SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Mirtazapine Solid Formulation

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

Telephone:+1-551-430-6000

Emergency telephone number :+1-215-631-6999

E-mail address

EHSSTEWARD@organon.com:

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

2. HAZARDS IDENTIFICATIONGHS Classification
Reproductive toxicity:

Category 2

Specific target organ toxicity repeated exposure (Oral):

Category 2 (Nervous system)

Long-term (chronic) aquatic
hazard:Category 3

GHS label elements
Hazard pictograms:

Signal word:

Warning

Hazard statements:

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.
H373 May cause damage to organs (Nervous system) throughprolonged or repeated exposure if swallowed.
H412 Harmful to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
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SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
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(+/-)-1,2,3,4,10,14b-Hexahydro-2methylpyrazino[2,1-a]pyrido[2,3c][2]benzazepine
StarchCAS-No.
85650-52-8

Concentration (% w/w)>= 10 -< 259005-25-8>= 10 -< 30

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 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.
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SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

If swallowed:

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

Notes to physician:

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Suspected of damaging fertility. Suspected of damaging theunborn child.
May cause damage to organs through prolonged or repeatedexposure if swallowed.
Contact with dust can cause mechanical irritation or drying of
the 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 MEASURES
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting::

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

Carbon oxides
Silicon 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 for:

Sweep up or vacuum up spillage and collect in suitable con3 / 15

SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

containment and cleaning up

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

tainer 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
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.
Use only with adequate ventilation.
Do not breathe dust.
Do not swallow.
Avoid contact with eyes.
Avoid prolonged or repeated contact with skin.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
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.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labelled containers.
Store locked up.
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.

(+/-)-1,2,3,4,10,14bHexahydro-2methylpyrazino[2,1a]pyrido[2,3-c][2]benzazepine

85650-52-8

4 / 15

Value type
(Form ofexposure)
TWA

Control parameters / Permissible
concentration
25 µg/m3

Basis

Wipe limit

250 µg/100 cm²Internal

Internal

SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

StarchEngineering measures

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

9005-25-8NAB
10 mg/m3
ID OEL
Further information: Not classified as carcinogenic to humans. Not
enough data to classify these materials as carcinogenic to humans or animals
TWA
10 mg/m3
ACGIH:

Ensure adequate ventilation, especially in confined areas.
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 thework area (i.e., there is no leakage from the equipment).

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:No data available

Odour

:

No data available

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SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

Odour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

No data available

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

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, dynamic:

No data available

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
6 / 15

SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Particle size

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23:

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
Information on likely routes of :exposure

Inhalation
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

Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Acute oral toxicity: LD50 (Rat): 320 - 490 mg/kg
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.
Serious eye damage/eye irritation
Not classified based on available information.

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SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

Components:
Starch:SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Starch:Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Germ cell mutagenicity
Not classified based on available information.
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Test system: Chinese hamster lung cells
Result: negative
Test Type: unscheduled DNA synthesis assay
Test system: mammalian cells
Result: negative
Test Type: sister chromatid exchange assay
Test system: mammalian cells
Result: negative
Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Rat
Cell type: Bone marrow
Application Route: Oral
Result: negative

Starch:Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
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SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

Result: negative
Carcinogenicity
Not classified based on available information.
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Species: MouseApplication Route: OralExposure time
: 18 month(s)LOAEL: 200 mg/kg body weight
Result: equivocal
Target Organs: Liver
Species
Application RouteExposure time
LOAEL
ResultTarget Organs

:
:
:
:
:
:

Rat
Oral
2 Years
20 mg/kg body weightequivocal
Liver, Thyroid

Reproductive toxicity
Suspected of damaging fertility. Suspected of damaging the unborn child.
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Effects on fertility: Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Oral
Fertility: LOAEL: 15 mg/kg body weight
Symptoms: Effect on estrous cycle, Increase of early resorptions
Result: Animal testing did not show any effects on fertility.,
Embryotoxic effects and adverse effects on the offspring weredetected.
Effects on foetal development:

Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 100 mg/kg body weight
Result: Embryotoxic effects and adverse effects on the offspring were detected., No teratogenic effects
Test Type: Development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: NOAEL: 40 mg/kg body weight
Result: No adverse effects, No teratogenic effects

Reproductive toxicity - As-:

Some evidence of adverse effects on sexual function and9 / 15

SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

sessment

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

fertility, based on animal experiments., Some evidence ofadverse effects on development, based on animal experiments.

