SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:Recombinant Follicle Stimulating Hormone 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 (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 read1 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

and understood.
P260 Do not breathe mist or vapours.
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 nameSucroseBenzyl alcohol

CAS-No.
57-50-1
100-51-6

Recombinant Follicle Stimulating
HormonePolyethylene glycol sorbitanmonolaurate

146479-72-3
9005-64-5

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

ENCS No.
3-1011>= 0.1 - < 0.3< 0.1

7-110, 8-55, 855

4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

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.
2 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayedProtection of first-aiders:

Notes to physician::

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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,and use the recommended personal protective equipment
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.

:

Carbon oxides
Metal oxides

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 for:Soak up with inert absorbent material.
3 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

containment and cleaning up

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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.

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.
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.

4 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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)

SucroseBenzyl alcohol

57-50-1
100-51-6

Wipe limit

50 μg/100 cm²Internal

ACGIH
JP OEL
JSOH
Further information: Skin sensitizing agent; Group 2 substances
which probably induce allergic reactions in humans.
146479-72-3 TWA
5 μg/m3 (OEB 4)Internal

Recombinant Follicle Stimulating Hormone

Engineering measures

Basis

TWA
OEL-C

Control parameters / Reference
concentration /Permissible concentration
10 mg/m3
25 mg/m3:

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 the recommended guidelines, use respiratory protection.
Filter type
: Combined particulates and organic vapour type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body protection:

Choose gloves to protect hands against chemicals dependingon the concentration and quantity of the hazardous substance and specific to place of work. Breakthrough time is notdetermined for the product. Change gloves often! For special
applications, we recommend clarifying the resistance tochemicals of the aforementioned protective gloves with theglove manufacturer. Wash hands before breaks and at theend 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).

9. PHYSICAL AND CHEMICAL PROPERTIES

5 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

Physical state:liquidColour: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:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, dynamic:

No data available

Viscosity, kinematic:

No data available:

No data available

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Density and / or relative density
Density:

No data available

Relative vapour density

No data available

Solubility(ies)
Water solubility:

6 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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.
Can react with strong oxidizing agents.

:::

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

10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 2,000 mg/kg
Method: Calculation method

Acute inhalation toxicity:

Acute toxicity estimate: > 5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method:

LD50 (Rat): 29,700 mg/kg

Components:
Sucrose:Acute oral toxicity
Benzyl alcohol:

7 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
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Revision Date:
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SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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

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
Polyethylene glycol sorbitan monolaurate:
Acute inhalation toxicity: LC50 (Rat): > 5.1 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity
Skin corrosion/irritation
Not classified based on available information.
Components:
Benzyl alcohol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Polyethylene glycol sorbitan monolaurate:
Species: RabbitMethod: OECD Test Guideline 404
Result: 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

8 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

Polyethylene glycol sorbitan monolaurate:
Species: Rabbit
Result: No eye irritation
Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Benzyl alcohol:
Test Type
Exposure routes
Species
MethodResult:::::Maximisation Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

Polyethylene glycol sorbitan monolaurate:
Test Type: Maximisation Test
Exposure routes: Skin contact
Species: Guinea pig
Method: OECD Test Guideline 406
Result: 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:9 / 18SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

Genotoxicity in vitro

SDS Number:
26810-00025:

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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

Polyethylene glycol sorbitan monolaurate:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
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

Effects on foetal development:

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

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

Recombinant Follicle Stimulating Hormone:
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SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
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Revision Date:
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Effects on fertility

SDS Number:
26810-00025:

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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 foetal 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 and fertility, based on animal experiments., Clear evidence of adverse
effects on development, based on animal experiments.

Polyethylene glycol sorbitan monolaurate:
Effects on foetal develop: Test Type: Embryo-foetal development
ment
Species: Rat
Application Route: Ingestion
Result: negative
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:
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SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
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Revision Date:
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Species
NOAEL
Application RouteExposure time
MethodSDS Number:
26810-00025

:
:
:
:
:

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
0.028 mg/kg
0.28 mg/kg
Subcutaneous
1 yearTestisSpecies
LOAEL
Exposure timeTarget Organs

:
:
:
:

Monkey, male
0.028 mg/kg
1 yearTestisAspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Recombinant Follicle Stimulating Hormone:
Inhalation: Symptoms: gynecomastia, Skin disorders, Headache, Nausea, Vomiting, Diarrhoea
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SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
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Revision Date:
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SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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

Polyethylene glycol sorbitan monolaurate:
Toxicity to fish
: LL50 (Danio rerio (zebra fish)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

NOEC (Daphnia magna (Water flea)): 10 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Persistence and degradability
Components:
Benzyl alcohol:
Biodegradability:

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

Polyethylene glycol sorbitan monolaurate:
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Formulation
Version
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Biodegradability

SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31:

Result: Readily biodegradable.
Biodegradation: > 60 %Exposure time: 28 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
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
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.

UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEnvironmentally hazardous

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicablenoIATA-DGR
UN/ID No.
Proper shipping name
Class

:
:
:

Not applicableNot applicableNot applicable

14. TRANSPORT INFORMATIONInternational Regulations

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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

SDS Number:
26810-00025

:
:
:
:

Not applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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
15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical nameMono(or poly)ether of (mono ester of anhydro(or dianhydro)glucitol anddodecanoic acid) and alpha-hydro-omega-hydroxypoly(oxyethylene)
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

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SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
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SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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
Article 57-2 (Enforcement Order Table 9)
Chemical nameBenzyl alcohol

Concentration (%)>0 - <10

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical namebenzyl alcohol

Remarks-

Remarks-

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
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

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SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
9.0

Revision Date:
2024/04/06

SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

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

Noxious liquid substance(Category Z)

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

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
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/

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
ACGIH / TWA
JP OEL JSOH / OEL-C::

8-hour, time-weighted average
Occupational Exposure Limit-Ceiling

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 for
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SAFETY DATA SHEETRecombinant Follicle Stimulating Hormone
Formulation
Version
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Revision Date:
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SDS Number:
26810-00025

Date of last issue: 2023/09/29
Date of first issue: 2014/10/31

Standardisation; 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.
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