SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:Betamethasone (0.05%) 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 1BSpecific target organ toxicity repeated exposure:

Category 1 (Pituitary gland, Immune system, muscle, thymus
gland, Blood, Adrenal gland)Long-term (chronic) aquatic
hazard:Category 1

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360D May damage the unborn child.
H372 Causes damage to organs (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) through prolonged or repeated exposure.
H410 Very toxic to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
1 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust/ fume/ gas/ mist/ vapours/ spray.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
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 namePetrolatum
Decamethylcyclopentasiloxane

CAS-No.
8009-03-8
541-02-6

Concentration (% w/w)>= 20 - <= 30
7Propylene glycol

57-55-6Glyceryl monostearate

123-94-4

3

2-669

4-Chloro-3-methylphenol

59-50-7

0.1

3-900

betamethasone
Alcohols, C16-18, ethoxylated

378-44-968439-49-6

0.064
0.05

7-97

< 10

ENCS No.
7-475
2-234

4. FIRST AID MEASURES
General advice:

If inhaled:

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.
2 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician::

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

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.
Causes damage to organs through prolonged or repeatedexposure.
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
Silicon oxides
Formaldehyde

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.

:

3 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

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.

Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

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 dust, fume, gas, mist, vapours or spray.
Do not swallow.
Avoid contact with 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
Keep container tightly closed.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Do not breathe decomposition products.
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.

Storage
Conditions for safe storage:

Materials to avoid:

7. HANDLING AND STORAGE

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:
4 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Strong oxidizing agents
Packaging material:

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)

Petrolatum

8009-03-8

OEL-M (Mist)

Glyceryl monostearate

4-Chloro-3-methylphenol

betamethasone

Control parameters / Reference
concentration /Permissible concentration
3 mg/m3Basis

JP OEL
JSOH
Further information: Group 1: carcinogenic to humans
TWA (Inhal5 mg/m3
ACGIH
able particulate matter)
123-94-4
TWA (Inhal10 mg/m3
ACGIH
able particulate matter)
TWA (Res3 mg/m3
ACGIH
pirable particulate matter)
59-50-7TWA
200 µg/m3 (OEBInternal2)
Wipe limit
100 µg/100 cm2Internal
378-44-9TWA
1 µg/m3 (OEB 4)Internal
Further information: Skin
Wipe limit
10 µg/100 cm²Internal

Occupational exposure limits of decomposition products
Components

Formaldehyde

CAS-No.

Value type
(Form ofexposure)
ACL
OEL-M

Control parameBasisters / Permissible
concentration
50-00-0
0.1 ppm
JP OEL ISHL
0.1 ppm
JP OEL0.12 mg/m3
JSOH
Further information: Airway sensitizing agent; Group 2 substances
which probably induce allergic reactions in humans., Skin sensitizing agent; Group 1 substances which induce allergic reactions inhumans, Group 2A: probably carcinogenic to humans
OEL-C
0.2 ppm
JP OEL0.24 mg/m3
JSOH
Further information: Airway sensitizing agent; Group 2 substances
which probably induce allergic reactions in humans., Skin sensitizing agent; Group 1 substances which induce allergic reactions inhumans, Group 2A: probably carcinogenic to humans
5 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

TWA
STEL
Engineering measures:

0.1 ppm
0.3 ppm

ACGIH
ACGIH

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, inorganic gas/vapour and organic
vapour type
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body 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.
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

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

6 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

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

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Density:

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:

Not applicable:Not classified as a reactivity hazard.

10. STABILITY AND REACTIVITY
Reactivity

7 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Chemical stability
Possibility of hazardous reactions::

Stable under normal conditions.
Vapours may form explosive mixture with air.
Can react with strong oxidizing agents.
Hazardous decomposition products will be formed at elevatedtemperatures.

