SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:

Mometasone Lotion Formulation

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

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

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008)
Flammable liquids, Category 2
H225: Highly flammable liquid and vapour.
Eye irritation, Category 2
H319: Causes serious eye irritation.
Specific target organ toxicity - single exH336: May cause drowsiness or dizziness.
posure, Category 3
Long-term (chronic) aquatic hazard, CatH411: Toxic to aquatic life with long lasting effects.
egory 22.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

DangerHazard statements

:

H225
H319

Highly flammable liquid and vapour.
Causes serious eye irritation.
1 / 21SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019
H336
H411

Precautionary statements:

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

May cause drowsiness or dizziness.
Toxic to aquatic life with long lasting effects.

Prevention:
P210 Keep away from heat, hot surfaces, sparks, open
flames and other ignition sources. No smoking.
P233 Keep container tightly closed.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P304 + P340 + P312 IF INHALED: Remove person to fresh
air and keep comfortable for breathing. Call a POISONCENTER/ doctor if you feel unwell.
P391 Collect spillage.

Hazardous components which must be listed on the label:
Propan-2-ol
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
Vapours may form explosive mixture with air.

SECTION 3: Composition/information on ingredients
3.2 Mixtures
Components
Chemical namePropan-2-ol

Mometasone

CAS-No.
EC-No.
Index-No.
Registration number
67-63-0200-661-7
603-117-00-0

Classification

Concentration(% w/w)

Flam. Liq. 2; H225
Eye Irrit. 2; H319
STOT SE 3; H336>= 30 - < 50

83919-23-7

Repr. 1B; H360Df
STOT RE 2; H373
(Immune system,
Liver, Kidney, Skin)
Aquatic Chronic 1;
H410>= 0,1 - < 0,25

M-Factor (Chronic
aquatic toxicity):100
For explanation of abbreviations see section 16.

2 / 21SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

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

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

If inhaled:

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

In case of skin contact:

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

In case of eye contact:

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:

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

4.2 Most important symptoms and effects, both acute and delayed
Risks: Causes serious eye irritation.
May cause drowsiness or dizziness.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:High volume water jet

5.2 Special hazards arising from the substance or mixture
Specific hazards during fire- : Do not use a solid water stream as it may scatter and spread
3 / 21SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

fighting

Hazardous combustion products
5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods

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

fire.
Flash back possible over considerable distance.
Vapours may form explosive mixtures with air.
Exposure to combustion products may be a hazard to health.
:

Carbon oxides:

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

:

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

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Personal precautions: 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).
6.2 Environmental precautions
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.

6.3 Methods and material for containment and cleaning up
Methods for 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
4 / 21SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

certain local or national requirements.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

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

Advice on safe handling:

Hygiene measures:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Keepareas and containers
tightly closed. Keep in a cool, well-ventilated place. Store inaccordance with the particular national regulations. Keepaway from heat and sources of ignition.
Advice on common storage:

Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Flammable solids
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures, which in contact with water, emit
5 / 21SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

flammable gases
Explosives
Gases
Very acutely toxic substances and mixtures
7.3 Specific end use(s)Specific use(s):No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
Components
Propan-2-ol

Mometasone

CAS-No.

Value type (Form Control parametersBasisof exposure)
67-63-0
OEL-RL400 ppm
ZA OEL
Further information: Occupational Exposure Limits - Restricted Limits For
Hazardous Chemical Agents
OEL- RL STEL/C 800 ppm
ZA OEL
Further information: Occupational Exposure Limits - Restricted Limits For
Hazardous Chemical Agents
83919-23-7
TWA
1 µg/m3 (OEB 4)Internal
Further information: Skin
Wipe limit
10 µg/100 cm²Internal

Biological occupational exposure limits
Substance namePropan-2-ol

CAS-No.
67-63-0

Control parameters
Acetone: 40 mg/l
(Urine)Sampling time
End of shift at endof workweek

