SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier
Trade name:Betamethasone (0.05%) Cream Formulation

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub: Pharmaceuticalstance/Mixture
Recommended restrictions
on use:Not applicable

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
30 Hudson Street, 33nd floor
07302 Jersey City, New Jersey, U.S.A
Telephone:+1-551-430-6000

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008)
Reproductive toxicity, Category 1B
H360D: May damage the unborn child.
Specific target organ toxicity - repeatedH372: Causes damage to organs through proexposure, Category 1
longed or repeated exposure.
Long-term (chronic) aquatic hazard, CatH410: Very toxic to aquatic life with long lastingegory 1effects.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

Danger

1 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

Hazard statements

SDS Number:
1685840-00016
:

H360D
H372
H410

Precautionary statements:

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

May damage the unborn child.
Causes damage to organs through prolonged orrepeated exposure.
Very toxic to aquatic life with long lasting effects.

Prevention:
P201
Obtain special instructions before use.
P264
Wash skin thoroughly after handling.
P273
Avoid release to the environment.
P280
Wear protective gloves/ protective clothing/ eyeprotection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P391
Collect spillage.

Hazardous components which must be listed on the label:betamethasone
Additional Labelling
EUH208
Contains 4-Chloro-3-methylphenol. May produce an allergic reaction.
2.3 Other hazards
This substance/mixture contains components considered to be either persistent, bioaccumulative
and toxic (PBT), or very persistent and very bioaccumulative (vPvB).
Ecological information: The substance/mixture does not contain components considered to haveendocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
Toxicological information: The substance/mixture does not contain components considered tohave endocrine disrupting properties according to REACH Article 57(f) or Commission Delegatedregulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

SECTION 3: Composition/information on ingredients
3.2 Mixtures
Components
Chemical name

4-Chloro-3-methylphenol

CAS-No.
EC-No.
Index-No.
Registration number
59-50-7
200-431-6
604-014-00-3

2 / 25Classification

Acute Tox. 4; H302
Skin Corr. 1C; H314
Eye Dam. 1; H318
Skin Sens. 1B; H317
STOT SE 3; H335
Aquatic Acute 1;

Concentration(% w/w)

0.1

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017
H400
Aquatic Chronic 3;
H412
M-Factor (Acuteaquatic toxicity): 1
Acute toxicity estimate

betamethasone

378-44-9
206-825-4

Acute oral toxicity:
600 mg/kg
Acute Tox. 2; H330
Repr. 1B; H360D
STOT RE 1; H372
(Pituitary gland, Immune system, muscle, thymus gland,
Blood, Adrenal gland)
Aquatic Chronic 1;
H410

0.064

M-Factor (Chronic
aquatic toxicity):
1,000

specific concentration
limit
STOT RE 1; H372>= 0.01 %Repr. 1B; H360D>= 0.01 %PBT and vPvB substance :Decamethylcyclopentasiloxane

541-02-6
208-764-9

7For explanation of abbreviations see section 16.

SECTION 4: First aid measures
4.1 Description of 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.
Protection of first-aiders:

First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
3 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

when the potential for exposure exists (see section 8).
If inhaled:

If inhaled, remove to fresh air.
Get medical attention.

In case of skin contact:

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.

In case of eye contact:

Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.

If swallowed:

If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.

4.2 Most important symptoms and effects, both acute and delayed
Risks: May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
May produce an allergic reaction.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:

None known.

5.2 Special hazards arising from the substance or mixture
Specific hazards during fire- : Vapours may form explosive mixtures with air.
fighting
Exposure to combustion products may be a hazard to health.
Hazardous combustion products:

Carbon oxides
Silicon oxides
Formaldehyde

4 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017:

In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

:

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.

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
6.2 Environmental precautions
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.

6.3 Methods and material for containment and cleaning up
Methods for 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.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handlingTechnical measures:
Local/Total ventilation:

Advice on safe handling:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust, fume, gas, mist, vapours or spray.
Do not swallow.
Avoid contact with eyes.
5 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Hygiene measures:

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

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.
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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Keepareas and containers
tightly closed. Store in accordance with the particular national
regulations.
Advice on common storage

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

:

No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
Components

CAS-No.

Petrolatum

8009-03-8

Propylene glycol

57-55-6Glyceryl monos-123-94-4

Value type (Formof exposure)
OELV - 8 hrs(TWA) (inhalable
fraction)
OELV - 8 hrs(TWA) (particles)
OELV - 8 hrs(TWA) (total (vapour and particles))
OELV - 8 hrs
6 / 25Control parametersBasis

5 mg/m3

IE OEL

10 mg/m3

IE OEL150 ppm
470 mg/m3

IE OEL

10 mg/m3

IE OELSAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

tearate
4-Chloro-3methylphenol
betamethasone

SDS Number:
1685840-00016

59-50-7

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

(TWA)
TWA

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

200 µg/m3 (OEB 2)Internal

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

10 µg/100 cm²Internal

Occupational exposure limits of decomposition products
Components

CAS-No.

