SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

Section 1: Identification
Product name:

Mometasone Lotion Formulation

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

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

Telephone:+1-551-430-6000

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

E-mail address

EHSSTEWARD@organon.com:

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

Section 2: Hazard identification
GHS Classification
Flammable liquids:

Category 2

Serious eye damage/eye irritation:

Category 2

Reproductive toxicity:

Category 1

Specific target organ toxicity single exposure:

Category 3

Aspiration hazard:

Category 1

Hazardous to the aquatic
environment - chronic hazard:

Category 2

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H225 Highly flammable liquid and vapour.
1 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

H304 May be fatal if swallowed and enters airways.
H319 Causes serious eye irritation.
H336 May cause drowsiness or dizziness.
H360Df May damage the unborn child. Suspected of damaging
fertility.
H411 Toxic to aquatic life with long lasting effects.
Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P210 Keep away from heat, hot surfaces, sparks, open flames
and other ignition sources. No smoking.
P233 Keep container tightly closed.
P241 Use explosion-proof electrical/ ventilating/ lighting equipment.
P242 Use non-sparking tools.
P243 Take action to prevent static discharges.
P261 Avoid breathing mist or vapours.
P264 Wash skin thoroughly after handling.
P271 Use only outdoors or in a well-ventilated area.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P301 + P310 IF SWALLOWED: Immediately call a POISONCENTER/ doctor.
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
P304 + P340 + P312 IF INHALED: Remove person to fresh air
and keep comfortable for breathing. Call a POISON CENTER/
doctor if you feel unwell.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact lenses, if present andeasy to do. Continue rinsing.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P331 Do NOT induce vomiting.
P337 + P313 If eye irritation persists: Get medical advice/ attention.
P391 Collect spillage.
Storage:
P403 + P235 Store in a well-ventilated place. Keep cool.
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification
Vapours may form explosive mixture with air.
2 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical namePropan-2-ol
Propylene glycol
Mometasone

CAS-No.
67-63-0
57-55-6
83919-23-7

Concentration (% w/w)>= 30 -< 50>= 20 -< 30>= 0.1 -< 0.25

Section 4: First-aid measures
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with plenty of water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of contact, immediately flush eyes with plenty of water
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
May be fatal if swallowed and enters airways.
Causes serious eye irritation.
May cause drowsiness or dizziness.
May damage the unborn child. Suspected of damaging fertility.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

Section 5: Fire-fighting measures
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemicalHigh volume water jet
Do not use a solid water stream as it may scatter and spread
fire.
Flash back possible over considerable distance.
3 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

Vapours may form explosive mixtures with air.
Exposure to combustion products may be a hazard to health.
Hazardous combustion products:

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.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.
2YE:

Section 6: Accidental release measures
Personal precautions, protec- :tive equipment and emergency procedures

Remove all sources of ignition.
Ventilate the area.
Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
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:

Non-sparking tools should be used.
Soak up with inert absorbent material.
Suppress (knock down) gases/vapours/mists with a water
spray jet.
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.

:

See Engineering measures under EXPOSURE

Section 7: Handling and storage
Technical measures

4 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Use explosion-proof electrical, ventilating and lighting equipment.
Do not get on skin or clothing.
Avoid breathing mist or vapours.
Do not swallow.
Do not get in eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Non-sparking tools should be used.
Keep container tightly closed.
Keep away from heat, hot surfaces, sparks, open flames andother ignition sources. No smoking.
Take precautionary measures against static discharges.
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 locked up.
Keep tightly closed.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
Keep away from heat and sources of ignition.
Do not store with the following product types:
Self-reactive substances and mixtures
Organic peroxides
Oxidizing agents
Flammable gases
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Poisonous gases
Explosives

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

CAS-No.

Value type
5 / 22Control parame-

Basis

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Propan-2-ol

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017(Form ofexposure)
WES-TWA

67-63-0

WES-STEL
TWA
STEL
57-55-6
WES-TWA(particulate)
WES-TWA(Vapour andparticulates)
83919-23-7
TWA
Further information: Skin
Wipe limit

Propylene glycol

Mometasone

ters / Permissible
concentration
400 ppm
983 mg/m3
500 ppm
1,230 mg/m3
200 ppm
400 ppm
10 mg/m3

NZ OELNZ OELACGIH
ACGIH
NZ OEL150 ppm
474 mg/m3

NZ OEL

1 µg/m3 (OEB 4)Internal

10 µg/100 cm²Internal

Biological occupational exposure limits
Components

CAS-No.

Controlparameters

Biological
specimen

Propan-2-ol

67-63-0

AcetoneUrine

Engineering measures:

Samplingtime
End ofshift atend ofworkweek

Permissible
concentration
40 mg/l

Basis

ACGIH
BEI

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.
Use explosion-proof electrical, ventilating and lighting equipment.

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. Take note that the product is flammable, which may impact the selection of hand protection.
Wear safety glasses with side shields or goggles.
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SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

Skin and body protection

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

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:

lotionColour:colourless, clear, to, translucent

Odour

:

No data available

Odour Threshold:

No data available

pH

:

4.5

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

18.4 °C
Method: closed cup

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

Ignitable (see flash point)

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:

No data available

7 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Solubility(ies)
Water solubility

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

No data available:

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

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Highly flammable liquid and vapour.
Vapours may form explosive mixture with air.
Can react with strong oxidizing agents.

Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

Heat, flames and sparks.
Oxidizing agents
No hazardous decomposition products are known.

