SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier
Trade name:

Desloratadine / Pseudoephedrine Formulation

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

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
30 Hudson Street, 33nd floor
07302 Jersey City, New Jersey, U.S.A
Telephone:+1-551-430-6000

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008)
Specific target organ toxicity - repeatedH372: Causes damage to organs through proexposure, Category 1
longed or repeated exposure.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

DangerHazard statements

:

H372

Causes damage to organs through prolonged orrepeated exposure.

1 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

Precautionary statements

SDS Number:
2111466-00017:

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

Prevention:
P264
Wash skin thoroughly after handling.
P270
Do not eat, drink or smoke when using this product.
Response:
P314
Get medical advice/ attention if you feel unwell.

Hazardous components which must be listed on the label:Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
Ecological information: The substance/mixture does not contain components considered to haveendocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
Toxicological information: The substance/mixture does not contain components considered tohave endocrine disrupting properties according to REACH Article 57(f) or Commission Delegatedregulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

SECTION 3: Composition/information on ingredients
3.2 Mixtures
Components
Chemical nameBis[[S-(R*,R*)]-(β-hydroxy-αmethylphenethyl)methylammonium] sulphate

CAS-No.
EC-No.
Index-No.
Registration number
7460-12-0
231-243-2

Classification

Concentration(% w/w)

Acute Tox. 4; H302
Acute Tox. 4; H332
STOT RE 1; H372
(Central nervous
system)
STOT RE 1; H372
(Cardio-vascularsystem)>= 20 - < 30

Acute toxicity estimate

Disodium EDTA, dihydrate

6381-92-6
2 / 25

Acute oral toxicity:
660 mg/kg
Acute inhalation toxicity (dust/mist): 2.38
mg/l
Acute Tox. 4; H332>= 1 - < 10

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Citric acid

77-92-9
201-069-1
607-750-00-3

Desloratadine

100643-71-8

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017
STOT RE 2; H373
(Respiratory Tract)
Eye Irrit. 2; H319
STOT SE 3; H335

Acute Tox. 4; H302
Eye Dam. 1; H318
Repr. 2; H361fd
Aquatic Chronic 2;
H411>= 1 - < 10>= 0.25 - < 1

For explanation of abbreviations see section 16.

SECTION 4: First aid measures
4.1 Description of first aid measures
General advice: In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
Protection of first-aiders:

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

If inhaled:

If inhaled, remove to fresh air.
Get medical attention.

In case of skin contact:

In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.

In case of eye contact:

Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.

If swallowed:

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

4.2 Most important symptoms and effects, both acute and delayed
Risks: Causes damage to organs through prolonged or repeatedexposure.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

3 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

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

None known.

5.2 Special hazards arising from the substance or mixture
Specific hazards during fire- : Exposure to combustion products may be a hazard to health.
fighting
Hazardous combustion products

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

Carbon oxides
Nitrogen oxides (NOx)
Metal oxides:

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

:

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

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
6.2 Environmental precautions
Environmental precautions:

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

6.3 Methods and material for containment and cleaning up
Methods for cleaning up: Sweep up or vacuum up spillage and collect in suitable container for disposal.
Local or national regulations may apply to releases and dis4 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

posal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handlingTechnical measures:
Local/Total ventilation
Advice on safe handling::

Hygiene measures:

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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store in accordance withareas and containers
the particular national regulations.
Advice on common storage

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

:

No data available

5 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
Components

CAS-No.

Cellulose

9004-34-6

Bis[[S-(R*,R*)]-(βhydroxy-αmethylphenethyl)m
ethylammonium]sulphate

7460-12-0

Starch, oxidized

65996-62-5

Silicon dioxide

Desloratadine

Value type (Formof exposure)
OELV - 8 hrs
(TWA)
TWA

Control parameters

Basis

10 mg/m3

IE OEL50 µg/m3 (OEB 3)

Internal

Wipe limit
500 µg/100 cm²Internal
OELV - 8 hrs
1 mg/m3
IE OEL(TWA) (Dust)
Further information: Chemical agents which following exposure may cause
sensitisation of the respiratory tract and lead to asthma, rhinitis or extrinsic
allergic alveolitis
7631-86-9
OELV - 8 hrs
2.4 mg/m3
IE OEL(TWA) (Respira(Silica)
ble dust)
OELV - 8 hrs
6 mg/m3
IE OEL(TWA) (inhalable (Silica)
dust)
100643-71TWA
20 µg/m3 (OEB 3)
Internal
8
Wipe limit
200 µg/100 cm²Internal

