SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Mometasone Cream Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

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

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

2. HAZARDS IDENTIFICATIONGHS classification of chemical productReproductive toxicity: Category 2
Long-term (chronic) aquatic
hazard:Category 2

GHS label elements
Hazard pictograms:

Signal word:

Warning

Hazard statements:

H361d Suspected of damaging the unborn child.
H411 Toxic to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
1 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P391 Collect spillage.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
Other hazards which do not result in classification
None known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical nameWhite mineral oil (petroleum)

CAS-No.
8042-47-5

Concentration (% w/w)>= 60 - < 70

2-Methyl-2,4-pentanediol

107-41-5>= 10 - < 20

Titanium dioxide

13463-67-7> 0 - < 10

Mometasone

83919-23-7>= 0.1 - < 0.25

ENCS No.
9-17002-240
1-558, 5-5225

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 and: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 soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Suspected of damaging the unborn child.

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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

delayedProtection of first-aiders:

Notes to physician:

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

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.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

Unsuitable extinguishingmedia
Specific hazards during firefighting::

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

Hazardous combustion products:

Carbon oxides
Metal oxides

Specific extinguishing methods:

Special protective equipment
for firefighters:

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.

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

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.
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:

Sweep up or vacuum up spillage and collect in suitable container for disposal.
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.

3 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

7. HANDLING AND STORAGE
Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe vapours.
Do not swallow.
Avoid contact with eyes.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
Take care to prevent spills, waste and minimize release to theenvironment.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review 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.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

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

CAS-No.

Value type
(Form ofexposure)White mineral oil (petroleum)8042-47-5

TWA (Inhalable particulate matter)4 / 24Control parameters / Reference
concentration /Permissible concentration
5 mg/m3

Basis

ACGIH

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

2-Methyl-2,4-pentanediol

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

107-41-5

TWA (Va25 ppm
ACGIH
pour)
STEL (Va50 ppm
ACGIH
pour)
STEL (Inhal- 10 mg/m3
ACGIH
able fraction,
Aerosol only)
13463-67-7
OEL-M
1.5 mg/m3
JP OEL(Respirable(Titanium)
JSOH
particulatematter)Further information: Group 2B: possibly carcinogenic to humans
OEL-M (Total 2 mg/m3
JP OELparticulate(Titanium)
JSOH
matter)Further information: Group 2B: possibly carcinogenic to humans
TWA (Res2.5 mg/m3
ACGIH
pirable par(Titanium dioxide)
ticulate matter)
83919-23-7
TWA
1 µg/m3 (OEB 4)Internal
Further information: Skin
Wipe limit
10 µg/100 cm²Internal

Titanium dioxide

Mometasone

This substance(s) is not bioavailable and therefore does not contribute to a dust inhalation
hazard.
Titanium dioxide
Engineering measures:

Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., vacuum conveying
from a closed system, packout head with inflatable seal fromstationary container, ventilated enclosure, etc.).
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.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Combined particulates and organic vapour type
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

Skin and body protection

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

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.

:

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state

:

cream

Colour:white to off-white

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

Not classified as a flammability hazard

Flammability (liquids):

Not applicable

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

No data available

Flash point:> 93.3 °C

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

Not applicableAuto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

6 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

No data available:

No data available

Relative vapour density:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

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

Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

None known.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
White mineral oil (petroleum):
Acute oral toxicity:
Acute inhalation toxicity:

LD50 (Rat): > 5,000 mg/kg
LC50 (Rat): > 5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhala7 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

tion toxicity
Acute dermal toxicity:

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

2-Methyl-2,4-pentanediol:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 420

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 402
Assessment: The substance or mixture has no acute dermal
toxicity

Titanium dioxide:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 6.82 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation 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:
White mineral oil (petroleum):Species:Result:RabbitNo skin irritation
8 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

2-Methyl-2,4-pentanediol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Titanium dioxide:
SpeciesResult::RabbitNo skin irritation

Mometasone:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
White mineral oil (petroleum):Species:Result:RabbitNo eye irritation

2-Methyl-2,4-pentanediol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

Titanium dioxide:
SpeciesResult::RabbitNo eye irritation

Mometasone:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
White mineral oil (petroleum):
Test Type:

Buehler Test
9 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Exposure routes
SpeciesResult:::Skin contact
Guinea pig
negative

2-Methyl-2,4-pentanediol:
Test Type
Exposure routes
Species
MethodResult:::::Maximisation Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

Titanium dioxide:
Test Type
Exposure routes
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
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:
White mineral oil (petroleum):
Genotoxicity in vitro:

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
Method: OECD Test Guideline 474
Result: negative
Remarks: Based on data from similar materials

2-Methyl-2,4-pentanediol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
10 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Titanium dioxide:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Result: negative

Mometasone:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

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

Germ cell mutagenicity Assessment:

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

Carcinogenicity
Not classified based on available information.

