SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Human Chorionic Gonadotropin 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 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 IDENTIFICATION
Manufacture, Storage and Import of Hazardous Chemicals Rules 1989
Classification
Not classified as hazardous according to criteria laid down in Part I of Schedule-1.
GHS Classification
Reproductive toxicity
Specific target organ toxicity repeated exposure:

Category 1A:Category 1 (Ovary)

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360Fd May damage fertility. Suspected of damaging the unborn child.
H372 Causes damage to organs (Ovary) through prolonged orrepeated exposure.

Precautionary statements:

Prevention:
1 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version
6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

P203 Obtain, read and follow all safety instructions before use.
P260 Do not breathe dust.
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:
P318 IF exposed or concerned, get medical advice.
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
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name

CAS-No.

Gonadotropin, chorionic

9002-61-3

Concentration (%w/w)>= 90 - <= 100

4. FIRST AID MEASURESGeneral 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 medicaladvice.

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayed:

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.
If in eyes, rinse well with water.
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. Suspected of damaging the unbornchild.
Causes damage to organs through prolonged or repeatedexposure.
2 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version
6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Protection of first-aiders:

Notes to physician:Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

Contact with dust can cause mechanical irritation or drying ofthe skin.
Dust contact with the eyes can lead to mechanical irritation.
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 MEASURESSuitable extinguishing media:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)Sulphur 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.
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:

Sweep up or vacuum up spillage and collect in suitable container for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
3 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version
6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust.
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.
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Do not eat, drink or smoke when using this product.
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.

Gonadotropin, chorionic

9002-61-3

Engineering measures:

Value type(Form ofexposure)
TWA
Wipe limit

Control parameters / Permissible
concentration
OEB 4 (3 µg/m3)
25 µg/100 cm²

Basis

Internal
Internal

Minimize workplace exposure concentrations.
Apply measures to prevent dust explosions.
Ensure that dust-handling systems (such as exhaust ducts,dust collectors, vessels, and processing equipment) are designed in a manner to prevent the escape of dust into the work
area (i.e., there is no leakage from the equipment).
4 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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
: Particulates type
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 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 goggles
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 the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColour:off-whiteOdour:

odourlessOdour 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:

Not applicable

Evaporation rate:

No data available

5 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

Flammability (solid, gas):

May form explosive dust-air mixture during processing, handling or other means.

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

No data available

Relative vapour density:

No data available

Relative density:

No data available

Solubility(ies)
Water solubility:

solublePartition coefficient: noctanol/water
Auto-ignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
6 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version
6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Information on likely routes of :exposure

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Skin corrosion/irritationNot 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.
Carcinogenicity
Not classified based on available information.
Reproductive toxicity
May damage fertility. Suspected of damaging the unborn child.
Components:
Gonadotropin, chorionic:
Effects on fertility:

Test Type: Fertility
Species: Rat
Application Route: Intravenous injection
Fertility: LOAEL: 8.89 mg/kg body weight
Result: Effects on fertility
Test Type: Fertility
Application Route: Intraperitoneal injection
Fertility: LOAEL: 0.883 mg/kg body weight
Result: Effects on fertility
Test Type: Fertility
Species: Monkey
Fertility: LOAEL: 0.224 mg/kg body weight
Result: Effects on fertility

Effects on foetal development:

Test Type: Embryo-foetal development
Species: Hamster
Application Route: Intraperitoneal injection
Embryo-foetal toxicity: LOAEL: 60 mg/kg body weight
Result: Embryo-foetal toxicity

Reproductive toxicity - As-:Positive evidence of adverse effects on sexual function and7 / 10

SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

sessment

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

fertility from human epidemiological studies., Some evidenceof adverse effects on development, based on animal experiments.

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Causes damage to organs (Ovary) through prolonged or repeated exposure.
Components:
Gonadotropin, chorionic:
Target Organs
Assessment::

Ovary
Causes damage to organs through prolonged or repeatedexposure.

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Gonadotropin, chorionic:
Inhalation:

Target Organs: ovaries
Symptoms: effects on menstruation, gynecomastia, Headache, mental depression, Irritability, restlessness, Fatigue

12. ECOLOGICAL INFORMATION
Ecotoxicity
No data available
Persistence and degradability
No data available
Bioaccumulative potential
No data available
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.
8 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Human Chorionic Gonadotropin Formulation
Version6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014

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

not determined

IECSC:

not determined

Revision Date:

26.09.2023

Further information
Sources of key data used tocompile the Safety DataSheet:

Internal technical data, data from raw material SDSs, OECDeChem Portal search results and European Chemicals Agency, http://echa.europa.eu/Date format:

dd.mm.yyyy

16. OTHER INFORMATION

Full text of other abbreviations

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 withx% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated withx% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
9 / 10SAFETY DATA SHEETaccording to the Globally Harmonized SystemHuman Chorionic Gonadotropin Formulation
Version6.1

Revision Date:
26.09.2023

SDS Number:
22130-00020

Date of last issue: 20.03.2023
Date of first issue: 15.10.2014- 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 - InternationalMaritime 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 (MedianLethal 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 beconsidered 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.
IN / EN

10 / 10