SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

SECTION 1: IDENTIFICATION
Product name:Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

Mometasone Suspension 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. HAZARDS IDENTIFICATIONGHS Classification
Not a hazardous substance or mixture.
GHS label elements
No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) required
Other hazards which do not result in classification
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Glycerine
Cellulose
Mometasone

CAS-No.
56-81-59004-34-6
83919-23-7

Concentration (% w/w)
< 10
< 10
< 0.3

SECTION 4. FIRST AID MEASURES
If inhaled:

In case of skin contact:

If inhaled, remove to fresh air.
Get medical attention if symptoms occur.
Wash with water and soap as a precaution.
1 / 18SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

In case of eye contact:

If swallowed:

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

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.

SECTION 5. FIREFIGHTING 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

Specific extinguishing methods:

Special protective equipment
for firefighters:

Hazchem Code: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.
Wear self-contained breathing apparatus for firefighting if necessary.
Use personal protective equipment.
•3Z

SECTION 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 contain2 / 18

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

ment 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.
SECTION 7. HANDLING AND STORAGE
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.
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.
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 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Components with workplace control parameters
Components

Glycerine
Cellulose
Mometasone

CAS-No.

Value type
(Form ofexposure)
56-81-5
TWA (Mist)
9004-34-6
TWA
TWA
83919-23-7
TWA
Further information: Skin
Wipe limit

3 / 18Control parameters / Permissible
concentration
10 mg/m3
10 mg/m3
10 mg/m3
1 µg/m3 (OEB 4)Basis

10 µg/100 cm²Internal

AU OELAU OELACGIHInternal

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

Engineering measures

SDS Number:
23580-00022:

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

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::

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:

liquidColour:white to off-white, opaque

Odour

:

odourlessOdour Threshold:

No data available

pH:

4.3 - 4.9

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

No data available

4 / 18SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

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:

No data available

Relative vapour density:

No data available

Relative density:

No data available

Density:

1 g/cm³

Solubility(ies)
Water solubility:

solublePartition coefficient: noctanol/water
Auto-ignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

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

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

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.
5 / 18SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

products
SECTION 11. TOXICOLOGICAL INFORMATION
Exposure routes:

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Glycerine:
Acute oral toxicity:

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

Acute dermal toxicity:

LD50 (Guinea pig): > 5,000 mg/kg

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

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

Skin corrosion/irritation
Not classified based on available information.
Components:
Glycerine:
6 / 18SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

SpeciesResult::RabbitNo skin irritation

Mometasone:
SpeciesResult::RabbitNo skin irritation

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Glycerine:
SpeciesResult::RabbitNo eye irritation

Mometasone:
SpeciesResult::RabbitNo eye irritation

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.

Chronic toxicity
Germ cell mutagenicity
Not classified based on available information.
Components:
Glycerine:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Bacterial reverse mutation assay (AMES)
7 / 18SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative
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

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
8 / 18SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

Germ cell mutagenicity Assessment

SDS Number:
23580-00022:

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

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

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

:
:
:
:

Rat
Ingestion
2 Years
negative

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

Reproductive toxicity
Not classified based on available information.
Components:
Glycerine:
Effects on fertility

Effects on foetal development:

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

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

9 / 18SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

Cellulose:
Effects on fertility

Effects on foetal development

Mometasone:
Effects on fertility

Effects on foetal development

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014:

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.

10 / 18

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

Reproductive toxicity - Assessment

SDS Number:
23580-00022:

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

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

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.

Glycerine:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
0.167 mg/l
0.622 mg/l
inhalation (dust/mist/fume)
13 Weeks

Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
8,000 - 10,000 mg/kg
Ingestion
2 yrSpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rabbit
5,040 mg/kg
Skin contact
45 Weeks

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Repeated dose toxicity
Components:

11 / 18

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

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

Aspiration toxicity
Not classified based on available information.
Components:
Mometasone:
Not applicable
Experience with human exposure
Components:
Mometasone:
Inhalation:

Skin contact:

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

Dermal absorption possible

Further information
Components:
Mometasone:
Remarks

12 / 18

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

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

LC50 (Oncorhynchus mykiss (rainbow trout)): 54,000 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 1,955 mg/l
Exposure time: 48 h

Toxicity to microorganisms:

NOEC (Pseudomonas putida): > 10,000 mg/l
Exposure time: 16 h
Method: DIN 38 412 Part 8

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
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 toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.00014
mg/l
13 / 18

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

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

Toxicity to microorganisms

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
Persistence and degradability
Components:
Glycerine:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 92 %Exposure time: 30 d
Method: OECD Test Guideline 301D

Cellulose:
Biodegradability:

Result: Readily biodegradable.

Mometasone:
Biodegradability:

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

Stability in water:

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

log Pow: -1.75

Bioaccumulative potential
Components:
Glycerine:
Partition coefficient: noctanol/water
Mometasone:
14 / 18

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

Bioaccumulation:

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

Partition coefficient: noctanol/water:log Pow: 4.68:

log Koc: 4.02

Mobility in soil
Components:
Mometasone:
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.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name

:
:

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

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
15 / 18

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

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

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
ADG
UN number
Proper shipping name

:
:

Class
Packing group
LabelsHazchem CodeEnvironmentally hazardous

:
:
:
:
:

UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(Mometasone, Benzalkonium chloride)
9
III
9
•3Z
yes

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.
SECTION 15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or mixture
Therapeutic Goods (Poisons : No poison schedule number allocated (Please use the originalStandard) Instrument
publication to check for specific uses, specific conditions or
threshold limits that might apply for this chemical)
Prohibition/Licensing Requirements:

There is no applicable prohibition,authorisation and restricted use
requirements, including for carcinogens referred to in Schedule 10 of
the model WHS Act and Regulations.

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

not determined

16 / 18

SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

IECSC

SDS Number:
23580-00022:

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

not determined

SECTION 16: ANY OTHER RELEVANT INFORMATION
Further information
Revision Date
Sources of key data used tocompile the Safety Data
Sheet

:
:

06.04.2024
Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Date format:

dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)AU OEL: Australia. Workplace Exposure Standards for Airborne Contaminants.
ACGIH / TWA
AU OEL / TWA::

8-hour, time-weighted average
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
- 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

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SAFETY DATA SHEET

Mometasone Suspension Formulation
Version
3.18

Revision Date:
06.04.2024

SDS Number:
23580-00022

Date of last issue: 26.09.2023
Date of first issue: 21.10.2014

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.
AU / EN

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