SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

SECTION 1. IDENTIFICATION
Product name:

Desloratadine Solid Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: 30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302
Telephone: 1-551-430-6000
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Combustible dust
Serious eye damage:

Category 1

Carcinogenicity (Inhalation):

Category 2

Reproductive toxicity:

Category 2

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
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 readand understood.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
1 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

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.
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
Contact with dust can cause mechanical irritation or drying of the skin.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
Cellulose
9004-34-6
Starch, oxidized
65996-62-5
Desloratadine
100643-71-8
Talc
14807-96-6
Titanium dioxide
13463-67-7
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 20 - < 30>= 10 - < 20>= 1 - < 5>= 1 - < 5>= 1 - < 5

SECTION 4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
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, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Causes serious eye damage.
2 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

and effects, both acute anddelayedProtection of first-aiders:

Notes to physician:

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

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.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides
Metal oxides
Oxides of phosphorus

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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

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

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

Environmental precautions:

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

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitablecontainer for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on
3 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

surfaces, as these may form an explosive mixture if they are
released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation
Advice on safe handling::

Conditions for safe storage:

Materials to avoid:

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.
Keep in properly labeled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
inert or nuisance dust
50 Million particles per cubic footValue type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
15 mg/m³
Value type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
5 mg/m³
Value type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
4 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

15 Million particles per cubic footValue type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
Dust, nuisance dust and particulates

10 mg/m³
Value type (Form of exposure): PEL (Total dust)
Basis: CAL PEL
5 mg/m³
Value type (Form of exposure): PEL (respirable dust fraction)
Basis: CAL PEL

Components

CAS-No.

Cellulose

9004-34-6

Starch, oxidized

65996-62-5

Desloratadine

100643-71-8

Talc

14807-96-6

Titanium dioxide

Engineering measures

13463-67-7:

Value type
(Form ofexposure)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA (inhalable dust)
TWA
Wipe limit
TWA (Dust)

TWA (Respirable)
TWA (Respirable particulate matter)
TWA (total
dust)

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

Basis

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

0.5 mg/m³

ACGIH

20 µg/m3 (OEB 3)
200 µg/100 cm²
20 Million
particles per cubic
foot
2 mg/m³

Internal
Internal
OSHA Z-3

2 mg/m³

ACGIH

15 mg/m³

OSHA Z-1

ACGIH
NIOSH RELNIOSH REL

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) aredesigned in a manner to prevent the escape of dust into thework area (i.e., there is no leakage from the equipment).

Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
5 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body protection:

Hygiene measures:

Choose gloves to protect hands against chemicals dependingon the concentration specific to place of work. Breakthroughtime is not determined for the product. Change gloves often!
For special applications, we recommend clarifying theresistance to chemicals of the aforementioned protective
gloves with the glove manufacturer. Wash hands before
breaks and at the end of workday.
Wear the following personal protective equipment:
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 exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powder

Color

:

white

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

No data available

Evaporation rate:

No data available
6 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

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

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition 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

SECTION 10. STABILITY AND REACTIVITY
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.

7 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

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

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 5,000 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
8 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

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:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Desloratadine:
Test Type
Routes of exposure::

Maximization Test
Dermal9 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

SpeciesResult::Guinea pig
negative

Talc:
Routes of exposure
SpeciesResult:::Skin contact
Humansnegative

Titanium dioxide:
Test Type
Routes of exposure
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
10 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

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
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 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

Remarks:

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

Carcinogenicity - Assessment:

Limited evidence of carcinogenicity in inhalation studies withanimals.

IARC

Group 2B: Possibly carcinogenic to humans
Titanium dioxide

13463-67-7

OSHA

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

NTP

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

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

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

Effects on fetal development:

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

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 fetal development:

Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: NOAEL: 30 mg/kg body weight
Result: No teratogenic effects.

12 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

Test Type: Embryo-fetal 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

Talc:
Effects on fetal 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-fetal 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 Route

:
:
:

Rat
30 mg/kg
Oral
13 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

Exposure timeTarget Organs
Remarks:::

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

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)
2yAspiration 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

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Cellulose:
Toxicity to fish:

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

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

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SAFETY DATA SHEET
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Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

Titanium dioxide:
Toxicity to fish

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015:

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

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

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-CodeNot regulated as a dangerous goodTransport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
Not regulated as a dangerous goodSpecial precautions for user
Not applicable
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Combustible dust
Carcinogenicity
Reproductive toxicity
Serious eye damage or eye irritation

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SARA 313

SDS Number:
49989-00020:

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
Calcium hydrogenorthophosphate dihydrate
Cellulose
Starch, oxidized
Desloratadine
Talc
Titanium dioxide7789-77-7
9004-34-6
65996-62-5
100643-71-8
14807-96-6
13463-67-7

California Prop. 65
WARNING: This product can expose you to chemicals including Titanium dioxide, which is/are
known to the State of California to cause cancer. For more information go to
www.P65Warnings.ca.gov.
California List of Hazardous Substances
Talc

14807-96-6

California Permissible Exposure Limits for Chemical Contaminants
Cellulose
Starch, oxidized
Talc
Titanium dioxide

9004-34-6
65996-62-5
14807-96-6
13463-67-7

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

NFPA 704:

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015
HMIS® IV:

Flammability

HEALTH1
Health30Special hazard*

3

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
ACGIH / TWA: 8-hour, time-weighted average
CAL PEL / PEL: Permissible exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
OSHA Z-1 / TWA: 8-hour time weighted average
OSHA Z-3 / TWA: 8-hour time weighted average
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Pre19 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine Solid Formulation
Version
8.2

Revision Date:
04/06/2024

SDS Number:
49989-00020

Date of last issue: 09/30/2023
Date of first issue: 01/23/2015

vention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

04/06/2024

The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release andshall not be considered a warranty or quality specification of any type. The information provided
relates only to the specific material identified at the top of this SDS and may not be valid when the
SDS material is used in combination with any other materials or in any process, unless specified
in the text. Material users should review the information and recommendations in the specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
US / Z8

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