SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

SECTION 1. IDENTIFICATION
Product name:

Montelukast Tablet 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
Carcinogenicity (Inhalation):

Category 2

GHS label elements
Hazard pictograms:

Signal Word:

Warning

Hazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
H351 Suspected of causing cancer if inhaled.

Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
P405 Store locked up.
Disposal:
1 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

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.
Cellulose
9004-34-6
Montelukast
151767-02-1
Magnesium stearate557-04-0
Titanium dioxide
13463-67-7
Aspartame
22839-47-0
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 30 - < 50>= 5 - < 10>= 1 - < 5>= 0.1 - < 1>= 0.1 - < 1

SECTION 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.
Get medical attention.
Wash with water and soap.
Get medical attention if symptoms occur.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.
Suspected of causing cancer if inhaled.
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:

Unsuitable extinguishing
media

:

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

2 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

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
Metal oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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

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

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

Environmental precautions:

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

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitablecontainer for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on
surfaces, as these may form an explosive mixture if they are
released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need 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.
Use only with adequate ventilation.
Do not breathe dust.
Do not swallow.
3 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Conditions for safe storage:

Materials to avoid:

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Avoid contact with eyes.
Avoid prolonged or repeated contact with skin.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure
assessment
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

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

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

Components

CAS-No.

Cellulose

9004-34-6

4 / 21

Value type
(Form ofexposure)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)

Control parameters / Permissible
concentration
10 mg/m³
5 mg/m³

Basis

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

ACGIH
NIOSH REL

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Montelukast

151767-02-1

Magnesium stearate557-04-0

Titanium dioxide

Engineering measures

13463-67-7:

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014
TWA (respirable fraction)
TWA
Wipe limit
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)
TWA (total
dust)

5 mg/m³

OSHA Z-1

40 µg/m3 (OEB 3)
400 µg/100 cm²
10 mg/m³

Internal
Internal
ACGIH

3 mg/m³

ACGIH

15 mg/m³

OSHA Z-1

All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., open-facecontainment devices).
Minimize open handling.

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:

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.
5 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

Hygiene measures

SDS Number:
23093-00024:

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

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
Appearance:

tabletColor:

coloredOdor:

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:

No data available

Flammability (solid, gas):

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

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

6 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Partition coefficient: noctanol/water
Autoignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available

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
Not classified based on available information.
Components:
Cellulose:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
7 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Acute dermal toxicity:

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

Montelukast:
Acute oral toxicity:

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

Acute inhalation toxicity:

Remarks: No data available

Acute dermal toxicity:

Remarks: No data available

Magnesium stearate:
Acute oral toxicity:

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

Acute dermal toxicity:

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

Titanium dioxide:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 6.82 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity

Aspartame:
Acute oral toxicity:

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

Skin corrosion/irritation
Not classified based on available information.
Components:
Montelukast:
SpeciesResult::RabbitMild skin irritation

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

Titanium dioxide:
8 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SpeciesResultSDS Number:
23093-00024::

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Montelukast:
SpeciesResult::RabbitSevere irritation

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

Titanium dioxide:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Montelukast:
Remarks:

No data available

Magnesium stearate:
Test Type
Routes of exposure
Species
MethodResultRemarks

:
:
:
:
:
:

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

Titanium dioxide:
Test Type
Routes of exposure
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative

Germ cell mutagenicity
Not classified based on available information.
9 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Components:
Cellulose:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

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

Montelukast:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Test system: Chinese hamster fibroblasts
Result: negative
Test Type: Chromosomal aberration
Test system: Chinese hamster ovary cells
Result: negative
Test Type: Alkaline elution assay
Test system: rat hepatocytes
Result: negative

Genotoxicity in vivo:

Test Type: Chromosomal aberration
Species: Mouse
Cell type: Bone marrow
Application Route: Oral
Result: negative

Magnesium stearate:
Genotoxicity in vitro:

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

Titanium dioxide:
10 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Result: negative

Aspartame:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

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

Carcinogenicity
Suspected of causing cancer if inhaled.
Components:
Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

Montelukast:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Oral
2 Years
negative

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Oral
92 weeks
negative

Titanium dioxide:
Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
The mechanism or mode of action may not be relevant in humans.
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SAFETY DATA SHEET
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Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

Carcinogenicity - Assessment
Aspartame:Species
Application RouteExposure time
ResultIARC

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014:

Limited evidence of carcinogenicity in inhalation studies withanimals.

