SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

SECTION 1. IDENTIFICATION
Product name:

Mirtazapine Solid Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: 30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302
Telephone: 1-551-430-6000
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Combustible dust
Reproductive toxicity:

Category 2

Specific target organ toxicity- repeated exposure (Oral):

Category 2 (Nervous system)

GHS label elements
Hazard pictograms:

Signal Word:

Warning

Hazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
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.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
1 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

Response:
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
(+/-)-1,2,3,4,10,14b-Hexahydro-285650-52-8
methylpyrazino[2,1-a]pyrido[2,3c][2]benzazepine
Starch
9005-25-8
Silica71187-19-4
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 10 - < 20>= 10 - < 20>= 1 - < 5

SECTION 4. FIRST AID MEASURES
General advice:

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

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayed: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.
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
2 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

Protection of first-aiders:

Notes to physician:

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

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.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

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 products:

Carbon oxides
Silicon oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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

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

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

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitablecontainer 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 anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to
3 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

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
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 labeled containers.
Store locked up.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
inert or nuisance dust
50 Million particles per cubic footValue type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
15 mg/m³
Value type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
5 mg/m³
Value type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
15 Million particles per cubic footValue type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
Dust, nuisance dust and particulates

10 mg/m³
Value type (Form of exposure): PEL (Total dust)
4 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

Basis: CAL PEL
5 mg/m³
Value type (Form of exposure): PEL (respirable dust fraction)
Basis: CAL PEL
Components

CAS-No.

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

85650-52-8

Starch

9005-25-8

Silica71187-19-4

Value type
(Form ofexposure)
TWA

Control parameters / Permissible
concentration
25 µg/m³

Basis

Wipe limit
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA (Dust)

250 µg/100 cm²
10 mg/m³
5 mg/m³

Internal
ACGIH
NIOSH REL

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

20 Million
particles per cubic
foot(Silica)
80 mg/m3/ %SiO2(Silica)
6 mg/m³(Silica)

OSHA Z-3

TWA (Dust)

TWA

Engineering measures:

Internal

OSHA Z-3

NIOSH REL

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) aredesigned 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: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
5 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

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 specific to place of work. Breakthroughtime is not determined for the product. Change gloves often!
For special applications, we recommend clarifying theresistance to chemicals of the aforementioned protective
gloves with the glove manufacturer. Wash hands before
breaks and at the end of workday.
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 theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColor:

No data available

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

No data available

Flammability (solid, gas):

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:

No data available
6 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

flammability limit
Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition 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 size:

No data available

SECTION 10. STABILITY AND REACTIVITY
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.

7 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

SECTION 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: 3,200 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

Silica:Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Remarks: Based on data from similar materials

Skin corrosion/irritation
Not classified based on available information.
Components:
Silica:ResultRemarks::

No skin irritation
Based on data from similar materials

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Starch:SpeciesResult::RabbitNo eye irritation

Silica:SpeciesResult::RabbitNo eye irritation
8 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

MethodRemarks

SDS Number:
50168-00021::

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

Draize Test
Based on data from similar materials

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Starch:Test Type
Routes of exposure
SpeciesResult::::Maximization 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)
Result: negative

Silica:Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
9 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

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

IARC

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.

OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as a known or anticipated carcinogen by NTP.

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 fetal 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
10 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

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.

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:
Routes of exposure: 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

11 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

Starch:Species
NOAEL
Application RouteExposure time
MethodSDS Number:
50168-00021

:
:
:
:
:

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

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:(+/-)-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
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:

12 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

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

Toxicity to algae/aquaticplants:LC50 (Brachydanio rerio (zebrafish)): > 10,000 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials:

EC50: > 10,000 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

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
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
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.

13 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-CodeNot regulated as a dangerous goodTransport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
Not regulated as a dangerous goodSpecial precautions for user
Not applicable
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Combustible dust
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

SARA 313:

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
D-Glucose, 4-O-β-D-galactopyranosyl-, monohydrate
Starch(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1a]pyrido[2,3-c][2]benzazepine
California Permissible Exposure Limits for Chemical Contaminants
StarchSilica14 / 1664044-51-5
9005-25-8
85650-52-8

9005-25-8
71187-19-4

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information
NFPA 704:

HMIS® IV:
Flammability

HEALTH1
Health00Special hazard*

2

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
ACGIH / TWA: 8-hour, time-weighted average
CAL PEL / PEL: Permissible exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
OSHA Z-1 / TWA: 8-hour time weighted average
OSHA Z-3 / TWA: 8-hour time weighted average
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Sub15 / 16

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Mirtazapine Solid Formulation
Version
8.1

Revision Date:
09/30/2023

SDS Number:
50168-00021

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

stances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; 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; HMIS - Hazardous Materials Identification System; 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; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; 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; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

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

Revision Date:

09/30/2023

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

16 / 16