SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier
Trade name:Recombinant Follicle Stimulating Hormone 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.
30 Hudson Street, 33nd floor
07302 Jersey City, New Jersey, U.S.A
Telephone:+1-551-430-6000

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)
Reproductive toxicity, Category 1B
H360FD: May damage fertility. May damage theunborn child.
Specific target organ toxicity - repeatedH372: Causes damage to organs through proexposure, Category 1
longed or repeated exposure.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

Danger
1 / 19SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

Hazard statements

SDS Number:
26806-00026:

H360FD
H372

Precautionary statements:

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014
May damage fertility. May damage the unborn
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:
Recombinant Follicle Stimulating Hormone
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.
Ecological information: The substance/mixture does not contain components considered to haveendocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
Toxicological information: The substance/mixture does not contain components considered tohave endocrine disrupting properties according to REACH Article 57(f) or Commission Delegatedregulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

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

CAS-No.
EC-No.
Index-No.
Registration number
100-51-6
202-859-9
603-057-00-5

Classification

Concentration(% w/w)

Acute Tox. 4; H302
Acute Tox. 4; H332
Eye Irrit. 2; H319>= 1 - < 10

Acute toxicity esti2 / 19

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014
mate

Recombinant Follicle Stimulating
Hormone146479-72-3

Acute oral toxicity:
1,620 mg/kg
Repr. 1B; H360FD
STOT RE 1; H372
(male reproductive
organs, female reproductive organs)>= 0.1 - < 0.3

specific concentration
limit
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
3 / 19SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

Risks

SDS Number:
26806-00026:

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

May damage fertility. May damage 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.

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:

Carbon oxides
Metal oxides:

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.
4 / 19SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

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.
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 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.
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.

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
5 / 19SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

regulations.
Advice on common storage

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

:

No data available

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

CAS-No.

Sucrose57-50-1

Recombinant Follicle Stimulating
Hormone146479-723

Value type (Formof exposure)
OELV - 8 hrs(TWA)
OELV - 15 min(STEL)TWA

Control parameters

Basis

10 mg/m3

IE OEL20 mg/m3

IE OEL

5 μg/m3 (OEB 4)Internal

Wipe limit

50 μg/100 cm²Internal

Derived No Effect Level (DNEL) according to Regulation (EC) No. 1907/2006:
Substance name

End UseExposure routes

Benzyl alcohol

Workers

Inhalation

Workers

Inhalation

Workers

Skin contact

Workers

Skin contact

Consumers

Inhalation

Consumers

Inhalation

Consumers

Skin contact

Consumers

Skin contact

Consumers

Ingestion
6 / 19Potential health effects
Long-term systemic
effects
Acute systemic effects
Long-term systemic
effects
Acute systemic effects
Long-term systemic
effects
Acute systemic effects
Long-term systemic
effects
Acute systemic effects
Long-term systemicValue
22 mg/m3
110 mg/m3
8 mg/kg
bw/day40 mg/kg
bw/day5.4 mg/m3
27 mg/m3
4 mg/kg
bw/day20 mg/kg
bw/day4 mg/kg

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Consumers

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

Ingestioneffects
Acute systemic effects

bw/day20 mg/kg
bw/dayPredicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:
Substance nameBenzyl alcohol

Environmental Compartment
Fresh water
Marine waterIntermittent use/release
Sewage treatment plant
Fresh water sediment
Marine sediment
Soil

Value
1 mg/l0.1 mg/l
2.3 mg/l
39 mg/l5.27 mg/kg
0.527 mg/kg
0.456 mg/kg

8.2 Exposure controls
Engineering measures
Minimize workplace exposure concentrations.
If sufficient ventilation is unavailable, use with local exhaust ventilation.
Personal protective equipment
Eye/face protection: Wear the following personal protective equipment:
Safety glasses
Equipment should conform to I.S. EN 166
Hand protection
Material:

Chemical-resistant gloves

Remarks:

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.
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 adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to I.S. EN 14387
Combined particulates and organic vapour type (A-P)

Skin and body protection:

Respiratory protection:

Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: liquid
7 / 19SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Colour:No data available

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

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

Flash point:

No data available

Auto-ignition temperature:

