SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:Betamethasone (0.05%) Cream Formulation

Manufacturer or supplier's details
Company: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

Emergency telephone number :+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

2. HAZARDS IDENTIFICATION
Manufacture, Storage and Import of Hazardous Chemicals Rules 1989
Classification
Not classified as hazardous according to criteria laid down in Part I of Schedule-1.
GHS Classification
Reproductive 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.
1 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

H410 Very toxic to aquatic life with long lasting effects.
Precautionary statements:

Prevention:
P203 Obtain, read and follow all safety instructions before use.
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:
P318 IF exposed or concerned, get medical advice.
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 name

CAS-No.

Petrolatum
Decamethylcyclopentasiloxane
Glyceryl monostearate
4-Chloro-3-methylphenol
betamethasone

8009-03-8
541-02-6
123-94-4
59-50-7
378-44-9

Concentration (%w/w)>= 20 - <= 30
7
3
0.1
0.064

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:

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.
2 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

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: 04.04.2023
Date of first issue: 17.05.2017

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.
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.
3 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

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.
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

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

CAS-No.

4-Chloro-3-methylphenol

59-50-7

Value type
(Form ofexposure)
TWA (Mist)
STEL (Mist)
TWA (Inhalable particulate matter)
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)
TWA

Petrolatum

8009-03-8

Glyceryl monostearate

123-94-4

betamethasone

378-44-9

Wipe limit
TWA
4 / 22Control parameters / Permissible
concentration
5 mg/m3
10 mg/m3
5 mg/m3

Basis

10 mg/m3

ACGIH

3 mg/m3

ACGIH

200 µg/m3 (OEB
2)
100 µg/100 cm2
1 µg/m3 (OEB 4)Internal

IN OELIN OELACGIHInternal
Internal

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

Further information: Skin
Wipe limit

10 µg/100 cm²Internal

Occupational exposure limits of decomposition products
Components

CAS-No.

Control parameters / Permissible
concentration
50-00-0
2 ppm
3 mg/m3
Further information: Suspected human carcinogens
TWA
1 ppm
1.5 mg/m3
Further information: Suspected human carcinogens
TWA
0.1 ppm
STEL
0.3 ppm

FormaldehydeEngineering measures:

Value type
(Form ofexposure)
STEL

Basis

IN OELIN OEL

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:

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 the task
being performed (e.g., sleevelets, apron, gauntlets, disposable
suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If 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.
5 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

cream

Colour

:

white

Odour

:

No data available

Odour 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

Vapour pressure:

No data available

Relative vapour density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available
6 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle size:

Not applicable

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.
Hazardous decomposition products will be formed at elevatedtemperatures.

Conditions to avoid
Incompatible materials::

None known.
Oxidizing agents

10. STABILITY AND REACTIVITY

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.
Product:
Acute inhalation toxicity:

Acute toxicity estimate: > 10 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method

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

Components:

7 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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

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 hSkin 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

8 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

Decamethylcyclopentasiloxane:
Species: Rabbit
Result: 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

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Petrolatum:Species
MethodResultRemarks::::

RabbitOECD Test Guideline 405
No eye irritation
Based on data from similar materials

Decamethylcyclopentasiloxane:
Species: Rabbit
Result: No eye irritation
Glyceryl monostearate:
SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

4-Chloro-3-methylphenol:
Species
MethodResult:::RabbitOECD Test Guideline 405
Irreversible effects on the eyebetamethasone:
SpeciesResult::RabbitNo eye irritation

9 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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
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

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
10 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

Genotoxicity in vivo

SDS Number:
1685839-00014:

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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

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

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
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)
11 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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.

Carcinogenicity
Not classified based on available information.
Components:
Petrolatum: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:
12 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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:

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

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.

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

Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.42 mg/kg body weight
Result: Malformations were observed.

13 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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.

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
Glyceryl monostearate:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

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

14 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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

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

Target Organs: Adrenal gland
Symptoms: Redness, pruritis, Irritation:

LL50 (Pimephales promelas (fathead minnow)): > 100 mg/l
Exposure time: 96 h
Test substance: Water Accommodated Fraction

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

15 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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

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

NOEC: 10 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)
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
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 microorganisms:

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

Toxicity to fish (Chronic toxicity):

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

Toxicity to daphnia and other:

NOEC: 15 µg/l
16 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

aquatic invertebrates (Chronic toxicity)

Glyceryl monostearate:
Toxicity to fish

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

Exposure time: 21 dSpecies: Daphnia magna (Water flea)
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility:

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 microorganisms:

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

4-Chloro-3-methylphenol:
Toxicity to fish

EC10 (Pseudomonas putida): > 1 mg/l
Exposure time: 18 h
Remarks: Based on data from similar materials
NOEC: > 0.22 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility
Based on data from similar materials:

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

17 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

EC10 ( Chlorella pyrenoidosa (algae)): 2.3 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
M-Factor (Acute aquatic toxicity):

1

Toxicity to microorganisms:

EC50: 22.86 mg/l
Exposure time: 60 h

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

betamethasone:
Toxicity to daphnia and otheraquatic invertebrates
Toxicity to algae/aquaticplants

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

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
NOEC ( 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: 0.052 mg/l
Exposure time: 32 d
Species: Pimephales promelas (fathead minnow)
Method: OECD Test Guideline 210
NOEC: 0.07 µg/l
Exposure time: 219 dSpecies: Oryzias latipes (Japanese medaka)
Method: OECD Test Guideline 229

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

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

M-Factor (Chronic aquatic
toxicity)

1,000

:

Persistence and degradability
Components:
Petrolatum:
18 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

Biodegradability

SDS Number:
1685839-00014:

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

Result: Not readily biodegradable.
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
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

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

Partition coefficient: noctanol/water
betamethasone:
Partition coefficient: noctanol/water:log Pow: 8.023:

log Pow: 6.1:

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

log Pow: 0.477:

log Pow: 2.11

19 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

Mobility in soil
No data available
Other adverse effects
No data available
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.

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.
(betamethasone)
9
III
9
yes

:
:
:
:

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 IMO instruments
Not applicable for product as supplied.
20 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

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

not determined

IECSC

:

not determined

Revision Date:

30.09.2023

Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

Date format:

dd.mm.yyyy

16. OTHER INFORMATION

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
IN OEL: India. Permissible levels of certain chemical substances inwork environment.
ACGIH / TWA
ACGIH / STELIN OEL / TWAIN OEL / STEL

:
:
:
:

8-hour, time-weighted average
Short-term exposure limit
Time-Weighted Average Concentration (TWA) (8 hrs.)
Short-term exposure Limit STEL (15 min)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 Or21 / 22

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone (0.05%) Cream Formulation
Version
4.2

Revision Date:
30.09.2023

SDS Number:
1685839-00014

Date of last issue: 04.04.2023
Date of first issue: 17.05.2017

ganisation 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 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.
IN / EN

22 / 22