SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:Betamethasone / Salicylic Acid Ointment Formulation

Manufacturer or supplier's details
Company: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

Emergency telephone number :+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

2. HAZARDS IDENTIFICATION
Manufacture, Storage and Import of Hazardous Chemicals Rules 1989
Classification
Not classified as hazardous according to criteria laid down in Part I of Schedule-1.
GHS Classification
Acute toxicity (Inhalation):

Category 5

Skin corrosion/irritation:

Category 3

Serious eye damage/eye irritation:

Category 1

Reproductive toxicity:

Category 1BSpecific target organ toxicity repeated exposure:

Category 1 (Pituitary gland, Immune system, muscle, thymus
gland, Blood, Adrenal gland)Long-term (chronic) aquatic
hazard:Category 1

GHS label elements

1 / 19SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Hazard pictograms:

Signal word:

DangerHazard statements:

H316 Causes mild skin irritation.
H318 Causes serious eye damage.
H333 May be harmful if inhaled.
H360D May damage the unborn child.
H372 Causes damage to organs (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) through prolonged or repeated exposure.
H410 Very toxic to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
P203 Obtain, read and follow all safety instructions before use.
P260 Do not breathe dust/ fume/ gas/ mist/ vapours/ spray.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P304 + P317 IF INHALED: Get medical help.
P305 + P354 + P338 + P317 IF IN EYES: Immediately rinse
with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Get medical help.
P318 IF exposed or concerned, get medical advice.
P332 + P317 If skin irritation occurs: Get medical help.
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

CAS-No.

Petrolatum
Paraffin oil

8009-03-8
8012-95-1
2 / 19Concentration (%
w/w)
86.93
10

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

salicylic acidbetamethasone

Date of last issue: 04.04.2023
Date of first issue: 21.08.201769-72-7
378-44-9

3
0.064

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 anddelayed:Protection of first-aiders:

Notes to physician:

If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with plenty of water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of contact, immediately flush eyes with plenty of water
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention immediately.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Causes mild skin irritation.
Causes serious eye damage.
May be harmful if inhaled.
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:

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.
3 / 19SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

Special protective equipment
for firefighters

SDS Number:
1884769-00018:

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

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

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

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

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

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

Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

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

7. HANDLING AND STORAGE

4 / 19SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

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

CAS-No.

Petrolatum

8009-03-8

Paraffin oil

8012-95-1

salicylic acid

69-72-7

betamethasone

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

Engineering measures:

Value type
(Form ofexposure)
TWA (Mist)
STEL (Mist)
TWA (Inhalable particulate matter)
TWA (Mist)
STEL (Mist)
TWA (Inhalable particulate matter)
TWA

Control parameters / Permissible
concentration
5 mg/m3
10 mg/m3
5 mg/m3Basis

5 mg/m3
10 mg/m3
5 mg/m3

IN OELIN OEL
ACGIH

100 µg/m3 (OEB
2)

Internal

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

10 µg/100 cm²Internal

IN OELIN OEL
ACGIH

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

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Combined particulates and organic vapour type
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye 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.
5 / 19SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Skin and body protection:

Hygiene measures:

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Work uniform or laboratory coat.
Additional body garments should be used based upon the task
being performed (e.g., sleevelets, apron, gauntlets, disposable
suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
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.

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

ointment

Colour:white, translucent

Odour

:

No data available

Odour Threshold:

No data available

pH:

4.6 - 5.3

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 classified as a flammability hazard

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

No data available

Relative vapour density:

No data available

Relative density:

No data available
6 / 19SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition 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:::

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

:::

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

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

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Skin contact
Ingestion
Eye contact

Acute toxicity
May be harmful if inhaled.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 5,000 mg/kg
Method: Calculation method

Acute inhalation toxicity:

Acute toxicity estimate: 7.5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method
7 / 19SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

Acute dermal toxicity

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017:

Acute toxicity estimate: > 5,000 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

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

salicylic acid:
Acute oral toxicity:

LD50 (Mouse): 480 mg/kg

Components:

LD50 (Rat): 891 mg/kg
LD50 (Rabbit): 1,300 mg/kg
Acute inhalation toxicity:

LC50 (Rat): 0.9 mg/l
Exposure time: 1 h

Acute dermal toxicity:

LD50 (Rat): 2,000 mg/kg
LD50 (Rabbit): 10,000 mg/kg

betamethasone:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
LD50 (Mouse): > 4,500 mg/kg

Acute inhalation toxicity:

LC50 (Rat): 0.4 mg/l
Exposure time: 4 hSkin corrosion/irritation
Causes mild skin irritation.

8 / 19SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Components:
Petrolatum:Species
MethodResultRemarks::::

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

Paraffin oil:SpeciesResult::RabbitNo skin irritation

salicylic acid:
Result:Skin irritation

betamethasone:
SpeciesResult::RabbitMild skin irritation

Serious eye damage/eye irritation
Causes serious eye damage.
Components:
Petrolatum:Species
MethodResultRemarks::::

RabbitOECD Test Guideline 405
No eye irritation
Based on data from similar materials

Paraffin oil:SpeciesResult::RabbitNo eye irritation

salicylic acid:
Species
Remarks::

RabbitSevere eye irritation

betamethasone:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.

