SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:Asenapine Formulation

Supplier's company name, address and phone number
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

E-mail address:

EHSSTEWARD@organon.com

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

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

2. HAZARDS IDENTIFICATIONGHS classification of chemical productAcute 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
Hazard pictograms:

1 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

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.
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
Important symptoms and out- : Dust contact with the eyes can lead to mechanical irritation.
lines of the emergency asContact with dust can cause mechanical irritation or drying ofsumed
the skin.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

Mixture2 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Components
Chemical nametrans-5-Chloro-2,3,3a,12btetrahydro-2-methyl-1Hdibenz[2,3:6,7]oxepino[4,5c]pyrrole maleate

CAS-No.
85650-56-2

Concentration (% w/w)>= 40 - < 50

ENCS No.

4. FIRST AID MEASURES
General advice:

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:

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, 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 centre 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.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Unsuitable extinguishing:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.
3 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

media
Specific hazards during firefighting

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19:

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
for firefighters:

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

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

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

Environmental precautions:

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

Methods and materials forcontainment and 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
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.

4 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

7. HANDLING AND STORAGE
Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

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.
Oxidizing agents
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.
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.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

5 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

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

TWA

Further information: Skin
Wipe limit
Engineering measures:

Control parameters / Reference
concentration /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.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

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.

9. PHYSICAL AND CHEMICAL PROPERTIES
6 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Physical state:

powderColour:white to off-white

Odour

:

odourlessOdour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

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

Flammability (liquids):

No data available

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit:

No data available

Flash point:

Not applicable

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

Not applicableAuto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density
Relative vapour density

No data available:

No data available:

Not applicable
7 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Explosive properties:

Not explosive

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.

10. STABILITY AND REACTIVITY

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
8 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Remarks: No mortality observed at this dose.
Acute inhalation toxicity:

Acute toxicity (other routes of :administration)

LC50 (Rat): 0.5 - 2 mg/l
Exposure time: 1 h
Test atmosphere: dust/mist
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)
9 / 18SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Result: negative
Test Type: Mouse Lymphoma
Result: negative
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 develop-:

Test Type: Embryo-foetal development
10 / 18

SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

ment

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 30 mg/kg body weight
Result: Embryotoxic effects and adverse effects on the offspring 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: Oral11 / 18

SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Exposure timeTarget Organs
Symptoms:::

52 Weeks
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
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
12 / 18

SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Method: OECD Test Guideline 203
Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 0.27
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

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
Hazardous to the ozone layer
Not applicable
13 / 18

SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Other adverse effects
No data available
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.

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.
14 / 18

SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

National Regulations
Refer to section 15 for specific national regulation.
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, and variations in regional or country regulations.
ERG Code:154

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable

15 / 18

SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Toxic and infectious substances (Article 2 and 3 of rules on shipping and storage of dangerous
goods and its Attached Table 1)
Aviation Law
Toxic and infectious substances (Article 194 of The Enforcement Rules of Aviation Law and its
Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined
16 / 18

SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

IECSC

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19:

not determined:

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

16. OTHER INFORMATION
Further information
Sources of key data used tocompile the Safety Data
Sheet

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

yyyy/mm/dd

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 concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance for
17 / 18

SAFETY DATA SHEETAsenapine Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
690795-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/05/19

safe 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.
JP / EN

18 / 18