SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Gentamicin Cream 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 1ASpecific target organ toxicity repeated exposure (Oral):

Category 2 (Kidney, inner ear)

Short-term (acute) aquatic
hazard:Category 1

Long-term (chronic) aquatic
hazard:Category 3

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360D May damage the unborn child.
H373 May cause damage to organs (Kidney, inner ear) throughprolonged or repeated exposure if swallowed.
H400 Very toxic to aquatic life.
H412 Harmful to aquatic life with long lasting effects.
1 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Precautionary statements:

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe vapours.
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 name
Propylene glycol monostearate

CAS-No.
1323-39-3

Concentration (% w/w)
10

ENCS No.
2-772, 2-2523

Polyethylene Glycol Sorbitan
Monostearate
Stearic acid

9005-67-8

6

8-55, 7-110

57-11-4

6

2-608

Propylene glycol

57-55-6

3

2-234

Gentamicin

1403-66-3

1

4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

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.
2 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

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: 2017/07/21

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.
May cause damage to organs through prolonged or repeatedexposure if swallowed.
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.
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.

:

3 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

Methods and materials forcontainment and cleaning up

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21:

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 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.
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 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

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)

Propylene glycol monostearate

1323-39-3

TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)
TWA

Polyethylene Glycol Sorbitan
Monostearate

9005-67-8

Stearic acid57-11-4

Gentamicin

1403-66-3

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

3 mg/m3

ACGIH

10 mg/m3

ACGIH

3 mg/m3

ACGIH

10 mg/m3

ACGIH

3 mg/m3

ACGIH

0.1 mg/m3 (OEB
2)

Internal

ACGIH

Further information: OTO
Engineering measures:

Use appropriate engineering controls and manufacturing
technologies to control airborne concentrations (e.g., dripless quick connections).
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Laboratory operations do not require special containment.

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
5 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Hand protection
Material:

Chemical-resistant gloves

Eye protection:

Skin and body 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.
Work uniform or laboratory coat.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state

:

cream

Colour:white to off-white

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

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:

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

6 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Density

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21:

No data available

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available:::

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

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Propylene glycol monostearate:
Acute oral toxicity: LD50 (Mouse): > 5,000 mg/kg
Polyethylene Glycol Sorbitan Monostearate:
Acute oral toxicity: LD50 (Rat): > 20,000 mg/kg
7 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg

Stearic acid:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Method: OECD Test Guideline 401

Acute inhalation toxicity:

LC50 (Rat): > 2 mg/l
Exposure time: 1 h
Test atmosphere: vapour
Remarks: Based on data from similar materials

Acute dermal toxicity:

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

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

Acute dermal toxicity:

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

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 :administration)

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

Skin corrosion/irritation
Not classified based on available information.

8 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Components:
Propylene glycol monostearate:
Result: No skin irritation
Polyethylene Glycol Sorbitan Monostearate:
Species: Rabbit
Result: No skin irritation
Stearic acid:
Species
MethodResult:::RabbitPatch Test 24 Hrs.
No skin irritation

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

Gentamicin:
SpeciesResult::RabbitMild skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Polyethylene Glycol Sorbitan Monostearate:
Species: Rabbit
Result: No eye irritation
Stearic acid:
SpeciesResult::RabbitNo eye irritation

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

Gentamicin:
SpeciesResult::RabbitMild eye irritation

9 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Polyethylene Glycol Sorbitan Monostearate:
Test Type: Maximisation Test
Exposure routes: Skin contact
Species: HumansResult: negative
Remarks: Based on data from similar materials
Stearic acid:
Test Type
Exposure routes
SpeciesResultRemarks:::::

Maximisation 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

Gentamicin:
Remarks:

No data available

Germ cell mutagenicity
Not classified based on available information.
Components:
Polyethylene Glycol Sorbitan Monostearate:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative
Stearic acid:
10 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

Genotoxicity in vitro

SDS Number:
1844940-00016:

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Remarks: Based on data from similar materials
Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative
Remarks: Based on data from similar materials
Test Type: Bacterial reverse mutation assay (AMES)
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

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

Carcinogenicity
Not classified based on available information.
Components:
Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative
11 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

