SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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.
Shotton Lane
NE23 3JU Cramlington NU - Great Britain
Telephone:+44 1 670 59 32 05

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) as amended by GB-CLP Regulation, UK
SI 2019/720, and UK SI 2020/1567)
Flammable liquids, Category 2
Eye irritation, Category 2
Specific target organ toxicity - single exposure, Category 3
Long-term (chronic) aquatic hazard, Category 2

H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
H411: Toxic to aquatic life with long lasting effects.

2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK SI
2019/720, and UK SI 2020/1567)

1 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Hazard pictograms:

Signal word:

DangerHazard statements

:

H225
H319
H336
H411

Precautionary statements:

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/ eyeprotection/ face protection.

Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Toxic to aquatic life with long lasting effects.

Response:
P304 + P340 + P312 IF INHALED: Remove person to fresh
air and keep comfortable for breathing. Call a
POISON CENTER/ 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
83919-23-7

2 / 25Classification

Concentration(% w/w)

Flam. Liq. 2; H225
Eye Irrit. 2; H319
STOT SE 3; H336
Repr. 1B; H360Df
STOT RE 2; H373
(Immune system,
Liver, Kidney, Skin)
Aquatic Chronic 1;>= 30 - < 50>= 0.1 - < 0.25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021
H410

M-Factor (Chronic
aquatic toxicity):
100
Substances with a workplace exposure limit :Propylene glycol
57-55-6
200-338-0>= 20 - < 30

For explanation of abbreviations see section 16.

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

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

If inhaled:

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

In case of skin contact:

In case of contact, immediately flush skin with 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.

3 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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 spreadfighting
fire.
Flash back possible over considerable distance.
Vapours may form explosive mixtures with air.
Exposure to combustion products may be a hazard to health.
Hazardous combustion products
5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods:

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.
If spillage enters rivers or watercourses, inform the Environment Agency (emergency telephone number 0800 807060).
4 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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
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,
5 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Flammable solids
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures, which in contact with water, emit
flammable gases
Explosives
Gases
Very acutely toxic substances and mixtures:

No data available

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

CAS-No.

Propan-2-ol

67-63-0

Value type (Formof exposure)
STEL
TWA

Propylene glycol

Mometasone

57-55-6

TWA (Total vapour and particles)
TWA (particles)
83919-23-7
TWA
Further information: Skin
Wipe limit

Control parameters

Basis

500 ppm
1,250 mg/m3
400 ppm
999 mg/m3
150 ppm
474 mg/m3

GB EH40

10 mg/m3
1 µg/m3 (OEB 4)

GB EH40
Internal

10 µg/100 cm²Internal

GB EH40
GB EH40

Derived No Effect Level (DNEL):
Substance name

End UseExposure routes

Propan-2-ol

Workers

Inhalation
6 / 25

Potential health effects
Long-term systemicValue
500 mg/m3

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

Propylene glycol

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Workers

Skin contact

Consumers

Inhalation

Consumers

Skin contact

Consumers

Ingestion

Workers

Inhalation

Workers

Inhalation

Consumers

Inhalation

Consumers

Inhalation

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
effects

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

Predicted No Effect Concentration (PNEC):
Substance namePropan-2-ol

Environmental Compartment
Fresh water
Marine waterIntermittent use/release
Sewage treatment plant
Fresh water sediment
Marine sediment
Soil

Propylene glycol

Oral (Secondary Poisoning)
Fresh water
Freshwater - intermittent
Marine water
Sewage treatment plant
Fresh water sediment
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.
7 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to BS EN 14387
Combined particulates and organic vapour type (A-P)

Skin and body protection:

Respiratory protection:

Filter type:

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

8 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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.

9.2 Other information
Flammability (liquids):

Ignitable (see flash point)

Molecular weight:Not applicable

Particle size:

Not applicable

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

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

9 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

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

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
10 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Assessment: The substance or mixture has no acute dermal
toxicity
Skin corrosion/irritation
Not classified based on available information.
Components:
Propan-2-ol:
SpeciesResult::RabbitNo skin irritation

Mometasone:
SpeciesResult::RabbitNo skin irritation

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

Propylene glycol:
Species
MethodResult:::RabbitOECD Test Guideline 405
No 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:
11 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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.

