SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:Loratadine / Montelukast Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

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

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

2. HAZARDS IDENTIFICATIONGHS classification of chemical productReproductive toxicity: Category 2
Short-term (acute) aquatic
hazard:Category 2

Long-term (chronic) aquatic
hazard:Category 2

GHS label elements
Hazard pictograms:

Signal word:

Warning

Hazard statements:

H361f Suspected of damaging fertility.
H411 Toxic to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
1 / 20SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P391 Collect spillage.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
Other hazards which do not result in classification
Important symptoms and out- : Dust contact with the eyes can lead to mechanical irritation.
lines of the emergency asContact with dust can cause mechanical irritation or drying ofsumed
the skin.
May form combustible dust concentrations in air during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Montelukast
Loratadine

CAS-No.
9004-34-6
151767-02-1
79794-75-5

Concentration (% w/w)>= 40 - < 50>= 1 - < 10>= 3 - < 10

ENCS No.

4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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.
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.
2 / 20SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Most important symptoms
and effects, both acute anddelayed:Protection of first-aiders:

Notes to physician:

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

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.

5. FIREFIGHTING 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
Metal oxides

Specific extinguishing methods:

Special protective equipment
for firefighters:

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

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

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

Environmental precautions:

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

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitable container 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 surfac3 / 20

SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

es, 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 and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
7. HANDLING AND STORAGE
Handling
Technical measures:

Local/Total ventilation
Advice on safe handling::

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
Use only with adequate ventilation.
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.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.
Keep in properly labelled containers.
Store locked up.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

4 / 20SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

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

CAS-No.

Value type
(Form ofexposure)

Cellulose
Montelukast

9004-34-6
151767-02-1

Loratadine

79794-75-5

TWA
TWA
Wipe limit
TWA
Wipe limit

Engineering measures:

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

Basis

ACGIH
Internal
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-face containment devices).
Minimize open handling.

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

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:tablet5 / 20SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Colour:No data available

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

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

Flammability (liquids):

Not applicable

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

No data available

Flash point:

Not applicable

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

Not applicableAuto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density

No data available:

No data available

Relative vapour density:

Not applicable

Explosive properties:

Not explosive
6 / 20SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form 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.

10. STABILITY AND REACTIVITY

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:
Acute oral toxicity:

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

Acute inhalation toxicity:

Remarks: No data available
7 / 20SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

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 sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Montelukast:
Remarks:

No data available
8 / 20SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

Loratadine:
Test Type
Exposure routes
Species
Assessment
ResultSDS Number:
4574878-00012

:
:
:
:
:

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Maximisation Test
DermalGuinea pig
Does not cause skin sensitisation.
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

Loratadine:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
9 / 20SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

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

Species:Monkey10 / 20

SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

Application RouteExposure time
NOAEL
ResultSDS Number:
4574878-00012

:
:
:
:

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Oral
17 Months
40 mg/kg body weight
negative

Reproductive toxicity
Suspected of damaging fertility.
Components:
Cellulose:
Effects on fertility

Effects on foetal development

Montelukast:
Effects on fertility:

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

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

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

Effects on foetal development:

Species: Rat, male
Application Route: Oral
Fertility: LOAEL: 64 mg/kg body weight
Result: Effects on fertility:

Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 48 mg/kg body weight
Result: Embryo-foetal toxicity
11 / 20

SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 48 mg/kg body weight
Result: Embryo-foetal 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 RouteExposure time
Remarks

:
:
:
:
:

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

Loratadine:
Species
NOAEL
LOAEL

:
:
:

Rat
4 mg/kg
8 mg/kg
12 / 20

SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Application RouteExposure timeTarget Organs
Remarks

:
:
:
:

Oral
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:

Remarks: May irritate skin.

Eye contact:

Symptoms: Severe irritation

Ingestion:

Symptoms: upper respiratory tract infection, pharyngitis,
Headache, Cough, Abdominal pain, Diarrhoea, Fever

Loratadine:
Ingestion:

Symptoms: Fatigue, Headache, dry mouth, Nausea

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:

EC50 (Daphnia magna (Water flea)): > 0.0675 mg/l
Exposure time: 48 h

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:

Toxicity to daphnia and otheraquatic invertebrates

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SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

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
mg/l
Exposure time: 72 h
14 / 20

SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Method: OECD Test Guideline 201
M-Factor (Acute aquatic toxicity)
Toxicity to fish (Chronic toxicity)

:

1

:

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

M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

:

1

:

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:log Pow: > 4.3

Bioaccumulative potential
Components:
Montelukast:
Partition coefficient: noctanol/water
Loratadine:

15 / 20

SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

Partition coefficient: noctanol/water

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08:

log Pow: 2.35:

log Koc: 5.25
Method: OECD Test Guideline 106

Mobility in soil
Components:
Loratadine:
Distribution among environmental compartments

Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name

:
:

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

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
16 / 20

SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

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

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.
Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
ERG Code:171

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
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SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Substances Subject to be Notified Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Miscellaneous dangerous substances and articles (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Miscellaneous dangerous substances and articles (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Classified as marine pollutant

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SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

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

not determined

IECSC

:

not determined:

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

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

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

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ACGIH / TWA:

8-hour, time-weighted average

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect
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SAFETY DATA SHEET

Loratadine / Montelukast Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
4574878-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/07/08

Loading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
JP / EN

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