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
May cause damage to organs (Nervous system) through prolonged or repeated exposure if swallowed.
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Exposure routes: Ingestion
Target Organs: Nervous system
Assessment: May cause damage to organs through prolonged or repeatedexposure.
Repeated dose toxicity
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Species: Rat
LOAEL: 120 mg/kg
Application Route: OralExposure time: 13 Weeks
Target Organs: Nervous system
Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Dog
15 mg/kg
Oral
52 Weeks
Nervous system
Tremors

Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Dog
20 mg/kg
Oral
13 Weeks
Nervous system, Testis
Tremors

Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

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

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SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Ingestion: Symptoms: Drowsiness, constipation, dry mouth, asthenia,
Dizziness, Disorientation
12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Toxicity to fish
: LC50 (Pimephales promelas (fathead minnow)): 6.92 mg/l
Exposure time: 96 h
Method: FDA 4.11
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 19.5 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 5.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 3.2
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 3.6 mg/l
Exposure time: 31 d
Method: OECD Test Guideline 210

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

NOEC (Daphnia magna (Water flea)): 0.32 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Toxicity to microorganisms

EC50 (Natural microorganism): > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209:

NOEC (Natural microorganism): < 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

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SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

Persistence and degradability
No data available
Bioaccumulative potential
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Bioaccumulation: Species: Oncorhynchus mykiss (rainbow trout)
Bioconcentration factor (BCF): 334
Method: OECD Test Guideline 305
Partition coefficient: noctanol/water:log Pow: 2.78

Mobility in soil
Components:(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine:
Distribution among environ: log Koc: 4.48
mental compartments
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.

UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
Labels

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable

IATA-DGR
UN/ID No.
Proper shipping nameClass
Subsidiary risk
Packing group

:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicable

14. TRANSPORT INFORMATIONInternational Regulations

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SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
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LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
50159-00021::

Not applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Special precautions for user
Not applicable
15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or mixture
Minister of Industry Regulation No. 23/M-IND/PER/4/2013 concerning the Revision of Minister of Industry Regulation No. 87/M-IND/PER/9/2009 concerning Globally Harmonized System of Classification and Labelling of Chemicals.
Regulation of the Minister of Health No. 472 of 1996 on the Safeguarding of Substances
Hazardous to Health
Hazardous substances that must be registered: Not applicable
Government Regulation No. 74 of 2001 on the Management of Hazardous and Toxic Substances
Hazardous substances approved for use: Not applicable
Prohibited substances:

Not applicable

Restricted substances:

Not applicable

Regulation of the Ministry of Trade No. 7 of 2022 on Distribution and Control of Hazardous
Materials
Type of hazardous materials subject to distribution and : Not applicable
control, Annex I
Type of hazardous materials subject to distribution and :control, Annex II

13 / 15

Not applicableSAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

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

not determined

IECSC

:

not determined

Revision Date:

2023/09/30

Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

Date format:

yyyy/mm/dd

16. OTHER INFORMATION

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

8-hour, time-weighted averageLong term exposure limit

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
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 Sub14 / 15

SAFETY DATA SHEET

Mirtazapine Solid Formulation
Version
4.1

Revision Date:
2023/09/30

SDS Number:
50159-00021

Date of last issue: 2023/04/04
Date of first issue: 2015/01/23

stances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
ID / EN

15 / 15