SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Section 1: Identification
Product identifier:

Asenapine 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 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)

Short-term (acute) aquatic
hazard:Category 1

Long-term (chronic) aquatic
hazard:Category 1

GHS Label elements, including precautionary statements
Hazard pictograms:

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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Signal word:

DangerHazard statements:

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.
H372 Causes damage to organs (Central nervous system)
through prolonged or repeated exposure if swallowed.
H410 Very toxic to aquatic life with long lasting effects.

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.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response:
P301 + P310 + P330 IF SWALLOWED: Immediately call a
POISON CENTER/ doctor. Rinse mouth.
P304 + P340 + P312 IF INHALED: Remove person to fresh air
and keep comfortable for breathing. Call a POISON CENTER/
doctor if you feel unwell.
P308 + P311 IF exposed or concerned: Call a POISONCENTER/ doctor.
P391 Collect spillage.
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

CAS-No.
2 / 16

Concentration (% w/w)

SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

trans-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

85650-56-2>= 30 -< 50

Section 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.
If not breathing, give artificial respiration.
If breathing is difficult, give oxygen.
Get medical attention.
In case of skin contact: In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of eye contact: If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed: If swallowed, DO NOT induce vomiting.
Call a physician or poison control centre immediately.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.
Most important symptoms and effects, both acute and delayed
Risks: 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.
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:

Water spray
Alcohol-resistant foam
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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

Unsuitable extinguishingmedia

SDS Number:
690800-00018:

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

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)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.
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: Surround spill with absorbents and place a damp coveringover the area to minimise entry of the material into the air.
Add excess liquid to allow the material to enter into solution.
Soak up with inert absorbent material.
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 and disposal of this material, as well as those materials and items
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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

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:

Hygiene measures:

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.
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.
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.

Conditions for safe storage, including any incompatibilities
Conditions for safe storage: Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
Materials to avoid: Do not store with the following product types:
Explosives

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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Section 8: Exposure controls/personal protection
Control parameters
Occupational Exposure Limits
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
Appropriate engineering
control measures:

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

10 µg/100 cm²Internal

Internal

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.

Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: 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.
Skin protection: 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.
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:

Consider double gloving.

Section 9: Physical and chemical properties
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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Appearance:

powderColour:white to off-white

Odour

:

odourlessOdour 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

Vapour pressure:

Not applicable

Relative vapour density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

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

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
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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Test atmosphere: dust/mist
Acute toxicity (other routes of :administration)

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 sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
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
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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
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SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Test Type: sister chromatid exchange assay
Result: negative
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

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 the offspring were detected.
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 30 mg/kg body weight
Result: Embryotoxic effects and adverse effects on the off10 / 16

SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
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SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

spring were detected only at high maternally toxic doses, No
teratogenic effects
Test Type: Embryo-foetal 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:
Exposure routes: 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:
Exposure routes: 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
Target Organs: Central nervous system
Symptoms: constriction of pupils

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SAFETY DATA SHEETAsenapine Formulation
Version
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Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

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
Toxicity
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/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 0.27
mg/l
Exposure time: 72 h
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SAFETY DATA SHEETAsenapine Formulation
Version
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Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 0.084
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
M-Factor (Acute aquatic toxicity)
Toxicity to fish (Chronic toxicity)

:

1

:

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

M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

:

100

:

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

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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

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)Packing group
LabelsEnvironmental hazards

:
:
:
:

IATA-DGR
UN/ID No.
UN 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::

Transport hazard class(es)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

Transport hazard class(es)Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

Transport in bulk according to IMO instruments
Not applicable for product as supplied.
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
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SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
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

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 con15 / 16

SAFETY DATA SHEETAsenapine Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
690800-00018

Date of last issue: 30.09.2023
Date of first issue: 19.05.2016

centration; 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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