SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

SECTION 1. IDENTIFICATION
Product name:Betamethasone / Salicylic Acid Lotion 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)
Flammable liquids: Category 2
Skin irritation:

Category 2

Eye irritation:

Category 2A

Reproductive toxicity:

Category 1BSpecific target organ toxicity- single exposure:

Category 3

Specific target organ toxicity- repeated exposure:

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

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H225 Highly flammable liquid and vapor.
H315 Causes skin irritation.
H319 Causes serious eye irritation.
H336 May cause drowsiness or dizziness.
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.
1 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

Precautionary Statements

SDS Number:
1832977-00019:

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P210 Keep away from heat, sparks, open flame and hot surfaces. No smoking.
P233 Keep container tightly closed.
P241 Use explosion-proof electrical, ventilating and lighting
equipment.
P242 Use only non-sparking tools.
P243 Take precautionary measures against static discharge.
P260 Do not breathe mist or vapors.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P271 Use only outdoors or in a well-ventilated area.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately
all contaminated clothing. Rinse skin with water.
P304 + P340 + P312 IF INHALED: Remove person to fresh air
and keep comfortable for breathing. Call a doctor if you feelunwell.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact lenses, if present and easy
to do. Continue rinsing.
P308 + P313 IF exposed or concerned: Get medical attention.
P332 + P313 If skin irritation occurs: Get medical attention.
P337 + P313 If eye irritation persists: Get medical attention.
P362 + P364 Take off contaminated clothing and wash it before
reuse.
Storage:
P403 + P235 Store in a well-ventilated place. Keep cool.
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.

Other hazards
Vapors may form explosive mixture with air.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical namePropan-2-ol

CAS-No.
67-63-0
2 / 21

Concentration (% w/w)>= 30 - < 50

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

Salicylic acid
69-72-7
Sodium hydroxide
1310-73-2
Betamethasone
378-44-9
Actual concentration is withheld as a trade secret>= 1 - < 5>= 0.5 - < 1>= 0.01 - < 0.1

SECTION 4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with plenty of water
for at least 15 minutes while removing 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.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Causes skin irritation.
Causes serious eye irritation.
May cause drowsiness or dizziness.
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.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemicalHigh volume water jet

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Do not use a solid water stream as it may scatter and spread
fire.
Flash back possible over considerable distance.
Vapors may form explosive mixtures with air.
Exposure to combustion products may be a hazard to health.

Hazardous combustion prod-:

Carbon oxides
3 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

ucts
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

Remove all sources of ignition.
Ventilate the area.
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:

Non-sparking tools should be used.
Soak up with inert absorbent material.
Suppress (knock down) gases/vapors/mists with a water sprayjet.
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.
Use explosion-proof electrical, ventilating and lighting equip4 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

ment.
Do not get on skin or clothing.
Do not breathe mist or vapors.
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
Non-sparking tools should be used.
Keep container tightly closed.
Keep away from heat, hot surfaces, sparks, open flames andother ignition sources. No smoking.
Take precautionary measures against static discharges.
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.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
Keep away from heat and sources of ignition.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Flammable solids
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures which in contact with water emit
flammable gases
Explosives
Gases
Very acutely toxic substances and mixtures

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

CAS-No.

Propan-2-ol

67-63-0

Value type
(Form ofexposure)
TWA
STEL
ST
TWA
TWA
5 / 21

Control parameters / Permissible
concentration
200 ppm
400 ppm
500 ppm
1,225 mg/m³
400 ppm
980 mg/m³
400 ppm

Basis

ACGIH
ACGIH
NIOSH RELNIOSH REL
OSHA Z-1

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Salicylic acid

69-72-7

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

TWA

Further information: DSEN
Wipe limit
1310-73-2
CC
TWA
378-44-9
TWA
Further information: Skin
Wipe limit

Sodium hydroxide

Betamethasone

980 mg/m³
100 µg/m3 (OEB
2)

Internal

100 µg/100 cm2
2 mg/m³
2 mg/m³
2 mg/m³
1 µg/m3 (OEB 4)Internal
ACGIH
NIOSH REL
OSHA Z-1
Internal

10 µg/100 cm²Internal

Biological occupational exposure limits
Components

CAS-No.

