SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:

Desloratadine Solid Formulation

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub: Pharmaceuticalstance/Mixture
Recommended restrictions
on use:Not applicable

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
Shotton Lane
NE23 3JU Cramlington NU - Great Britain
Telephone:+44 1 670 59 32 05

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK
SI 2019/720, and UK SI 2020/1567)
Serious eye damage, Category 1
Reproductive toxicity, Category 2
Long-term (chronic) aquatic hazard, Category 3

H318: Causes serious eye damage.
H361fd: Suspected of damaging fertility. Suspectedof damaging the unborn child.
H412: Harmful to aquatic life with long lasting effects.

2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK SI
2019/720, and UK SI 2020/1567)

1 / 21SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Hazard pictograms:

Signal word:

DangerHazard statements:

H318
H361fdH412

Precautionary statements:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Causes serious eye damage.
Suspected of damaging fertility. Suspected ofdamaging the unborn child.
Harmful to aquatic life with long lasting effects.

Prevention:
P201
Obtain special instructions before use.
P273
Avoid release to the environment.
P280
Wear protective gloves/ protective clothing/ eyeprotection/ face protection.
Response:
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiouslywith water for several minutes. Remove contactlenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
P405

Store locked up.

Hazardous components which must be listed on the label:
Desloratadine
EUH212
Warning! Hazardous respirable dust may be formed when used. Do not breathedust.
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
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
3.2 Mixtures
Components
Chemical name

Desloratadine

CAS-No.
EC-No.
Index-No.
Registration number
100643-71-8
2 / 21

Classification

Concentration(% w/w)

Acute Tox. 4; H302>= 3 - < 10

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021
Eye Dam. 1; H318
Repr. 2; H361fd
Aquatic Chronic 2;
H411

Substances with a workplace exposure limit :Cellulose
9004-34-6
232-674-9
Starch, oxidized
65996-62-5
Talc

14807-96-6
238-877-9
13463-67-7
236-675-5

Titanium dioxide>= 20 - < 30>= 10 - < 20>= 1 - < 10>= 1 - < 10

For explanation of abbreviations see section 16.

SECTION 4: First aid measures
4.1 Description of 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.
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).

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
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention immediately.

If swallowed:

If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.

4.2 Most important symptoms and effects, both acute and delayed
Risks: Causes serious eye damage.
Suspected of damaging fertility. Suspected of damaging the
3 / 21SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

unborn child.
Contact with dust can cause mechanical irritation or drying of
the skin.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:

None known.

5.2 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

5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods:

Carbon oxides
Metal oxides
Oxides of phosphorus:

In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

:

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.

SECTION 6: Accidental release measures
6.1 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).

4 / 21SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

6.2 Environmental precautions
Environmental precautions

SDS Number:
9371548-00007:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
If spillage enters rivers or watercourses, inform the Environment Agency (emergency telephone number 0800 807060).

6.3 Methods and material 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.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handlingTechnical measures:

Local/Total ventilation
Advice on safe handling::

Hygiene measures:

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 theenvironment.
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.
5 / 21SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Keepareas and containers
tightly closed. Store in accordance with the particular national
regulations.
Advice on common storage

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents:

No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
dust of any kind
10 mg/m3
Value type (Form of exposure): TWA (Inhalable)
Basis: GB EH40
4 mg/m3
Value type (Form of exposure): TWA (Respirable fraction)
Basis: GB EH40
Components
Cellulose

Starch, oxidized

Desloratadine

Talc
Titanium dioxide

CAS-No.

Value type (Form Control parametersof exposure)9004-34-6
TWA (inhalable
10 mg/m3
dust)
TWA (Respirable 4 mg/m3
dust)
STEL (inhalable
20 mg/m3
dust)65996-62-5
TWA (inhalable
10 mg/m3
dust)
Further information: Capable of causing occupational asthma.
STEL (inhalable
30 mg/m3
dust)
Further information: Capable of causing occupational asthma.
100643-71TWA
20 µg/m3 (OEB 3)
8
Wipe limit
200 µg/100 cm²14807-96-6
TWA (Respirable 1 mg/m3
dust)
13463-67-7
TWA (inhalable
10 mg/m3
dust)
TWA (Respirable 4 mg/m3
dust)

6 / 21Basis
GB EH40
GB EH40
GB EH40
GB EH40

GB EH40

Internal
Internal
GB EH40
GB EH40
GB EH40SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

8.2 Exposure controls
Engineering measures
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 the work area
(i.e., there is no leakage from the equipment).
Personal protective equipment
Eye/face protection: Wear the following personal protective equipment:
Chemical resistant goggles must be worn.
If splashes are likely to occur, wear:
Face-shield
Equipment should conform to BS EN 166
Hand protection
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.
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.
Equipment should conform to BS EN 143
Particulates type (P)Skin and body protection:

Respiratory protection:

Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: powderColour: whiteOdour: 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
7 / 21SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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.

Upper explosion limit / Upper
flammability limit:

No data available

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::

No data available
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.