11 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Components:
White mineral oil (petroleum):Species:
Application Route:Exposure time:
Result:Titanium dioxide:
Species
Application RouteExposure time
MethodResultRemarks

Rat
Ingestion
24 Months
negative

:
:
:
:
:
:

Rat
inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
The mechanism or mode of action may not be relevant in
humans.
This substance(s) is not bioavailable and therefore does notcontribute to a dust inhalation hazard.

:

Limited evidence of carcinogenicity in inhalation studies withanimals.

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

Carcinogenicity - Assessment

Reproductive toxicity
Suspected of damaging the unborn child.
Components:
White mineral oil (petroleum):
Effects on fertility:

Effects on foetal development:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Skin contact
Result: negative
Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative
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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

2-Methyl-2,4-pentanediol:
Effects on fertility

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 443
Result: negative

Effects on foetal development:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 443
Result: positive

Reproductive toxicity - Assessment:

Some evidence of adverse effects on development, based onanimal experiments.

:

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

Mometasone:
Effects on fertility

Effects on foetal development

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
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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

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
Not classified based on available information.
Components:
Mometasone:
Remarks:

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

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

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

Repeated dose toxicity
Components:
White mineral oil (petroleum):Species:
LOAEL:
Application Route:Exposure time:Rat
160 mg/kg
Ingestion
90 DaysSpecies
LOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 1 mg/l
inhalation (dust/mist/fume)
4 Weeks
OECD Test Guideline 412

2-Methyl-2,4-pentanediol:
Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 450 mg/kg
Ingestion
13 Weeks
OECD Test Guideline 408

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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Titanium dioxide:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
24,000 mg/kg
Ingestion
28 DaysSpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rat
10 mg/m3
inhalation (dust/mist/fume)
2 yrMometasone:
Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

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

:
:
:
:
:

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

:
:
:
:
:

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

:
:
:
:
:

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

Aspiration toxicity
Not classified based on available information.
Components:
Mometasone:
Not applicable

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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Experience with human exposure
Components:
2-Methyl-2,4-pentanediol:
Eye contact:

Target Organs: Eyes
Symptoms: Irritation

Mometasone:
Inhalation:

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

Skin contact:

Symptoms: Dermatitis, Itching:

Dermal absorption possible

Further information
Components:
Mometasone:
Remarks
12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
White mineral oil (petroleum):
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:NOEC (Pseudokirchneriella subcapitata (green algae)): 100
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Oncorhynchus mykiss (rainbow trout)): 1,000 mg/l
Exposure time: 28 d

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
2-Methyl-2,4-pentanediol:
Toxicity to fish:

NOEC (Daphnia magna (Water flea)): 1,000 mg/l
Exposure time: 21 d

LC50 (Gambusia affinis (Mosquito fish)): 8,510 mg/l
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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Exposure time: 96 h
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 2,800 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Raphidocelis subcapitata (freshwater green alga)): >429 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
EC10 (Raphidocelis subcapitata (freshwater green alga)): >429 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

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

NOEC (Daphnia magna (Water flea)): 25 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Toxicity to microorganisms:

NOEC (Bacteria): 200 mg/l
Exposure time: 10 dTitanium dioxide:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 (Skeletonema costatum (marine diatom)): > 10,000 mg/l
Exposure time: 72 h

Toxicity to microorganisms:

EC50: > 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

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

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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

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

Persistence and degradability
Components:
White mineral oil (petroleum):
Biodegradability:

2-Methyl-2,4-pentanediol:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 31 %Exposure time: 28 d

Result: Readily biodegradable.
Biodegradation: 81 %Exposure time: 28 d
Method: OECD Test Guideline 301F

Mometasone:
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SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Biodegradability:

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

Stability in water:

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

log Pow: < 4
Remarks: Calculation:

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

log Pow: 4.68:

log Koc: 4.02

Bioaccumulative potential
Components:
2-Methyl-2,4-pentanediol:
Partition coefficient: noctanol/water
Mometasone:
Bioaccumulation

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

Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
19 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

UN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Mometasone)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Mometasone)
9
III
Miscellaneous
956

:

956

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Mometasone)
9III
9
F-A, S-F
yes

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

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

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Designated Flammable Substances, Flammable solid, (3000 kilogram)

20 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

Chemical Substance Control Law
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical nameMineral oil
2-Methyl-2,4-pentanediol
Titanium(IV) oxide

Concentration (%)>=60 - <70>=10 - <20>0 - <10

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical nameMineral oil
2-Methyl-2,4-pentanediol
Titanium(IV) oxide

Remarks-

Remarks-

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable

21 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

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

Not classified as noxious liquid substance

Pack transportation:

Classified as marine pollutant

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

not determined

IECSC

:

not determined

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
Further information
Sources of key data used to:Internal technical data, data from raw material SDSs, OECD
22 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

compile the Safety Data
Sheet

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

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

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

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
ACGIH / TWA
ACGIH / STELJP OEL JSOH / OEL-M:::

8-hour, time-weighted average
Short-term exposure limit
Occupational Exposure Limit-Mean

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 mate23 / 24

SAFETY DATA SHEET

Mometasone Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1688400-00017

Date of last issue: 2023/09/30
Date of first issue: 2017/05/21

rial is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
JP / EN

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