SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

Section 1: Identification
Product name:Betamethasone 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

Section 2: Hazard identification
GHS Classification
Reproductive toxicity:

Category 1

Specific target organ toxicity repeated exposure:

Category 1 (Pituitary gland, Immune system, muscle, thymus
gland, Blood, Adrenal gland)

Hazardous to the aquatic
environment - chronic 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 / 20SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

P201 Obtain special instructions before use.
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.
Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical namePetrolatum
Paraffin oil
Hexadecan-1-ol. Ethoxylated
4-Chloro-3-methylphenol
betamethasone

CAS-No.
8009-03-8
8012-95-1
9004-95-9
59-50-7
378-44-9

Concentration (% w/w)>= 10 -< 20>= 2.5 -< 10>= 1 -< 10>= 0.1 -< 0.25>= 0.025 -< 0.1

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 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.
2 / 20SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

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: 19.07.2017

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.

Section 5: Fire-fighting measures
Suitable extinguishing media:

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

Specific extinguishing methods:

Special protective equipment
for firefighters
Hazchem Code: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.
3Z:

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

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.
Prevent spreading over a wide area (e.g. by containment or oilbarriers).
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:

Soak up with inert absorbent material.
For large spills, provide dyking or other appropriate containment to keep material from spreading. If dyked material canbe pumped, store recovered material in appropriate container.
3 / 20SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

Clean up remaining materials from spill with suitable absorbent.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
Section 7: Handling and storage
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

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 vapours.
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.
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.
Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

Section 8: Exposure controls/personal protection
Components with workplace control parameters
Components

CAS-No.

Value type
(Form ofexposure)
4 / 20Control parameters / Permissible
concentration

Basis

SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Petrolatum

8009-03-8

Paraffin oil

8012-95-1

4-Chloro-3-methylphenol

59-50-7

WES-TWA(Mist)
WES-STEL(Mist)TWA (Inhalable particulate matter)
WES-TWA(Mist)
WES-STEL(Mist)TWA (Inhalable particulate matter)
TWA

Wipe limit
378-44-9
TWA
Further information: Skin
Wipe limit

betamethasone

Engineering measures

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017:

5 mg/m3

NZ OEL

10 mg/m3

NZ OEL

5 mg/m3

ACGIH

5 mg/m3

NZ OEL

10 mg/m3

NZ OEL

5 mg/m3

ACGIH

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

10 µg/100 cm²Internal

Internal
Internal

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.
If handled in a laboratory, use a properly designed biosafetycabinet, fume hood, or other containment device if the potential exists for aerosolization. If this potential does not exist,
handle over lined trays or benchtops.

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

Chemical-resistant gloves

Remarks
Eye protection::

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.
5 / 20SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

Use appropriate degowning techniques to remove potentiallycontaminated clothing.
Section 9: Physical and chemical properties
Appearance

:

cream

Colour:No data available

Odour

:

No data available

Odour Threshold:

No data available

pH

:

5

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:> 93.3 °C

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

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:

No data available

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

Viscosity
6 / 20SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Viscosity, kinematic

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017:

No data available

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.

Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

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

Section 10: Stability and reactivity

Section 11: Toxicological information
Exposure routes:

Inhalation
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

Paraffin oil:
Acute oral toxicity:

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

Acute dermal toxicity:

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

7 / 20SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

Hexadecan-1-ol. Ethoxylated:
Acute oral toxicity:

LD50 (Rat): 2,500 mg/kg

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

Paraffin oil:SpeciesResult::RabbitNo skin irritation

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.

8 / 20SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

Components:
Petrolatum:SpeciesResult
MethodRemarks::::

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

Paraffin oil:SpeciesResult::RabbitNo eye irritation

Hexadecan-1-ol. Ethoxylated:
Result:Remarks:

Irritation to eyes, reversing within 21 days
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

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

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
9 / 20SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
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betamethasone:
Exposure routes
SpeciesResultSDS Number:
1841204-00016:::

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

DermalGuinea pig
Weak sensitizer

Chronic toxicity
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

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.

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SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

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:

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.

Reproductive toxicity
May damage the unborn child.
Components:
Petrolatum:
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
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SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

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.

