SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

SECTION 1. IDENTIFICATION
Product name:

Desloratadine / Pseudoephedrine 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)
Reproductive toxicity: Category 2
Specific target organ toxicity- repeated exposure (Oral):

Category 1 (Central nervous system)

Specific target organ toxicity- repeated exposure(Inhalation):

Category 1 (Cardio-vascular system)

Specific target organ toxicity- repeated exposure:

Category 2 (Respiratory Tract)

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H361fd Suspected of damaging fertility. Suspected of damaging
the unborn child.
H372 Causes damage to organs (Central nervous system)
through prolonged or repeated exposure if swallowed.
H372 Causes damage to organs (Cardio-vascular system)
through prolonged or repeated exposure if inhaled.
H373 May cause damage to organs (Respiratory Tract) throughprolonged or repeated exposure.

Precautionary Statements:

Prevention:
1 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust, fume, gas, mist, vapors or spray.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
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
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
Cellulose
9004-34-6
Bis[[S-(R*,R*)]-(β-hydroxy-α7460-12-0
methylphenethyl)methylammonium]sulphate
Starch, oxidized
65996-62-5
Silicon dioxide
7631-86-9
Disodium EDTA, dihydrate
6381-92-6
Citric acid
77-92-9
Desloratadine
100643-71-8
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 30 - < 50>= 20 - < 30>= 1 - < 5>= 1 - < 5>= 1 - < 5>= 1 - < 5>= 0.1 - < 1

SECTION 4. 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:

In case of skin contact:

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.
2 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

In case of eye contact:

If swallowed:

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

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Thoroughly clean shoes before reuse.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Suspected of damaging fertility. Suspected of damaging theunborn child.
Causes damage to organs through prolonged or repeatedexposure if swallowed.
Causes damage to organs through prolonged or repeatedexposure if inhaled.
May cause damage to organs through prolonged or repeatedexposure.
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:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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

:

Exposure to combustion products may be a hazard to health.

:

Carbon oxides
Nitrogen oxides (NOx)
Metal oxides

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.

:

3 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

Methods and materials forcontainment and cleaning up

SDS Number:
2095077-00014:

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Sweep up or vacuum up spillage and collect in suitablecontainer for disposal.
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:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
Use only with adequate ventilation.
Do not breathe dust, fume, gas, mist, vapors or spray.
Do not swallow.
Avoid contact with eyes.
Avoid prolonged or repeated contact with skin.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure
assessment
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
Components

CAS-No.

Cellulose

9004-34-6

Bis[[S-(R*,R*)]-(β-hydroxy-αmethylphenethyl)methylammonium] sulphate

7460-12-0

4 / 24

Value type
(Form ofexposure)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA

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

50 µg/m3 (OEB 3)

Internal

ACGIH
NIOSH REL

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Starch, oxidized

65996-62-5

Silicon dioxide

7631-86-9

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017
Wipe limit
TWA (inhalable dust)
TWA (Dust)

TWA (Dust)

TWA
Desloratadine

Engineering measures

100643-71-8:

TWA
Wipe limit

500 µg/100 cm²
0.5 mg/m³

Internal
ACGIH

20 Million
particles per cubic
foot(Silica)
80 mg/m3/ %SiO2(Silica)
6 mg/m³(Silica)
20 µg/m3 (OEB 3)
200 µg/100 cm²

OSHA Z-3

OSHA Z-3

NIOSH RELInternal
Internal

All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., open-facecontainment devices).
Minimize open handling.

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.
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:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets,
disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentially
5 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

Hygiene measures

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

contaminated clothing.
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.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

:

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

solid

Color

:

white, blue

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:

Not applicable

Evaporation rate:

Not applicable

Flammability (solid, gas):

Not classified as a flammability hazard

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:

Not applicable

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

6 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle size:

No data available

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

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

:::

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

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

Acute toxicity estimate: 2,451 mg/kg
Method: Calculation method

Acute inhalation toxicity:

Acute toxicity estimate: 5.4 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method:

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

Components:
Cellulose:
Acute oral toxicity

7 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

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

Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Acute oral toxicity: LD50 (Rat): 660 mg/kg
LD50 (Mouse): 371 mg/kg
Acute inhalation toxicity:

LC50 (Rat): > 2.37 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Remarks: Information given is based on data obtained fromsimilar substances.

