SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Mometasone Suspension Formulation

Supplier's company name, address and phone number
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

E-mail address:

EHSSTEWARD@organon.com

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

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

2. HAZARDS IDENTIFICATIONGHS classification of chemical product
Short-term (acute) aquatic: Category 3
hazardLong-term (chronic) aquatic
hazard:GHS label elements
Hazard pictograms:

Signal word
Hazard statements::

Precautionary statements:

Category 2

None
H402 Harmful to aquatic life.
H411 Toxic to aquatic life with long lasting effects.
Prevention:
P273 Avoid release to the environment.
Response:
P391 Collect spillage.
Disposal:
1 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

P501 Dispose of contents/ container to an approved waste
disposal plant.
Other hazards which do not result in classification
None known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Mometasone
Benzalkonium chloride

CAS-No.
9004-34-6
83919-23-7
8001-54-5

Concentration (% w/w)>= 1 - < 10>= 0.025 - < 0.1>= 0.0025 - < 0.025

ENCS No.

4. FIRST AID MEASURES
If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayedProtection of first-aiders
Notes to physician:

If inhaled, remove to fresh air.
Get medical attention if symptoms occur.
Wash with water and soap as a precaution.
Get medical attention if symptoms occur.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.
None known.

::

No special precautions are necessary for first aid responders.
Treat symptomatically and supportively.

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

Specific extinguishing methods:

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.

5. FIREFIGHTING MEASURES

2 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

Special protective equipment
for firefighters

SDS Number:
23603-00024:

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Evacuate area.
Wear self-contained breathing apparatus for firefighting if necessary.
Use personal protective equipment.

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

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.
Prevent spreading over a wide area (e.g. by containment or oilbarriers).
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:

Soak up with inert absorbent material.
For large spills, provide dyking or other appropriate containment to keep material from spreading. If dyked material canbe pumped, store recovered material in appropriate container.
Clean up remaining materials from spill with suitable absorbent.
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.

Handling
Technical measures:

Local/Total ventilation
Advice on safe handling::

Avoidance of contact
Hygiene measures::

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
Use only with adequate ventilation.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Take care to prevent spills, waste and minimize release to theenvironment.
Oxidizing agents
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 of

7. HANDLING AND STORAGE

3 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

engineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.
Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Keep in properly labelled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

Cellulose
Mometasone

9004-34-6
TWA
83919-23-7
TWA
Further information: Skin
Wipe limit

Engineering measures:

Value type
(Form ofexposure)

Control parameters / Reference
concentration /Permissible concentration
10 mg/m3
1 µg/m3 (OEB 4)Basis

10 µg/100 cm²Internal

ACGIH
Internal

All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Essentially no open handling permitted.
Use closed processing systems or containment technologies.
If handled in a laboratory, use a properly designed biosafetycabinet, fume hood, or other containment device if the potential exists for aerosolization. If this potential does not exist,
handle over lined trays or benchtops.

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
: Combined particulates and organic vapour type
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye 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 a
4 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

Skin and body protection

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

potential 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.

:

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:liquidColour:white to off-white, opaque

Odour

:

odourlessOdour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit:

No data available

Flash point:

No data available

Decomposition temperature:

No data available

pH:

4.3 - 4.9

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

soluble:Not applicable

Partition coefficient: noctanol/water

5 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Density

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21:

1 g/cm³

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:Not applicable

Particle characteristics
Particle size:

Not applicable:::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.

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

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
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

6 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Acute dermal toxicity:

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

Mometasone:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
LD50 (Mouse): > 2,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 3.3 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Remarks: No mortality observed at this dose.
LC50 (Mouse): > 3.2 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute toxicity (other routes of :administration)

LD50 (Rat): 300 mg/kg
Application Route: Subcutaneous
Symptoms: Breathing difficulties

Benzalkonium chloride:
Acute oral toxicity:

LD50 (Rat): 240 mg/kg

Acute inhalation toxicity:

LC50 (Rat, male): > 0.05 - 0.5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403
Assessment: Corrosive to the respiratory tract.
Remarks: Based on data from similar materials

Acute dermal toxicity:

LD50 (Rat, female): 704 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Components:
Mometasone:
SpeciesResult::RabbitNo skin irritation

Benzalkonium chloride:
SpeciesResult::HumanCorrosive after 4 hours or less of exposure

Serious eye damage/eye irritation
Not classified based on available information.