Basis
ZA BEI

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

End UseExposure routes

Propan-2-ol

Workers

Inhalation

Workers

Skin contact

Consumers

Inhalation

Consumers

Skin contact

Consumers

Ingestion

Workers

Inhalation

Workers

Inhalation

Consumers

Inhalation

Consumers

Inhalation

Propylene glycol

6 / 21

Potential health effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term local effects
Long-term systemic
effects
Long-term local effects
Long-term systemic
effectsValue
500 mg/m3
888 mg/kg
bw/day89 mg/m3
319 mg/kg
bw/day26 mg/kg
bw/day10 mg/m3
168 mg/m3
10 mg/m3
50 mg/m3

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

Predicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:
Substance namePropan-2-ol

Environmental Compartment
Fresh water
Marine waterIntermittent use/release
Sewage treatment plant
Fresh water sediment
Marine sediment
Soil
Oral (Secondary Poisoning)
Fresh water
Freshwater - intermittent
Marine water
Sewage treatment plant
Fresh water sediment

Propylene glycol

Marine sediment
Soil

Value
140,9 mg/l
140,9 mg/l
140,9 mg/l
2251 mg/l
552 mg/kg dryweight (d.w.)
552 mg/kg dryweight (d.w.)
28 mg/kg dryweight (d.w.)
160 mg/kg food
260 mg/l
183 mg/l
26 mg/l
20000 mg/l
572 mg/kg dryweight (d.w.)
57,2 mg/kg dryweight (d.w.)
50 mg/kg dryweight (d.w.)

8.2 Exposure controls
Engineering measures
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect products, workers, and the environment.
Essentially no open handling permitted.
Use closed processing systems or containment technologies.
If handled in a laboratory, use a properly designed biosafety cabinet, 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
Eye/face protection: Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Consider double gloving. Take note that the product is flammable, which may impact the selection of hand protection.
Work uniform or laboratory coat.
Additional body garments should be used based upon the task
being performed (e.g., sleevelets, apron, gauntlets, disposable
suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.

Skin and body protection:

7 / 21SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

Respiratory protection

Filter typeSDS Number:
1288482-00019:

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

If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Combined particulates and organic vapour type (A-P):

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: lotion
Colour: 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
Flash point:

No data available:

18,4 °C
Method: closed cup

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

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::

No data available
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.

Solubility(ies)
Water solubility
Partition coefficient: noctanol/water
Auto-ignition temperature

8 / 21SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

9.2 Other information
Flammability (liquids):

Ignitable (see flash point)

Molecular weight:Not applicable

Particle size:

Not applicable

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: Highly flammable liquid and vapour.
Vapours may form explosive mixture with air.
Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

Heat, flames and sparks.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on toxicological effects
Information on likely routes of : Inhalation
exposure
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
Exposure time: 6 h
Test atmosphere: vapour

Acute dermal toxicity:

LD50 (Rabbit): > 5.000 mg/kg
9 / 21SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

Mometasone:
Acute oral toxicity

SDS Number:
1288482-00019:

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

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

Mometasone:
SpeciesResult::RabbitNo skin irritation

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

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.
10 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

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

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.

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

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
11 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

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

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:
Propan-2-ol:
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
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SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

Application Route: Ingestion
Result: negative
Mometasone:
Effects on fertility

Effects on foetal development:

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.

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.
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SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

Mometasone:
Remarks

SDS Number:
1288482-00019:

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

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.

Propan-2-ol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
12,5 mg/l
inhalation (vapour)
104 Weeks

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

Repeated dose toxicity
Components:

14 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

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

SECTION 12: Ecological information
12.1 Toxicity
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

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
15 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

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 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

Toxicity to fish (Chronic toxicity):

NOEC: 0,00014 mg/l
Exposure time: 32 d
Species: Pimephales promelas (fathead minnow)
Method: OECD Test Guideline 210

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

NOEC: 0,34 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility

M-Factor (Chronic aquatic
toxicity)100:

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

Result: rapidly degradable

BOD/COD:

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

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

16 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

Stability in water

SDS Number:
1288482-00019

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

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

log Pow: 0,05:

Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): 107,1
Method: OECD Test Guideline 305:

log Pow: 4,68:

log Koc: 4,02

12.3 Bioaccumulative potential
Components:
Propan-2-ol:
Partition coefficient: noctanol/water
Mometasone:
Bioaccumulation

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

12.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.

