SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:Betamethasone / Salicylic Acid Lotion 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
Emergency Overview
Appearance
Colour
Odour

:
:
:

lotioncolourless, translucent
No data available

Highly flammable liquid and vapour. Causes skin irritation. Causes serious eye irritation. May
cause drowsiness or dizziness. May damage the unborn child. Causes damage to organs throughprolonged or repeated exposure. Very toxic to aquatic life with long lasting effects.
GHS Classification
Flammable liquids:

Category 2

Skin corrosion/irritation:

Category 2

Serious eye damage/eye irritation:

Category 2A

Reproductive toxicity:

Category 1BSpecific target organ toxicity single exposure:

Category 3

Specific target organ toxicity -:Category 1
1 / 21SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

repeated exposure
Long-term (chronic) aquatic
hazard:Category 1

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H225 Highly flammable liquid and vapour.
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 through prolonged or repeatedexposure.
H410 Very toxic to aquatic life with long lasting effects.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P210 Keep away from heat/ sparks/ open flames/ hot surfaces.
No smoking.
P233 Keep container tightly closed.
P241 Use explosion-proof electrical/ ventilating/ lighting equipment.
P242 Use only non-sparking tools.
P243 Take precautionary measures against static discharge.
P260 Do not breathe mist or vapours.
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.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/ shower.
P304 + P340 + P312 IF INHALED: Remove person to fresh air
and keep comfortable for breathing. Call a POISON CENTER/
doctor if you feel unwell.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact lenses, if present and2 / 21SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

easy to do. Continue rinsing.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P332 + P313 If skin irritation occurs: Get medical advice/ attention.
P337 + P313 If eye irritation persists: Get medical advice/ attention.
P362 + P364 Take off contaminated clothing and wash it before
reuse.
P391 Collect spillage.
Storage:
P403 + P235 Store in a well-ventilated place. Keep cool.
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
Physical and chemical hazards
Highly flammable liquid and vapour.
Health hazards
Causes skin irritation. Causes serious eye irritation. May damage the unborn child. May cause
drowsiness or dizziness. Causes damage to organs through prolonged or repeated exposure.
Environmental hazards
Very toxic to aquatic life with long lasting effects.
Other hazards which do not result in classification
Vapours may form explosive mixture with air.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical namePropan-2-ol
salicylic acid
Sodium hydroxide
betamethasone

CAS-No.
67-63-0
69-72-71310-73-2
378-44-9

Concentration (% w/w)>= 30 -< 50>= 1 -< 3>= 0.5 -< 1>= 0.025 -< 0.1

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.
3 / 21SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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:

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

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.

5. FIREFIGHTING 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.
Vapours may form explosive mixtures with air.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides

Specific extinguishing methods:

Special protective equipment:

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.
4 / 21SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

for firefighters

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

Use personal protective equipment.

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 oilbarriers).
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Non-sparking tools should be used.
Soak up with inert absorbent material.
Suppress (knock down) gases/vapours/mists with a water
spray jet.
For large spills, provide dyking or other appropriate containment to keep material from spreading. If dyked material canbe pumped, store recovered material in appropriate container.
Clean up remaining materials from spill with suitable absorbent.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

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 equipment.
Do not get on skin or clothing.
Do not breathe mist or vapours.
Do not swallow.
Do not get in eyes.

7. HANDLING AND STORAGE

5 / 21SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

Avoidance of contact:

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

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

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.
Oxidizing agents
Keep in properly labelled 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:
Self-reactive substances and mixtures
Organic peroxides
Oxidizing agents
Flammable gases
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Poisonous gases
Explosives
Unsuitable material: None known.

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

CAS-No.

Value type
(Form ofexposure)
PC-TWA
PC-STEL
TWA
STEL
TWA

Propan-2-ol

67-63-0

salicylic acid

69-72-7

Sodium hydroxide

Further information: DSEN
Wipe limit
1310-73-2
MAC
6 / 21

Control parameters / Permissible
concentration
350 mg/m3
700 mg/m3
200 ppm
400 ppm
100 µg/m3 (OEB
2)

Basis

100 µg/100 cm2
2 mg/m3

Internal
CN OELCN OELCN OEL
ACGIH
ACGIH
Internal

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

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

betamethasone

2 mg/m3
1 µg/m3 (OEB 4)

ACGIHInternal

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 the potential exists for aerosolization. If this potential does not exist,
handle over lined trays or benchtops.
Use explosion-proof electrical, ventilating and lighting equipment.