Conditions to avoid
Incompatible materials::

None known.
Oxidizing agents

Hazardous decomposition products
Thermal decomposition: Formaldehyde
11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Petrolatum:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Method: OECD Test Guideline 401
Remarks: Based on data from similar materials

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 402
Assessment: The substance or mixture has no acute dermal
toxicity
Remarks: Based on data from similar materials

Decamethylcyclopentasiloxane:
Acute oral toxicity: LD50 (Rat): > 5,000 mg/kg
Acute inhalation toxicity:

LC50 (Rat): 8.67 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403

Acute dermal toxicity:

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

Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
8 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Exposure time: 4 h
Test atmosphere: dust/mist
Acute dermal toxicity:

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

Glyceryl monostearate:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Method: OECD Test Guideline 401
Remarks: Based on data from similar materials

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Remarks: Based on data from similar materials

4-Chloro-3-methylphenol:
Acute oral toxicity:

LD50 (Mouse): 600 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 2.871 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

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

betamethasone:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
LD50 (Mouse): > 4,500 mg/kg

Acute inhalation toxicity:

LC50 (Rat): 0.4 mg/l
Exposure time: 4 hAlcohols, C16-18, ethoxylated:
Acute oral toxicity: LD50 (Rat): > 2,000 mg/kg
Remarks: Based on data from similar materials
Skin corrosion/irritation
Not classified based on available information.
Components:
Petrolatum:Species
MethodResultRemarks::::

RabbitOECD Test Guideline 404
No skin irritation
Based on data from similar materials

Decamethylcyclopentasiloxane:
9 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

SpeciesResult::RabbitNo skin irritation

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

Glyceryl monostearate:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

4-Chloro-3-methylphenol:
Species
MethodResult:::RabbitOECD Test Guideline 404
Corrosive after 1 to 4 hours of exposure

betamethasone:
SpeciesResult::RabbitMild skin irritation

Alcohols, C16-18, ethoxylated:
Species:
Method:Result:Remarks:

RabbitOECD Test Guideline 404
No skin irritation
Based on data from similar materials

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Petrolatum:SpeciesResult
MethodRemarks::::

RabbitNo eye irritation
OECD Test Guideline 405
Based on data from similar materials

Decamethylcyclopentasiloxane:
Species: Rabbit
Result: No eye irritation
Propylene glycol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405
10 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Glyceryl monostearate:
SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

4-Chloro-3-methylphenol:
SpeciesResult
Method:::RabbitIrreversible effects on the eyeOECD Test Guideline 405

betamethasone:
SpeciesResult::RabbitNo eye irritation

Alcohols, C16-18, ethoxylated:
Species:Result:
Method:Remarks:

RabbitNo eye irritation
OECD Test Guideline 405
Based on data from similar materials

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Petrolatum:
Test Type
Exposure routes
SpeciesResultRemarks:::::

Buehler Test
Skin contact
Guinea pig
negative
Based on data from similar materials

Decamethylcyclopentasiloxane:
Test Type: Local lymph node assay (LLNA)
Exposure routes: Skin contact
Species: MouseResult: negative
Propylene glycol:
Test Type
Exposure routes
Species:::

Maximisation Test
Skin contact
Guinea pig
11 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Result:negative

Glyceryl monostearate:
Test Type
Exposure routes
SpeciesResultRemarks:::::

Buehler Test
Skin contact
Guinea pig
negative
Based on data from similar materials

4-Chloro-3-methylphenol:
Test Type
Exposure routes
Species:::

Maximisation Test
Skin contact
Guinea pig

Assessment:

Probability or evidence of low to moderate skin sensitisation
rate in humans

betamethasone:
Exposure routes
SpeciesResult:::DermalGuinea pig
Weak sensitizer

Alcohols, C16-18, ethoxylated:
Test Type:
Exposure routes:
Species:
Method:Result:Remarks:

Buehler Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative
Based on data from similar materials

Germ cell mutagenicity
Not classified based on available information.
Components:
Petrolatum:
Genotoxicity in vitro:

Test Type: Chromosome aberration test in vitro
Result: negative
Remarks: Based on data from similar materials