:
:
:
:

Rat
Ingestion
104 weeks
negative

Group 2B: Possibly carcinogenic to humans
Aspartame
Group 2B: Possibly carcinogenic to humans
Titanium dioxide

22839-47-0
13463-67-7

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
Not classified based on available information.
Components:
Cellulose:
Effects on fertility:

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

Effects on fetal development:

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

Montelukast:
Effects on fertility:

Test Type: Fertility
Species: Rat, male
Application Route: Oral
Fertility: NOAEL: 800 mg/kg body weight
Result: Animal testing did not show any effects on fertility.
Test Type: Fertility
Species: Rat, female
Application Route: Oral
Fertility: LOAEL: 200 mg/kg body weight
Symptoms: Reduced fertility
Test Type: Fertility
Species: Rat, female
12 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Application Route: Oral
Fertility: NOAEL: 100 mg/kg body weight
Symptoms: Reduced fertility
Magnesium stearate:
Effects on fertility:

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

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Aspartame:
Effects on fertility:

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

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 DaysMontelukast:
Species
NOAEL
Application RouteExposure time
Remarks:::::

Monkey, male and female
150 - 300 mg/kg
Oral
53 Weeks
No significant adverse effects were reported
13 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
50 mg/kgOral
53 Weeks
No significant adverse effects were reported

Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Mouse
50 mg/kg
Oral
14 Weeks
No significant adverse effects were reported

Magnesium stearate:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

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

Titanium dioxide:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
24,000 mg/kg
Ingestion
28 DaysSpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rat
10 mg/m³
inhalation (dust/mist/fume)
2yAspartame:Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 4,000 mg/kg
Ingestion
104 WeeksAspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Montelukast:
Skin contact
Eye contact
Ingestion:::

Remarks: May irritate skin.
Symptoms: Severe irritation
Symptoms: upper respiratory tract infection, pharyngitis,
Headache, Cough, Abdominal pain, Diarrhea, Fever

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Cellulose:
Toxicity to fish:

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

Montelukast:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 0.0778 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: No toxicity at the limit of solubility.

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 0.0675 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility.

Toxicity to algae/aquaticplants:NOEC (Pseudokirchneriella subcapitata (green algae)): 100
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility.
EC50 (Pseudokirchneriella subcapitata (green algae)): > 100
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility.

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.073 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210
Remarks: No toxicity at the limit of solubility.
NOEC (Cyprinodon variegatus (sheepshead minnow)): 0.0816
mg/l
Exposure time: 7 dRemarks: No toxicity at the limit of solubility.

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

NOEC (Daphnia magna (Water flea)): 0.23 mg/l
Exposure time: 21 d
Remarks: No toxicity at the limit of solubility.

Toxicity to microorganisms

EC50: > 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility.

:

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Montelukast Tablet Formulation
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Revision Date:
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Magnesium stearate:
Toxicity to fish

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014:

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

Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to algae/aquaticplants:EL50 (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
No toxicity at the limit of solubility.
NOELR (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

Toxicity to microorganisms:

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

Titanium dioxide:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 (Skeletonema costatum (marine diatom)): > 10,000 mg/l
Exposure time: 72 h

Toxicity to microorganisms:

EC50: > 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

Aspartame:
Toxicity to fish:

LC50 (Danio rerio (zebra fish)): > 20 g/l
Exposure time: 96 h
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

ErC50 (Desmodesmus subspicatus (green algae)): > 100 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Montelukast:
Biodegradability:

Result: not rapidly degradable
Biodegradation: 0 %Exposure time: 28 d

Stability in water:

Hydrolysis: 50 %(21.7 h)

Magnesium stearate:
Biodegradability:

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

Aspartame:
Biodegradability:

Result: Readily biodegradable.
Method: OECD Test Guideline 301F

Montelukast:
Partition coefficient: noctanol/water:log Pow: > 4.3

Magnesium stearate:
Partition coefficient: noctanol/water:log Pow: > 4

Aspartame:
Partition coefficient: noctanol/water:log Pow: 0.07
Remarks: Calculation

Bioaccumulative potential
Components:

Mobility in soil
No data available

17 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste
handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

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

Combustible dust
Carcinogenicity

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.

18 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

US State Regulations
Pennsylvania Right To Know
D-mannitol
Cellulose
D-Glucose, 4-O-β-D-galactopyranosyl-, monohydrate
Montelukast
Croscarmellose sodium
Hydroxypropyl cellulose

69-65-89004-34-6
64044-51-5
151767-02-1
74811-65-7
9004-64-2

California Prop. 65
WARNING: This product can expose you to chemicals including Titanium dioxide, which is/are
known to the State of California to cause cancer. For more information go to
www.P65Warnings.ca.gov.
California Permissible Exposure Limits for Chemical Contaminants
Cellulose
Magnesium stearate

9004-34-6
557-04-0

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information
NFPA 704:

HMIS® IV:
Flammability

HEALTH1
Health00Special hazard*

0

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

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

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

CAL PEL:

NIOSH REL
OSHA Z-1::

OSHA Z-3:

ACGIH / TWACAL PEL / PELNIOSH REL / TWA:::

OSHA Z-1 / TWA
OSHA Z-3 / TWA::

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

California permissible exposure limits for chemical contaminants (Title 8, Article 107)
USA. NIOSH Recommended Exposure Limits
USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
8-hour, time-weighted average
Permissible exposure limit
Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
8-hour time weighted average
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;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:

04/06/2024

20 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Tablet Formulation
Version
9.0

Revision Date:
04/06/2024

SDS Number:
23093-00024

Date of last issue: 09/26/2023
Date of first issue: 10/17/2014

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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