9.2 Other information
Flammability (liquids):

No data available

Molecular weight:

No data available

Particle size:

No data available

Solubility(ies)
Water solubility
Partition coefficient: noctanol/water
Auto-ignition temperature

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.

8 / 21SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

Heat, flames and sparks.
Avoid dust formation.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on toxicological effects
Information on likely routes of : Inhalation
exposure
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:

LD50 (Rat): > 549 mg/kg

Components:
Desloratadine:
Acute oral toxicity

LD50 (Mouse): 353 mg/kg
LD50 (Monkey): > 250 mg/kg
Symptoms: Vomiting
Remarks: No mortality observed at this dose.
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
9 / 21SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Acute dermal toxicity:

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

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.
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:
Species:

Rabbit10 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

ResultSDS Number:
9371548-00007:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

No 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

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:
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

Cellulose:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
11 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

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
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
Not classified based on available information.
Components:
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.

Cellulose:
Species:Rat
12 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Application RouteExposure time
Result:::Ingestion
72 weeks
negative

Talc:
Species
Application RouteExposure time
Result

:
:
:
:

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

Titanium dioxide:
Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
The mechanism or mode of action may not be relevant in humans.

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

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
13 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

Cellulose:
Effects on fertility

Effects on foetal development

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: 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: 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:
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.

14 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

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 DaysTitanium 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:
15 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

Inhalation
Eye contact
Ingestion

SDS Number:
9371548-00007:::

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

SECTION 12: Ecological information
12.1 Toxicity
Components:
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 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

Toxicity to fish (Chronic toxicity):

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

Cellulose:
Toxicity to fish:

NOEC: 0.12 mg/l
Exposure time: 32 d
Species: Pimephales promelas (fathead minnow)
Method: OECD Test Guideline 210
NOEC: 0.48 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)
Method: OECD Test Guideline 211

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
16 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Exposure time: 48 h
Remarks: Based on data from similar materials
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

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

12.2 Persistence and degradability
Components:
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

Cellulose:
Biodegradability:

Result: Readily biodegradable.

:

log Pow: 1.24
Method: OECD Test Guideline 107

12.3 Bioaccumulative potential
Components:
Desloratadine:
Partition coefficient: noctanol/water

17 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

12.4 Mobility in soil
Components:
Desloratadine:
Distribution among environmental compartments:

log Koc: 3.00
Method: OECD Test Guideline 10612.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.

:

This substance/mixture does not contain components considered to have endocrine disrupting properties for environment
according to UK REACH Article 57(f).

12.6 Other adverse effects
Product:
Endocrine disrupting potential

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

SECTION 14: Transport information
14.1 UN number
ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous good

14.2 UN proper shipping name18 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

14.3 Transport hazard class(es)14.4 Packing group

14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Not applicable
14.7 Transport in bulk according to Annex II of Marpol and the IBC CodeRemarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
Relevant EU provisions transposed through retained EU law
UK REACH List of restrictions (Annex 17)
UK REACH Candidate list of substances of very highconcern (SVHC) for Authorisation
The Persistent Organic Pollutants Regulations (retained
Regulation (EU) 2019/1021 as amended for Great Britain)
Regulation (EC) No 1005/2009 on substances that deplete the ozone layer
UK REACH List of substances subject to authorisation
19 / 21::

Not applicableNot applicable:Not applicable:Not applicable:Not applicableSAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021(Annex XIV)GB Export and import of hazardous chemicals - Prior: Not applicable
Informed Consent (PIC) Regulation
Control of Major Accident Hazards Regulations 2015 (COMAH)
Not applicable
Other regulations:
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to new and expectant mothers at work contained in Regulation 16 to 18) and of thePregnant Workers Directive 92/85/EEC.
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to protection of young people at work contained in Regulation 19) and of Directive
94/33/EC on the protection of young people at work.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined15.2 Chemical safety assessment
A Chemical Safety Assessment has not been carried out.

SECTION 16: Other information
Other information:

Items where changes have been made to the previous version
are highlighted in the body of this document by two verticallines.

Full text of H-Statements
H302
H318
H361fd

:
:
:

H411

:

Harmful if swallowed.
Causes serious eye damage.
Suspected of damaging fertility. Suspected of damaging theunborn child.
Toxic to aquatic life with long lasting effects.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Aquatic Chronic: Long-term (chronic) aquatic hazard
Eye Dam.
: Serious eye damage
Repr.
: Reproductive toxicity
GB EH40: UK. EH40 WEL - Workplace Exposure Limits
GB EH40 / TWA: Long-term exposure limit (8-hour TWA reference period)
GB EH40 / STEL
: Short-term exposure limit (15-minute reference period)
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA 20 / 21

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Desloratadine Solid Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371548-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

European Chemicals Agency; EC-Number - European Community number; 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; 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 and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China;
IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL
- Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization;
KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of very high concern; TCSI - Taiwan Chemical Substance Inventory; 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
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/

Classification of the mixture:

Classification procedure:

Eye Dam. 1

H318

Calculation method

Repr. 2

H361fdCalculation method

Aquatic Chronic 3

H412

Calculation method

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.
GB / EN

21 / 21