SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

SECTION 1. IDENTIFICATION
Product name:

Mianserin Formulation

Manufacturer or supplier's details
Company: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:

1-551-430-6000

Emergency telephone:

1-215-631-6999

E-mail address:

EHSSTEWARD@organon.com

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

SECTION 2. HAZARDS IDENTIFICATIONGHS Classification
Reproductive toxicity
Specific target organ toxicity single exposure:

Category 2:

Category 1 (Central nervous system)

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.
H370 Causes damage to organs (Central nervous system).

Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust/ fume/ gas/ mist/ vapors/ spray.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves/ protective clothing/ eye protec1 / 12

SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

tion/ face protection.
Response:
P308 + P311 IF exposed or concerned: Call a POISONCENTER/ doctor.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
Other hazards which do not result in classification
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical namemianserin hydrochloride
StarchCAS-No.
21535-47-7
9005-25-8

Concentration (% w/w)>= 10 -< 20>= 10 -< 20

SECTION 4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

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.
Never give anything by mouth to an unconscious person.
Suspected of damaging fertility. Suspected of damaging theunborn child.
Causes damage to organs.
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.

:

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SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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

:

Exposure to combustion products may be a hazard to health.

:

Carbon oxides
Metal oxides
Oxides of phosphorus
Silicon oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

SECTION 6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

Use personal protective equipment.
Follow safe handling advice (see section 7) and personal
protective equipment recommendations (see section 8).

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
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:

Surround spill with absorbents and place a damp coveringover the area to minimize entry of the material into the air.
Add excess liquid to allow the material to enter into solution.
Soak up with inert absorbent material.
Clean up remaining materials from spill with suitable
absorbent.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
Use only with adequate ventilation.
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

Do not breathe dust, fume, gas, mist, vapors or spray.
Do not swallow.
Avoid contact with eyes.
Avoid prolonged or repeated contact with skin.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure
assessment
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store locked up.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

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

CAS-No.

Value type
Control parameBasis(Form ofters / Permissible
exposure)
concentration
21535-47-7
TWA
20 µg/m3 (OEB 3) Internal
Further information: Skin
Wipe limit
200 µg/100 cm²Internal
9005-25-8
CMP
10 mg/m³
AR OEL
Further information: A4 - Not classifiable as a human carcinogen
TWA
10 mg/m³
ACGIH

mianserin hydrochloride

StarchEngineering measures:

Ensure adequate ventilation, especially in confined areas.
Minimize workplace exposure concentrations.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or
exposure assessment demonstrates exposures outside therecommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Choose gloves to protect hands against chemicals dependingon the concentration specific to place of work. Breakthroughtime is not determined for the product. Change gloves often!
For special applications, we recommend clarifying theresistance to chemicals of the aforementioned protective
gloves with the glove manufacturer. Wash hands before
breaks and at the end of workday.
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Eye protection:

Skin and body protection:

Hygiene measures:

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

Wear the following personal protective equipment:
Safety glasses
Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

Crystalline solid

Color

:

white to off-white

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

No data available

Flammability (solid, gas):

Not classified as a flammability hazard

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

5 / 12

SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

Partition coefficient: noctanol/water
Autoignition 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:Not applicable

Particle size:

No data available

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

Not classified as a reactivity hazard.
Stable under normal conditions.
Can react with strong oxidizing agents.

:::

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

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Skin contact
Ingestion
Eye contact

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

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

LD50 (Rat): 780 mg/kg

Components:
mianserin hydrochloride:
Acute oral toxicity

LD50 (Mouse): 224 mg/kg
Acute toxicity (other routes of :administration)

LD50 (Mouse): 32 mg/kg
Application Route: Intravenous

Starch:6 / 12

SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

Acute oral toxicity:

LD50 (Rat): > 5.000 mg/kg

Acute dermal toxicity:

LD50 (Rabbit): > 2.000 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Components:
mianserin hydrochloride:
Remarks:

Not classified due to lack of data.

Serious eye damage/eye irritation
Not classified based on available information.
Components:
mianserin hydrochloride:
Remarks:

Not classified due to lack of data.

Starch:SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
mianserin hydrochloride:
Remarks:

Not classified due to lack of data.

