SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Clotrimazole / Gentamicin / Betamethasone (0.05%) 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 sys1 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

tem, muscle, thymus gland, Blood, Adrenal gland) through prolonged 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 mist or vapours.
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
Propylene glycol

CAS-No.
8009-03-8
57-55-6

Concentration (% w/w)>= 10 - < 20>= 10 - < 20

Paraffin oil
Hexadecan-1-ol. Ethoxylated

8012-95-1
9004-95-9> 0 - < 10
2.3

7-97

clotrimazole
Benzyl alcohol

23593-75-1
100-51-6>= 1 - < 2.5> 0 - < 103-1011

Gentamicin
betamethasone

1403-66-3
378-44-9>= 0.1 - < 0.25>= 0.025 - < 0.1

2 / 32

ENCS No.
2-234

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

4. FIRST AID MEASURES
General advice:

If inhaled:

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::

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.
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

3 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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.
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.

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 mist or 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.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.

7. HANDLING AND STORAGE

4 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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:

Packaging material:

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
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)

Paraffin oil

clotrimazole
Benzyl alcohol

Gentamicin

betamethasone

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

JP OEL
JSOH
Further information: Group 1: carcinogenic to humans
TWA (Inhal5 mg/m3
ACGIH
able particulate matter)
8012-95-1
OEL-M (Mist) 3 mg/m3
JP OEL
JSOH
Further information: Group 1: carcinogenic to humans
TWA (Inhal5 mg/m3
ACGIH
able particulate matter)
23593-75-1
TWA
0.2 mg/m3 (OEBInternal
2)100-51-6
OEL-C
25 mg/m3
JP OEL
JSOH
Further information: Skin sensitizing agent; Group 2 substances
which probably induce allergic reactions in humans.
1403-66-3
TWA
0.1 mg/m3 (OEBInternal
2)
Further information: OTO
378-44-9TWA
1 µg/m3 (OEB 4)Internal
Further information: Skin
5 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Wipe limit
Engineering measures:

10 µg/100 cm²Internal

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.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:liquidColour: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 applicable
6 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

Flammability (liquids)

SDS Number:
610543-00021:

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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:

No data available

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Density:

No data available

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle characteristics
Particle size:

Not applicable:Not classified as a reactivity hazard.

10. STABILITY AND REACTIVITY
Reactivity

7 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29::

Stable under normal conditions.
Can react with strong oxidizing agents.

:::

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

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
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 inhalation toxicity:

Acute toxicity estimate: > 5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method

Acute dermal toxicity:

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

Petrolatum:
Acute oral toxicity:

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

Acute dermal toxicity:

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

Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Components:

8 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Acute dermal toxicity:

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

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

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

LD50 (Rat): 2,500 mg/kg

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

Benzyl alcohol:
Acute oral toxicity:

LD50 (Rat): 1,620 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 4.178 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403

Gentamicin:
Acute oral toxicity:

LD50 (Rat): 8,000 - 10,000 mg/kg
LD50 (Mouse): 10,000 mg/kg

Acute inhalation toxicity:

Acute toxicity (other routes of :LC50 (Rat): > 0.2 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Remarks: No mortality observed at this dose.
LD50 (Rat): 67 - 96 mg/kg
9 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

administration)

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Application Route: Intravenous
LD50 (Rat): 371 - 384 mg/kg
Application Route: Intramuscular
LDLo (Monkey): 30 mg/kg
Application Route: Intravenous

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

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

Paraffin oil:SpeciesResult::RabbitNo skin irritation

clotrimazole:
SpeciesResult::RabbitNo skin irritation

Benzyl alcohol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Gentamicin:
10 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

SpeciesResult::RabbitMild skin irritation

betamethasone:
SpeciesResult::RabbitMild skin irritation

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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

Propylene glycol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

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

clotrimazole:
SpeciesResult::RabbitMild eye irritation

Benzyl alcohol:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

Gentamicin:
SpeciesResult::RabbitMild eye irritation

11 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

betamethasone:
SpeciesResultSDS Number:
610543-00021::

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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

Propylene glycol:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Benzyl alcohol:
Test Type
Exposure routes
Species
MethodResult:::::Maximisation Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

Gentamicin:
Remarks:

No data available

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

Germ cell mutagenicity
Not classified based on available information.
Components:
Petrolatum:
12 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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

Propylene glycol:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

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

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:

Weight of evidence does not support classification as a germ
cell mutagen.
13 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Benzyl alcohol:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

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

Gentamicin:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Chromosome aberration test in vitro
Result: equivocal

Genotoxicity in vivo:

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

betamethasone:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

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

Germ cell mutagenicity Assessment:

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

Carcinogenicity
Not classified based on available information.