Derived No Effect Level (DNEL) according to Regulation (EC) No. 1907/2006:
Substance name

End UseExposure routes

Silicon dioxide

Workers

Inhalation

Disodium EDTA, dihydrate

Workers

Inhalation

Workers

Inhalation

Workers

Inhalation

Workers
Consumers

Inhalation
Inhalation

Consumers
Consumers

Inhalation
Ingestion

Potential health effects
Long-term systemic
effects
Long-term systemic
effects
Acute systemic effects
Long-term local effects
Acute local effects
Long-term local effects
Acute local effects
Long-term systemic
effects

Value
4 mg/m3
1.5 mg/m3
3 mg/m3
1.5 mg/m3
3 mg/m3
0.6 mg/m3
1.2 mg/m3
25 mg/kg
bw/dayPredicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:
Substance name

Environmental Compartment
6 / 25Value

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

Disodium EDTA, dihydrate

Fresh water
Marine water
Sewage treatment plant
Soil

Citric acid

Fresh water
Marine water
Sewage treatment plant
Fresh water sediment
Marine sedimentSoil

2.5 mg/l
0.25 mg/l
50 mg/l
1.1 mg/kg dryweight (d.w.)
0.44 mg/l
0.044 mg/l
1000 mg/l
34.6 mg/kg dryweight (d.w.)
3.46 mg/kg dryweight (d.w.)
33.1 mg/kg dryweight (d.w.)

8.2 Exposure controls
Engineering measures
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect 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
Eye/face protection: 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.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Skin and body protection::

Respiratory protection:

Consider double gloving.
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.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to I.S. EN 143
Particulates type (P)Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: solid
7 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

Colour:white, blue

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

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

Flash point:

Not applicableAuto-ignition temperature:

No data available

Decomposition temperature:

No data available

pH:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Relative density:

No data available

Density:

No data available

Relative vapour density:

Not applicable

Particle characteristics
Particle size:

No data available

8 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

9.2 Other information
Explosives

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Evaporation rate:

Not applicable

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

None known.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
Information on likely routes of : Skin contact
exposure
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

Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
9 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

Acute oral toxicity

SDS Number:
2111466-00017:

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

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.

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
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
10 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

Desloratadine:
SpeciesResultSDS Number:
2111466-00017::

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

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

Citric acid:
Species
MethodResult:::RabbitOECD Test Guideline 405
Irritation to eyes, reversing within 21 days

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

11 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

Desloratadine:
Test Type
Exposure routes
SpeciesResultSDS Number:
2111466-00017

:
:
:
:

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

Maximisation Test
DermalGuinea pig
negative

Germ cell mutagenicity
Not classified based on available information.
Components:
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:

Disodium EDTA, dihydrate:
Genotoxicity in vitro:

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

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

12 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

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:
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

Disodium EDTA, dihydrate:
Species
Application RouteExposure time
ResultRemarks

:
:
:
:
:

Rat
Ingestion
103 weeks
negative
Based on data from similar materials

13 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

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
Not classified based on available information.
Components:
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 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.

Disodium EDTA, dihydrate:
Effects on fertility:

Effects on foetal development:

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

14 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

Citric acid:
Effects on foetal development

Desloratadine:
Effects on fertility

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017:

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

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

Effects on foetal development:

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

15 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

Components:
Citric acid:
Assessment:

May cause respiratory irritation.