Starch:Test Type
Routes of exposure
SpeciesResult::::Maximization Test
Skin contact
Guinea pig
negative

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

Test Type: gene mutation test
Result: positive
Test Type: Bacterial reverse mutation assay (AMES)
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

Result: negative
Remarks: Based on data from similar materials
Test Type: sister chromatid exchange assay
Result: negative
Remarks: Based on data from similar materials
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Remarks: Based on data from similar materials
Test Type: unscheduled DNA synthesis assay
Result: negative
Remarks: Based on data from similar materials
Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Rat
Cell type: Bone marrow
Application Route: Oral
Result: negative
Remarks: Based on data from similar materials

Starch:Genotoxicity in vitro:

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

Carcinogenicity
Not classified based on available information.
Components:
mianserin hydrochloride:
Remarks:

Not classified due to lack of data.

Reproductive toxicity
Suspected of damaging fertility. Suspected of damaging the unborn child.
Components:
mianserin hydrochloride:
Effects on fertility:

Test Type: Fertility
Species: Rat, maleFertility: NOAEL: 100 mg/kg body weight
Result: No effects on fertility., No effects on mating
performance.
Test Type: Fertility
Species: Rat, female
Fertility: LOAEL: 30 mg/kg body weight
Result: Preimplantation loss., ovarian dysfunction, Effect on
estrous cycle

Effects on fetal development:

Test Type: Development
Species: Rat
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 10 mg/kg body weight
Result: Effects on postnatal development.
Test Type: Development
Species: Rat
Developmental Toxicity: LOAEL: 3 mg/kg body weight
Result: Embryolethal effects., No teratogenic effects.
Test Type: Development
Species: Rabbit
Result: Reduced fetal weight., No teratogenic effects.
Test Type: Development
Species: Mouse
Developmental Toxicity: NOAEL: 30 mg/kg body weight
Result: No effects on fetal development.
Reproductive toxicity - Assessment:

Suspected of damaging fertility. Suspected of damaging theunborn child.

STOT-single exposure
Causes damage to organs (Central nervous system).
Components:
mianserin hydrochloride:
Target Organs
Assessment::

Central nervous system
Causes damage to organs.

STOT-repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
mianserin hydrochloride:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
30 mg/kg
Oral
6 Months
No significant adverse effects were reported

Species
LOAEL
Application RouteExposure time
Symptoms

:
:
:
:
:

Dog
3 - 30 mg/kg
Oral
6 Months
Reduced body weight

Starch:Species
NOAEL
Application Route

:
:
:

Rat
>= 2.000 mg/kg
Skin contact
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

Exposure time
MethodSDS Number:
1609327-00012::

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

28 Days
OECD Test Guideline 410

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
mianserin hydrochloride:
Inhalation:

Skin contact:

Eye contact
Ingestion::

Remarks: May be harmful if inhaled.
May cause irritation of respiratory tract.
Remarks: Can be absorbed through skin.
May irritate skin.
Remarks: May irritate eyes.
Symptoms: central nervous system effects, dry mouth, constipation, Headache, Tremors

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
No data available
Persistence and degradability
No data available
Bioaccumulative potential
Components:
mianserin hydrochloride:
Partition coefficient: noctanol/water:log Pow: 3,36

Mobility in soil
No data available
Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
Empty containers should be taken to an approved waste
handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
10 / 12SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-CodeNot regulated as a dangerous goodTransport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Special precautions for user
Not applicable
SECTION 15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or
mixtureArgentina. Carcinogenic Substances and Agents: Not applicable
Registry.
Control of precursors and essential chemicals for the
preparation of drugs.

:

Not applicable

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Revision Date
Date format::

30.09.2023
dd.mm.yyyy

Further information
Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
AR OEL: Argentina. Occupational Exposure Limits
ACGIH / TWA
AR OEL / CMP::

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

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
11 / 12SAFETY DATA SHEET

Mianserin Formulation
Version
2.8

Revision Date:
30.09.2023

SDS Number:
1609327-00012

Date of last issue: 04.04.2023
Date of first issue: 01.05.2017

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 for safe handling, use, processing, storage, transportation, disposal and release andshall not be considered a warranty or quality specification of any type. The information provided
relates only to the specific material identified at the top of this SDS and may not be valid when the
SDS material is used in combination with any other materials or in any process, unless specified
in the text. Material users should review the information and recommendations in the specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
AR / Z8

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