7 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Components:
Mometasone:
SpeciesResult::RabbitNo eye irritation

Benzalkonium chloride:
SpeciesResult::RabbitIrreversible effects on the eye

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Mometasone:
Test Type
Exposure routes
Species
Assessment
ResultRemarks

:
:
:
:
:
:

Maximisation Test
DermalGuinea pig
Does not cause skin sensitisation.
negative
The results of a test on guinea pigs showed this substance tobe a weak skin sensitiser.

Benzalkonium chloride:
Test Type
Exposure routes
SpeciesResult::::Human repeat insult patch test (HRIPT)
Skin contact
Humansnegative

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
8 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Result: negative
Mometasone:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosomal aberration
Test system: Chinese hamster lung cells
Result: negative
Test Type: Chromosomal aberration
Test system: Chinese hamster ovary cells
Result: positive
Test Type: Mouse Lymphoma
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Application Route: Oral
Result: negative
Test Type: Chromosomal aberration
Species: Rat
Cell type: Bone marrow
Result: negative
Test Type: unscheduled DNA synthesis assay
Species: Rat
Cell type: Liver cells
Result: negative

Germ cell mutagenicity Assessment
Benzalkonium chloride:
Genotoxicity in vitro:

Weight of evidence does not support classification as a germ
cell mutagen.

:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative
Remarks: Based on data from similar materials
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Remarks: Based on data from similar materials

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
9 / 20SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Species: Mouse
Application Route: Ingestion
Method: OECD Test Guideline 474
Result: negative
Remarks: Based on data from similar materials
Carcinogenicity
Not classified based on available information.
Components:
Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

Mometasone:
Species
Application RouteExposure time
Dose
Result

:
:
:
:
:

Rat
Inhalation
2 Years
0.067 mg/kg body weight
negative

Species
Application RouteExposure time
Dose
Result

:
:
:
:
:

Mouse
Inhalation
19 Months
0.160 mg/kg body weight
negative

Benzalkonium chloride:
Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
Ingestion
2 Years
OECD Test Guideline 453
negative
Based on data from similar materials

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Skin contact
80 weeks
negative

Species
Application RouteExposure time
Result::::RabbitSkin contact
90 weeks
negative

Reproductive toxicity
Not classified based on available information.
10 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Components:
Cellulose:
Effects on fertility

Effects on foetal development

Mometasone:
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:

Test Type: Fertility
Species: Rat
Application Route: Subcutaneous
Fertility: NOAEL: 0.015 mg/kg body weight
Symptoms: Reduced embryonic survival, Reduced foetal
weightResult: No effects on fertility, Effect on reproduction capacity:

Test Type: Embryo-foetal development
Species: Mouse
Application Route: Subcutaneous
Embryo-foetal toxicity: LOAEL: 0.06 mg/kg body weight
Result: Embryotoxic effects., Teratogenicity and developmental toxicity
Test Type: Embryo-foetal development
Species: Rat
Application Route: Dermal
Embryo-foetal toxicity: LOAEL: 0.3 mg/kg body weight
Result: Embryo-foetal toxicity
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Dermal
Embryo-foetal toxicity: LOAEL: 0.15 mg/kg body weight
Result: Embryo-foetal toxicity, Malformations were observed.
Test Type: Embryo-foetal development
Species: Rat
Application Route: Subcutaneous
Embryo-foetal toxicity: LOAEL: 0.15 mg/kg body weight
Result: Effects on newborn
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Embryo-foetal toxicity: LOAEL: 0.7 mg/kg body weight
Result: Embryo-foetal toxicity, Malformations were observed.
11 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

Reproductive toxicity - Assessment

Benzalkonium chloride:
Effects on fertility

Effects on foetal development

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21:

Clear evidence of adverse effects on development, based onanimal experiments., Some evidence of adverse effects on
sexual function and fertility, based on animal experiments.

:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 416
Result: negative
Remarks: Based on data from similar materials:

Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Ingestion
Method: OECD Test Guideline 414
Result: negative
Remarks: Based on data from similar materials

STOT - single exposure
Not classified based on available information.
Components:
Mometasone:
Remarks:

Based on available data, the classification criteria are not met.

STOT - repeated exposure
Not classified based on available information.
Components:
Mometasone:
Exposure routes
Target Organs
Assessment:::

inhalation (dust/mist/fume)
Immune system, Liver, Kidney, Skin
May cause damage to organs through prolonged or repeatedexposure.

Benzalkonium chloride:
Assessment:

No significant health effects observed in animals at concentrations of 100 mg/kg bw or less.

