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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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

1.1 Product identifier
Trade name:

Mianserin 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 2
H361fd: Suspected of damaging fertility. Suspectedof damaging the unborn child.
Specific target organ toxicity - single exH370: Causes damage to organs.
posure, Category 1
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

DangerHazard statements:

H361fdSuspected of damaging fertility. Suspected of
1 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

H370
Precautionary statements:

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

damaging the unborn child.
Causes damage to organs.

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 + P311 IF exposed or concerned: Call a POISONCENTER/ doctor.
Storage:
P405

Store locked up.

Hazardous components which must be listed on the label:mianserin hydrochloride
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 namemianserin hydrochloride

CAS-No.
EC-No.
Index-No.
Registration number
21535-47-7
244-426-7

For explanation of abbreviations see section 16.

2 / 16Classification

Concentration(% w/w)

Acute Tox. 4; H302
Repr. 2; H361fd
STOT SE 1; H370
(Central nervous
system)>= 10 - < 20

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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.
Never give anything by mouth to an unconscious person.

4.2 Most important symptoms and effects, both acute and delayed
Risks: Suspected of damaging fertility. Suspected of damaging theunborn child.
Causes damage to organs.
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.

3 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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
Oxides of phosphorus
Silicon 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.
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: 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.

4 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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.
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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Store inareas and containers
accordance with the particular national 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.

Starch

9005-25-8

Value type (Formof exposure)
OELV - 8 hrs(TWA) (Respirable dust)
OELV - 8 hrs
5 / 16

Control parametersBasis

4 mg/m3

IE OEL

10 mg/m3

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

mianserin hydrochloride

SilicaSDS Number:
1609316-00013

21535-47-7

Date of last issue: 30.09.2023
Date of first issue: 01.05.2017(TWA) (inhalable
dust)
TWA

Further information: Skin
Wipe limit
71187-19-4
OELV - 8 hrs(TWA) (Respirable dust)
OELV - 8 hrs(TWA) (inhalable
dust)

20 µg/m3 (OEB 3)

Internal

200 µg/100 cm²
2.4 mg/m3(Silica)

Internal
IE OEL

6 mg/m3(Silica)IE OEL

8.2 Exposure controls
Engineering measures
Ensure adequate ventilation, especially in confined areas.
Minimize workplace exposure concentrations.
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 143
Particulates type (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: Crystalline solid
Colour:white to off-white
6 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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 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

Flash point:

Not applicableAuto-ignition temperature:

No data available

Decomposition temperature:

No data available

pH:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Relative density:

No data available

Density:

No data available

Relative vapour density:

No data available

Particle characteristics
Particle size:

No data available

9.2 Other information

7 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

Explosives:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Evaporation rate:

No data available

Molecular weight:Not applicable

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 : Skin contact
exposure
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
8 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

Acute toxicity (other routes of :administration)

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

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

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.

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.

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
9 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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

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
10 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

Test Type: Development
Species: Mouse
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.

::Central nervous system
Causes damage to organs.

STOT - single exposure
Causes damage to organs.
Components:
mianserin hydrochloride:
Target Organs
Assessment

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 weightAspiration 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.

11 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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
12.1 Toxicity
No data available
12.2 Persistence and degradability
No data available
12.3 Bioaccumulative potential
Components:
mianserin hydrochloride:
Partition coefficient: noctanol/water:log Pow: 3.36

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

12 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

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.
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

14.2 UN proper shipping name14.3 Transport hazard class(es)14.4 Packing group

13 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

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
Remarks: 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: Not applicablethe market and use of certain dangerous substances,mixtures and articles (Annex XVII)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.
Quantity 1
Quantity 2
H3
STOT SPECIFIC TARGET 50 t
200 t
ORGAN TOXICITY –SINGLE EXPOSURE
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

14 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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
H361fd

:
:

H370

:

Harmful if swallowed.
Suspected of damaging fertility. Suspected of damaging theunborn child.
Causes damage to organs.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Repr.
: Reproductive toxicity
STOT SE: Specific target organ toxicity - single 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)
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 ofChemicals; 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;
15 / 16

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

Mianserin Formulation
Version
2.9

Revision Date:
06.04.2024

SDS Number:
1609316-00013

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

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. 2

H361fdCalculation method

STOT SE 1

H370

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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