Silicon dioxide:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Method: OECD Test Guideline 401

Acute inhalation toxicity:

LC50 (Rat): > 2.08 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity

Acute dermal toxicity:

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

Disodium EDTA, dihydrate:
Acute oral toxicity:

LD50 (Rat): 2,800 mg/kg

Acute inhalation toxicity:

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

Citric acid:
Acute oral toxicity:

LD50 (Mouse): 5,400 mg/kg

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 402
Assessment: The substance or mixture has no acute dermal
toxicity

Desloratadine:
Acute oral toxicity:

LD50 (Rat): > 549 mg/kg

8 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

LD50 (Mouse): 353 mg/kg
LD50 (Monkey): > 250 mg/kg
Symptoms: Vomiting
Remarks: No mortality observed at this dose.
Skin corrosion/irritation
Not classified based on available information.
Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Species: Rabbit
Result: No skin irritation
Silicon dioxide:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Citric acid:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Desloratadine:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Species: Rabbit
Result: No eye irritation
Silicon dioxide:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

Disodium EDTA, dihydrate:
Species:Result:RabbitNo eye irritation

Citric acid:
Species

Rabbit:9 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Result
Method::Irritation to eyes, reversing within 21 days
OECD Test Guideline 405

Desloratadine:
Species
Remarks::

RabbitSevere eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Remarks: No data available
Disodium EDTA, dihydrate:
Test Type
Routes of exposure
Species
MethodResultRemarks

:
:
:
:
:
:

Maximization Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative
Based on data from similar materials

Desloratadine:
Test Type
Routes of exposure
SpeciesResult::::Maximization Test
DermalGuinea pig
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
10 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Information given is based on data obtained fromsimilar substances.
Test Type: Chromosomal aberration
Result: negative
Remarks: Information given is based on data obtained fromsimilar substances.
Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Rat
Application Route: Oral
Result: negative
Remarks: Based on data from similar materials

Silicon dioxide:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative

Genotoxicity in vivo:

Test Type: Mutagenicity (in vivo mammalian bone-marrowcytogenetic test, chromosomal analysis)
Species: Rat
Application Route: Ingestion
Result: negative

Disodium EDTA, dihydrate:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

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

Citric acid:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
11 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Test Type: in vitro micronucleus test
Result: positive
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Genotoxicity in vivo:

Test Type: Mutagenicity (in vivo mammalian bone-marrowcytogenetic test, chromosomal analysis)
Species: Rat
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

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

:
:
:
:

Rat
Ingestion
72 weeks
negative

Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Species: Rat
Application Route: OralExposure time
: 2 Years
Result: negative
Remarks: Based on data from similar materials
Species
Application RouteExposure time
ResultRemarks

:
:
:
:
:

Mouse
Oral
2 Years
negative
Based on data from similar materials

12 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Silicon dioxide:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
103 weeks
negative

Disodium EDTA, dihydrate:
Species
Application RouteExposure time
ResultRemarks

:
:
:
:
:

Rat
Ingestion
103 weeks
negative
Based on data from similar materials

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.

IARC

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.

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
13 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Effects on fertility: Test Type: Fertility
Species: Rat
Application Route: Oral
Fertility: LOAEL: 80 mg/kg body weight
Symptoms: male reproductive effects
Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Oral
Result: No teratogenic effects.
Test Type: Embryo-fetal development
Application Route: Oral
Developmental Toxicity: LOAEL: 27 mg/kg body weight
Result: No embryotoxic effects have been observed in animal
tests., No teratogenic effects.
Remarks: Maternal toxicity observed.

Silicon dioxide:
Effects on fetal development:

Disodium EDTA, dihydrate:
Effects on fertility:

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

Test Type: Four-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Effects on fetal development:

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

Citric acid:
Effects on fetal development:

Test Type: One-generation reproduction toxicity study
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
14 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

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.
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:

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

STOT-single exposure
Not classified based on available information.
Components:
Citric acid:
Assessment:

May cause respiratory irritation.

STOT-repeated exposure
Causes damage to organs (Central nervous system) through prolonged or repeated exposure if
swallowed.
Causes damage to organs (Cardio-vascular system) through prolonged or repeated exposure if
inhaled.
May cause damage to organs (Respiratory Tract) through prolonged or repeated exposure.

