SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

SECTION 1. IDENTIFICATION
Product name:

Gentamicin Cream Formulation

Manufacturer or supplier's details
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
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Reproductive toxicity: Category 1ASpecific target organ toxicity- repeated exposure (Oral):

Category 1 (Kidney, inner ear)

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H360D May damage the unborn child.
H372 Causes damage to organs (Kidney, inner ear) throughprolonged or repeated exposure if swallowed.

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 vapors.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
1 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
Propylene glycol monostearate
1323-39-3
Polyethylene Glycol Sorbitan Monos- 9005-67-8
tearateStearic acid57-11-4
Propylene glycol
57-55-6
Gentamicin
1403-66-3

Concentration (% w/w)
10
6
6
3
1

SECTION 4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

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 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.

:

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Water spray2 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

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 fire-fighters:

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.

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

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

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Prevent spreading over a wide area (e.g., by containment or
oil barriers).
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 diking or other appropriate
containment to keep material from spreading. If diked material
can be pumped, store recovered material in appropriate
container.
Clean up remaining materials from spill with suitable
absorbent.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
3 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

Do not get on skin or clothing.
Do not breathe vapors.
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.
Keep in properly labeled 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
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
Components

CAS-No.

Propylene glycol monostearate

1323-39-3

Polyethylene Glycol Sorbitan
Monostearate

Stearic acid

Propylene glycol
Gentamicin

9005-67-8

57-11-4

57-55-6
1403-66-3
4 / 21

Value type
(Form ofexposure)
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
TWA

Control parameters / 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

10 mg/m³
0.1 mg/m3 (OEBUS WEELInternal

ACGIH

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017
2)

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: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material: Chemical-resistant gloves
Eye protection:

Skin and body protection
Hygiene measures::

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.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking 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.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

cream

Color

:

white to off-white

Odor

:

No data available

Odor Threshold:

No data available
5 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle size:

No data available

SECTION 10. STABILITY AND REACTIVITY
6 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

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

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017:::

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.

SECTION 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
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: vapor
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
7 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

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.
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.
8 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

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

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Polyethylene Glycol Sorbitan Monostearate:
Test Type: Maximization Test
Routes of exposure: Skin contact
Species: HumansResult: negative
Remarks: Based on data from similar materials
Stearic acid:
Test Type
Routes of exposure
SpeciesResultRemarks:::::

Maximization Test
Skin contact
Guinea pig
negative
Based on data from similar materials

Propylene glycol:
Test Type
Routes of exposure
SpeciesResult::::Maximization Test
Skin contact
Guinea pig
negative

9 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

Gentamicin:
Remarks

SDS Number:
1844915-00015:

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

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:
Genotoxicity in vitro:

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
10 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

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

Gentamicin:
Carcinogenicity - Assess: No data available
ment
IARC
No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.
OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as a known or anticipated carcinogen by NTP.

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 fetal development:

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

Stearic acid:
Effects on fertility:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
11 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials
Effects on fetal development:

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

Propylene glycol:
Effects on fertility:

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

Effects on fetal development:

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

Gentamicin:
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 fetal development:

Test Type: Embryo-fetal development
Species: Rabbit
Developmental Toxicity: NOAEL: 3.6 mg/kg body weight
Result: No embryo-fetal toxicity.
Test Type: Embryo-fetal development
Species: Rat
Application Route: Intraperitoneal
Developmental Toxicity: LOAEL: 75 mg/kg body weight
Result: Embryo-fetal toxicity.
Test Type: Embryo-fetal development
Species: Mouse
Application Route: Intraperitoneal
Developmental Toxicity: LOAEL: 10 mg/kg body weight
Result: Fetal mortality., No malformations were observed.
Test Type: Embryo-fetal development
Species: Rat
Application Route: Intraperitoneal
Developmental Toxicity: LOAEL: 50 mg/kg body weight
12 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

Result: Fetal 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
Causes 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
Application Route: Ingestion
Exposure time: 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
2y

Gentamicin:
Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Dog
3 mg/kg
Intramuscular
12 Months
KidneyVomiting, Salivation

13 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

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
KidneyAspiration 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

SECTION 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
14 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

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.

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

15 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

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

Toxicity to microorganisms:

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

16 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

Bioaccumulative potential
Components:
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

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

Mobility in soil
No data available
Other adverse effects
No data available
SECTION 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.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name

:
:

Class
Packing group
LabelsPacking instruction (cargo
aircraft)::::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
Miscellaneous964

17 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

Packing instruction (passenger aircraft)
Environmentally hazardous

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

:

964

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(Gentamicin)
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.
Domestic regulation
49 CFR
UN/ID/NA number
Proper shipping name

:
:

Class
Packing group
LabelsERG Code
Marine pollutant
Remarks

:
:
:
:
:
:

UN 3082
Environmentally hazardous substance, liquid, n.o.s.
(Gentamicin)
9
III
CLASS 9171
yes(Gentamicin)
Above applies only to containers over 119 gallons or 450
liters.
Shipment by ground under DOT is non-regulated; however it
may be shipped per the applicable hazard classification tofacilitate multi-modal transport involving ICAO (IATA) or IMO.

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, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

18 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

SARA 313:

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
Water
Propylene glycol monostearate
Isopropyl myristate
Polyethylene Glycol Sorbitan Monostearate
Stearic acid
Propylene glycol

7732-18-5
1323-39-3
110-27-0
9005-67-8
57-11-4
57-55-6

California Prop. 65
WARNING: This product can expose you to chemicals including Gentamicin, which is/are known
to the State of California to cause birth defects or other reproductive harm. For more information
go to www.P65Warnings.ca.gov.
The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information
NFPA 704:

HMIS® IV:
Flammability

HEALTH1
Health00Special hazard*

3

FLAMMABILITY

1

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
19 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

ACGIH
US WEEL
ACGIH / TWA
US WEEL / TWASDS Number:
1844915-00015::::

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

USA. ACGIH Threshold Limit Values (TLV)
USA. Workplace Environmental Exposure Levels (WEEL)
8-hour, time-weighted average
8-hr TWAAIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; 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; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

09/30/2023

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 for safe handling, use, processing, storage, transportation, disposal and release andshall 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

20 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Gentamicin Cream Formulation
Version
4.8

Revision Date:
09/30/2023

SDS Number:
1844915-00015

Date of last issue: 04/04/2023
Date of first issue: 07/21/2017

context of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
US / Z8

21 / 21