Controlparameters

Biological
specimen

Propan-2-ol

67-63-0

AcetoneUrine

Engineering measures:

Samplingtime
End ofshift atend ofworkweek

Permissible
concentration
40 mg/l

Basis

ACGIH
BEI

All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Essentially no open handling permitted.
Use closed processing systems or containment technologies.
If handled in a laboratory, use a properly designed biosafetycabinet, fume hood, or other containment device if thepotential exists for aerosolization. If this potential does notexist, handle over lined trays or benchtops.
Use explosion-proof electrical, ventilating and lighting
equipment.

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

6 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Remarks:

Eye protection:

Skin and body protection:

Hygiene measures:

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

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

lotionColor:

colorless, translucent

Odor

:

No data available

Odor 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:

70.5 - 72.0 °F / 21.4 - 22.2 °C

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

Not applicable

Upper explosion limit / Upper:

No data available
7 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

flammability limit
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 characteristics
Particle size:

No data available

SECTION 10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Highly flammable liquid and vapor.
Vapors may form explosive mixture with air.
Can react with strong oxidizing agents.

Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

Heat, flames and sparks.
Oxidizing agents
No hazardous decomposition products are known.

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

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

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

Acute inhalation toxicity:

Acute toxicity estimate: 11.25 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method

Acute dermal toxicity:

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

Propan-2-ol:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 25 mg/l
Exposure time: 6 h
Test atmosphere: vapor

Acute dermal toxicity:

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

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

Sodium hydroxide:
Acute inhalation toxicity:

Assessment: Corrosive to the respiratory tract.
9 / 21SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

Betamethasone:
Acute oral toxicity

SDS Number:
1832977-00019:

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

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

Acute inhalation toxicity:

LC50 (Rat): 0.4 mg/l
Exposure time: 4 h

Propan-2-ol:
SpeciesResult::RabbitNo skin irritation

Salicylic acid:
Result:Skin irritation

Sodium hydroxide:
Result:Corrosive after 3 minutes or less of exposure

Betamethasone:
SpeciesResult::RabbitMild skin irritation

Skin corrosion/irritation
Causes skin irritation.
Components:

Serious eye damage/eye irritation
Causes serious eye irritation.
Components:
Propan-2-ol:
SpeciesResult::RabbitIrritation to eyes, reversing within 21 days

Salicylic acid:
Species
Remarks::

RabbitSevere eye irritation

Sodium hydroxide:
ResultRemarks::

Irreversible effects on the eye
Based on skin corrosivity.

10 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

Betamethasone:
SpeciesResultSDS Number:
1832977-00019::

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Propan-2-ol:
Test Type
Routes of exposure
Species
MethodResult:::::Buehler Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

Salicylic acid:
Test TypeSpeciesResult:::Local lymph node assay (LLNA)
Mouse
negative

Sodium hydroxide:
Test Type
Routes of exposure
Result:::Human repeat insult patch test (HRIPT)
Skin contact
negative

Betamethasone:
Routes of exposure
SpeciesResult:::DermalGuinea pig
Weak sensitizer

Germ cell mutagenicity
Not classified based on available information.
Components:
Propan-2-ol:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
11 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

Species: Mouse
Application Route: Intraperitoneal injection
Result: negative
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
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:
Propan-2-ol:
Species
Application RouteExposure time
MethodResult

:
:
:
:
:

Rat
inhalation (vapor)
104 weeks
OECD Test Guideline 451
negative

12 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

Salicylic acid:
Species
Application RouteExposure time
NOAEL
ResultSDS Number:
1832977-00019

:
:
:
:
:

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

Mouse
Skin contact
1 Years
2 mg/cm2
negative

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:
Propan-2-ol:
Effects on fertility:

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

Effects on fetal development:

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

Salicylic acid:
Effects on fetal development:

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

Reproductive toxicity - Assessment
Betamethasone:
Effects on fetal development:

Suspected of damaging the unborn child.

:Species: Rabbit
Application Route: Intramuscular
13 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

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
May cause drowsiness or dizziness.
Components:
Propan-2-ol:
Assessment:

May cause drowsiness or dizziness.