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

Paraffin oil:Species
LOAEL
Application RouteExposure time

:
:
:
:

Rat, female
161 mg/kg
Ingestion
90 Days

4-Chloro-3-methylphenol:
Species
NOAEL
LOAEL

:
:
:

Rat
200 mg/kg
400 mg/kg
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SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

Application RouteExposure time::

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.
Components:
Paraffin oil:
The substance or mixture is known to cause human aspiration toxicity hazards or has to be regarded as if it causes a human aspiration toxicity hazard.
Experience with human exposure
Components:
betamethasone:
Inhalation
Skin contact::

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

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SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

Section 12: Ecological information
Ecotoxicity
Components:
Petrolatum:
Toxicity to fish:

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

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

Paraffin oil:
Toxicity to fish

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

LL50 (Scophthalmus maximus (turbot)): > 100 mg/l
Exposure time: 96 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EL50 (Acartia tonsa (Calanoid copepod)): > 100 mg/l
Exposure time: 48 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

Toxicity to algae/aquaticplants:EL50 (Skeletonema costatum (marine diatom)): > 100 mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials
NOELR (Skeletonema costatum (marine diatom)): > 1 mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

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SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Hexadecan-1-ol. Ethoxylated:
Toxicity to fish:

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

LC50 : > 1 - 10 mg/l
Exposure time: 96 h
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50: > 1 - 10 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Toxicity to algae/aquaticplants:

EC50: > 10 - 100 mg/l
Exposure time: 72 h
Remarks: 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

4-Chloro-3-methylphenol:
Toxicity to fish

EC10 (Chlorella pyrenoidosa (algae)): 2.3 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
M-Factor (Acute aquatic tox- :icity)
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

1

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

NOEC (Pseudokirchneriella subcapitata (green algae)): 34
mg/l
Exposure time: 72 h
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SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

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

:

Persistence and degradability
Components:
Petrolatum:
Biodegradability:

Hexadecan-1-ol. Ethoxylated:
Biodegradability:

4-Chloro-3-methylphenol:
Biodegradability

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

Result: Readily biodegradable.
Biodegradation: > 99 %Exposure time: 19 d:

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

log Pow: > 4
Remarks: Calculation:

Species: Cyprinus carpio (Carp)

Bioaccumulative potential
Components:
Paraffin oil:
Partition coefficient: noctanol/water
4-Chloro-3-methylphenol:
Bioaccumulation

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SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

Bioconcentration factor (BCF): 5.5 - 13
Partition coefficient: noctanol/water
betamethasone:
Partition coefficient: noctanol/water:log Pow: 0.477:

log Pow: 2.11

Mobility in soil
No data available
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 information
International Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name

:
:

Class
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
Environmentally hazardous
IMDG-CodeUN number

UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)
9
III
9
yes

:
:
:
:

UN 3082
Environmentally hazardous substance, liquid, n.o.s.
(betamethasone)
9
III
Miscellaneous
964

:

964

:

yes

:

UN 3082
17 / 20

SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Proper shipping name

:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)
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.
National Regulations
NZS 5433
UN number
Proper shipping name

:
:

Class
Packing group
LabelsHazchem CodeMarine pollutant

:
:
:
:
:

UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)
9
III
9
3Z
no

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.
Section 15: Regulatory information
Safety, health and environmental regulations/legislation specific for the substance or mixture
HSNO Approval Number
not allocated
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 to:Internal technical data, data from raw material SDSs, OECD

Section 16: Other information

18 / 20

SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

compile the Safety Data
Sheet
Date format

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

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

dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)NZ OEL: New Zealand. Workplace Exposure Standards for Atmospheric Contaminants
ACGIH / TWANZ OEL / WES-TWANZ OEL / WES-STEL:::

8-hour, time-weighted average
Workplace Exposure Standard - Time Weighted average
Workplace Exposure Standard - Short-Term Exposure Limit

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS 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 their

19 / 20

SAFETY DATA SHEET

Betamethasone Cream Formulation
Version
7.1

Revision Date:
30.09.2023

SDS Number:
1841204-00016

Date of last issue: 04.04.2023
Date of first issue: 19.07.2017

intended 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.
NZ / EN

20 / 20