SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Section 1: Identification
Product name:

Desloratadine / Pseudoephedrine Formulation

Manufacturer or supplier's details
Company: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

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

E-mail address

EHSSTEWARD@organon.com:

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

Section 2: Hazard identification
GHS Classification
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.
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SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

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:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
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/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification
None known.
Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Bis[[S-(R*,R*)]-(β-hydroxy-αmethylphenethyl)methylammonium] sulphate
Starch, oxidized
Citric acid
Disodium EDTA, dihydrate
Desloratadine

CAS-No.
9004-34-6
7460-12-0
65996-62-5
77-92-96381-92-6
100643-71-8

Concentration (% w/w)>= 30 -< 50>= 20 -< 30>= 1 -< 10>= 1 -< 10>= 1 -< 10>= 0.25 -< 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:

If inhaled, remove to fresh air.
Get medical attention.
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SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

In case of skin contact:

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: 23.10.2017

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.
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 firefighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
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).

3 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

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 suitable container for disposal.
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.

Technical measures:

Local/Total ventilation
Advice on safe handling::

Hygiene measures:

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, vapours 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.
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.
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.
Keep in properly labelled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

Section 7: Handling and storage

Section 8: Exposure controls/personal protection
Components with workplace control parameters
Components

CAS-No.

Value type
4 / 22Control parame-

Basis

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Cellulose

9004-34-6

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

7460-12-0

Starch, oxidized

65996-62-5

Desloratadine

100643-71-8

Engineering measures:

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017(Form ofexposure)
WES-TWA
TWA
TWA

ters / Permissible
concentration
10 mg/m3
10 mg/m3
50 µg/m3 (OEB 3)NZ OELACGIHInternal

Wipe limit
TWA (inhalable dust)
TWA
Wipe limit

500 µg/100 cm²
0.5 mg/m3

Internal
ACGIH

20 µg/m3 (OEB 3)
200 µg/100 cm²Internal
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-face containment devices).
Minimize open handling.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
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 potentiallycontaminated clothing.

Section 9: Physical and chemical properties
Appearance

:

solid

Colour:white, blue

Odour

:

No data available
5 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Odour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

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

Vapour pressure:

Not applicable

Relative vapour density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition 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

6 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

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
Exposure routes:

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

Acute inhalation toxicity:

Acute toxicity estimate: > 5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
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

Components:

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 from
7 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

similar substances.
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

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

Desloratadine:
Acute oral toxicity:

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

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
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.
8 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Species: Rabbit
Result: No eye irritation
Citric acid:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

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

Desloratadine:
Species
Remarks

RabbitSevere eye irritation::

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
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
Exposure routes
Species
MethodResultRemarks

:
:
:
:
:
:

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

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

9 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Chronic toxicity
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

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

Citric acid:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
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
10 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

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

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
11 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

ResultRemarks::

negative
Based on data from similar materials

Species
Application RouteExposure time
ResultRemarks

:
:
:
:
:

Mouse
Oral
2 Years
negative
Based on data from similar materials

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.

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

Effects on foetal development:

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

Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Effects on fertility: Test Type: Fertility
Species: Rat
12 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Application Route: Oral
Fertility: LOAEL: 80 mg/kg body weight
Symptoms: male reproductive effects
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Result: No teratogenic effects
Test Type: Embryo-foetal 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.

Citric acid:
Effects on foetal development:

Disodium EDTA, dihydrate:
Effects on fertility:

Effects on foetal development

Desloratadine:
Effects on fertility

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

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

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

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

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SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

Effects on foetal development

SDS Number:
2095092-00013:

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

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

Reproductive toxicity - Assessment:

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

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

inhalation (dust/mist/fume)
14 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

Target Organs
Assessment

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017::

Respiratory Tract
May cause damage to organs through prolonged or repeatedexposure.

:
:
:
:

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

Repeated dose toxicity
Components:
Cellulose:
Species
NOAEL
Application RouteExposure timeBis[[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

Citric acid:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

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

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

Desloratadine:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
30 mg/kg
Oral
3 Months
Kidney15 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Remarks:

Significant 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
Eye contact
Ingestion:::

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

Section 12: Ecological information
Ecotoxicity
Components:
Cellulose:
Toxicity to fish:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
Exposure time: 48 h
16 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Remarks: Based on data from similar materials
Citric acid:
Toxicity to fish

Toxicity to daphnia and otheraquatic invertebrates:

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

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
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:

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

Toxicity to daphnia and other :aquatic 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:

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SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

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
Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Citric acid:
Biodegradability:

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

Disodium EDTA, dihydrate:
Biodegradability:

Desloratadine:
Biodegradability:

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

Result: Not readily biodegradable.
Biodegradation: 67.4 %Exposure time: 28 d
Method: OECD Test Guideline 314
Result: Not readily biodegradable.
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SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

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
Citric acid:
Partition coefficient: noctanol/water:

Disodium EDTA, dihydrate:
Bioaccumulation:

Partition coefficient: noctanol/water
Desloratadine:
Partition coefficient: noctanol/waterlog Pow: -1.72

Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): < 500
Remarks: Based on data from similar materials:

log Pow: -4.3:

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:

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

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SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Section 14: Transport information
International Regulations
UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
Labels
IATA-DGR
UN/ID No.
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
NZS 5433
UN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsHazchem Code

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableSpecial precautions for user
Not applicable

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SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017

Section 15: Regulatory information
Safety, health and environmental regulations/legislation specific for the substance or mixture
HSNO Approval Number
HSR100425 Pharmaceutical Active Ingredients Group Standard
HSW Controls
Certified handler certificate not required.
Tracking hazardous substance not required.
Refer to the Health and Safety at Work (Hazardous Substances) Regulations 2017, for further information.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

Revision Date:

30.09.2023

Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

Section 16: Other information

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

dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)NZ OEL: New Zealand. Workplace Exposure Standards for Atmospheric Contaminants
ACGIH / TWANZ OEL / WES-TWA::

8-hour, time-weighted average
Workplace Exposure Standard - Time Weighted average

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
21 / 22

SAFETY DATA SHEET

Desloratadine / Pseudoephedrine Formulation
Version
6.0

Revision Date:
30.09.2023

SDS Number:
2095092-00013

Date of last issue: 04.04.2023
Date of first issue: 23.10.2017- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
NZ / EN

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