STOT - repeated exposure
Causes damage to organs 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:
Target Organs:
Assessment:

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

Repeated dose toxicity
Components:
Bis[[S-(R*,R*)]-(β-hydroxy-α-methylphenethyl)methylammonium] sulphate:
Remarks: No data available
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

Citric acid:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

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

Desloratadine:
16 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

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.
11.2 Information on other hazards
Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

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

17 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

Desloratadine:
Inhalation
Eye contact
Ingestion

SDS Number:
2111466-00017:::

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

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

SECTION 12: Ecological information
12.1 Toxicity
Components:
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 microorganisms:

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

Toxicity to daphnia and otheraquatic invertebrates
Desloratadine:
Toxicity to fish

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

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
18 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

Method: FDA 4.11
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 9.6 mg/l
Exposure time: 48 h
Method: FDA 4.08

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 1.6
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 0.36
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to microorganisms:

EC50 (Natural microorganism): 53.7 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
NOEC (Natural microorganism): 12 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

Toxicity to fish (Chronic toxicity):

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

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

12.2 Persistence and degradability
Components:
Disodium EDTA, dihydrate:
Biodegradability:

Citric acid:
Biodegradability:

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

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

19 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

Desloratadine:
Biodegradability

SDS Number:
2111466-00017:

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

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

12.3 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: noctanol/waterSpecies: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): < 500
Remarks: Based on data from similar materials:

log Pow: -4.3

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 10612.4 Mobility in soil
Components:
Desloratadine:
Distribution among environmental compartments

12.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
20 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

0.1% or higher.
12.6 Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

12.7 Other adverse effects
No data available

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

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

SECTION 14: Transport information
14.1 UN number or ID number
ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous good:Not regulated as a dangerous good

14.2 UN proper shipping name14.3 Transport hazard class(es)ADN

21 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

ADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

14.4 Packing group

14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Not applicable
14.7 Maritime transport in bulk according to IMO instruments
Remarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
REACH - Restrictions on the manufacture, placing on: Conditions of restriction for the folthe market and use of certain dangerous substances,lowing entries should be considered:mixtures and articles (Annex XVII)
Number on list 75
Substance(s) or mixture(s) are listed
here according to their appearance
in the regulation, irrespective of theiruse/purpose or the conditions of therestriction. Please refer to the conditions in corresponding Regulation todetermine whether an entry is applicable to the placing on the market ornot.
If you intend to use this product astattoo ink, please contact your vendor.
REACH - Candidate List of Substances of Very High
Concern for Authorisation (Article 59).
Regulation (EC) No 1005/2009 on substances that deplete the ozone layer
22 / 25:

Not applicable:Not applicableSAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

Regulation (EU) 2019/1021 on persistent organic pollu: Not applicabletants (recast)
Regulation (EU) No 649/2012 of the European Parlia: Not applicablement and the Council concerning the export and importof dangerous chemicals
REACH - List of substances subject to authorisation: Not applicable(Annex XIV)
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control ofmajor-accident hazards involving dangerous substances.
Not applicable
Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

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

SECTION 16: Other information
Other information:

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

Full text of H-Statements
H302
H318
H319
H332
H335
H361fd

:
:
:
:
:
:

H372

:

H372

:

H373

:

H411

:

Harmful if swallowed.
Causes serious eye damage.
Causes serious eye irritation.
Harmful if inhaled.
May cause respiratory irritation.
Suspected of damaging fertility. Suspected of damaging theunborn child.
Causes damage to organs through prolonged or repeatedexposure if inhaled.
Causes damage to organs through prolonged or repeatedexposure if swallowed.
May cause damage to organs through prolonged or repeatedexposure.
Toxic to aquatic life with long lasting effects.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Aquatic Chronic: Long-term (chronic) aquatic hazard
Eye Dam.
: Serious eye damage
23 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Eye Irrit.
Repr.
STOT RESTOT SEIE OEL:::::IE OEL / OELV - 8 hrs (TWA) :Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

Eye irritation
Reproductive toxicity
Specific target organ toxicity - repeated exposure
Specific target organ toxicity - single exposure
Ireland. List of Chemical Agents and Carcinogens with Occupational Exposure Limit Values - Code of Practice, Schedule 1
and 2
Occupational exposure limit value (8-hour reference period)

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; ECx - Concentration
associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air
Transport Association; IBC - International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China;
IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL
- Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization;
KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Substance Inventory; TECI Thailand Existing Chemicals Inventory; TRGS - Technical Rule for Hazardous Substances; TSCA
- Toxic Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent andVery Bioaccumulative
Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

Classification of the mixture:

Classification procedure:

STOT RE 1

Calculation method

H372

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
24 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Desloratadine / Pseudoephedrine Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
2111466-00017

Date of last issue: 30.09.2023
Date of first issue: 23.10.2017

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.
IE / EN

25 / 25