SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

SECTION 1. IDENTIFICATION
Product name:Asenapine 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
Acute toxicity (Oral):

Category 3

Acute toxicity (Inhalation):

Category 4

Reproductive toxicity:

Category 2

Specific target organ toxicity- single exposure (Oral):

Category 1 (Central nervous system, Cardio-vascular system)

Specific target organ toxicity- repeated exposure (Oral):

Category 1 (Central nervous system)

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
H301 Toxic if swallowed.
H332 Harmful if inhaled.
H361fd Suspected of damaging fertility. Suspected of damaging
the unborn child.
H370 Causes damage to organs (Central nervous system, Cardio-vascular system) if swallowed.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

H372 Causes damage to organs (Central nervous system)
through prolonged 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.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P271 Use only outdoors or in a well-ventilated area.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P301 + P310 + P330 IF SWALLOWED: Immediately call a
POISON CENTER. Rinse mouth.
P304 + P340 + P312 IF INHALED: Remove person to fresh air
and keep comfortable for breathing. Call a doctor if you feelunwell.
P307 + P311 IF exposed: Call a doctor.
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.
trans-5-Chloro-2,3,3a,12b-tetrahydro- 85650-56-2
2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole
maleateActual concentration is withheld as a trade secretConcentration (% w/w)>= 30 - < 50

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.

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

If inhaled, remove to fresh air.
If not breathing, give artificial respiration.
If breathing is difficult, give oxygen.
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.
Call a physician or poison control center immediately.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.
Toxic if swallowed.
Harmful if inhaled.
Suspected of damaging fertility. Suspected of damaging theunborn child.
Causes damage to organs if swallowed.
Causes 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.

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
Nitrogen oxides (NOx)Specific extinguishing methods:

Special 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.
In the event of fire, wear self-contained breathing apparatus.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

for fire-fighters

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

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:

Surround spill with absorbents and place a damp coveringover the area to minimize entry of the material into the air.
Add excess liquid to allow the material to enter into solution.
Soak up with inert absorbent material.
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.
Clean up remaining materials from spill with suitable
absorbent.
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 todetermine 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:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
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
Keep container tightly closed.
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.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Conditions for safe storage:

Materials to avoid:

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store locked up.
Keep tightly closed.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

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

Components

CAS-No.

trans-5-Chloro-2,3,3a,12btetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5c]pyrrole maleate85650-56-2

Value type
(Form ofexposure)
TWA

Further information: Skin
Wipe limit

5 / 17

Control parameters / Permissible
concentration
1 µg/m3 (OEB 4)Basis

10 µg/100 cm²Internal

Internal

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

Engineering measures

SDS Number:
690801-00018:

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., vacuum conveying
from a closed system, packout head with inflatable seal fromstationary container, ventilated enclosure, etc.).
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Essentially no open handling permitted.
Use closed processing systems or containment technologies.

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.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Hygiene measures:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets,
disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
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.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

Appearance:

powderColor:white to off-white

Odor

:

odorless

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:

Not applicable

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

Vapor pressure:

Not applicable

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Particle size:

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

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.

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Toxic if swallowed.
Harmful if inhaled.
Product:
Acute oral toxicity:

Acute toxicity estimate: 238.4 mg/kg
Method: Calculation method

Acute inhalation toxicity:

Acute toxicity estimate: 1.08 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method

Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Acute oral toxicity: LD50 (Rat): 110 - 178 mg/kg
LD50 (Dog): > 200 mg/kg
Remarks: No mortality observed at this dose.
Acute inhalation toxicity:

LC50 (Rat): 0.5 - 2 mg/l
Exposure time: 1 h
Test atmosphere: dust/mist

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SAFETY DATA SHEET
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Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Acute toxicity (other routes of :administration)

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

LD50 (Rat): > 200 mg/kg
Application Route: Intravenous
Target Organs: Central nervous system
Remarks: No mortality observed at this dose.

Skin corrosion/irritation
Not classified based on available information.
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Remarks: No data available
Serious eye damage/eye irritation
Not classified based on available information.
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Remarks: No data available
Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Species: Guinea pig
Result: Not a skin sensitizer.
Germ cell mutagenicity
Not classified based on available information.
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Mouse Lymphoma
Result: negative
Test Type: sister chromatid exchange assay
Result: negative
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

Test Type: Chromosomal aberration
Test system: Human lymphocytes
Result: negative
Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Rat
Application Route: Oral
Result: negative

Carcinogenicity
Not classified based on available information.
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Species: MouseApplication Route: Subcutaneous
Exposure time
: 89 - 98 weeks
Result: negative
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Subcutaneous
100 - 106 weeks
negative

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:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Effects on fertility: Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Oral
Fertility: LOAEL: 1.0 mg/kg body weight
Symptoms: Reduced maternal body weight gain., Reduced
offspring weight gain., Effects on fertility., Effects on F1 offspring.
Result: Embryotoxic effects and adverse effects on theoffspring were detected.