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

12 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Decamethylcyclopentasiloxane:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
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: Rat
Application Route: inhalation (vapour)
Method: OECD Test Guideline 474
Result: negative
Test Type: Unscheduled DNA synthesis (UDS) test withmammalian liver cells in vivo
Species: Rat
Application Route: Inhalation
Method: OECD Test Guideline 486
Result: negative

Propylene glycol:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Result: negative

Glyceryl monostearate:
Genotoxicity in vitro:

Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Remarks: Based on data from similar materials
Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Remarks: Based on data from similar materials

13 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Remarks: Based on data from similar materials
4-Chloro-3-methylphenol:
Genotoxicity in vitro:

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

betamethasone:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Chromosome aberration test in vitro
Result: positive

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Oral
Result: equivocal

Germ cell mutagenicity Assessment:

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

Alcohols, C16-18, ethoxylated:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Remarks: Based on data from similar materials
Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative
Remarks: Based on data from similar materials
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Remarks: Based on data from similar materials
Carcinogenicity
Not classified based on available information.
Components:
Petrolatum:Species:Rat
14 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Application RouteExposure time
Result:::Ingestion
2 Years
negative

Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative:

Test Type: Reproduction/Developmental toxicity screening
test
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Skin contact
Result: negative
Remarks: Based on data from similar materials

Reproductive toxicity
May damage the unborn child.
Components:
Petrolatum:
Effects on fertility

Effects on foetal development

Decamethylcyclopentasiloxane:
Effects on fertility: Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: inhalation (vapour)
Method: OPPTS 870.3800
Result: negative
Effects on foetal development

Propylene glycol:
Effects on fertility

Effects on foetal development:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: inhalation (vapour)
Method: OPPTS 870.3800
Result: negative:

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

Test Type: Embryo-foetal development
Species: Mouse
15 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Application Route: Ingestion
Result: negative
Glyceryl monostearate:
Effects on fertility

Effects on foetal development

4-Chloro-3-methylphenol:
Effects on fertility

Effects on foetal development

betamethasone:
Effects on foetal development:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials:

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

Test Type: Reproduction/Developmental toxicity screening
test
Species: Rat
Application Route: Ingestion
Result: negative:

Species: Rabbit
Application Route: Intramuscular
Developmental Toxicity: LOAEL: 0.05 mg/kg body weight
Result: Fetotoxicity, Malformations were observed.
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.42 mg/kg body weight
Result: Malformations were observed.
Species: Mouse
Application Route: Intramuscular
Developmental Toxicity: LOAEL: 1 mg/kg body weight
Result: Malformations were observed.

Reproductive toxicity - Assessment:

Clear evidence of adverse effects on development, based onanimal experiments.
16 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Alcohols, C16-18, ethoxylated:
Effects on fertility: Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Skin contact
Result: negative
Remarks: Based on data from similar materials
Effects on foetal development:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Skin contact
Result: negative
Remarks: Based on data from similar materials

STOT - single exposure
Not classified based on available information.
Components:
4-Chloro-3-methylphenol:
Assessment:

May cause respiratory irritation.

STOT - repeated exposure
Causes damage to organs (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) through prolonged or repeated exposure.
Components:
betamethasone:
Target Organs:

Assessment:

Pituitary gland, Immune system, muscle, thymus gland, Blood,
Adrenal gland
Causes damage to organs through prolonged or repeatedexposure.

Repeated dose toxicity
Components:
Petrolatum:Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
5,000 mg/kg
Ingestion
2 yr

Decamethylcyclopentasiloxane:
Species: Rat
NOAEL: 1,000 mg/kg
LOAEL: > 1,000 mg/kg
Application Route: Ingestion
Method: OECD Test Guideline 408
17 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Glyceryl monostearate:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
>= 12,500 mg/kg
Ingestion
84 DaysBased on data from similar materials

4-Chloro-3-methylphenol:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
200 mg/kg
400 mg/kg
Ingestion
28 Daysbetamethasone:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rabbit0.05 %
Skin contact
10 - 30 d
Pituitary gland, Immune system, muscle

