SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:Betamethasone Lotion Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

Emergency telephone number :+1-215-631-6999

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

2. HAZARDS IDENTIFICATIONGHS classification of chemical product
Flammable liquids: Category 2
Serious eye damage/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)Long-term (chronic) aquatic
hazard:Category 1

GHS label elements
Hazard pictograms:

Signal word:

Danger
1 / 21SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Hazard statements:

Precautionary statements:

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

H225 Highly flammable liquid and vapour.
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.
H410 Very toxic to aquatic life with long lasting effects.
Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P210 Keep away from heat, hot surfaces, sparks, open flames
and other ignition sources. No smoking.
P233 Keep container tightly closed.
P241 Use explosion-proof electrical/ ventilating/ lighting equipment.
P242 Use non-sparking tools.
P243 Take action to prevent static discharges.
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.
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 andeasy to do. Continue rinsing.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P337 + P313 If eye irritation persists: Get medical advice/ attention.
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.

2 / 21SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

Other hazards which do not result in classification
Important symptoms and out- : Vapours may form explosive mixture with air.
lines of the emergency assumed
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Propylene glycol

CAS-No.
57-55-6

Concentration (% w/w)>= 30 - < 40

Propan-2-ol

67-63-0>= 30 - < 40

betamethasone

378-44-9>= 0.025 - < 0.1

ENCS No.
2-234
2-207

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.
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.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
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
3 / 21SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

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
for firefighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

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

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
4 / 21SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

certain local or national requirements.
7. HANDLING AND STORAGE
Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

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.
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
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.
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:
Oxidizing solids
Oxidizing liquids
Unsuitable material: None known.
5 / 21SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

Value type
(Form ofexposure)

Propan-2-ol

67-63-0

ACL
OEL-C

betamethasone

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

Control parameters / Reference
concentration /Permissible concentration
200 ppm
400 ppm
980 mg/m3
200 ppm
400 ppm
1 µg/m3 (OEB 4)Basis

10 µg/100 cm²Internal

JP OEL ISHLJP OEL
JSOH
ACGIH
ACGIH
Internal

Biological occupational exposure limits
Components

CAS-No.

Target substance

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
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Consider double gloving. Take note that the product is flam6 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Eye protection:

Skin and body protection:

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

mable, which may impact the selection of hand protection.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
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.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

lotionColour:colourless

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

Not applicable

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit
Flash point:

No data available:

21.4 °C
Method: closed cup

Decomposition temperature:

No data available

pH

:

4.5

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
7 / 21SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Viscosity, kinematic:

No data available:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Solubility(ies)
Water solubility

Density

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16:

No data available

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle characteristics
Particle size:

Not applicable

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
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Propylene glycol:
8 / 21SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

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

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

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
Not classified based on available information.
Components:
Propylene glycol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

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

betamethasone:
SpeciesResult::RabbitMild skin irritation

Serious eye damage/eye irritation
Causes serious eye irritation.

9 / 21SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

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

Propan-2-ol:
SpeciesResult::RabbitIrritation to eyes, reversing within 21 days

betamethasone:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Propylene glycol:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Propan-2-ol:
Test Type
Exposure routes
Species
MethodResult:::::Buehler Test
Skin contact
Guinea pig
OECD Test Guideline 406
negativebetamethasone:
Exposure routes
SpeciesResult:::DermalGuinea pig
Weak sensitizer

Germ cell mutagenicity
Not classified based on available information.
Components:
Propylene glycol:
10 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

Genotoxicity in vitro

SDS Number:
1288505-00019:

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Result: negative

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

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.

11 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

Components:
Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

Propan-2-ol:
Species
Application RouteExposure time
MethodResult

:
:
:
:
:

Rat
inhalation (vapour)
104 weeks
OECD Test Guideline 451
negative:

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

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

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:

Species: Rabbit
Application Route: Intramuscular
Developmental Toxicity: LOAEL: 0.05 mg/kg body weight
Result: Fetotoxicity, Malformations were observed.

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

Effects on foetal development

Propan-2-ol:
Effects on fertility

Effects on foetal development

betamethasone:
Effects on foetal development

Species: Rat
Application Route: Subcutaneous
12 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

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:
Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Propan-2-ol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
12.5 mg/l
inhalation (vapour)
104 Weeks

betamethasone:
Species
LOAEL::

Rabbit0.05 %
13 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

Application RouteExposure timeTarget Organs:::

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:
betamethasone:
Inhalation:

Target Organs: Adrenal gland

Skin contact:

Symptoms: Redness, pruritis, Irritation:

LC50 (Oncorhynchus mykiss (rainbow trout)): 40,613 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 18,340 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Skeletonema costatum (marine diatom)): 19,300 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Propylene glycol:
Toxicity to fish

14 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

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

Propan-2-ol:
Toxicity to fish

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

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

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

betamethasone:
Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to algae/aquaticplantsNOEC (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 (Chronic toxicity)

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

M-Factor (Chronic aquatic
toxicity)

1,000

:

Persistence and degradability
Components:
Propylene glycol:
15 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

Biodegradability:

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

Propan-2-ol:
Biodegradability:

Result: rapidly degradable

BOD/COD:

BOD: 1,19 (BOD5)
COD: 2,23
BOD/COD: 53 %Propylene glycol:
Partition coefficient: noctanol/water:log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8

Propan-2-ol:
Partition coefficient: noctanol/water:log Pow: 0.05

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

Bioaccumulative potential
Components:

Mobility in soil
No data available
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
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.

16 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Packing group
LabelsEnvironmentally hazardous

:
:
:
:
:
:

UN 1219ISOPROPANOL SOLUTION
3
II
3
yes

:
:
:
:
:
:

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
Refer to section 15 for specific national regulation.
Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
ERG Code:

129

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Group 4, Type 2 petroleums, Water insoluble liquid, (1000 litre), Hazardous rank III
17 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical name
Isopropyl alcohol
Propane-1,2-diol

Number102
106

Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical name
Propyl alcohol
propane-1,2-diol

Concentration (%)>=30 - <40>=30 - <40

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical name
Propyl alcohol
propane-1,2-diol

Remarks
From April 1st, 2025

Remarks
From April 1st, 2025

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Organic Solvents Class 2

18 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Inflammable Substance
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Flammable liquids (Article 2 and 3 of rules on shipping and storage of dangerous goods and its
Attached Table 1)
Aviation Law
Flammable liquid (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table
1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Noxious liquid substance(Category Z)

Pack transportation:

Classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Specially Controlled Industrial Waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
Further information
Sources of key data used to:Internal technical data, data from raw material SDSs, OECD
19 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

compile the Safety Data
Sheet

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ACGIH BEI
: ACGIH - Biological Exposure Indices (BEI)
JP OEL ISHL
: Japan. Administrative Control Levels
JP OEL JSOH
: Japan. The Japan Society for Occupational Health. Recommendation of Occupational Exposure Limits
ACGIH / TWA
ACGIH / STELJP OEL ISHL / ACLJP OEL JSOH / OEL-C

:
:
:
:

8-hour, time-weighted average
Short-term exposure limit
Administrative Control level
Occupational Exposure Limit-Ceiling

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
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
20 / 21

SAFETY DATA SHEET

Betamethasone Lotion Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
1288505-00019

Date of last issue: 2023/09/30
Date of first issue: 2017/02/16

safe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
JP / EN

21 / 21