SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Section 1: Identification
Product identifier:

Desloratadine Solid Formulation

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
Manufacturer or supplier's details
Company: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

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

E-mail address

EHSSTEWARD@organon.com:

Section 2: Hazard identification
Classification of the substance or mixture
Serious eye damage/eye irri- : Category 1
tationCarcinogenicity (Inhalation):

Category 2

Reproductive toxicity:

Category 2

GHS Label elements, including precautionary statements
Hazard pictograms:

Signal word:

DangerHazard statements:

H318 Causes serious eye damage.
H351 Suspected of causing cancer if inhaled.
H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been read1 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

and understood.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response:
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously withwater for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing. Immediately call a POISONCENTER/ doctor.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
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
Contact with dust can cause mechanical irritation or drying of the skin.
May form explosive dust-air mixture during processing, handling or other means.
Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Starch, oxidized
Desloratadine
Talc
Titanium dioxide

CAS-No.
9004-34-6
65996-62-5
100643-71-8
14807-96-6
13463-67-7

Concentration (% w/w)>= 20 -< 30>= 10 -< 20>= 3 -< 10>= 1 -< 10>= 1 -< 10Section 4: First-aid measures
Description of necessary first-aid measures
General advice: In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled: If inhaled, remove to fresh air.
Get medical attention.
In case of skin contact: 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.
In case of eye contact: In case of contact, immediately flush eyes with plenty of water
2 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

If swallowed:

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention immediately.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.

Most important symptoms and effects, both acute and delayed
Risks: Causes serious eye damage.
Suspected of causing cancer if inhaled.
Suspected of damaging fertility. Suspected of damaging theunborn child.
Contact with dust can cause mechanical irritation or drying of
the skin.
Protection of first-aiders: 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).
Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.
Section 5: Fire-fighting measures
Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

:

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

Special hazards arising from the substance or mixture
Specific hazards during fire- : Avoid generating dust; fine dust dispersed in air in sufficient
fighting
concentrations, 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
Oxides of phosphorus

Special protective actions for fire-fighters
Special protective equipment : In the event of fire, wear self-contained breathing apparatus.
for firefighters
Use personal protective equipment.
Specific extinguishing meth- : Use extinguishing measures that are appropriate to local cirods
cumstances 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.

3 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Section 6: Accidental release measures
Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
Environmental precautions
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 for containment and cleaning up
Methods for 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 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 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.
Section 7: Handling and storage
Precautions for safe handlingTechnical measures:

Local/Total ventilation
Advice on safe handling::

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
Use only with adequate ventilation.
Do not breathe dust.
Do not swallow.
Do not get in 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
Keep container tightly closed.
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 the
4 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

Hygiene measures

SDS Number:
49988-00021:

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

environment.
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.

Conditions for safe storage, including any incompatibilities
Conditions for safe storage: Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Materials to avoid: Do not store with the following product types:
Strong oxidizing agents
Section 8: Exposure controls/personal protection
Control parameters
Occupational Exposure Limits
Components

CAS-No.

Cellulose

9004-34-6

Starch, oxidized

65996-62-5

Desloratadine

100643-71-8

Talc

14807-96-6

Titanium dioxide

Appropriate engineering
control measures

13463-67-7:

Value type
(Form ofexposure)
PEL (longterm)
TWA
TWA (inhalable dust)
TWA
Wipe limit
PEL (longterm)
TWA (Respirable particulate matter)
PEL (longterm)

Control parameters / Permissible
concentration
10 mg/m3

Basis

10 mg/m3
0.5 mg/m3

ACGIH
ACGIH

20 µg/m3 (OEB 3)
200 µg/100 cm²
2 mg/m3

Internal
Internal
SG OEL

2 mg/m3

ACGIH

10 mg/m3

SG OELSG OEL

Ensure adequate ventilation, especially in confined areas.
Minimize workplace exposure concentrations.
Apply measures to prevent dust explosions.
Ensure that dust-handling systems (such as exhaust ducts,
dust collectors, vessels, and processing equipment) are designed in a manner to prevent the escape of dust into thework area (i.e., there is no leakage from the equipment).

Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: Wear the following personal protective equipment:
5 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Skin protection:

Respiratory protection:

Filter type
Hand protection:

Chemical resistant goggles must be worn.
If splashes are likely to occur, wear:
Face-shield
Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Particulates type

Material:

Chemical-resistant gloves

Remarks:

Choose gloves to protect hands against chemicals dependingon the concentration and quantity of the hazardous substance and specific to place of work. Breakthrough time is notdetermined for the product. Change gloves often! For special
applications, we recommend clarifying the resistance tochemicals of the aforementioned protective gloves with theglove manufacturer. Wash hands before breaks and at theend of workday.

