SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Desloratadine Liquid 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 productNot a hazardous substance or mixture according to the Globally Harmonised System (GHS).
GHS label elements
No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) required
Other hazards which do not result in classification
None known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Propylene glycol

CAS-No.
57-55-6

Concentration (% w/w)>= 10 - < 20

ENCS No.
2-234

Desloratadine
Ethylenediaminetetraacetic aciddisodium salt

100643-71-8
139-33-3>= 0.025 - < 0.1< 0.1

2-1265

4. FIRST AID MEASURES
1 / 19SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

If inhaled:

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:

If inhaled, remove to fresh air.
Get medical attention if symptoms occur.
Wash with water and soap as a precaution.
Get medical attention if symptoms occur.
Flush eyes with water as a precaution.
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.
None known.

::

No special precautions are necessary for first aid responders.
Treat symptomatically and supportively.

Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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

:

Exposure to combustion products may be a hazard to health.

:

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

5. FIREFIGHTING MEASURES

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.
Prevent spreading over a wide area (e.g. by containment or oilbarriers).
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

:

2 / 19SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

Methods and materials forcontainment and cleaning up

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23:

Soak up with inert absorbent material.
For large spills, provide dyking or other appropriate containment to keep material from spreading. If dyked material canbe pumped, store recovered material in appropriate container.
Clean up remaining materials from spill with suitable absorbent.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

Handling
Technical measures:

Local/Total ventilation
Advice on safe handling::

Avoidance of contact
Hygiene measures::

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
Use only with adequate ventilation.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
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.

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

7. HANDLING AND STORAGE

Keep in properly labelled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

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)

Desloratadine

100643-71-8

TWA
Wipe limit

3 / 19Control parameters / Reference
concentration /Permissible concentration
20 µg/m3 (OEB 3)
200 µg/100 cm²

Basis

Internal
Internal

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

Engineering measures

SDS Number:
771472-00018:

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Ensure adequate ventilation, especially in confined areas.
Minimize workplace exposure concentrations.

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
Remarks
Eye protection::

Skin and body protection:

Wash hands before breaks and at the end of workday.
Wear the following personal protective equipment:
Safety glasses
Skin should be washed after contact.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:liquidColour

:

clear

Odour

:

sweet

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):

Not applicable

Flammability (liquids):

No data available

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

No data available

Flash point:

No data available

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

4 / 19SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Viscosity
Viscosity, dynamic:

No data available

Viscosity, kinematic:

No data available:

solublePartition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Solubility(ies)
Water solubility

Density

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23:

No data available

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Can react with strong oxidizing agents.

:::

None known.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
5 / 19SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Components:
Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Assessment: The substance or mixture has no acute dermal
toxicity

Desloratadine:
Acute oral toxicity:

LD50 (Rat): > 549 mg/kg
LD50 (Mouse): 353 mg/kg
LD50 (Monkey): > 250 mg/kg
Symptoms: Vomiting
Remarks: No mortality observed at this dose.

Ethylenediaminetetraacetic acid disodium salt:
Acute oral toxicity: LD50 (Rat): 2,800 mg/kg
Acute inhalation toxicity:

LC50 (Rat, male): > 1 mg/l
Exposure time: 6 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 412

Skin corrosion/irritation
Not classified based on available information.
Components:
Propylene glycol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Desloratadine:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.

6 / 19SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Components:
Propylene glycol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

Desloratadine:
Species
Remarks::

RabbitSevere eye irritation

Ethylenediaminetetraacetic acid disodium salt:
Species: Rabbit
Result: No eye irritation
Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Propylene glycol:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Desloratadine:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
DermalGuinea pig
negative

Ethylenediaminetetraacetic acid disodium salt:
Test Type: Maximisation Test
Exposure routes: Skin contact
Species: Guinea pig
Method: OECD Test Guideline 406
Result: negative
Remarks: Based on data from similar materials
Germ cell mutagenicity
Not classified based on available information.

