SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:Betamethasone / Clotrimazole Ointment Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

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

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

2. HAZARDS IDENTIFICATIONGHS classification of chemical productReproductive toxicity: Category 1BSpecific target organ toxicity repeated exposure:

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

Short-term (acute) aquatic
hazard:Category 2

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 pro1 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

longed or repeated exposure.
H401 Toxic to aquatic life.
H410 Very toxic to aquatic life with long lasting effects.
Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust/ fume/ gas/ mist/ vapours/ spray.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P391 Collect spillage.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification
None known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical namePetrolatum
White mineral oil (petroleum)

CAS-No.
8009-03-8
8042-47-5

Concentration (% w/w)>= 90 - <= 100> 0 - < 10

clotrimazole
betamethasone

23593-75-1
378-44-9>= 1 - < 2.5>= 0.025 - < 0.1

ENCS No.
9-17004. FIRST AID MEASURES
General advice:

If inhaled:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
2 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician::

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Get medical attention.
In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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

:

Exposure to combustion products may be a hazard to health.

:

Carbon oxides

Specific extinguishing methods:

Special protective equipment
for firefighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).

Environmental precautions

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.

:

3 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitable container for disposal.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust, fume, gas, mist, vapours or spray.
Do not swallow.
Avoid contact with eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

Storage
Conditions for safe storage:

Materials to avoid:

7. HANDLING AND STORAGE

Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
4 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Strong oxidizing agents
Packaging material:

Unsuitable material: None known.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

Value type
(Form ofexposure)

Petrolatum

8009-03-8

OEL-M (Mist)Basis

JP OEL
JSOH
Further information: Group 1: carcinogenic to humans
TWA (Inhal5 mg/m3
ACGIH
able particulate matter)
8042-47-5
TWA (Inhal5 mg/m3
ACGIH
able particulate matter)
23593-75-1
TWA
0.2 mg/m3 (OEBInternal
2)378-44-9TWA
1 µg/m3 (OEB 4)Internal
Further information: Skin
Wipe limit
10 µg/100 cm²Internal

White mineral oil (petroleum)

clotrimazole
betamethasone

Engineering measures

Control parameters / Reference
concentration /Permissible concentration
3 mg/m3:

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 and organic vapour type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Consider double gloving.
5 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Eye protection:

Skin and body protection:

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

Viscous semi-solid

Colour:No data available

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

Not classified as a flammability hazard

Flammability (liquids):

No data available

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit:

No data available

Flash point:

Not applicable

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

Not applicableAuto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available
6 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

No data available:

No data available

Relative vapour density:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle characteristics
Particle size:

Not applicable:::Not classified as a reactivity hazard.
Stable under normal conditions.
Can react with strong oxidizing agents.

:::

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

10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

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

Acute dermal toxicity:

Acute toxicity estimate: > 2,000 mg/kg
7 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Method: Calculation method
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

White mineral oil (petroleum):
Acute oral toxicity:

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

Acute inhalation toxicity:

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

Acute dermal toxicity:

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

clotrimazole:
Acute oral toxicity:

LD50 (Rat): 708 mg/kg
LD50 (Mouse): 761 mg/kg
LD50 (Rabbit): > 1,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 0.73 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Mouse): 923 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
8 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Skin corrosion/irritation
Not classified based on available information.
Components:
Petrolatum:Species
MethodResultRemarks::::

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

White mineral oil (petroleum):Species:Result:RabbitNo skin irritation

clotrimazole:
SpeciesResult::RabbitNo skin irritation

betamethasone:
SpeciesResult::RabbitMild skin irritation

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

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

White mineral oil (petroleum):Species:Result:RabbitNo eye irritation

clotrimazole:
SpeciesResult::RabbitMild eye irritation

betamethasone:
SpeciesResult::RabbitNo eye irritation
9 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

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

White mineral oil (petroleum):
Test Type:
Exposure routes:
Species:Result:Buehler Test
Skin contact
Guinea pig
negativebetamethasone:
Exposure routes
SpeciesResultDermalGuinea 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

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

White mineral oil (petroleum):

10 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Genotoxicity in vitro:

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: Mouse
Application Route: Intraperitoneal injection
Method: OECD Test Guideline 474
Result: negative
Remarks: Based on data from similar materials

clotrimazole:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Test Type: in vitro micronucleus test
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Rat
Application Route: Oral
Result: negative
Test Type: Mammalian spermatogonial chromosome aberration test (in vivo)
Species: Hamster
Result: negative

Germ cell mutagenicity Assessment
betamethasone:
Genotoxicity in vitro:

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

:

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
11 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

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

White mineral oil (petroleum):Species:
Application Route:Exposure time:
Result:Rat
Ingestion
24 Months
negative

clotrimazole:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Oral
78 weeks
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

White mineral oil (petroleum):
12 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Effects on fertility:

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

Effects on foetal development:

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

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Oral
Fertility: LOAEL: 50 mg/kg body weight
Result: Effects on fertility:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 100 mg/kg body weight
Result: Embryo-foetal toxicity, No teratogenic effects

clotrimazole:
Effects on fertility

Effects on foetal development

Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Developmental Toxicity: NOAEL: 50 mg/kg body weight
Result: Embryo-foetal toxicity, No teratogenic effects
Test Type: Embryo-foetal development
Species: Mouse
Application Route: Oral
Developmental Toxicity: NOAEL: 200 mg/kg body weight
Result: No effects on foetal development
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: NOAEL: 180 mg/kg body weight
Result: No effects on foetal development
Reproductive toxicity - Assessment

betamethasone:
Effects on foetal development:

Some evidence of adverse effects on sexual function andfertility, based on animal experiments., Some evidence ofadverse effects on development, based on animal experiments.