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.05 %
Skin contact
8 Weeks
thymus glandSpecies
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Mouse
0.1 %
Skin contact
8 Weeks
thymus glandSpecies
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.05 mg/kg
Oral
28 d
Blood, thymus gland, Adrenal gland

Alcohols, C16-18, ethoxylated:
Species: Rat
NOAEL: > 100 mg/kg
18 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

Application RouteExposure time
MethodRemarks

SDS Number:
1682148-00015

:
:
:
:

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Ingestion
90 Days
OECD Test Guideline 408
Based on data from similar materials

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
betamethasone:
Inhalation:

Target Organs: Adrenal gland

Skin contact:

Symptoms: Redness, pruritis, Irritation:

LL50 (Pimephales promelas (fathead minnow)): > 100 mg/l
Exposure time: 96 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 10,000 mg/l
Exposure time: 48 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

Toxicity to algae/aquaticplants:NOEL (Pseudokirchneriella subcapitata (green algae)): >=100 mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Petrolatum:
Toxicity to fish

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

NOEC (Daphnia magna (Water flea)): 10 mg/l
Exposure time: 21 d
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

Decamethylcyclopentasiloxane:
Toxicity to fish
: LC50 (Oncorhynchus mykiss (rainbow trout)): > 16 µg/l
Exposure time: 96 h
19 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Remarks: No toxicity at the limit of solubility
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 2.9 µg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility

Toxicity to algae/aquaticplants:

ErC50 (Pseudokirchneriella subcapitata (green algae)): > 12µg/l
Exposure time: 96 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility
EC10 (Pseudokirchneriella subcapitata (green algae)): > 12µg/l
Exposure time: 96 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility

Toxicity to fish (Chronic toxicity):

NOEC (Oncorhynchus mykiss (rainbow trout)): 14 µg/l
Exposure time: 90 d
Method: OECD Test Guideline 210
Remarks: No toxicity at the limit of solubility

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

NOEC (Daphnia magna (Water flea)): 15 µg/l
Exposure time: 21 d
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility

Toxicity to microorganisms:

EC50: > 2,000 mg/l
Exposure time: 3 hMethod: 88/302/EC

Propylene glycol:
Toxicity to fish:

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

Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to algae/aquaticplants:

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

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

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

Glyceryl monostearate:
20 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Toxicity to fish:

LL50 (Leuciscus idus (Golden orfe)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EL50 (Daphnia magna (Water flea)): > 32 mg/l
Exposure time: 47 h
Method: Directive 67/548/EEC, Annex V, C.2.
Remarks: No toxicity at the limit of solubility
Based on data from similar materials

Toxicity to algae/aquaticplants:EL50 (Pseudokirchneriella subcapitata (green algae)): > 100
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility
NOELR (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility

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

NOEC (Daphnia magna (Water flea)): > 0.22 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility
Based on data from similar materials

Toxicity to microorganisms:

EC10 (Pseudomonas putida): > 1 mg/l
Exposure time: 18 h
Remarks: Based on data from similar materials

4-Chloro-3-methylphenol:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 917 µg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 1.5 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

ErC50 (Chlorella pyrenoidosa (algae)): 15 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
EC10 (Chlorella pyrenoidosa (algae)): 2.3 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

M-Factor (Acute aquatic toxicity):

1

21 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

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

NOEC (Daphnia magna (Water flea)): 0.32 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Toxicity to microorganisms:

EC50: 22.86 mg/l
Exposure time: 60 h

betamethasone:
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Americamysis): > 50 mg/l
Exposure time: 96 h:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 34
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility

Toxicity to algae/aquaticplantsNOEC (Pseudokirchneriella subcapitata (green algae)): 34
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)): 0.052 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210
NOEC (Oryzias latipes (Japanese medaka)): 0.07 µg/l
Exposure time: 219 d
Method: OECD Test Guideline 229

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

NOEC (Daphnia magna (Water flea)): 8 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

M-Factor (Chronic aquatic
toxicity)