Formaldehyde

50-00-0

Value type (Formof exposure)
TWA

Control parameters

Basis

0.3 ppm2004/37/EC
0.37 mg/m3
Further information: Dermal sensitisation, Carcinogens or mutagens
STEL
0.6 ppm2004/37/EC
0.74 mg/m3
Further information: Dermal sensitisation, Carcinogens or mutagens
OELV - 8 hrs
0.3 ppm
IE OEL(TWA)
0.37 mg/m3
Further information: Chemical agents which following exposure may cause
sensitisation of the respiratory tract and lead to asthma, rhinitis or extrinsic
allergic alveolitis, Carc 1B - Substances presumed to have carcinogenic potential for humans
OELV - 15 min
0.6 ppm
IE OEL(STEL)
0.738 mg/m3
Further information: Chemical agents which following exposure may cause
sensitisation of the respiratory tract and lead to asthma, rhinitis or extrinsic
allergic alveolitis, Carc 1B - Substances presumed to have carcinogenic potential for humans

Derived No Effect Level (DNEL) according to Regulation (EC) No. 1907/2006:
Substance name

End UseExposure routes

Decamethylcyclopentasiloxane

Workers

Inhalation

Workers

Inhalation

Workers

Inhalation

Consumers

Inhalation

Consumers

Inhalation

Consumers

Ingestion

Workers

Inhalation

Workers

Inhalation

Consumers

Inhalation

Propylene glycol

7 / 25

Potential health effects
Long-term systemic
effects
Acute systemic effects
Long-term local effects
Long-term systemic
effects
Long-term local effects
Long-term systemic
effects
Long-term local effects
Long-term systemic
effects
Long-term local effects

Value
97.3 mg/m3
62 mg/m3
24.2 mg/m3
17.3 mg/m3
4.3 mg/m3
5 mg/kg
bw/day10 mg/m3
168 mg/m3
10 mg/m3

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

4-Chloro-3methylphenol

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

Consumers

Inhalation

Workers

Inhalation

Workers

Skin contact

Consumers

Inhalation

Consumers

Skin contact

Consumers

Ingestion

Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects

50 mg/m3
6.289 mg/m3
3.567 mg/kg
bw/day1.551 mg/m3
1.783 mg/kg
bw/day0.892 mg/kg
bw/dayPredicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:
Substance namePetrolatum
Decamethylcyclopentasiloxane

Propylene glycol

Environmental Compartment
Oral (Secondary Poisoning)
Sewage treatment plant
Fresh water sediment
Marine sediment
Soil
Oral (Secondary Poisoning)
Fresh water
Freshwater - intermittent
Marine water
Sewage treatment plant
Fresh water sediment
Marine sediment
Soil

4-Chloro-3-methylphenol

Fresh waterIntermittent use/release
Marine water
Sewage treatment plant
Fresh water sediment
Marine sediment
Soil

Value
9.33 mg/kg food
10 mg/l
11 mg/kg
1.1 mg/kg
3.77 mg/kg
13 mg/kg food
260 mg/l
183 mg/l
26 mg/l
20000 mg/l
572 mg/kg dryweight (d.w.)
57.2 mg/kg dryweight (d.w.)
50 mg/kg dryweight (d.w.)
0.015 mg/l
0.015 mg/l
0.002 mg/l
2.286 mg/l
13.981 mg/kg dryweight (d.w.)
13.981 mg/kg dryweight (d.w.)
6.399 mg/kg dryweight (d.w.)

8.2 Exposure controls
Engineering measures
Containment technologies suitable for controlling compounds are required to control at source
and to prevent migration of the compound to uncontrolled areas (e.g., vacuum conveying from aclosed system, packout head with inflatable seal from stationary container, ventilated enclosure,etc.).
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect products, workers, and the environment.
Essentially no open handling permitted.
Use closed processing systems or containment technologies.
8 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

Personal protective equipment
Eye/face protection: 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.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Skin and body protection::

Respiratory protection:

Consider double gloving.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to I.S. EN 14387
Combined particulates, inorganic gas/vapour and organic
vapour type (AB-P)

Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: creamColour

:

white

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

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

9 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

Flash point:> 93.3 °C

Auto-ignition temperature:

No data available

Decomposition temperature:

No data available

pH:

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

Relative density:

No data available

Density:

No data available

Relative vapour density:

Not applicable

Particle characteristics
Particle size:

Not applicable:Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Evaporation rate:

Not applicable

9.2 Other information
Explosives

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: Vapours may form explosive mixture with air.
Can react with strong oxidizing agents.
Hazardous decomposition products will be formed at elevatedtemperatures.
10.4 Conditions to avoid
10 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Conditions to avoid:

None known.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

10.6 Hazardous decomposition products
Thermal decomposition: Formaldehyde

SECTION 11: Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
Information on likely routes of : Skin contact
exposure
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Components:
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 h

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

11 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

Skin corrosion/irritation
Not classified based on available information.
Components:
4-Chloro-3-methylphenol:
Species
MethodResult:::RabbitOECD Test Guideline 404
Corrosive after 1 to 4 hours of exposure

betamethasone:
SpeciesResult::RabbitMild skin irritation

Decamethylcyclopentasiloxane:
Species: Rabbit
Result: No skin irritation
Serious eye damage/eye irritation
Not classified based on available information.
Components:
4-Chloro-3-methylphenol:
Species
MethodResult:::RabbitOECD Test Guideline 405
Irreversible effects on the eyebetamethasone:
SpeciesResult::RabbitNo eye irritation

Decamethylcyclopentasiloxane:
Species: Rabbit
Result: No eye irritation
Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
4-Chloro-3-methylphenol:
Test Type
Exposure routes
Species:::

Maximisation Test
Skin contact
Guinea pig
12 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

Assessment:

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

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

Decamethylcyclopentasiloxane:
Test Type: Local lymph node assay (LLNA)
Exposure routes: Skin contact
Species: MouseResult: negative
Germ cell mutagenicity
Not classified based on available information.
Components:
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.

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
13 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

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

Carcinogenicity
Not classified based on available information.
Reproductive toxicity
May damage the unborn child.
Components:
4-Chloro-3-methylphenol:
Effects on fertility

Effects on foetal development

betamethasone:
Effects on foetal development:

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
14 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

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.

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:

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

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

:
:
:
:
:

Rat
200 mg/kg
400 mg/kg
Ingestion
28 Daysbetamethasone:
Species:

Rabbit15 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:

0.05 %
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

Decamethylcyclopentasiloxane:
Species: Rat
NOAEL: 1,000 mg/kg
LOAEL: > 1,000 mg/kg
Application Route: Ingestion
Method: OECD Test Guideline 408
Aspiration toxicity
Not classified based on available information.
11.2 Information on other hazards
Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

Experience with human exposure
Components:
betamethasone:
Inhalation
Skin contact::

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

16 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

SECTION 12: Ecological information
12.1 Toxicity
Components:
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

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)
17 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

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

:

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 :aquatic invertebrates (Chronic toxicity)

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

18 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

12.2 Persistence and degradability
Components:
4-Chloro-3-methylphenol:
Biodegradability:

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

Decamethylcyclopentasiloxane:
Biodegradability: Result: Not readily biodegradable.
Biodegradation: 0.14 %Exposure time: 28 d
Method: OECD Test Guideline 310
12.3 Bioaccumulative potential
Components:
4-Chloro-3-methylphenol:
Bioaccumulation

Partition coefficient: noctanol/water
betamethasone:
Partition coefficient: noctanol/water:Species: Cyprinus carpio (Carp)
Bioconcentration factor (BCF): 5.5 - 13:

log Pow: 0.477:

log Pow: 2.11

Decamethylcyclopentasiloxane:
Bioaccumulation: Species: Pimephales promelas (fathead minnow)
Bioconcentration factor (BCF): 7,060 - 13,300
Method: OECD Test Guideline 305
Partition coefficient: noctanol/water:log Pow: 8.023

12.4 Mobility in soil
No data available
12.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains components considered tobe either persistent, bioaccumulative and toxic (PBT), or very
persistent and very bioaccumulative (vPvB).

Components:
Decamethylcyclopentasiloxane:
Assessment: Substance is persistent, bioaccumulative, and toxic (PBT).
19 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016:

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

Substance is very persistent and very bioaccumulative (vPvB).

12.6 Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

12.7 Other adverse effects
No data available

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
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.

SECTION 14: Transport information
14.1 UN number or ID number
ADN:

UN 3077

ADR:

UN 3077

RID:

UN 3077

IMDG:

UN 3077

IATA:

UN 3077ADN:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(betamethasone)

ADR:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(betamethasone)

RID:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.