STOT-repeated exposure
Causes damage to organs (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) through prolonged or repeated exposure.
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:
Propan-2-ol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
12.5 mg/l
inhalation (vapor)
104 Weeks

Salicylic acid:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
50 mg/kg
Ingestion
2y
14 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

Species
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
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Mouse
0.1 %
Skin contact
8 Weeks
thymus glandSpecies
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.05 mg/kg
Oral
28 d
Blood, thymus gland, Adrenal gland

Aspiration toxicity
Not classified based on available information.
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

15 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Propan-2-ol:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): 9,640 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 10,000 mg/l
Exposure time: 24 h

Toxicity to microorganisms:

EC50 (Pseudomonas putida): > 1,050 mg/l
Exposure time: 16 h

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)
Betamethasone:
Toxicity to daphnia and otheraquatic invertebrates
Toxicity to algae/aquaticplantsNOEC (Daphnia magna (Water flea)): 10 mg/l
Exposure time: 21 d:

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

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

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.052 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210
16 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

NOEC (Oryzias latipes (Japanese medaka)): 0.07 µg/l
Exposure time: 219 d
Method: OECD Test Guideline 229
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

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

Persistence and degradability
Components:
Propan-2-ol:
Biodegradability:

Result: rapidly degradable

BOD/COD:

BOD: 1,19 (BOD5)
COD: 2,23
BOD/COD: 53 %Propan-2-ol:
Partition coefficient: noctanol/water:log Pow: 0.05

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

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

Bioaccumulative potential
Components:

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.
Empty containers retain residue and can be dangerous.
Do not pressurize, cut, weld, braze, solder, drill, grind, or
expose such containers to heat, flame, sparks, or other17 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

sources of ignition. They may explode and cause injury and/or
death.
If not otherwise specified: Dispose of as unused product.
SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Packing group
LabelsEnvironmentally hazardous

:
:
:
:
:
:

UN 1219ISOPROPANOL SOLUTION
3
II
3
no

:
:
:
:
:
:

UN 1219
Isopropanol solution
3IIFlammable Liquids
364

:

353

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 1219ISOPROPANOL SOLUTION(Betamethasone)
3II3
F-E, S-D
yes

IATA-DGR
UN/ID No.
Proper shipping nameClass
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

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 nameClass
Packing group
LabelsERG Code
Marine pollutant

:
:
:
:
:
:
:

UN 1219
Isopropanol SOLUTION
3IIFLAMMABLE LIQUID
129
yes(Betamethasone)

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
18 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

Sheet. Transportation classifications may vary by mode of transportation, package sizes, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
Components

CAS-No.

Sodium hydroxide

1310-73-2

Component RQ
(lbs)
1000

Calculated product RQ(lbs)
200000SARA 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:

Flammable (gases, aerosols, liquids, or solids)
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)
Skin corrosion or irritation
Serious eye damage or eye irritation

SARA 313:

The following components are subject to reporting levels
established by SARA Title III, Section 313:
Propan-2-ol

67-63-0>= 30 - < 50 %US State Regulations
Pennsylvania Right To Know
Water
Propan-2-ol
Sodium hydroxide7732-18-5
67-63-01310-73-2

California List of Hazardous Substances
Propan-2-ol
Salicylic acid

67-63-0
69-72-7

California Permissible Exposure Limits for Chemical Contaminants
Propan-2-ol

67-63-0

The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

19 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

SECTION 16. OTHER INFORMATION
Further information
NFPA 704:

HMIS® IV:
Flammability

HEALTH

3
Health20Special hazard*

3

FLAMMABILITY

3

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
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ACGIH BEI
: ACGIH - Biological Exposure Indices (BEI)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
ACGIH / TWA: 8-hour, time-weighted average
ACGIH / STEL
: Short-term exposure limit
ACGIH / C
: Ceiling limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
NIOSH REL / ST
: STEL - 15-minute TWA exposure that should not be exceededat any time during a workday
NIOSH REL / C: Ceiling value not be exceeded at any time.
OSHA Z-1 / TWA: 8-hour time weighted average
AIIC - 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
20 / 21

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.12

Revision Date:
04/06/2024

SDS Number:
1832977-00019

Date of last issue: 09/30/2023
Date of first issue: 07/13/2017

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:

04/06/2024

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 specificcontext 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