SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

SECTION 1. IDENTIFICATION
Product name:

Montelukast Granules 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
GHS label elements
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.

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.
Montelukast
151767-02-1
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 0.1 - < 1

SECTION 4. FIRST AID MEASURES
General advice:

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

If inhaled:

If inhaled, remove to fresh air.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayedProtection of first-aiders
Notes to physician:::

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

Get medical attention if symptoms occur.
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.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
No special precautions are necessary for first aid responders.
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides

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.
Wear self-contained breathing apparatus for firefighting if
necessary.
Use personal protective equipment.

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

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.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

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::

Conditions for safe storage:

Materials to avoid:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
Use only with adequate ventilation.
Do not breathe dust.
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)
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

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.

Montelukast

151767-02-1

Engineering measures:

Value type
(Form ofexposure)
TWA
Wipe limit

Control parameters / Permissible
concentration
40 µg/m3 (OEB 3)
400 µg/100 cm²

Basis

Internal
Internal

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.
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

Hygiene measures

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

:

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColor:

No data available

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

No data available

Flammability (solid, gas):

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

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
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)5 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

Water solubility:

No data available

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 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:
Montelukast:
Acute oral toxicity:

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

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

Acute inhalation toxicity:

Remarks: No data available

Acute dermal toxicity:

Remarks: No data available

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

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

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

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

Genotoxicity in vivo

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014:

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

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

Components:
Montelukast:
Genotoxicity in vitro

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

Carcinogenicity
Not classified based on available information.
Product:
Species
Application RouteExposure time
Dose
Result

:
:
:
:
:

Rat
Oral
2 Years
200 mg/kg body weight
negative

Species
Application RouteExposure time
Dose
Result

:
:
:
:
:

Mouse
Oral
92 weeks
100 mg/kg body weight
negative

:
:

Rat
Oral

Components:
Montelukast:
Species
Application Route8 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Exposure time
Result::2 Years
negative

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Oral
92 weeks
negative

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

IARC

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

OSHA

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

NTP

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

Reproductive toxicity
Not classified based on available information.
Product:
Effects on fertility:

Test Type: Fertility
Species: Rat, male
Application Route: Oral
Fertility: NOAEL Parent: 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 Parent: 200 mg/kg body weight
Symptoms: Reduced fertility

Components:
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
Application Route: Oral
Fertility: NOAEL: 100 mg/kg body weight
Symptoms: Reduced fertility
9 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

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

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

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

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Product:
Skin contact
Eye contact
Ingestion:::

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

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

Components:
Montelukast:
Skin contact
Eye contact
Ingestion

10 / 15

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
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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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

Persistence and degradability
Components:
Montelukast:
Biodegradability:

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

Stability in water:

Hydrolysis: 50 %(21.7 h):log Pow: > 4.3

Bioaccumulative potential
Components:
Montelukast:
Partition coefficient: noctanol/water
Mobility in soil
No data available
Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste
handling site for recycling or disposal.
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 good

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

Special 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

SARA 313:

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

US State Regulations
Pennsylvania Right To Know
D-mannitol

69-65-8

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information

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SAFETY DATA SHEET
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Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

NFPA 704:

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014
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
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
CAL PEL / PEL: Permissible exposure limit
OSHA Z-3 / TWA: 8-hour time weighted average
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Montelukast Granules Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
23015-00024

Date of last issue: 03/20/2023
Date of first issue: 10/17/2014

REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

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

Revision Date:

09/26/2023

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

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