7 / 19SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Components:
Propylene glycol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

Genotoxicity in vivo:

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

Desloratadine:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosomal aberration
Test system: Human lymphocytes
Result: negative

Genotoxicity in vivo:

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

Ethylenediaminetetraacetic acid disodium salt:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Based on data from similar materials
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Remarks: Based on data from similar materials
Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Method: OECD Test Guideline 474
Result: negative

8 / 19SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Carcinogenicity
Not classified based on available information.
Components:
Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

Desloratadine:
Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Oral
2 Years
negative

Species
Application Route
LOAEL
ResultTarget Organs
Remarks

:
:
:
:
:
:

Rat
Oral
10 mg/kg body weightequivocal
Liver
Based on data from similar materials
The mechanism or mode of action may not be relevant in
humans.

Ethylenediaminetetraacetic acid disodium salt:
Species: Rat
Application Route: Ingestion
Exposure time
: 103 weeks
Result: negative
Remarks: Based on data from similar materials
Reproductive toxicity
Not classified based on available information.
Components:
Propylene glycol:
Effects on fertility

Effects on foetal development:

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

Test Type: Embryo-foetal development
Species: Mouse
Application Route: Ingestion
Result: negative

Desloratadine:
9 / 19SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

Effects on fertility

SDS Number:
771472-00018:

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Test Type: Fertility
Species: Rat, male
Application Route: Oral
Fertility: LOAEL: 12 mg/kg body weight
Symptoms: Reduced fertility
Result: positive
Remarks: The mechanism or mode of action may not be relevant in humans.
Test Type: Fertility
Species: Rat, female
Fertility: NOAEL: 3 mg/kg body weight
Symptoms: No effects on fertility
Result: negative

Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: NOAEL: 30 mg/kg body weight
Result: No teratogenic effects
Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 9 mg/kg body weight
Symptoms: Preimplantation loss, Reduced body weight
Result: Specific developmental abnormalities
Remarks: The mechanism or mode of action may not be relevant in humans.
Test Type: Two-generation study
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 18 mg/kg body weight
Result: No adverse effects

Reproductive toxicity - Assessment:

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

Ethylenediaminetetraacetic acid disodium salt:
Effects on fertility: Test Type: Four-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative
10 / 19

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Components:
Ethylenediaminetetraacetic acid disodium salt:
Exposure routes: inhalation (dust/mist/fume)Target Organs: Respiratory Tract
Assessment: May cause damage to organs through prolonged or repeatedexposure.
Repeated dose toxicity
Components:
Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat, male>= 1,700 mg/kg
Ingestion
2 yr

Desloratadine:
Species
LOAEL
Application RouteExposure timeTarget Organs
Remarks

:
:
:
:
:
:

Rat
30 mg/kg
Oral
3 Months
KidneySignificant toxicity observed in testing
The mechanism or mode of action may not be relevant in
humans.

Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:
:

Monkey6 mg/kg
12 mg/kg
Oral
3 Months
Central nervous system
Gastrointestinal disturbanceSpecies
NOAEL
Application RouteExposure time
Remarks:::::

Monkey40 mg/kg
Oral
17 Months
No significant adverse effects were reported

SpeciesNOAEL::

Monkey6 mg/kg
11 / 19

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

Application RouteExposure time
Symptoms

SDS Number:
771472-00018:::

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Oral
3 Months
Gastrointestinal disturbance, Fatigue

Ethylenediaminetetraacetic acid disodium salt:
Species: Rat
NOAEL: 500 mg/kg
Application Route: Ingestion
Exposure time: 13 Weeks
Species
LOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
0.03 mg/l
inhalation (dust/mist/fume)
4 Weeks
OECD Test Guideline 412

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Desloratadine:
Inhalation:

Remarks: May cause respiratory tract irritation.