:

Species: Rabbit
Application Route: Intramuscular
13 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

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

Clear evidence of adverse effects on development, based onanimal experiments.

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Causes damage to organs (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) through prolonged or repeated exposure.
Components:
clotrimazole:
Target Organs
Assessment::

Liver, Kidney, Adrenal gland
May cause damage to organs through prolonged or repeatedexposure.

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

:
:
:
:

White mineral oil (petroleum):Species
:
LOAEL
:

Rat
5,000 mg/kg
Ingestion
2 yr

Rat
160 mg/kg
14 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Application RouteExposure time::

Ingestion
90 DaysSpecies
LOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 1 mg/l
inhalation (dust/mist/fume)
4 Weeks
OECD Test Guideline 412

clotrimazole:
Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Rabbit5 - 40 mg/kg
Skin contact
3 Weeks
Skin
Oedema, Fissuring, Necrosis, Redness

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
10 mg/kg
Oral
18 Months
Liver, Kidney, Adrenal glandSpecies
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Dog
25 mg/kgOral
6 - 12 Months
Adrenal gland
Salivation, Lachrymation, Vomiting

betamethasone:
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 gland

15 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

Species
LOAEL
Application RouteExposure timeTarget Organs

SDS Number:
610352-00020

:
:
:
:
:

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

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:
clotrimazole:
Skin contact:

Symptoms: Rash, Itching, Blistering, Oedema, Redness

Ingestion:

Symptoms: Abdominal pain, Nausea, Vomiting, Diarrhoea

betamethasone:
Inhalation:

Target Organs: Adrenal gland

Skin contact:

Symptoms: Redness, pruritis, Irritation:

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

Toxicity to daphnia and otheraquatic invertebrates:

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

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

Toxicity to daphnia and other:

NOEC (Daphnia magna (Water flea)): 10 mg/l

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

16 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

aquatic invertebrates (Chronic toxicity)

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Exposure time: 21 d
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

White mineral oil (petroleum):
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:NOEC (Pseudokirchneriella subcapitata (green algae)): 100
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Oncorhynchus mykiss (rainbow trout)): 1,000 mg/l
Exposure time: 28 d

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

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

LC50 (Brachydanio rerio (zebrafish)): > 0.29 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 0.02 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 (Desmodesmus subspicatus (green algae)): 0.268 mg/l
Exposure time: 72 h
NOEC (Desmodesmus subspicatus (green algae)): 0.017 mg/l
Exposure time: 72 h

M-Factor (Acute aquatic toxicity)
Toxicity to fish (Chronic toxicity)

:

10

:

NOEC (Oncorhynchus mykiss (rainbow trout)): 0.025 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210

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

NOEC (Daphnia magna (Water flea)): 0.01 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

M-Factor (Chronic aquatic

10:

17 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

toxicity)
Toxicity to microorganisms

betamethasone:
Toxicity to daphnia and otheraquatic invertebrates
Toxicity to algae/aquaticplantsSDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08:

EC50: > 10,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209:

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 (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:

White mineral oil (petroleum):
Biodegradability:

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

Result: Not readily biodegradable.
18 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Biodegradation: 31 %Exposure time: 28 dclotrimazole:
Stability in water:

Hydrolysis: 50 %(242 d):log Pow: 2.11

Bioaccumulative potential
Components:
betamethasone:
Partition coefficient: noctanol/water
Mobility in soil
No data available
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(betamethasone, clotrimazole)
9
III
9
yes
UN 3077
Environmentally hazardous substance, solid, n.o.s.
(betamethasone, clotrimazole)
19 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

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

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

:
:
:
:

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, clotrimazole)
9III
9F-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
Refer to section 15 for specific national regulation.
Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
ERG Code:171

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
20 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical namePetrolatum
Mineral oil

Concentration (%)>=90 - <=100>0 - <10

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical namePetrolatum
Mineral oil

Remarks
From April 1st, 2026-

Remarks
From April 1st, 2026-

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable

21 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

SDS Number:
610352-00020

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

Explosive Control Law
Not applicable
Vessel Safety Law
Miscellaneous dangerous substances and articles (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Miscellaneous dangerous substances and articles (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
Further information
Sources of key data used 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/

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
22 / 23

SAFETY DATA SHEET

Betamethasone / Clotrimazole Ointment Formulation
Version
11.0

Revision Date:
2024/04/06

ACGIH / TWA
JP OEL JSOH / OEL-M

SDS Number:
610352-00020::

Date of last issue: 2023/09/30
Date of first issue: 2016/04/08

8-hour, time-weighted average
Occupational Exposure Limit-Mean

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 theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
JP / EN

23 / 23