15 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Routes of exposure: Ingestion, Inhalation
Target Organs: Central nervous system, Cardio-vascular system
Assessment: Causes damage to organs through prolonged or repeatedexposure.
Disodium EDTA, dihydrate:
Routes of exposure:
Target Organs:
Assessment:

inhalation (dust/mist/fume)Respiratory Tract
May cause damage to organs through prolonged or repeatedexposure.

Repeated dose toxicity
Components:
Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Remarks: No data available
Starch, oxidized:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
22,500 mg/kg
Ingestion
90 Days

Silicon dioxide:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
1.3 mg/m³
inhalation (dust/mist/fume)
13 Weeks

Disodium EDTA, dihydrate:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
500 mg/kg
Ingestion
13 Weeks

Species
LOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
0.03 mg/l
inhalation (dust/mist/fume)
4 Weeks
OECD Test Guideline 412
16 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Citric acid:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
4,000 mg/kg
8,000 mg/kg
Ingestion
10 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.

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

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Inhalation: Remarks: May cause irritation of respiratory tract.
Eye contact: Remarks: May irritate eyes.
Ingestion: Symptoms: central nervous system effects, tachycardia, Palpitation
Desloratadine:
Inhalation:

Remarks: May cause respiratory tract irritation.
17 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

Eye contact
Ingestion

SDS Number:
2095077-00014::

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

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

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

Silicon dioxide:
Toxicity to fish:

LC50 (Danio rerio (zebra fish)): > 10,000 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 1,000 mg/l
Exposure time: 24 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Desmodesmus subspicatus (green algae)): > 10,000
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
NOEC (Desmodesmus subspicatus (green algae)): 10,000
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

Disodium EDTA, dihydrate:
Toxicity to fish:

LC50 (Lepomis macrochirus (Bluegill sunfish)): > 100 mg/l
Exposure time: 96 h
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to algae/aquaticplants:

ErC50 (Pseudokirchneriella subcapitata (green algae)): > 100
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
EC10 (Pseudokirchneriella subcapitata (green algae)): > 1
18 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

Citric acid:
Toxicity to fish

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

LC50 (Pimephales promelas (fathead minnow)): > 100 mg/l
Exposure time: 96 h:

EC50 (Daphnia magna (Water flea)): 1,535 mg/l
Exposure time: 24 h:

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

Toxicity to daphnia and otheraquatic invertebrates
Desloratadine:
Toxicity to fish

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
19 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Persistence and degradability
Components:
Cellulose:
Biodegradability:

Disodium EDTA, dihydrate:
Biodegradability:

Result: Readily biodegradable.

Result: Not readily biodegradable.
Biodegradation: 2 %Exposure time: 28 d
Method: OECD Test Guideline 301D

Citric acid:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 97 %Exposure time: 28 d
Method: OECD Test Guideline 301B

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

Bioaccumulative potential
Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Partition coefficient: n: log Pow: 0.89
octanol/water
Disodium EDTA, dihydrate:
Bioaccumulation:

Partition coefficient: n-:Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): < 500
Remarks: Based on data from similar materials
log Pow: -4.3
20 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

octanol/water
Citric acid:
Partition coefficient: noctanol/water:log Pow: -1.72

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

log Koc: 3.00
Method: OECD Test Guideline 106

Mobility in soil
Components:
Desloratadine:
Distribution among environmental compartments
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

21 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

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:

Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

SARA 313:

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
Cellulose
Bis[[S-(R*,R*)]-(β-hydroxy-αmethylphenethyl)methylammonium] sulphate
Hydroxypropyl methylcellulose
Starch, oxidized
Polyvinyl pyrrolidone
Silicon dioxide

9004-34-6
7460-12-0
9004-65-3
65996-62-5
9003-39-8
7631-86-9

California List of Hazardous Substances
Polyvinyl pyrrolidone
Silicon dioxide

9003-39-8
7631-86-9

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

9004-34-6
65996-62-5
7631-86-9

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

22 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

NFPA 704:

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017
HMIS® IV:

Flammability

HEALTH1
Health10Special hazard*

3

FLAMMABILITY

1

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)
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
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 Prevention 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
23 / 24

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Desloratadine / Pseudoephedrine Formulation
Version
3.9

Revision Date:
09/30/2023

SDS Number:
2095077-00014

Date of last issue: 04/04/2023
Date of first issue: 10/23/2017

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:

09/30/2023

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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