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Asenapine Formulation
Version
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Revision Date:
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Effects on fetal development

SDS Number:
690801-00018:

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 30 mg/kg body weight
Result: Embryotoxic effects and adverse effects on theoffspring were detected only at high maternally toxic doses,
No teratogenic effects.
Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Intravenous injection
Developmental Toxicity: NOAEL: 0.626 mg/kg body weight
Result: 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
Causes damage to organs (Central nervous system, Cardio-vascular system) if swallowed.
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Routes of exposure: OralTarget Organs: Central nervous system, Cardio-vascular system
Assessment: Causes damage to organs.
STOT-repeated exposure
Causes damage to organs (Central nervous system) through prolonged or repeated exposure if
swallowed.
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Routes of exposure: Ingestion
Target Organs: Central nervous system
Assessment: Causes damage to organs through prolonged or repeatedexposure.
Repeated dose toxicity
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Species: Rat
LOAEL: 0.6 mg/kg
Application Route: OralExposure time
: 52 Weeks
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

Target Organs
Symptoms::

Central nervous systemconstriction of pupils

Species
LOAEL
Application RouteExposure time
Symptoms

:
:
:
:
:

Rat
0.1 mg/kg
Intravenous
14 Weeksconstriction of pupils, Lachrymation

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.5 mg/kg
Subcutaneous
13 Weeks
Central nervous system

Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Dog
> 1.25 mg/kg
Oral
13 - 52 Weeks
Central nervous systemconstriction of pupils, Tremors, Irritability

Aspiration toxicity
Not classified based on available information.
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Not applicable
Experience with human exposure
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Ingestion: Symptoms: restlessness, Drowsiness, Dizziness, decrease inheart rate, hypotension
SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Toxicity to fish
: LC50 (Cyprinus carpio (Carp)): 0.53 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Toxicity to algae/aquatic:

EC50 (Pseudokirchneriella subcapitata (green algae)): 0.27
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SAFETY DATA SHEET
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Asenapine Formulation
Version
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Revision Date:
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SDS Number:
690801-00018

plantsDate of last issue: 04/04/2023
Date of first issue: 05/19/2016

mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 0.084
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.04 mg/l
Exposure time: 21 d

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

NOEC (Daphnia magna (Water flea)): 0.00086 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Toxicity to microorganisms

EC50: 37 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209:

NOEC: 10 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Persistence and degradability
No data available
Bioaccumulative potential
Components:
trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate:
Bioaccumulation: Species: Cyprinus carpio (Carp)
Bioconcentration factor (BCF): 2,424
Partition coefficient: noctanol/water:log Pow: 4.9

Mobility in soil
No data available
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.
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SAFETY DATA SHEET
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Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

If not otherwise specified: Dispose of as unused product.
SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 2811TOXIC SOLID, ORGANIC, N.O.S.
(trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate)
6.1
III
6.1
yes

:
:
:
:

UN 2811
Toxic solid, organic, n.o.s.
(trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate)
6.1
III
Toxic
677

:

670

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 2811TOXIC SOLID, ORGANIC, N.O.S.
(trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate)
6.1
III
6.1
F-A, S-A
yes

Class
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
UN/ID/NA number
Proper shipping name

:
:

Class
Packing group
LabelsERG Code
Marine pollutant

:
:
:
:
:

UN 2811
Toxic solids, organic, n.o.s.
(trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate)
6.1
III
TOXIC
154
yes(trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate)
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, andvariations in regional or country regulations.
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
Acute toxicity (any route of exposure)
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 Knowtrans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate
Gelatins
D-mannitol

85650-56-2
9000-70-8
69-65-8

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

15 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

NFPA 704:

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016
HMIS® IV:

Flammability

HEALTH1
Health20Special hazard*

4

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
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
CAL PEL / PEL: Permissible exposure limit
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 Substances 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;
16 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Asenapine Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
690801-00018

Date of last issue: 04/04/2023
Date of first issue: 05/19/2016

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

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

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