SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Corifollitropin Alfa Formulation

Manufacturer or supplier's details
Company: Organon & Co.
Address:JL Raya Pandaan KM. 48
Pandaan, Jawa Timur - Indonesia

Telephone:+1-551-430-6000

Emergency telephone number :+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

2. HAZARDS IDENTIFICATIONGHS Classification
Reproductive toxicity:

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360F May damage fertility.

Precautionary statements:

Category 1B

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.

1 / 12

SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

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 nameSucroseCorifollitropin Alfa

CAS-No.
57-50-1
195962-23-3

Concentration (% w/w)
< 10>= 0.01 -< 0.3

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.

Notes to physician:

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.

:

Water spray:

5. FIREFIGHTING MEASURES
Suitable extinguishing media

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SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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

:

Exposure to combustion products may be a hazard to health.

:

Carbon 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 forcontainment and 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.

Technical measures:

Local/Total ventilation:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.

7. HANDLING AND STORAGE

3 / 12

SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

Do not get on skin or clothing.
Do not breathe vapours or spray mist.
Do not swallow.
Avoid contact with eyes.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
Take care to prevent spills, waste and minimize release to theenvironment.
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

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Components with workplace control parameters
Components

CAS-No.

Value type
Control parameBasis(Form ofters / Permissible
exposure)
concentration
57-50-1NAB
10 mg/m3
ID OEL
Further information: Not classified as carcinogenic to humans. Not
enough data to classify these materials as carcinogenic to humans or animals
TWA
10 mg/m3
ACGIH
195962-23-3 TWA
8 µg/m3 (OEB 4)Internal
Wipe limit
80 µg/100 cm²Internal

SucroseCorifollitropin Alfa

Engineering measures:

All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Essentially no open handling permitted.
Use closed processing systems or containment technologies.
If handled in a laboratory, use a properly designed biosafetycabinet, fume hood, or other containment device if the potential exists for aerosolization. If this potential does not exist,
handle over lined trays or benchtops.

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
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

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SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Remarks
Eye protection::

Skin and body protection:

Hygiene measures:

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
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.

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

Aqueous solution

Colour:No data available

Odour

:

No data available

Odour 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:

No data available
5 / 12

SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

flammability limit
Vapour pressure:

No data available

Relative vapour density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

Not applicable:

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.

Particle size:

Not applicable:::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.

6 / 12

SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

Components:
Sucrose:Acute oral toxicity:

LD50 (Rat): 29,700 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Serious eye damage/eye irritation
Not classified based on available information.
Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
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

Corifollitropin Alfa:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Test system: human lymphoblastoid cells
Method: Mutagenicity (in vitro mammalian cytogenetic test)
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Rat
Method: Mutagenicity (micronucleus test)
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.

7 / 12

SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

Components:
Corifollitropin Alfa:
Effects on fertility

Effects on foetal development:

Species: Rat
Application Route: Subcutaneous
Duration of Single Treatment: 2 dFertility: LOAEL: 2 µg/kg
Result: Superovulation:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.8 µg/kg
Result: Postimplantation loss.
Remarks: The mechanism or mode of action is not relevant in
humans.
Test Type: Fertility/early embryonic development
Species: Rabbit
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.9 µg/kg
Result: Teratogenic potential, Postimplantation loss.
Remarks: The mechanism or mode of action is not relevant in
humans.

Reproductive toxicity - Assessment:

Clear evidence of adverse effects on sexual function and fertility, based on animal experiments.

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
Corifollitropin Alfa:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.000164 mg/kg
Subcutaneous
13 Weeks
Reproductive organs, Endocrine system

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.00041 mg/kg
Subcutaneous
39 Weeks
Endocrine system, Reproductive organs

8 / 12

SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Corifollitropin Alfa:
Ingestion:

Symptoms: Nausea, Headache, Fatigue, breast tenderness

12. ECOLOGICAL INFORMATION
Ecotoxicity
No data available
Persistence and degradability
No data available
Bioaccumulative potential
Components:
Sucrose:Partition coefficient: noctanol/water:

Pow: < 1

Mobility in soil
No data available
Other adverse effects
No data available
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.

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
Labels9 / 12

SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

IATA-DGR
UN/ID No.
Proper shipping nameClass
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:
26205-00023

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

Transport 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
15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or mixture
Minister of Industry Regulation No. 23/M-IND/PER/4/2013 concerning the Revision of Minister of Industry Regulation No. 87/M-IND/PER/9/2009 concerning Globally Harmonized System of Classification and Labelling of Chemicals.
Regulation of the Minister of Health No. 472 of 1996 on the Safeguarding of Substances
Hazardous to Health
Hazardous substances that must be registered: Not applicable
Government Regulation No. 74 of 2001 on the Management of Hazardous and Toxic Substances
Hazardous substances approved for use: Not applicable
Prohibited substances:

Not applicable

Restricted substances:

Not applicable

Regulation of the Ministry of Trade No. 7 of 2022 on Distribution and Control of Hazardous
Materials
10 / 12SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

Type of hazardous materials subject to distribution and :control, Annex I

Not applicable

Type of hazardous materials subject to distribution and :control, Annex II

Not applicable

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

not determined

IECSC

:

not determined

Revision Date:

2023/09/29

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/

Date format:

yyyy/mm/dd

16. OTHER INFORMATION

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ID OEL: Indonesia. Occupational Exposure Limits
ACGIH / TWA
ID OEL / NAB::

8-hour, time-weighted averageLong term exposure limit

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
11 / 12SAFETY DATA SHEET

Corifollitropin Alfa Formulation
Version
4.1

Revision Date:
2023/09/29

SDS Number:
26205-00023

Date of last issue: 2023/04/04
Date of first issue: 2014/10/29

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.
ID / EN

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