14 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Components:
Petrolatum:Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

clotrimazole:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Oral
78 weeks
negative

Benzyl alcohol:
Species
Application RouteExposure time
MethodResult

:
:
:
:
:

Mouse
Ingestion
103 weeks
OECD Test Guideline 451
negative:

No data available:

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

Gentamicin:
Carcinogenicity - Assessment
Reproductive toxicity
May damage the unborn child.
Components:
Petrolatum:
Effects on fertility

Effects on foetal development

15 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

Propylene glycol:
Effects on fertility

Effects on foetal development

clotrimazole:
Effects on fertility

Effects on foetal development

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29:

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

Test Type: Embryo-foetal development
Species: Mouse
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
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:

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

Benzyl alcohol:
16 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Effects on fertility:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Effects on foetal development:

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

Test Type: Two-generation reproduction toxicity study
Species: Rat
Fertility: NOAEL: 20 mg/kg body weight
Result: No significant adverse effects were reported:

Test Type: Embryo-foetal development
Species: Rabbit
Developmental Toxicity: NOAEL: 3.6 mg/kg body weight
Result: No embryo-foetal toxicity

Gentamicin:
Effects on fertility

Effects on foetal development

Test Type: Embryo-foetal development
Species: Rat
Application Route: Intraperitoneal
Developmental Toxicity: LOAEL: 75 mg/kg body weight
Result: Embryo-foetal toxicity
Test Type: Embryo-foetal development
Species: Mouse
Application Route: Intraperitoneal
Developmental Toxicity: LOAEL: 10 mg/kg body weight
Result: foetal mortality, No malformations were observed.
Test Type: Embryo-foetal development
Species: Rat
Application Route: Intraperitoneal
Developmental Toxicity: LOAEL: 50 mg/kg body weight
Result: foetal mortality, No malformations were observed.
Reproductive toxicity - Assessment
betamethasone:
Effects on foetal development:

Positive evidence of adverse effects on development fromhuman epidemiological studies.

:

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

17 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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.

Gentamicin:
Target Organs
Assessment::

Kidney, inner ear
Causes 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

:
:
:
:

Rat
5,000 mg/kg
Ingestion
2 yr

18 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Paraffin oil:Species
LOAEL
Application RouteExposure time

:
:
:
:

Rat, female
161 mg/kg
Ingestion
90 Daysclotrimazole:
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

Benzyl alcohol:
Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
1.072 mg/l
inhalation (dust/mist/fume)
28 Days
OECD Test Guideline 412

Gentamicin:
Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Dog
3 mg/kg
Intramuscular
12 Months
KidneyVomiting, Salivation

19 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Monkey50 mg/kg
Subcutaneous
3 Weeks
Kidney, inner ear

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Monkey6 mg/kg
Intramuscular
3 Weeks
Blood, Kidney, inner ear, Liver

Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
5 mg/kg
10 mg/kg
Intramuscular
52 Weeks
Kidney, Blood

Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
12.5 mg/kg
50 mg/kg
Intramuscular
13 Weeks
Kidneybetamethasone:
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
20 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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:
clotrimazole:
Skin contact:

Symptoms: Rash, Itching, Blistering, Oedema, Redness

Ingestion:

Symptoms: Abdominal pain, Nausea, Vomiting, Diarrhoea

Gentamicin:
Ingestion:

Target Organs: Kidney
Target Organs: inner ear
Symptoms: Dizziness, Vertigo, hearing loss, tinnitus, fetal
deafnessbetamethasone:
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:

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

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

Toxicity to daphnia and otheraquatic invertebrates

21 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

Toxicity to algae/aquaticplantsSDS Number:
610543-00021:

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

Propylene glycol:
Toxicity to fish

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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

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

Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to algae/aquaticplants:

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

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

Paraffin oil:
Toxicity to fish

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

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
22 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Remarks: Based on data from similar materials
Hexadecan-1-ol. Ethoxylated:
Toxicity to fish:

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 (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

clotrimazole:
Toxicity to fish

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
toxicity)
Toxicity to microorganisms

:

10

:

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

LC50 (Pimephales promelas (fathead minnow)): 460 mg/l
Exposure time: 96 h

Benzyl alcohol:
Toxicity to fish

23 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 230 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 770
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 310
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

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

NOEC (Daphnia magna (Water flea)): 51 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

EC50 (Daphnia magna (Water flea)): 86 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
LC50 (Americamysis): 30 mg/l
Exposure time: 96 h
Method: US-EPA OPPTS 850.1035

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 10 µg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 1.5µg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
EC50 (Anabaena flos-aquae (cyanobacterium)): 4.7 µg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Anabaena flos-aquae (cyanobacterium)): 1.6 µg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

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

:

100

:

1

:

EC50: 288.7 mg/l
24 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
betamethasone:
Toxicity to daphnia and otheraquatic invertebrates
Toxicity to algae/aquaticplants:

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:

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

Propylene glycol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 98.3 %Exposure time: 28 d
25 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

Method: OECD Test Guideline 301F
Hexadecan-1-ol. Ethoxylated:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: > 99 %Exposure time: 19 dclotrimazole:
Stability in water:

Hydrolysis: 50 %(242 d)

Benzyl alcohol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 92 - 96 %Exposure time: 14 d

Gentamicin:
Biodegradability:

Result: rapidly degradable
Biodegradation: 100 %Exposure time: 28 d
Method: OECD Test Guideline 314

Propylene glycol:
Partition coefficient: noctanol/water:log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8

Paraffin oil:
Partition coefficient: noctanol/water:log Pow: > 4
Remarks: Calculation

Benzyl alcohol:
Partition coefficient: noctanol/water:log Pow: 1.05

Gentamicin:
Partition coefficient: noctanol/water:log Pow: < -2

betamethasone:
Partition coefficient: noctanol/water:log Pow: 2.11

Bioaccumulative potential
Components:

Mobility in soil
No data available
26 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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

:
:
:
:

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

:

964

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code::::

UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone, clotrimazole)
9III
9F-A, S-F

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

27 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

Marine pollutant

SDS Number:
610543-00021:

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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
Priority Assessment Chemical SubstanceChemical namePropane-1,2-diolalpha-Alkyl(C=9-11)-omega-hydroxypoly(oxyethylene) (It is limited thata number-average molecular weight of the polymer is less than 1,000.)alpha-Alkyl(C=12-15)-omega-hydroxypoly(oxyethylene) (It is limited thata number-average molecular weight of the polymer is less than 1,000.)[alpha-(Alkyl(C=16-18))-omega-hydroxypoly(oxyethane-1,2-diyl) or alpha-(alkenyl(C=16-18))-omega-hydroxypoly(oxyethane-1,2-diyl)]

Number
106
188
189
250

Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
28 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical namePetrolatum
propane-1,2-diol
Mineral oil
Benzyl alcohol

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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

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

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

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

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
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 ThereofClass I Designated Chemical Substances
Chemical namealpha-Alkyl-omegahydroxypoly(oxyethane-1,2-diyl) (limited
to those the alkyl group is C=16-18 andthe mixture thereof, and the number average molecular weight is less than
1,000), alpha-alkenyl-omegahydroxypoly(oxyethane-1,2-diyl) (limited
to those the alkenyl group is C=16-18
and the mixture thereof, and the number

Administration number
578

29 / 32

Concentration (%)
2.3

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

average molecular weight is less than
1,000), and the mixture thereof
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Miscellaneous dangerous substances and articles (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Miscellaneous dangerous substances and articles (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Noxious liquid substance(Category Z)

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.

30 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

Date format

SDS Number:
610543-00021:

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29

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
ACGIH / TWA
JP OEL JSOH / OEL-M
JP OEL JSOH / OEL-C:::

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

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance 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.
31 / 32

SAFETY DATA SHEET

Clotrimazole / Gentamicin / Betamethasone(0.05%) Formulation
Version
12.0

Revision Date:
2024/04/06

SDS Number:
610543-00021

JP / EN

32 / 32

Date of last issue: 2023/09/30
Date of first issue: 2016/04/29