
Remarks

:
:
:
:
:

Rat
0,14 mg/kg
13 Weeks
Endocrine system
No significant adverse effects were reported

Species
LOAEL
Exposure timeTarget Organs
Remarks

:
:
:
:
:

Dog
0,14 mg/kg
13 Weeks
TestisNo significant adverse effects were reported

Species
NOAEL
LOAEL

:
:
:

Rat
0,028 mg/kg
0,28 mg/kg
10 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Application RouteExposure timeTarget Organs:::

Subcutaneous
1 yearTestisSpecies
LOAEL
Exposure timeTarget Organs

:
:
:
:

Monkey, male
0,028 mg/kg
1 yearTestisDate of last issue: 04.04.2023
Date of first issue: 31.10.2014

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Recombinant Follicle Stimulating Hormone:
Inhalation: Symptoms: gynecomastia, Skin disorders, Headache, Nausea, Vomiting, Diarrhea
SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Benzyl alcohol:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): 460 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 230 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 770
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 310
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

NOEC (Daphnia magna (Water flea)): 51 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Persistence and degradability
Components:
Benzyl alcohol:
11 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

Biodegradability

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014:

Result: Readily biodegradable.
Biodegradation: 92 - 96 %Exposure time: 14 d

Sucrose:Partition coefficient: noctanol/water:

Pow: < 1

Benzyl alcohol:
Partition coefficient: noctanol/water:log Pow: 1,05

Bioaccumulative potential
Components:

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.
Special precautions for user
Not applicable
SECTION 15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or
mixture12 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

Argentina. Carcinogenic Substances and Agents
Registry.

:

Not applicable

Control of precursors and essential chemicals for the
preparation of drugs.

:

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::

29.09.2023
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
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
AR OEL: Argentina. Occupational Exposure Limits
ACGIH / TWA
AR OEL / CMP::

8-hour, time-weighted average
TLV (Threshold Limit Value)

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 Develop13 / 14

SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
5.11

Revision Date:
29.09.2023

SDS Number:
26781-00024

Date of last issue: 04.04.2023
Date of first issue: 31.10.2014

ment; 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.
AR / Z8

14 / 14