Gentamicin:
Carcinogenicity - Assessment

SDS Number:
1844940-00016:

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

No data available

Reproductive toxicity
May damage the unborn child.
Components:
Polyethylene Glycol Sorbitan Monostearate:
Effects on fertility: Test Type: Three-generation reproduction toxicity study
Species: Mouse
Application Route: Ingestion
Result: negative
Effects on foetal development

Stearic acid:
Effects on fertility

Effects on foetal development

Propylene glycol:
Effects on fertility

Effects on foetal development:

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

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials:

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

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

Gentamicin:
12 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Effects on fertility:

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

Effects on foetal development:

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

Positive evidence of adverse effects on development fromhuman epidemiological studies.

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
May cause damage to organs (Kidney, inner ear) through prolonged or repeated exposure if
swallowed.
Components:
Gentamicin:
Target Organs
Assessment::

Kidney, inner ear
Causes damage to organs through prolonged or repeatedexposure.

Repeated dose toxicity
Components:
Polyethylene Glycol Sorbitan Monostearate:
Species: Rat
NOAEL: 1,355 mg/kg
13 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Application RouteExposure time::

Ingestion
13 Weeks

Stearic acid:
Species
NOAEL
Application RouteExposure time
MethodRemarks

:
:
:
:
:
:

Rat
1,000 mg/kg
Ingestion
42 Days
OECD Test Guideline 422
Based on data from similar materials

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Gentamicin:
Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Dog
3 mg/kg
Intramuscular
12 Months
KidneyVomiting, Salivation

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
Kidney14 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Gentamicin:
Ingestion:

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

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Polyethylene Glycol Sorbitan Monostearate:
Toxicity to fish
: LC50 : > 10 - 100 mg/l
Exposure time: 96 h
Stearic acid:
Toxicity to fish:

LL50 (Leuciscus idus (Golden orfe)): > 10,000 mg/l
Exposure time: 48 h
Method: DIN 38412

Toxicity to daphnia and otheraquatic invertebrates:

EL50 (Daphnia magna (Water flea)): > 10 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: Based on data from similar materials
No toxicity at the limit of solubility

Toxicity to algae/aquaticplants:NOELR (Pseudokirchneriella subcapitata (green algae)): > 10
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
No toxicity at the limit of solubility
EL50 (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
No toxicity at the limit of solubility

15 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

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

NOELR (Daphnia magna (Water flea)): > 0.5 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211
Remarks: Based on data from similar materials
No toxicity at the limit of solubility

Toxicity to microorganisms:

EC10 (Pseudomonas putida): 883 mg/l
Exposure time: 18 h

Propylene glycol:
Toxicity to fish:

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:

Gentamicin:
Toxicity to daphnia and otheraquatic invertebrates:

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

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
16 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

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

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

:

100

:

1

:

EC50: 288.7 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

Persistence and degradability
Components:
Polyethylene Glycol Sorbitan Monostearate:
Biodegradability: Result: Not readily biodegradable.
Stearic acid:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 71 %Exposure time: 28 d
Method: OECD Test Guideline 301B

Propylene glycol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 98.3 %Exposure time: 28 d
Method: OECD Test Guideline 301F

Gentamicin:
Biodegradability:

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

Stearic acid:
Partition coefficient: noctanol/water:log Pow: 8.23

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

log Pow: < -2

Bioaccumulative potential
Components:

Gentamicin:
Partition coefficient: n-

17 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

octanol/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 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(Gentamicin)
9
III
9
yes

:
:
:
:

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

:

964

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class

:

UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(Gentamicin)
9

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

18 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
1844940-00016

:
:
:
:

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

III
9
F-A, S-F
yes

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
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-diol

Number106

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
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical namepropane-1,2-diol

Concentration (%)>0 - <10

19 / 22

Remarks
From April 1st, 2025

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical namepropane-1,2-diol

Remarks
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 Thereof
Not applicable
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)
20 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

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)
ACGIH / TWA:

8-hour, time-weighted average

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
21 / 22

SAFETY DATA SHEET

Gentamicin Cream Formulation
Version
7.0

Revision Date:
2024/04/06

SDS Number:
1844940-00016

Date of last issue: 2023/09/30
Date of first issue: 2017/07/21

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

22 / 22