SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

SECTION 1. IDENTIFICATION
Product name
Other means of identification::

Mometasone Cream Formulation
No data available

Manufacturer or supplier's details
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
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the Hazardous Products Regulations
Reproductive toxicity: Category 1B
GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H360Df May damage the unborn child. Suspected of damaging
fertility.

Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.

1 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

Other hazards
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical nameWhite mineral oil (petroleum)
2-Methyl-2,4pentanediol
Aluminum starch octenylsuccinate

CommonCAS-No.
Name/Synonym
Paraffinum8042-47-5
liquidum
Hexylene glycol 107-41-5

Concentration (% w/w)

Starch, hydro- 9087-61-0
gen 2-(octen-1yl)butanedioate,
aluminum salt
Titanium dioxide
Titanic anhy13463-67-7
drideMometasone
No data availa- 83919-23-7
ble* Actual concentration or concentration range is withheld as a trade secret>= 60 - < 80 *>= 10 - < 30 *>= 10 - < 30 *>= 1 - < 5 *>= 0.1 - < 1 *SECTION 4. 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.

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

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.
May damage the unborn child. Suspected of damaging fertility.

Notes to physician::

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

SECTION 5. FIRE-FIGHTING MEASURES
2 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

Suitable extinguishing media:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Vapors 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 fire-fighters:

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.

SECTION 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 suitablecontainer for disposal.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

Advice on safe handling:

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 vapors.
Do not swallow.
Avoid contact with eyes.
Handle in accordance with good industrial hygiene and safety
3 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Conditions for safe storage:

Materials to avoid:

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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.
Keep in properly labeled 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
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
Components

CAS-No.

White mineral oil (petroleum)8042-47-5

2-Methyl-2,4-pentanediol

107-41-5

Value type
(Form ofexposure)
TWA (Mist)
STEL (Mist)
TWA (Mist)
TWAEV (Mist- Inhalable
dust)
TWA
(Inhalable
particulatematter)(c)
C

Aluminum starchoctenylsuccinate

9087-61-0

Titanium dioxide

13463-67-7

4 / 22

TWA (Vapor)
STEL(Vapor)STEL(Inhalable
fraction,Aerosol only)
TWAEV(respirable
dust)
TWA
TWA (Total
dust)
TWA (respirable dust

Control parameters / Permissible
concentration
5 mg/m³
10 mg/m³
1 mg/m³
5 mg/m³Basis

5 mg/m³

ACGIH

25 ppm
121 mg/m³
25 ppm
121 mg/m³
25 ppm50 ppmCA AB OEL

10 mg/m³

ACGIH

5 mg/m³

CA QC OEL

10 mg/m³
10 mg/m³

CA AB OELCA BC OEL

3 mg/m³

CA BC OEL

CA AB OEL
CA AB OELCA BC OELCA QC OELCA QC OEL
ACGIH
ACGIH

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

fraction)
TWAEV (total dust)
TWA(Respirable
particulatematter)83919-23-7
TWA
Further information: Skin
Wipe limit

Mometasone

10 mg/m³

CA QC OEL

2.5 mg/m³(Titanium dioxide)

ACGIH

1 µg/m3 (OEB 4)Internal

10 µg/100 cm²InternalThis 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 therecommended guidelines, use respiratory protection.
Filter type
: Combined particulates and organic vapor type
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Hygiene measures:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets,
disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
5 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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.
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

cream

Color

:

white to off-white

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:> 93.3 °C

Evaporation rate:

Not applicable

Flammability (solid, gas):

Not classified as a flammability hazard

Flammability (liquids):

Not applicable

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

Not applicable

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available
6 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle size:

No data available

SECTION 10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Vapors 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.

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 2,000 mg/kg
Method: Calculation method

Components:
White mineral oil (petroleum):
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Assessment: The substance or mixture has no acute dermal
toxicity
7 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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

Aluminum starch octenylsuccinate:
Acute oral toxicity: Assessment: The substance or mixture has no acute oral toxicity
Acute inhalation toxicity:

LC50 (Rat): > 200 mg/l
Exposure time: 1 h
Test atmosphere: dust/mist

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):
8 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

SpeciesResult::RabbitNo skin irritation

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 sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.

9 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

Components:
White mineral oil (petroleum):
Test Type:
Routes of exposure:
Species:Result:Buehler Test
Skin contact
Guinea pig
negative

2-Methyl-2,4-pentanediol:
Test Type
Routes of exposure
Species
MethodResultMaximization Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

:
:
:
:
:

Aluminum starch octenylsuccinate:
Test Type: Human repeat insult patch test (HRIPT)
Routes of exposure: Skin contact
Species: HumansResult: negative
Titanium dioxide:
Test Type
Routes of exposure
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative

Mometasone:
Test Type
Routes of exposure
Species
Assessment
ResultRemarks

:
:
:
:
:
:

Maximization Test
DermalGuinea pig
Does not cause skin sensitization.
negative
The results of a test on guinea pigs showed this substance tobe a weak skin sensitizer.

