SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Section 1: Identification
Product identifier:

Mirtazapine Disintegrating 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
Acute toxicity (Oral): Category 4
Reproductive toxicity:

Category 2

Specific target organ toxicity repeated exposure (Oral):

Category 2 (Nervous system)

GHS Label elements, including precautionary statements
Hazard pictograms:

Signal word:

Warning

Hazard statements:

H302 Harmful if swallowed.
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.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
1 / 19SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response:
P301 + P312 + P330 IF SWALLOWED: Call a POISONCENTER/ doctor if you feel unwell. Rinse mouth.
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.
Section 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
Citric acid
Cellulose
Magnesium stearate

CAS-No.
85650-52-8

Concentration (% w/w)>= 20 -< 25

77-92-99004-34-6
557-04-0>= 1 -< 10>= 1 -< 10>= 1 -< 10Section 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.
2 / 19SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

In case of eye contact:

If swallowed:

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.

Most important symptoms and effects, both acute and delayed
Risks: Harmful if swallowed.
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.
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).
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- : Avoid generating dust; fine dust dispersed in air in sufficient
fighting
concentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.
Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)
Metal 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.
3 / 19SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

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

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.
Wash skin thoroughly after handling.
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.
4 / 19SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

Hygiene measures

SDS Number:
50204-00023:

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
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
Components

CAS-No.

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

85650-52-8

Cellulose

9004-34-6

Magnesium stearate557-04-0

Appropriate engineering
control measures:

Value type
(Form ofexposure)
TWA

Control parameters / Permissible
concentration
25 µg/m3

Basis

Wipe limit
PEL (longterm)
TWA
PEL (longterm)
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)

250 µg/100 cm²
10 mg/m3

Internal
SG OEL

10 mg/m3
10 mg/m3

ACGIH
SG OEL

10 mg/m3

ACGIH

3 mg/m3

ACGIH

Internal

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 de5 / 19

SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

signed in a manner to prevent the escape of dust into thework area (i.e., there is no leakage from the equipment).
Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: Wear the following personal protective equipment:
Safety goggles
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:

powderColour:No data available

Odour

:

No data available

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:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

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

6 / 19SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

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

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

Particle characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

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

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

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

Section 10: Stability and reactivity

7 / 19SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Section 11: Toxicological information
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Harmful if swallowed.
Product:
Acute oral toxicity:

Acute toxicity estimate: 1,588 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
Citric acid:
Acute oral toxicity:

LD50 (Mouse): 5,400 mg/kg

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 402
Assessment: The substance or mixture has no acute dermal
toxicity

Cellulose:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

Magnesium stearate:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 423
Assessment: The substance or mixture has no acute oral toxicity
Remarks: Based on data from similar materials

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Remarks: Based on data from similar materials

Skin corrosion/irritation
Not classified based on available information.

8 / 19SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Components:
Citric acid:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Citric acid:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Magnesium stearate:
Test Type
Exposure routes
Species
MethodResultRemarks

:
:
:
:
:
:

Maximisation Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative
Based on data from similar materials

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:
9 / 19SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

Genotoxicity in vitro

SDS Number:
50204-00023:

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

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

Citric acid:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: in vitro micronucleus test
Result: positive
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Genotoxicity in vivo:

Test Type: Mutagenicity (in vivo mammalian bone-marrowcytogenetic test, chromosomal analysis)
Species: Rat
Application Route: Ingestion
Result: negative

Cellulose:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative

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SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

Magnesium stearate:
Genotoxicity in vitro

SDS Number:
50204-00023:

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Remarks: Based on data from similar materials
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Remarks: Based on data from similar materials
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Based on data from similar materials

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

Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

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 resorp11 / 19

SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

tions
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 - Assessment:

Some evidence of adverse effects on sexual function andfertility, based on animal experiments., Some evidence ofadverse effects on development, based on animal experiments.

:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative

Magnesium stearate:
Effects on fertility:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials

Effects on foetal develop-:

Test Type: Embryo-foetal development

Citric acid:
Effects on foetal development

Cellulose:
Effects on fertility

Effects on foetal development

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SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

ment

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

STOT - single exposure
Not classified based on available information.
Components:
Citric acid:
Assessment:

May cause respiratory irritation.

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

Citric acid:
13 / 19

SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
4,000 mg/kg
8,000 mg/kg
Ingestion
10 Days

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 Days

Magnesium stearate:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
> 100 mg/kg
Ingestion
90 DaysBased on data from similar materials

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
Section 12: Ecological information
Toxicity
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
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SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

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
Citric acid:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 100 mg/l
Exposure time: 96 h:

EC50 (Daphnia magna (Water flea)): 1,535 mg/l
Exposure time: 24 h

Cellulose:
Toxicity to fish:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Magnesium stearate:
Toxicity to fish:

LC50 (Leuciscus idus (Golden orfe)): > 100 mg/l
Exposure time: 48 h
Method: DIN 38412
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EL50 (Daphnia magna (Water flea)): > 1 mg/l
Exposure time: 47 h
Test substance: Water Accommodated Fraction
Method: Directive 67/548/EEC, Annex V, C.2.
Remarks: Based on data from similar materials
No toxicity at the limit of solubility

Toxicity to algae/aquaticplants:EL50 (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction

Toxicity to daphnia and otheraquatic invertebrates

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SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
No toxicity at the limit of solubility
NOELR (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
Toxicity to microorganisms:

EC10 (Pseudomonas putida): > 100 mg/l
Exposure time: 16 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

Persistence and degradability
Components:
Citric acid:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 97 %Exposure time: 28 d
Method: OECD Test Guideline 301B

Cellulose:
Biodegradability:

Result: Readily biodegradable.

Magnesium stearate:
Biodegradability:

Result: Not biodegradable
Remarks: Based on data from similar materials

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
Citric acid:
Partition coefficient: noctanol/water
Magnesium stearate:
Partition coefficient: n-:log Pow: 2.78:

log Pow: -1.72:

log Pow: > 4
16 / 19

SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
50204-00023

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

octanol/water
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
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
IATA-DGR
UN/ID No.
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
Labels

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
17 / 19

SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

EmS Code
Marine pollutant

SDS Number:
50204-00023::

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Not applicableNot applicable

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

Revision Date:

06.04.2024

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/

Section 16: Other information

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:

8-hour, time-weighted average
18 / 19

SAFETY DATA SHEET

Mirtazapine Disintegrating Formulation
Version
5.0

Revision Date:
06.04.2024

SG OEL / PEL (long term)

SDS Number:
50204-00023:

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

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
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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