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

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
12 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Test Type: Mouse Lymphoma
Result: negative
Genotoxicity in vivo:

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

Germ cell mutagenicity- Assessment
Propylene glycol:
Genotoxicity in vitro:

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

:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: 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

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 Route

:
:

Rat
Inhalation
13 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Exposure time
Dose
Result:::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

Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

Reproductive toxicity
Not classified based on available information.
Components:
Propan-2-ol:
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: 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
14 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

Propylene glycol:
Effects on fertility

Effects on foetal development:

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

:

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

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

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.

15 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Repeated dose toxicity
Components:

16 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

17 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

Toxicity to daphnia and otheraquatic invertebrates

SDS Number:
9373191-00008:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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 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

:

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

Propylene glycol:
Toxicity to fish

18 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

Toxicity to microorganisms

SDS Number:
9373191-00008:

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

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

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

Stability in water:

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

Propylene glycol:
Biodegradability:

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

log Pow: 0.05:

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

log Pow: 4.68:

log Pow: -1.07

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

Partition coefficient: noctanol/water
Propylene glycol:
Partition coefficient: n-

19 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

octanol/water

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Method: Regulation (EC) No. 440/2008, Annex, A.8

12.4 Mobility in soil
Components:
Mometasone:
Distribution among environmental compartments:

log Koc: 4.02

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.

:

This substance/mixture does not contain components considered to have endocrine disrupting properties for environment
according to UK REACH Article 57(f).

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 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
14.1 UN number
ADN:

UN 1219ADR:

UN 1219RID:

UN 1219
20 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

Subsidiary risks

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)

RID
Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

II
F1
33
3

IMDG
Packing group
LabelsEmS Code

:
:
:

II
3
F-E, S-D

:

364

:

Y341

14.4 Packing group

IATA (Cargo)
Packing instruction (cargo
aircraft)Packing instruction (LQ)

21 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

Packing group
LabelsSDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021::

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 (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
Relevant EU provisions transposed through retained EU law
UK REACH List of restrictions (Annex 17):

Conditions of restriction for the following entries should be considered:
Number on list 3
Substance(s) or mixture(s) are listed
here according to their appearance
in the regulation, irrespective of theiruse/purpose or the conditions of therestriction. Please refer to the conditions in corresponding Regulation todetermine whether an entry is applicable to the placing on the market ornot.

UK REACH Candidate list of substances of very highconcern (SVHC) for Authorisation
The Persistent Organic Pollutants Regulations (retained:

Not applicable:Not applicable

22 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Regulation (EU) 2019/1021 as amended for Great Britain)
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
UK REACH List of substances subject to authorisation: Not applicable(Annex XIV)GB Export and import of hazardous chemicals - Prior: Not applicable
Informed Consent (PIC) Regulation
Control of Major Accident Hazards Regulations 2015 (COMAH)
Quantity 1
P5c
FLAMMABLE LIQUIDS
5,000 tQuantity 2
50,000 t

E2

500 t

ENVIRONMENTAL
HAZARDS

200 t

Other regulations:
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to new and expectant mothers at work contained in Regulation 16 to 18) and of thePregnant Workers Directive 92/85/EEC.
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to protection of young people at work contained in Regulation 19) and of Directive
94/33/EC on the protection of young people at work.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

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

SECTION 16: Other information
Other information:

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

Full text of H-Statements
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
23 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Aquatic Chronic
Eye Irrit.
Flam. Liq.
Repr.
STOT RESTOT SEGB EH40
GB EH40 / TWA
GB EH40 / STEL

:
:
:
:
:
:
:
:
:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Long-term (chronic) aquatic hazard
Eye irritation
Flammable liquids
Reproductive toxicity
Specific target organ toxicity - repeated exposure
Specific target organ toxicity - single exposure
UK. EH40 WEL - Workplace Exposure Limits
Long-term exposure limit (8-hour TWA reference period)
Short-term exposure limit (15-minute reference period)

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

24 / 25

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Mometasone Lotion Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
9373191-00008

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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.
GB / EN

25 / 25