SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

SECTION 1. IDENTIFICATION
Product name:Loratadine / Montelukast 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
Reproductive toxicity:

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.
H361f Suspected of damaging fertility.

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 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

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
Loratadine
79794-75-5
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 30 - < 50>= 5 - < 10>= 5 - < 10

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:

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:

If inhaled, remove to fresh air.
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.
Get medical attention.
Rinse mouth thoroughly with water.
Suspected of damaging fertility.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
2 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

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
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:

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.
3 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

Do not breathe dust.
Do not swallow.
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 locked up.
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 / 19

Value type
(Form ofexposure)
TWA
TWA (Respirable)

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

Basis

ACGIH
NIOSH REL

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Montelukast

151767-02-1

Loratadine

79794-75-5

Engineering measures:

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA
Wipe limit
TWA
Wipe limit

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

40 µg/m3 (OEB 3)
400 µg/100 cm²
40 µg/m3 (OEB 3)
400 µg/100 cm²Internal
Internal
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:

Hygiene measures:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets,
disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
5 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

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:

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:

Not applicable

Flammability (solid, gas):

May form combustible dust concentrations in air during processing, handling or other means.

Flammability (liquids):

Not applicable

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

Not applicable

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available:

Not applicable:

No data available

Partition coefficient: noctanol/water
Autoignition temperature

6 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

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 combustible dust concentrations in air 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

Acute dermal toxicity:

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

Montelukast:
7 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

Acute oral toxicity

SDS Number:
4574883-00011:

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

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

Loratadine:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 0.05 mg/l
Exposure time: 1 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity

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

Loratadine:
SpeciesResult::RabbitNo skin irritation

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

Loratadine:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
8 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

Components:
Montelukast:
Remarks:

No data available

Loratadine:
Test Type
Routes of exposure
Species
Assessment
Result:::::Maximization Test
DermalGuinea pig
Does not cause skin sensitization.
negative

Germ cell mutagenicity
Not classified based on available information.
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

9 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

Loratadine:
Genotoxicity in vitro

SDS Number:
4574883-00011:

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Cell type: Bone marrow
Application Route: Oral
Result: negative

Germ cell mutagenicity Assessment:

Weight of evidence does not support classification as a germ
cell mutagen.

Carcinogenicity
Not classified based on available information.
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

Loratadine:
Species
Application RouteExposure time
LOAEL
Result

:
:
:
:
:

Rat
Oral
2 Years
10 mg/kg body weight
positive

10 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

Species
Application RouteExposure time
NOAEL
ResultSDS Number:
4574883-00011
:
:
:
:
:

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

MonkeyOral
17 Months
40 mg/kg body weight
negative

IARC

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

OSHA

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

NTP

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

Reproductive toxicity
Suspected of damaging fertility.
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
Application Route: Oral
Fertility: NOAEL: 100 mg/kg body weight
Symptoms: Reduced fertility

Loratadine:
Effects on fertility:

Species: Rat, male
11 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

Application Route: Oral
Fertility: LOAEL: 64 mg/kg body weight
Result: Effects on fertility.
Effects on fetal development:

Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 48 mg/kg body weight
Result: Embryo-fetal toxicity.
Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 48 mg/kg body weight
Result: Embryo-fetal toxicity.
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 12 mg/kg body weight

Reproductive toxicity - Assessment:

Some evidence of adverse effects on sexual function andfertility, based on animal experiments.

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

Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

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

Species
NOAEL
Application Route

:
:
:

Mouse
50 mg/kg
Oral
12 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

Exposure time
Remarks::

14 Weeks
No significant adverse effects were reported

Loratadine:
Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs
Remarks

:
:
:
:
:
:
:

Rat
4 mg/kg
8 mg/kgOral
180 Days
Central nervous system
Effects are of limited toxicological significance.

Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs
Remarks

:
:
:
:
:
:
:

Monkey0.4 mg/kg
4 mg/kgOral
180 Days
Central nervous system
Effects are of limited toxicological significance.

Aspiration 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

Loratadine:
Ingestion:

Symptoms: Fatigue, Headache, dry mouth, Nausea

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.
13 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

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.

Loratadine:
Toxicity to fish:

LC50 (Lepomis macrochirus (Bluegill sunfish)): 0.382 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 0.83 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 0.95
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 0.053
14 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.084 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210

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

NOEC (Daphnia magna (Water flea)): 0.078 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Toxicity to microorganisms

EC50: > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209:

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)

Loratadine:
Biodegradability:

Result: not rapidly degradable
Biodegradation: 50 %Exposure time: 20 d
Method: OECD Test Guideline 314

Stability in water:

Degradation half life (DT50): 283 d

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

Loratadine:
Partition coefficient: noctanol/water:log Pow: 2.35

Bioaccumulative potential
Components:

15 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

Mobility in soil
Components:
Loratadine:
Distribution among environmental compartments:

log Koc: 5.25
Method: OECD Test Guideline 106

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
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Loratadine)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Loratadine)
9
III
Miscellaneous
956

:

956

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group::

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Loratadine)
9
III

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

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

LabelsEmS Code
Marine pollutant:::

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

9
F-A, S-F
yes

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

:
:

Class
Packing group
LabelsERG Code
Marine pollutant
Remarks

:
:
:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Loratadine)
9
III
CLASS 9171
yes(Loratadine)
Above applies only to containers over 119 gallons or 450
liters.
Shipment by ground under DOT is non-regulated; however it
may be shipped per the applicable hazard classification tofacilitate multi-modal transport involving ICAO (IATA) or IMO.

Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Combustible dust
Reproductive toxicity

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
Cellulose
LactoseMontelukast

9004-34-6
63-42-3
151767-02-1
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

Loratadine
Croscarmellose sodium

79794-75-5
74811-65-7

California Permissible Exposure Limits for Chemical Contaminants
Cellulose

9004-34-6

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

2

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)
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
ACGIH / TWA: 8-hour, time-weighted average
CAL PEL / PEL: Permissible exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
OSHA Z-1 / TWA: 8-hour time weighted average
OSHA Z-3 / TWA: 8-hour time weighted average
18 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Loratadine / Montelukast Formulation
Version
2.1

Revision Date:
09/30/2023

SDS Number:
4574883-00011

Date of last issue: 04/04/2023
Date of first issue: 07/08/2019

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:

09/30/2023

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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