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
Eye/face protection: Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Skin and body protection: 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.
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Consider double gloving. Take note that the product is flam7 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

Hygiene measures

SDS Number:
1832968-00019

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

mable, which may impact the selection of hand protection.
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:

lotionColour:colourless, 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:

21.4 - 22.2 °C

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

Not applicable

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

8 / 21SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

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 characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Highly flammable liquid and vapour.
Vapours 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.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
Exposure routes:

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
9 / 21SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

Method: Calculation method
Acute inhalation toxicity:

Acute toxicity estimate: > 10 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: vapour

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.

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 h

10 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

Skin corrosion/irritation
Causes skin irritation.
Components:
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

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.

betamethasone:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
11 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

Respiratory sensitisation
Not classified based on available information.
Components:
Propan-2-ol:
Test Type
Exposure routes
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
Exposure routes
Result:::Human repeat insult patch test (HRIPT)
Skin contact
negativebetamethasone:
Exposure routes
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)
Species: Mouse
Application Route: Intraperitoneal injection
Result: negative

salicylic acid:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
12 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

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 (vapour)
104 weeks
OECD Test Guideline 451
negative

salicylic acid:
Species
Application Route

:
:

Mouse
Skin contact
13 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

Exposure time
NOAEL
ResultSDS Number:
1832968-00019

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

1 Years
2 mg/cm2
negative:

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

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

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

Reproductive toxicity
May damage the unborn child.
Components:
Propan-2-ol:
Effects on fertility

Effects on foetal development

salicylic acid:
Effects on foetal development

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
14 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

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 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 (vapour)
104 Weeks

salicylic 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:
15 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

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:

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

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

16 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

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
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 (Chron-

NOEC (Daphnia magna (Water flea)): 8 mg/l
Exposure time: 21 d
17 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

ic toxicity)
M-Factor (Chronic aquatic
toxicity)

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

Method: OECD Test Guideline 211
:

1,000

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
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.
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 other sourcesof ignition. They may explode and cause injury and/or death.
If not otherwise specified: Dispose of as unused product.
18 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

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.
National Regulations
GB 6944/12268
UN number
Proper shipping nameClass
Packing group
LabelsMarine pollutant

:
:
:
:
:
:

UN 1219ISOPROPANOL SOLUTION
3
II
3
no

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.
19 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

15. REGULATORY INFORMATION
National regulatory information
Law on the Prevention and Control of Occupational Diseases
Regulations on Safety Management of Hazardous Chemicals
Catalogue of Hazardous Chemicals: Listed
Identification of Major Hazard Installations for Hazardous Chemicals (GB 18218)
No. / Code
Chemical name / Category
Threshold quantity
W5.3
Flammable liquids
1,000 tRegulation on the Administration of Precursor Chemicals
Catalogue and Classification of Precursor Chemicals:

Not listed

Yangtze River Protection Law
This product does not contain any dangerous chemicals prohibited for inland river transport.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

Revision Date:

2024/04/06

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:

yyyy/mm/dd

16. OTHER INFORMATION

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ACGIH BEI
: ACGIH - Biological Exposure Indices (BEI)
CN OEL: Occupational exposure limits for hazardous agents in theworkplace - Chemical hazardous agents.
ACGIH / TWA
ACGIH / STELACGIH / CCN OEL / PC-TWACN OEL / PC-STEL
CN OEL / MAC

:
:
:
:
:
:

8-hour, time-weighted average
Short-term exposure limit
Ceiling limit
Permissible concentration - time weighted average
Permissible concentration - short term exposure limit
Maximum allowable concentration
20 / 21

SAFETY DATA SHEET
according to GB/T 16483 and GB/T 17519

Betamethasone / Salicylic Acid Lotion Formulation
Version
4.10

Revision Date:
2024/04/06

SDS Number:
1832968-00019

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

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

21 / 21