Section 10: Stability and reactivity

Section 11: Toxicological information
Exposure routes:

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Propan-2-ol:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 25 mg/l
8 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

Exposure time: 6 h
Test atmosphere: vapour
Acute dermal toxicity:

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

Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Assessment: The substance or mixture has no acute dermal
toxicity

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:
Propan-2-ol:
SpeciesResult::RabbitNo skin irritation

Propylene glycol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Mometasone:
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SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
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Revision Date:
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SpeciesResultSDS Number:
1288479-00019::

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

RabbitNo skin irritation

Serious eye damage/eye irritation
Causes serious eye irritation.
Components:
Propan-2-ol:
SpeciesResult::RabbitIrritation to eyes, reversing within 21 days

Propylene glycol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

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:
Propan-2-ol:
Test Type
Exposure routes
Species
MethodResult:::::Buehler Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

Propylene glycol:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Mometasone:
Test Type
Exposure routes
Species
Assessment

:
:
:
:

Maximisation Test
DermalGuinea pig
Does not cause skin sensitisation.
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Mometasone Lotion Formulation
Version
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Revision Date:
06.04.2024

ResultRemarks

SDS Number:
1288479-00019::

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

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:
Propan-2-ol:
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: Intraperitoneal injection
Result: negative

Propylene glycol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
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
11 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

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:

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

Carcinogenicity
Not classified based on available information.
Components:
Propan-2-ol:
Species
Application RouteExposure time
MethodResult

:
:
:
:
:

Rat
inhalation (vapour)
104 weeks
OECD Test Guideline 451
negative

Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
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
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SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

Reproductive toxicity
May damage the unborn child. Suspected of damaging fertility.
Components:
Propan-2-ol:
Effects on fertility

Effects on foetal development

Propylene glycol:
Effects on fertility

Effects on foetal development

Mometasone:
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:

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

Test Type: Embryo-foetal development
Species: Mouse
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
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SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

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.
Reproductive toxicity - Assessment:

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
May cause drowsiness or dizziness.
Components:
Propan-2-ol:
Assessment:

May cause drowsiness or dizziness.

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.

:
:
:
:

Rat
12.5 mg/l
inhalation (vapour)
104 Weeks

Repeated dose toxicity
Components:
Propan-2-ol:
Species
NOAEL
Application RouteExposure time

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SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat, male>= 1,700 mg/kg
Ingestion
2 yr

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
May be fatal if swallowed and enters airways.
Components:
Propan-2-ol:
The substance or mixture is known to cause human aspiration toxicity hazards or has to be regarded as if it causes a human aspiration toxicity hazard.
Mometasone:
Not applicable

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SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

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

Section 12: Ecological information
Ecotoxicity
Components:
Propan-2-ol:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): 9,640 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 10,000 mg/l
Exposure time: 24 h

Toxicity to microorganisms:

EC50 (Pseudomonas putida): > 1,050 mg/l
Exposure time: 16 h

Propylene glycol:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 40,613 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 18,340 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Skeletonema costatum (marine diatom)): 19,300 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

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

NOEC (Ceriodaphnia dubia (water flea)): 13,020 mg/l
Exposure time: 7 d
NOEC (Pseudomonas putida): > 20,000 mg/l
Exposure time: 18 h

Mometasone:
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Version
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Revision Date:
06.04.2024

Toxicity to fish

SDS Number:
1288479-00019:

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

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
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

17 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

Persistence and degradability
Components:
Propan-2-ol:
Biodegradability:

Result: rapidly degradable

BOD/COD:

BOD: 1,19 (BOD5)
COD: 2,23
BOD/COD: 53 %Propylene glycol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 98.3 %Exposure time: 28 d
Method: OECD Test Guideline 301F

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

Propan-2-ol:
Partition coefficient: noctanol/water:log Pow: 0.05

Propylene glycol:
Partition coefficient: noctanol/water:log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8:

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

log Pow: 4.68

Bioaccumulative potential
Components:

Mometasone:
Bioaccumulation

Partition coefficient: noctanol/water
Mobility in soil
Components:
Mometasone:

18 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

Distribution among environmental compartments

SDS Number:
1288479-00019:

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

log Koc: 4.02

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.
Empty containers retain residue and can be dangerous.
Do not pressurize, cut, weld, braze, solder, drill, grind, or expose such containers to heat, flame, sparks, or other sourcesof ignition. They may explode and cause injury and/or death.
If not otherwise specified: Dispose of as unused product.

Section 14: Transport information
International Regulations
UNRTDGUN number
Proper shipping nameClass
Packing group
LabelsEnvironmentally hazardous

:
:
:
:
:
:

UN 1219ISOPROPANOL SOLUTION
3
II
3
yes

:
:
:
:
:
:

UN 1219
Isopropanol solution
3IIFlammable Liquids
364

:

353

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 1219ISOPROPANOL SOLUTION(Mometasone)
3II3
F-E, S-D
yes

IATA-DGR
UN/ID No.
Proper shipping nameClass
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

19 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

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

:
:
:
:
:
:
:

UN 1219ISOPROPANOL SOLUTION
3
II
3
2YE
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
HSNO Approval Number
HSR100425 Pharmaceutical Active Ingredients Group Standard
Tolerable Exposure Limits (TEL)
Not applicable
Environmental Exposure Limits (EEL)
Not applicable
HSW Controls
Certified handler certificate not required.
Tracking hazardous substance not required.
Refer to the Health and Safety at Work (Hazardous Substances) Regulations 2017, for further information.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

Revision Date:

06.04.2024

Further information
Sources of key data used to:Internal technical data, data from raw material SDSs, OECD

Section 16: Other information

20 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

compile the Safety Data
Sheet
Date format

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/:

dd.mm.yyyy

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

:
:
:
:

8-hour, time-weighted average
Short-term exposure limit
Workplace Exposure Standard - Time Weighted average
Workplace Exposure Standard - Short-Term Exposure Limit

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.
21 / 22

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
6.1

Revision Date:
06.04.2024

SDS Number:
1288479-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017

Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
NZ / EN

22 / 22