14.2 UN proper shipping name20 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017(betamethasone)
IMDG:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(betamethasone)

IATA

:

Environmentally hazardous substance, solid, n.o.s.
(betamethasone)

14.3 Transport hazard class(es)Class

Subsidiary risks

ADN

:

9

ADR

:

9

RID

:

9

IMDG

:

9

IATA

:

9

ADN
Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

III
M7
90
9

ADR
Packing groupClassification CodeHazard Identification Number
LabelsTunnel restriction code

:
:
:
:
:

III
M7
90
9
(-)

RID
Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

III
M7
90
9

IMDG
Packing group
LabelsEmS Code

:
:
:

III
9
F-A, S-F

:

956

:
:
:

Y956
III
Miscellaneous

:

956

:

Y956

14.4 Packing group

IATA (Cargo)
Packing instruction (cargo
aircraft)Packing instruction (LQ)
Packing group
LabelsIATA (Passenger)
Packing instruction (passenger aircraft)
Packing instruction (LQ)

21 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

Packing group
LabelsSDS Number:
1685840-00016::

III
Miscellaneous

ADN
Environmentally hazardous

:

yes

ADR
Environmentally hazardous

:

yes

RID
Environmentally hazardous

:

yes

IMDG
Marine pollutant:

yes

IATA (Passenger)
Environmentally hazardous:

yes

IATA (Cargo)
Environmentally hazardous:

yes

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

14.5 Environmental hazards

14.6 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.
14.7 Maritime transport in bulk according to IMO instruments
Remarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
REACH - Restrictions on the manufacture, placing on: Conditions of restriction for the folthe market and use of certain dangerous substances,lowing entries should be considered:mixtures and articles (Annex XVII)
Number on list 75
Substance(s) or mixture(s) are listed
here according to their appearance
in the regulation, irrespective of theiruse/purpose or the conditions of therestriction. Please refer to the conditions in corresponding Regulation todetermine whether an entry is applicable to the placing on the market ornot.
If you intend to use this product astattoo ink, please contact your vendor.
Decamethylcyclopentasiloxane(Number on list 70)
22 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

REACH - Candidate List of Substances of Very High: Decamethylcyclopentasiloxane
Concern for Authorisation (Article 59).
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
Regulation (EU) 2019/1021 on persistent organic pollu: Not applicabletants (recast)
Regulation (EU) No 649/2012 of the European Parlia: Not applicablement and the Council concerning the export and importof dangerous chemicals
REACH - List of substances subject to authorisation: Not applicable(Annex XIV)
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control ofmajor-accident hazards involving dangerous substances.
Quantity 1
Quantity 2
E1
ENVIRONMENTAL
100 t
200 t
HAZARDS
Other regulations:
Take note of Directive 92/85/EEC regarding maternity protection or stricter national regulations,where applicable.
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined15.2 Chemical safety assessment
A Chemical Safety Assessment has not been carried out.

SECTION 16: Other information
Other information:

Items where changes have been made to the previous version
are highlighted in the body of this document by two verticallines.

Full text of H-Statements
H302
H314
H317
H318
H330
H335
H360D
H372

:
:
:
:
:
:
:
:

H400

:

Harmful if swallowed.
Causes severe skin burns and eye damage.
May cause an allergic skin reaction.
Causes serious eye damage.
Fatal if inhaled.
May cause respiratory irritation.
May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
Very toxic to aquatic life.
23 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0
H410
H412

Revision Date:
06.04.2024

SDS Number:
1685840-00016::

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

Very toxic to aquatic life with long lasting effects.
Harmful to aquatic life with long lasting effects.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Aquatic Acute: Short-term (acute) aquatic hazard
Aquatic Chronic: Long-term (chronic) aquatic hazard
Eye Dam.
: Serious eye damage
Repr.
: Reproductive toxicity
Skin Corr.
: Skin corrosion
Skin Sens.
: Skin sensitisation
STOT RE: Specific target organ toxicity - repeated exposure
STOT SE: Specific target organ toxicity - single exposure
2004/37/EC: Europe. Directive 2004/37/EC on the protection of workers
from the risks related to exposure to carcinogens or mutagens
at work
IE OEL: Ireland. List of Chemical Agents and Carcinogens with Occupational Exposure Limit Values - Code of Practice, Schedule 1
and 2
2004/37/EC / STEL
: Short term exposure limit
2004/37/EC / TWA: Long term exposure limit
IE OEL / OELV - 8 hrs (TWA) : Occupational exposure limit value (8-hour reference period)
IE OEL / OELV - 15 min: Occupational exposure limit value (15-minute reference peri(STEL)od)
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; 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; 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 and Equipment 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;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof 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; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
24 / 25

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone (0.05%) Cream Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
1685840-00016

Date of last issue: 30.09.2023
Date of first issue: 17.05.2017

SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Substance Inventory; TECI Thailand Existing Chemicals Inventory; TRGS - Technical Rule for Hazardous Substances; TSCA
- Toxic Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent andVery Bioaccumulative
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/

Classification of the mixture:

Classification procedure:

Repr. 1B

H360D

Calculation method

STOT RE 1

H372

Calculation method

Aquatic Chronic 1

H410

Calculation method

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance 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.
IE / EN

25 / 25