:
:

Rat
>= 9,000 mg/kg

Repeated dose toxicity
Components:
Cellulose:
Species
NOAEL

12 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Application RouteExposure time::

Ingestion
90 Days

Mometasone:
Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
0.005 mg/kg
0.3 mg/kg
Oral
30 d
Lymph nodes, Liver, Adrenal gland, Skin, thymus glandSpecies
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.5 mg/kg
Oral
30 d
Lymph nodes, Liver, Adrenal gland, Skin, thymus glandSpecies
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.00013 mg/l
inhalation (dust/mist/fume)
90 dAdrenal gland, Lungs, Lymph nodes, spleen, Bone marrow,
Kidney, Liver, thymus glandSpecies
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.0005 mg/l
inhalation (dust/mist/fume)
90 dAdrenal gland, Lungs, Lymph nodes, spleen, Bone marrow,
Kidney, thymus gland, Liver

Benzalkonium chloride:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 100 mg/kg
Ingestion
12 WeeksAspiration toxicity
Not classified based on available information.
Components:
Mometasone:
Not applicable
Experience with human exposure
Components:
Mometasone:
13 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Inhalation:

Symptoms: allergic rhinitis, Headache, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, Back pain,
musculoskeletal pain, immune system effects, indigestion

Skin contact:

Symptoms: Dermatitis, Itching:

Dermal absorption possible

Cellulose:
Toxicity to fish:

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

Mometasone:
Toxicity to fish:

LC50 (Menidia beryllina (Silverside)): 0.11 mg/l
Exposure time: 96 h
Remarks: No toxicity at the limit of solubility

Further information
Components:
Mometasone:
Remarks
12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:

LC50 (Cyprinodon variegatus (sheepshead minnow)): > 5 mg/l
Exposure time: 7 dRemarks: No toxicity at the limit of solubility
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 5 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility
EC50 (Americamysis): > 5 mg/l
Exposure time: 96 h
Method: US-EPA OPPTS 850.1035
Remarks: No toxicity at the limit of solubility

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 3.2
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility

Toxicity to fish (Chronic tox-:

NOEC (Pimephales promelas (fathead minnow)): 0.00014
14 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

icity)

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)): 0.34 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility

M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

:

100

:

EC50: > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility
NOEC: 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility

Benzalkonium chloride:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): 0.28 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 0.0056 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Chlorella pyrenoidosa (algae)): 0.09 mg/l
Exposure time: 72 h

M-Factor (Acute aquatic toxicity)
Toxicity to fish (Chronic toxicity)

:

100

:

NOEC (Pimephales promelas (fathead minnow)): 0.032 mg/l
Exposure time: 34 d

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Mometasone:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 50 %Exposure time: 28 d
Method: OECD Test Guideline 314
15 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Stability in water:

Hydrolysis: 50 %(12 d)
Method: OECD Test Guideline 111

Benzalkonium chloride:
Biodegradability:

Result: Readily biodegradable.
Method: OECD Test Guideline 301D
Remarks: Based on data from similar materials:

Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): 107.1
Method: OECD Test Guideline 305:

log Pow: 4.68:

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

log Pow: 1.692
Remarks: Calculation:

log Koc: 4.02

Bioaccumulative potential
Components:
Mometasone:
Bioaccumulation

Partition coefficient: noctanol/water
Benzalkonium chloride:
Bioaccumulation

Partition coefficient: noctanol/water
Mobility in soil
Components:
Mometasone:
Distribution among environmental compartments

Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
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.

16 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(Mometasone, Benzalkonium chloride)
9
III
9
yes

:
:
:
:

UN 3082
Environmentally hazardous substance, liquid, n.o.s.
(Mometasone, Benzalkonium chloride)
9
III
Miscellaneous
964

:

964

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(Mometasone, Benzalkonium chloride)
9III
9
F-A, S-F
yes

Class
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
Environmentally hazardous

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.
Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
ERG Code:171

17 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical nameSalt of alkyl(C=12-16)(benzyl)(dimethyl)ammonium

Number184

Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
18 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Miscellaneous dangerous substances and articles (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Miscellaneous dangerous substances and articles (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Noxious liquid substance(Category Z)

Pack transportation:

Classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined:

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

16. OTHER INFORMATION
Further information
Sources of key data used tocompile the Safety Data
Sheet

19 / 20

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
23603-00024

Date of last issue: 2023/09/26
Date of first issue: 2014/10/21

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

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ACGIH / TWA:

8-hour, 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
- 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.
JP / EN

20 / 20