9 / 19SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

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

salicylic acid:
Test TypeSpeciesResult:::Local lymph node assay (LLNA)
Mouse
negativebetamethasone:
Exposure routes
SpeciesResult:::DermalGuinea pig
Weak sensitizer

Germ cell mutagenicity
Not classified based on available information.
Components:
Petrolatum:
Genotoxicity in vitro:

Test Type: Chromosome aberration test in vitro
Result: negative
Remarks: Based on data from similar materials

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Method: OECD Test Guideline 474
Result: negative
Remarks: Based on data from similar materials

salicylic acid:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: Mammalian bone marrow sister chromatid exchange
Species: Mouse
Application Route: Intraperitoneal injection
Result: negative

10 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Test Type: Sister chromatid exchange analysis in spermatogonia
Species: Mouse
Application Route: Intraperitoneal 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.
Components:
Petrolatum:Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

salicylic acid:
Species
Application RouteExposure time
NOAEL
Result

:
:
:
:
:

Mouse
Skin contact
1 Years
2 mg/cm2
negative:

Test Type: Reproduction/Developmental toxicity screening
test

Reproductive toxicity
May damage the unborn child.
Components:
Petrolatum:
Effects on fertility

11 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials
Effects on foetal development

salicylic acid:
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Skin contact
Result: negative
Remarks: Based on data from similar materials:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 380 mg/kg body weight
Result: Maternal toxicity observed., Embryo-foetal toxicity
Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Developmental Toxicity: NOAEL: 80 mg/kg body weight
Result: No effects on foetal development

Reproductive toxicity - Assessment
betamethasone:
Effects on foetal development:

Suspected of damaging the unborn child.

:Species: Rabbit
Application Route: Intramuscular
Developmental Toxicity: LOAEL: 0.05 mg/kg body weight
Result: Fetotoxicity, Malformations were observed.
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.42 mg/kg body weight
Result: Malformations were observed.
Species: Mouse
Application Route: Intramuscular
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.
12 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Components:
betamethasone:
Target Organs:

Assessment:

Pituitary gland, Immune system, muscle, thymus gland, Blood,
Adrenal gland
Causes damage to organs through prolonged or repeatedexposure.

Repeated dose toxicity
Components:
Petrolatum:Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
5,000 mg/kg
Ingestion
2 yr

Paraffin oil:Species
LOAEL
Application RouteExposure time

:
:
:
:

Rat, female
161 mg/kg
Ingestion
90 Dayssalicylic acid:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
50 mg/kg
Ingestion
2 yrSpecies
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
500 mg/kg
Oral
3d
Liver

betamethasone:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rabbit0.05 %
Skin contact
10 - 30 d
Pituitary gland, Immune system, muscle

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.05 %
Skin contact
8 Weeks
thymus glandSpecies:Mouse
13 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:

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

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:
salicylic acid:
Skin contact
Eye contact
Ingestion:::

Symptoms: Skin irritation
Symptoms: Severe irritation
Symptoms: Gastrointestinal discomfort, hearing loss, Dizziness, electrolyte imbalance

betamethasone:
Inhalation
Skin contact::

Target Organs: Adrenal gland
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

14 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

Toxicity to algae/aquaticplantsSDS Number:
1884769-00018:

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

Paraffin oil:
Toxicity to fish

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

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

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
Remarks: Based on data from similar materials

salicylic acid:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): 1,380 mg/l
Exposure time: 96 h
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 870 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 ( Desmodesmus subspicatus (green algae)): > 100 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

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

NOEC: 10 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)

betamethasone:
15 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Americamysis): > 50 mg/l
Exposure time: 96 h

Toxicity to algae/aquaticplants:

EC50 ( Pseudokirchneriella subcapitata (green algae)): > 34
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility
NOEC ( Pseudokirchneriella subcapitata (green algae)): 34
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility

Toxicity to fish (Chronic toxicity):

NOEC: 0.052 mg/l
Exposure time: 32 d
Species: Pimephales promelas (fathead minnow)
Method: OECD Test Guideline 210
NOEC: 0.07 µg/l
Exposure time: 219 dSpecies: Oryzias latipes (Japanese medaka)
Method: OECD Test Guideline 229

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

NOEC: 8 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)
Method: OECD Test Guideline 211

M-Factor (Chronic aquatic
toxicity)

1,000

:

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:

log Pow: > 4
Remarks: Calculation

Bioaccumulative potential
Components:
Paraffin oil:
Partition coefficient: noctanol/water

16 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

salicylic acid:
Partition coefficient: noctanol/water:log Pow: 2.25

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

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

Mobility in soil
No data available
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
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

:
:

Class
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
Environmentally hazardous
IMDG-CodeUN number

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(betamethasone)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(betamethasone)
9
III
Miscellaneous
956

:

956

:

yes

:

UN 3077
17 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Proper shipping name

:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(betamethasone)
9III
9
F-A, S-F
yes

Transport in bulk according to IMO instruments
Not applicable for product as supplied.
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.
15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or mixture
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

Revision Date:

30.09.2023

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/

Date format:

dd.mm.yyyy

16. OTHER INFORMATION

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
IN OEL: India. Permissible levels of certain chemical substances inwork environment.
ACGIH / TWAIN OEL / TWAIN OEL / STEL:::

8-hour, time-weighted averageTime-Weighted Average Concentration (TWA) (8 hrs.)
Short-term exposure Limit STEL (15 min)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 18 / 19

SAFETY DATA SHEET
according to the Globally Harmonized System

Betamethasone / Salicylic Acid Ointment Formulation
Version
4.9

Revision Date:
30.09.2023

SDS Number:
1884769-00018

Date of last issue: 04.04.2023
Date of first issue: 21.08.2017

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.
IN / EN

19 / 19