1,000

:

Alcohols, C16-18, ethoxylated:
Toxicity to fish
: LC50 (Leuciscus idus (Golden orfe)): > 1 - 10 mg/l
Exposure time: 96 h
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Persistence and degradability
Components:
Petrolatum:
Biodegradability:

Result: Not readily biodegradable.
22 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Biodegradation: 31 %Exposure time: 28 d
Method: OECD Test Guideline 301F
Remarks: Based on data from similar materials
Decamethylcyclopentasiloxane:
Biodegradability: Result: Not readily biodegradable.
Biodegradation: 0.14 %Exposure time: 28 d
Method: OECD Test Guideline 310
Propylene glycol:
Biodegradability:

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

Glyceryl monostearate:
Biodegradability:

Result: Readily biodegradable.
Remarks: Based on data from similar materials

4-Chloro-3-methylphenol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 78 %Exposure time: 15 d
Method: OECD Test Guideline 301

Alcohols, C16-18, ethoxylated:
Biodegradability: Result: Readily biodegradable.
Biodegradation: > 60 %Exposure time: 28 d
Method: OECD Test Guideline 301B
Remarks: Based on data from similar materials
Bioaccumulative potential
Components:
Decamethylcyclopentasiloxane:
Bioaccumulation: Species: Pimephales promelas (fathead minnow)
Bioconcentration factor (BCF): 7,060 - 13,300
Method: OECD Test Guideline 305
Partition coefficient: noctanol/water
Propylene glycol:
Partition coefficient: n-:log Pow: 8.023:

log Pow: -1.07
23 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

octanol/water
Glyceryl monostearate:
Partition coefficient: noctanol/water
4-Chloro-3-methylphenol:
Bioaccumulation

Partition coefficient: noctanol/water
betamethasone:
Partition coefficient: noctanol/water

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

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

log Pow: 6.1:

Species: Cyprinus carpio (Carp)
Bioconcentration factor (BCF): 5.5 - 13:

log Pow: 0.477:

log Pow: 2.11

Alcohols, C16-18, ethoxylated:
Bioaccumulation: Species: Fish
Bioconcentration factor (BCF): < 500
Remarks: Based on data from similar materials
Partition coefficient: noctanol/water:log Pow: > 4

Mobility in soil
No data available
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
UNRTDGUN number
Proper shipping name::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(betamethasone)
24 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

9
III
9
yes

IATA-DGR
UN/ID No.
Proper shipping name

:
:
:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(betamethasone)
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.
(betamethasone)
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)Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical namePropane-1,2-diol

Number106
25 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17[alpha-(Alkyl(C=16-18))-omega-hydroxypoly(oxyethane-1,2-diyl) or alpha-(alkenyl(C=16-18))-omega-hydroxypoly(oxyethane-1,2-diyl)]

250

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 namePetrolatum
decamethylcyclopentasiloxane
propane-1,2-diol
4-chlorocresol

Concentration (%)>=20 - <=30
>0 - <10<10>0 - <10

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical namePetrolatum
decamethylcyclopentasiloxane
propane-1,2-diol

Remarks
From April 1st, 2026
From April 1st, 2026
From April 1st, 2025
From April 1st, 2025

Remarks
From April 1st, 2026
From April 1st, 2026
From April 1st, 2025

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

26 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

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
27 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

compile the Safety Data
Sheet

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

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 ISHL
: Japan. Administrative Control Levels
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
ACGIH / TWA
ACGIH / STELJP OEL ISHL / ACLJP OEL JSOH / OEL-M
JP OEL JSOH / OEL-C

:
:
:
:
:

8-hour, time-weighted average
Short-term exposure limit
Administrative Control level
Occupational Exposure Limit-Mean
Occupational Exposure Limit-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
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
28 / 29SAFETY DATA SHEET

Betamethasone (0.05%) Cream Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1682148-00015

Date of last issue: 2023/09/30
Date of first issue: 2017/05/17

safe 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.
JP / EN

29 / 29