SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

Section 1: Identification
Product identifier:

Mianserin Formulation

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

Section 2: Hazard identification
Classification of the substance or mixture
Reproductive toxicity: Category 2
Specific target organ toxicity single exposure:

Category 1 (Central nervous system)

GHS Label elements, including precautionary statements
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/ vapours/ spray.
P264 Wash skin thoroughly after handling.
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing 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
Description of necessary 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: 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.
Never give anything by mouth to an unconscious person.
Most important symptoms and effects, both acute and delayed
Risks: Suspected of damaging fertility. Suspected of damaging the
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Protection of first-aiders:

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

unborn 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).

Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.
Section 5: Fire-fighting measures
Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

:

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

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 prod- : Carbon oxides
ucts
Metal oxides
Oxides of phosphorus
Silicon oxides
Special protective actions for fire-fighters
Special protective equipment : In the event of fire, wear self-contained breathing apparatus.
for firefighters
Use personal protective equipment.
Specific extinguishing meth- : Use extinguishing measures that are appropriate to local cirods
cumstances 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
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).
Environmental precautions
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 for containment and cleaning up
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

Methods for cleaning up

SDS Number:
1601085-00013:

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

Surround spill with absorbents and place a damp coveringover the area to minimise 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 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.

Section 7: Handling and storage
Precautions for safe handlingTechnical measures:
Local/Total ventilation
Advice on safe handling::

Hygiene measures:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
Use only with adequate ventilation.
Do not breathe dust, fume, gas, mist, vapours 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.
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.

Conditions for safe storage, including any incompatibilities
Conditions for safe storage: Keep in properly labelled containers.
Store locked up.
Store in accordance with the particular national regulations.
Materials to avoid: Do not store with the following product types:
Strong oxidizing agents
Section 8: Exposure controls/personal protection
Control parameters
Occupational Exposure Limits

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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Components

CAS-No.

Value type
(Form ofexposure)
21535-47-7
TWA
Further information: Skin
Wipe limit
9005-25-8
PEL (long
term)
TWA

mianserin hydrochloride

StarchAppropriate engineering
control measures

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017:

Control parameters / Permissible
concentration
20 µg/m3 (OEB 3)

Basis

200 µg/100 cm²
10 mg/m3

Internal
SG OEL

10 mg/m3

ACGIH

Internal

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

Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: Wear the following personal protective equipment:
Safety glasses
Skin protection: 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).
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:

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.

Section 9: Physical and chemical properties
Appearance:

Crystalline solid

Colour:white to off-white

Odour

:

No data available

Odour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

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

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:

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 characteristics
Particle size:

No data available::

Not classified as a reactivity hazard.
Stable under normal conditions.

Section 10: Stability and reactivity
Reactivity
Chemical stability

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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017:

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: > 2,000 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: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.

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SAFETY DATA SHEET

Mianserin Formulation
Version
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Revision Date:
06.04.2024

Starch:SpeciesResultSDS Number:
1601085-00013::

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

RabbitNo eye irritation

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

Not classified due to lack of data.

Starch:Test Type
Exposure routes
SpeciesResult::::Maximisation 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)
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
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

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 foetal development:

Test Type: Development
Species: Rat
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 foetal weight, No teratogenic effects
Test Type: Development
Species: Mouse
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

Developmental Toxicity: NOAEL: 30 mg/kg body weight
Result: No effects on foetal 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 RouteExposure time
Method

:
:
:
:
:

Rat
>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410

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

Remarks: May be harmful if inhaled.
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Skin contact:

Eye contact
Ingestion::

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

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
Toxicity
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 information
International Regulations
UNRTDGUN numberUN proper shipping name
Transport hazard class(es)Subsidiary risk
Packing group
LabelsEnvironmentally hazardous

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicablenoIATA-DGR
UN/ID No.

:

Not applicable
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Version
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Revision Date:
06.04.2024

UN proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN numberUN proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
1601085-00013

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

Transport in bulk according to IMO instruments
Not applicable for product as supplied.
Special precautions for user
Not applicable
Section 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
Workplace Safety and Health Act and Workplace Safety and Health (General Provisions) Regulations: This product is subjected to the SDS, labelling, PEL and other requirements in the
Act/Regulations.
Environmental Protection and Management Act and: Not applicable
Environmental Protection and Management (Hazardous Substances) Regulations
Fire Safety (Petroleum and Flammable Materials)
Regulations:

Not applicable

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

not determined

IECSC

:

not determined:

06.04.2024

Section 16: Other information
Revision Date
Further information
12 / 14

SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

Sources of key data used tocompile the Safety Data
Sheet

SDS Number:
1601085-00013:

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

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

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

dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
SG OEL: Singapore. Workplace Safety and Health (General Provisions)
Regulations - First Schedule Permissible Exposure Limits of
Toxic Substances.
ACGIH / TWA
SG OEL / PEL (long term)::

8-hour, time-weighted average
Permissible Exposure Level (PEL) Long Term

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
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
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SAFETY DATA SHEET

Mianserin Formulation
Version
2.0

Revision Date:
06.04.2024

SDS Number:
1601085-00013

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017

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.
SG / EN

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