Eye contact:

Symptoms: Eye irritation

Ingestion:

Symptoms: dry mouth, muscle pain, Fatigue, Drowsiness,sore throat, painful menstration:

LC50 (Oncorhynchus mykiss (rainbow trout)): 40,613 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 18,340 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Skeletonema costatum (marine diatom)): 19,300 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Propylene glycol:
Toxicity to fish

Toxicity to daphnia and other :aquatic invertebrates (Chron-

NOEC (Ceriodaphnia dubia (water flea)): 13,020 mg/l
Exposure time: 7 d
12 / 19

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

ic toxicity)
Toxicity to microorganisms:

NOEC (Pseudomonas putida): > 20,000 mg/l
Exposure time: 18 h

Desloratadine:
Toxicity to fish:

LC50 (Lepomis macrochirus (Bluegill sunfish)): 9.2 mg/l
Exposure time: 96 h
Method: FDA 4.11

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 9.6 mg/l
Exposure time: 48 h
Method: FDA 4.08

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 1.6
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 0.36
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.12 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)): 0.48 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Toxicity to microorganisms

EC50 (Natural microorganism): 53.7 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209:

NOEC (Natural microorganism): 12 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Ethylenediaminetetraacetic acid disodium salt:
Toxicity to fish
: LC50 (Lepomis macrochirus (Bluegill sunfish)): > 100 mg/l
Exposure time: 96 h
Remarks: Based on data from similar materials
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 140 mg/l
Exposure time: 48 h
Method: DIN 38412

Toxicity to algae/aquatic:

ErC50 (Pseudokirchneriella subcapitata (green algae)): > 100
13 / 19

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

plantsDate of last issue: 2023/09/30
Date of first issue: 2016/06/23

mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
EC10 (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

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

NOEC (Daphnia magna (Water flea)): 25 mg/l
Exposure time: 21 d
EC10 (activated sludge): > 500 mg/l
Exposure time: 30 min
Method: OECD Test Guideline 209

Persistence and degradability
Components:
Propylene glycol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 98.3 %Exposure time: 28 d
Method: OECD Test Guideline 301F

Desloratadine:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 67.4 %Exposure time: 28 d
Method: OECD Test Guideline 314
Result: Not readily biodegradable.
Biodegradation: 0 %Exposure time: 28 d
Method: FDA 3.11

Stability in water:

Hydrolysis: < 10 % at 50 °C(5 d)Method: FDA 3.09

Ethylenediaminetetraacetic acid disodium salt:
Biodegradability: Result: Not readily biodegradable.
Biodegradation: 2 %Exposure time: 28 d
Method: OECD Test Guideline 301D

14 / 19

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Bioaccumulative potential
Components:
Propylene glycol:
Partition coefficient: noctanol/water:log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8

Desloratadine:
Partition coefficient: noctanol/water:log Pow: 1.24
Method: OECD Test Guideline 107

Ethylenediaminetetraacetic acid disodium salt:
Bioaccumulation: Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): < 500
Remarks: Based on data from similar materials
Partition coefficient: noctanol/water:log Pow: -4.3:

log Koc: 3.00
Method: OECD Test Guideline 106

Mobility in soil
Components:
Desloratadine:
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.

::

Not applicableNot applicable

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name15 / 19

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

Class
Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
771472-00018

:
:
:
:
:

Not applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

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
Not applicable
15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical namePropane-1,2-diol
Sodium salt of 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
16 / 19

Number
106
268

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical namepropane-1,2-diol

Concentration (%)>=10 - <20

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical namepropane-1,2-diol

Remarks
From April 1st, 2025

Remarks
From April 1st, 2025

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

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SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

Explosive Control Law
Not applicable
Vessel Safety Law
Not regulated as a dangerous good
Aviation Law
Not regulated as a dangerous goodMarine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Not classified as marine pollutant

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

not determined

IECSC

:

not determined

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

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

yyyy/mm/dd

Full text of other abbreviations

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with18 / 19

SAFETY DATA SHEET

Desloratadine Liquid Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
771472-00018

Date of last issue: 2023/09/30
Date of first issue: 2016/06/23

x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance 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

19 / 19