No data available

Decomposition temperature:

No data available

pH:

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:

No data available

Relative vapour density:

No data available

Particle characteristics
Particle size:

No data available

Solubility(ies)
Water solubility

8 / 19Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

9.2 Other information
Explosives

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Evaporation rate:

No data available

Molecular weight:

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 hazard classes as defined in Regulation (EC) No 1272/2008
Information on likely routes of : Inhalation
exposure
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
9 / 19SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

Test atmosphere: dust/mist
Method: Calculation method
Components:
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

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:
Species
MethodResult:::RabbitOECD Test Guideline 405
Irritation to eyes, reversing within 21 days

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.

10 / 19

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

Components:
Benzyl alcohol:
Test Type
Exposure routes
Species
MethodResult:::::Maximisation Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

Germ cell mutagenicity
Not classified based on available information.
Components:
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

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

:
:
:
:

Mouse
Ingestion
103 weeks
OECD Test Guideline 451
11 / 19

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

ResultSDS Number:
26806-00026:

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

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:
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 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.

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Causes damage to organs through prolonged or repeated exposure.
12 / 19

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

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
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 yearTestis13 / 19

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

Aspiration toxicity
Not classified based on available information.
11.2 Information on other hazards
Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

Experience with human exposure
Components:
Recombinant Follicle Stimulating Hormone:
Inhalation: Symptoms: gynecomastia, Skin disorders, Headache, Nausea, Vomiting, Diarrhoea

SECTION 12: Ecological information
12.1 Toxicity
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: 51 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)
Method: OECD Test Guideline 211
14 / 19

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

12.2 Persistence and degradability
Components:
Benzyl alcohol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 92 - 96 %Exposure time: 14 d:log Pow: 1.05

12.3 Bioaccumulative potential
Components:
Benzyl alcohol:
Partition coefficient: noctanol/water
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.

12.6 Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

12.7 Other adverse effects
No data available

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

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.
15 / 19

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

Contaminated packaging

SDS Number:
26806-00026:

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

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 or ID 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 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

:

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

14.2 UN proper shipping name14.3 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 Maritime transport in bulk according to IMO instruments
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

Remarks

SDS Number:
26806-00026:

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
REACH - Restrictions on the manufacture, placing on: Conditions of restriction for the folthe market and use of certain dangerous substances,lowing entries should be considered:mixtures and articles (Annex XVII)
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 conditions in corresponding Regulation todetermine whether an entry is applicable to the placing on the market ornot.
REACH - Candidate List of Substances of Very High: Not applicable
Concern for Authorisation (Article 59).
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
Regulation (EU) 2019/1021 on persistent organic pollu: Not applicabletants (recast)
Regulation (EU) No 649/2012 of the European Parlia: Not applicablement and the Council concerning the export and importof dangerous chemicals
REACH - List of substances subject to authorisation: Not applicable(Annex XIV)
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control ofmajor-accident hazards involving dangerous substances.
Not applicable
Other regulations:
Take note of Directive 92/85/EEC regarding maternity protection or stricter national regulations,where applicable.
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

15.2 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
H302
H319
H332
H360FD
H372

:
:
:
:
:

Harmful if swallowed.
Causes serious eye irritation.
Harmful if inhaled.
May damage fertility. May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Eye Irrit.
: Eye irritation
Repr.
: Reproductive toxicity
STOT RE: Specific target organ toxicity - repeated exposure
IE OEL: Ireland. List of Chemical Agents and Carcinogens with Occupational Exposure Limit Values - Code of Practice, Schedule 1
and 2
IE OEL / OELV - 8 hrs (TWA) : Occupational exposure limit value (8-hour reference period)
IE OEL / OELV - 15 min: Occupational exposure limit value (15-minute reference peri(STEL)od)
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 of
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Recombinant Follicle Stimulating Hormone
Formulation
Version
2.13

Revision Date:
06.04.2024

SDS Number:
26806-00026

Date of last issue: 29.09.2023
Date of first issue: 31.10.2014

Chemicals; 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; TRGS - Technical Rule for Hazardous Substances; TSCA
- Toxic Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent andVery 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

H360FD

Calculation 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.
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.
IE / EN

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