:

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

12.6 Other adverse effects
Product:
Endocrine disrupting potential

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste han17 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

dling 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
14.1 UN number
ADN:

UN 1219ADR:

UN 1219RID:

UN 1219

IMDG:

UN 1219IATA:

UN 1219ADN:

ISOPROPANOL, SOLUTIONADR:

ISOPROPANOL, SOLUTIONRID:

ISOPROPANOL, SOLUTION

IMDG

:

ISOPROPANOL, SOLUTION(Mometasone)

IATA

:

Isopropanol, solution

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

:

3

ADR

:

3

RID

:

3

IMDG

:

3

IATA

:

3

ADN
Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

II
F1
33
3

ADR
Packing groupClassification CodeHazard Identification Number
LabelsTunnel restriction code

:
:
:
:
:

II
F1
33
3
(D/E)

Subsidiary risks

14.4 Packing group

RID
18 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

II
F1
33
3

IMDG
Packing group
LabelsEmS Code

:
:
:

II
3
F-E, S-D

:

364

:
:
:

Y341
II
Flammable Liquids

:

353

:
:
:

Y341
II
Flammable Liquids

ADN
Environmentally hazardous

:

yes

ADR
Environmentally hazardous

:

yes

RID
Environmentally hazardous

:

yes

IMDG
Marine pollutant:

yes

IATA (Cargo)
Packing instruction (cargo
aircraft)Packing instruction (LQ)
Packing group
LabelsIATA (Passenger)
Packing instruction (passenger aircraft)
Packing instruction (LQ)
Packing group
Labels
14.5 Environmental hazards

14.6 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.
14.7 Transport in bulk according to Annex II of Marpol and the IBC CodeRemarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined
19 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

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

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

SECTION 16: Other information
Other information:

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

Full text of H-Statements
H225
H319
H336
H360Df

:
:
:
:

H373

:

H410

:

Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
May damage the unborn child. Suspected of damaging fertility.
May cause damage to organs through prolonged or repeatedexposure if inhaled.
Very toxic to aquatic life with long lasting effects.

Full text of other abbreviations
Aquatic Chronic: Long-term (chronic) aquatic hazard
Eye Irrit.
: Eye irritation
Flam. Liq.
: Flammable liquids
Repr.
: Reproductive toxicity
STOT RE: Specific target organ toxicity - repeated exposure
STOT SE: Specific target organ toxicity - single exposure
ZA BEI: South Africa. The Regulations for Hazardous Chemical
Agents, Biological Exposure IndicesZA OEL: South Africa. The Regulations for Hazardous Chemical
Agents, Occupational Exposure LimitsZA OEL / OEL-RL: Occupational Exposure Limit Restricted limit - 8- hour exposure or equivalent (12 hour shifts)
ZA OEL / OEL- RL STEL/C: Occupational Exposure Limit Restricted limit - Short term occupational exposure limits / ceiling limits
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; ECx - Concentration
associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air
Transport Association; IBC - International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China;
IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL
- Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization;
KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - Interna20 / 21

SAFETY DATA SHEET

Mometasone Lotion Formulation
Version
7.0

Revision Date:
06.04.2024

SDS Number:
1288482-00019

Date of last issue: 30.09.2023
Date of first issue: 15.02.2017tional Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of very high concern; TCSI - Taiwan Chemical Substance Inventory; TECI Thailand Existing Chemicals Inventory; 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
Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

Classification of the mixture:

Classification procedure:Flam. Liq. 2

H225

Based on product data or assessment

Eye Irrit. 2

H319

Calculation method

STOT SE 3

H336

Calculation method

Aquatic Chronic 2

H411

Calculation method

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

21 / 21