Section 9: Physical and chemical properties
Appearance:

powderColour

:

white

Odour

:

No data available

Odour 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:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

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

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

6 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

No data available

Relative vapour density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, dynamic:

No data available

Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

Section 10: Stability and reactivity

Section 11: Toxicological information
7 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Information on likely routes of :exposure

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 2,000 mg/kg
Method: Calculation method

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

Desloratadine:
Acute oral toxicity:

LD50 (Rat): > 549 mg/kg

Components:

LD50 (Mouse): 353 mg/kg
LD50 (Monkey): > 250 mg/kg
Symptoms: Vomiting
Remarks: No mortality observed at this dose.
Talc:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Remarks: Based on data from similar materials

Titanium dioxide:
Acute oral toxicity:

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

Acute inhalation toxicity:

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

Skin corrosion/irritation
Not classified based on available information.

8 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Components:
Desloratadine:
SpeciesResult::RabbitNo skin irritation

Talc:
SpeciesResult::RabbitNo skin irritation

Titanium dioxide:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Causes serious eye damage.
Components:
Desloratadine:
Species
Remarks::

RabbitSevere eye irritation

Talc:
SpeciesResult::RabbitNo eye irritation

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

9 / 19SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Talc:
Exposure routes
SpeciesResult:::Skin contact
Humansnegative

Titanium dioxide:
Test Type
Exposure routes
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
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

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

Talc:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

Test Type: Chromosome aberration test in vitro
Species: Rat
10 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Application Route: Ingestion
Result: negative
Titanium dioxide:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

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

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

:
:
:
:

Rat
Ingestion
72 weeks
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.

Talc:
Species
Application RouteExposure time
Result

:
:
:
:

Mouse
inhalation (dust/mist/fume)
2 Years
negative

Titanium dioxide:
Species
Application RouteExposure time
MethodResult

:
:
:
:
:

Rat
inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
11 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Remarks:

The mechanism or mode of action may not be relevant in humans.

Carcinogenicity - Assessment:

Limited evidence of carcinogenicity in inhalation studies withanimals.

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

Effects on foetal development

Desloratadine:
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: 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 rele12 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

vant 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

Talc:
Effects on foetal development:

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

:

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

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

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 Days

Starch, oxidized:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
22,500 mg/kg
Ingestion
90 Days

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.
13 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

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

Species
NOAEL
Application RouteExposure time
Symptoms

:
:
:
:
:

Monkey6 mg/kgOral
3 Months
Gastrointestinal disturbance, Fatigue

Titanium dioxide:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

:
:
:
:

Rat
10 mg/m3
inhalation (dust/mist/fume)
2 yr

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

Remarks: May cause respiratory tract irritation.
Symptoms: Eye irritation
Symptoms: dry mouth, muscle pain, Fatigue, Drowsiness,sore throat, painful menstration

Section 12: Ecological information
Toxicity
Components:
Cellulose:
14 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Toxicity to fish:

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

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
Talc:
Toxicity to fish:

LC50 (Brachydanio rerio (zebrafish)): > 100,000 mg/l
Exposure time: 24 h

Titanium dioxide:
Toxicity to fish:

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

15 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to algae/aquaticplants:

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

Toxicity to microorganisms:

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

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

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:

log Pow: 1.24
Method: OECD Test Guideline 107:

log Koc: 3.00
Method: OECD Test Guideline 106

Bioaccumulative potential
Components:
Desloratadine:
Partition coefficient: noctanol/water
Mobility in soil
Components:
Desloratadine:
Distribution among environmental compartments
Other adverse effects
No data available

16 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Section 13: Disposal considerations
Disposal methods
Waste from residues:

Contaminated packaging:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
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 information
International Regulations
UNRTDGUN numberUN proper shipping name
Transport hazard class(es)Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
UN proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN numberUN proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Transport in bulk according to IMO instruments
Not applicable for product as supplied.
Special precautions for user
Not applicable

17 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

Section 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
Workplace Safety and Health Act and Workplace Safety and Health (General Provisions) Regulations: This product is subjected to the SDS, labelling, PEL and other requirements in the
Act/Regulations.
Environmental Protection and Management Act and: Not applicable
Environmental Protection and Management (Hazardous Substances) Regulations
Fire Safety (Petroleum and Flammable Materials)
Regulations:

Not applicable

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

not determined

IECSC

:

not determined

Revision Date:

06.04.2024

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/

Section 16: Other information

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

dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
SG OEL: Singapore. Workplace Safety and Health (General Provisions)
Regulations - First Schedule Permissible Exposure Limits of
Toxic Substances.
ACGIH / TWA
SG OEL / PEL (long term)::

8-hour, time-weighted average
Permissible Exposure Level (PEL) Long Term

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 with18 / 19

SAFETY DATA SHEET

Desloratadine Solid Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
49988-00021

Date of last issue: 30.09.2023
Date of first issue: 23.01.2015

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.
SG / EN

19 / 19