Germ cell mutagenicity
Not classified based on available information.
Components:
White mineral oil (petroleum):
Genotoxicity in vitro:

Genotoxicity in vivo:

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Method: OECD Test Guideline 474
10 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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
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

11 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

Germ cell mutagenicity Assessment

SDS Number:
1688391-00017:

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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

Carcinogenicity
Not classified based on available information.
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
May damage the unborn child. Suspected of damaging fertility.
Components:
White mineral oil (petroleum):
Effects on fertility:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Skin contact
Result: negative

12 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

Effects on fetal development:

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

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

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

Effects on fetal 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.

Mometasone:
Effects on fertility:

Test Type: Fertility
Species: Rat
Application Route: Subcutaneous
Fertility: NOAEL: 0.015 mg/kg body weight
Symptoms: Reduced embryonic survival, Reduced fetal
weight.
Result: No effects on fertility., Effect on reproduction capacity.

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Mouse
Application Route: Subcutaneous
Embryo-fetal toxicity.: LOAEL: 0.06 mg/kg body weight
Result: Embryotoxic effects., Teratogenicity anddevelopmental toxicity
Test Type: Embryo-fetal development
Species: Rat
Application Route: Dermal
Embryo-fetal toxicity.: LOAEL: 0.3 mg/kg body weight
Result: Embryo-fetal toxicity.
Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Dermal
Embryo-fetal toxicity.: LOAEL: 0.15 mg/kg body weight
Result: Embryo-fetal toxicity., Malformations were observed.
Test Type: Embryo-fetal development
Species: Rat
Application Route: Subcutaneous
13 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

Embryo-fetal toxicity.: LOAEL: 0.15 mg/kg body weight
Result: Effects on newborn.
Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Oral
Embryo-fetal toxicity.: LOAEL: 0.7 mg/kg body weight
Result: Embryo-fetal 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:
Routes of exposure
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 Route

:
:
:

Rat
>= 450 mg/kg
Ingestion
14 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

Exposure time
Method::13 Weeks
OECD Test Guideline 408

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)2yMometasone:
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

15 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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

Target Organs: Eyes
Symptoms: Irritation

Mometasone:
Inhalation:

Skin contact:

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

Dermal absorption possible

Further information
Components:
Mometasone:
Remarks

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
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

Toxicity to daphnia and otheraquatic invertebrates

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

LC50 (Gambusia affinis (Mosquito fish)): 8,510 mg/l
Exposure time: 96 h:

EC50 (Ceriodaphnia dubia (water flea)): 2,800 mg/l
Exposure time: 48 h
16 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

Toxicity to algae/aquaticplantsSDS Number:
1688391-00017:

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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.
EC50 (Americamysis): > 5 mg/l
Exposure time: 96 h
Method: US-EPA OPPTS 850.1035
Remarks: No toxicity at the limit of solubility.

17 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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.

Toxicity to microorganisms

EC50: > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility.

:

NOEC: 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility.
Persistence and degradability
Components:
White mineral oil (petroleum):
Biodegradability:

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

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

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

Mometasone:
Biodegradability:

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

Stability in water:

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

18 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

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

Partition coefficient: noctanol/water: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

Mobility in soil
Components:
Mometasone:
Distribution among environmental compartments
Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Mometasone)
9
III
9
yes
UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Mometasone)
19 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

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

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

:
:
:
:

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

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

:
:

Class
Packing group
LabelsERG Code
Marine pollutant

:
:
:
:
:

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Mometasone)
9
III
9
171
yes(Mometasone)

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, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATION
The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

20 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

SECTION 16. OTHER INFORMATION
Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)CA AB OEL
: Canada. Alberta, Occupational Health and Safety Code (table
2: OEL)CA BC OEL
: Canada. British Columbia OEL
CA QC OEL
: Québec. Regulation respecting occupational health and safety, Schedule 1, Part 1: Permissible exposure values for airborne contaminants
ACGIH / TWA: 8-hour, time-weighted average
ACGIH / STEL
: Short-term exposure limit
CA AB OEL / TWA: 8-hour Occupational exposure limit
CA AB OEL / STEL
: 15-minute occupational exposure limit
CA AB OEL / (c): ceiling occupational exposure limit
CA BC OEL / TWA: 8-hour time weighted average
CA QC OEL / TWAEV: Time-weighted average exposure value
CA QC OEL / C: Ceiling
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

Sources of key data used tocompile the Material Safety:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agen21 / 22

SAFETY DATA SHEET
according to the Hazardous Products Regulations

Mometasone Cream Formulation
Version
6.0

Revision Date:
09/30/2023

SDS Number:
1688391-00017

Data Sheet
Revision Date
Date format

Date of last issue: 04/04/2023
Date of first issue: 05/21/2017

cy, http://echa.europa.eu/::

09/30/2023
mm/dd/yyyy

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 for safe handling, use, processing, storage, transportation, disposal and release andshall 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 specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
CA / Z8

22 / 22