SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:Betamethasone Sodium Phosphate 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 productReproductive toxicity: Category 1BSpecific target organ toxicity repeated exposure:

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

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

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.

1 / 19SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Precautionary statements:

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe mist or vapours.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P391 Collect spillage.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification
Important symptoms and out- : Dust contact with the eyes can lead to mechanical irritation.
lines of the emergency asContact with dust can cause mechanical irritation or drying ofsumed
the skin.
May form combustible dust concentrations in air during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical namebetamethasone
Disodium EDTA, dihydrate

CAS-No.
378-44-9
6381-92-6

Concentration (% w/w)>= 0.3 - < 1< 0.1

ENCS No.
2-1265, 2-1265

4. FIRST AID MEASURES
General advice:

If inhaled:

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.
2 / 19SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

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: 2019/01/29

In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

:

Exposure to combustion products may be a hazard to health.

:No hazardous combustion products are known

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

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.

:

3 / 19SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

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:

Soak up with inert absorbent material.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration.
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:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe mist or vapours.
Do not swallow.
Avoid contact with eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Do not eat, drink or smoke when using this product.

7. HANDLING AND STORAGE

4 / 19SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

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.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

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

CAS-No.

betamethasone

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

Engineering measures:

Value type
(Form ofexposure)

Control parameters / Reference
concentration /Permissible concentration
1 µg/m3 (OEB 4)Basis

10 µg/100 cm²Internal

Internal

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.

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the rec5 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

Filter type
Hand protection:

ommended guidelines, use respiratory protection.
Particulates type

Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Consider double gloving.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
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:

Aqueous solution

Colour:No data available

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):

May form combustible dust concentrations in air during processing, handling or other means.

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:

No data available

Flash point:

No data available

Decomposition temperature:

No data available

6 / 19SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

pH:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Density

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29:

No data available

Relative vapour density:

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:

Not applicable

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form combustible dust concentrations in air during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

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

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
7 / 19SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Information on likely routes of :exposure

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Product:
Acute inhalation toxicity:

Acute toxicity estimate: > 5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method:

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

Components:
betamethasone:
Acute oral toxicity

LD50 (Mouse): > 4,500 mg/kg
Acute inhalation toxicity:

Disodium EDTA, dihydrate:
Acute oral toxicity:
Acute inhalation toxicity:

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

LD50 (Rat): 2,800 mg/kg
LC50 (Rat, male): > 1 mg/l
Exposure time: 6 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 412

Skin corrosion/irritation
Not classified based on available information.
Components:
betamethasone:
SpeciesResult::RabbitMild skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
betamethasone:
Species:

Rabbit8 / 19SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

ResultSDS Number:
3960234-00012:

No eye irritation

Disodium EDTA, dihydrate:
Species:Result:RabbitNo eye irritation

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
betamethasone:
Exposure routes
SpeciesResult:::DermalGuinea pig
Weak sensitizer

Disodium EDTA, dihydrate:
Test Type
Exposure routes
Species
MethodResultRemarks

:
:
:
:
:
:

Maximisation Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative
Based on data from similar materials

Germ cell mutagenicity
Not classified based on available information.
Components:
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
9 / 19SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

Germ cell mutagenicity Assessment

SDS Number:
3960234-00012:

Disodium EDTA, dihydrate:
Genotoxicity in vitro:

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

Weight of evidence does not support classification as a germ
cell mutagen.

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Based on data from similar materials
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Remarks: Based on data from similar materials

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Method: OECD Test Guideline 474
Result: negative

Carcinogenicity
Not classified based on available information.
Components:
Disodium EDTA, dihydrate:
Species
Application RouteExposure time
ResultRemarks

:
:
:
:
:

Rat
Ingestion
103 weeks
negative
Based on data from similar materials:

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:
betamethasone:
Effects on foetal development

Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.42 mg/kg body weight
Result: Malformations were observed.
10 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

Species: Mouse
Application Route: Intramuscular
Developmental Toxicity: LOAEL: 1 mg/kg body weight
Result: Malformations were observed.
Reproductive toxicity - Assessment:

Disodium EDTA, dihydrate:
Effects on fertility:

Effects on foetal development:

Clear evidence of adverse effects on development, based onanimal experiments.

Test Type: Four-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials
Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Causes damage to organs (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) through prolonged or repeated exposure.
Components:
betamethasone:
Target Organs:

Assessment:

Disodium EDTA, dihydrate:
Exposure routes:
Target Organs:
Assessment:

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

inhalation (dust/mist/fume)Respiratory Tract
May cause damage to organs through prolonged or repeatedexposure.

Repeated dose toxicity
Components:
betamethasone:
Species
LOAEL::

Rabbit0.05 %
11 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

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

Disodium EDTA, dihydrate:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
500 mg/kg
Ingestion
13 Weeks

Species
LOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
0.03 mg/l
inhalation (dust/mist/fume)
4 Weeks
OECD Test Guideline 412

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

12 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
betamethasone:
Toxicity to daphnia and otheraquatic invertebrates
Toxicity to algae/aquaticplants:

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 (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

:

Disodium EDTA, dihydrate:
Toxicity to fish:

LC50 (Lepomis macrochirus (Bluegill sunfish)): > 100 mg/l
Exposure time: 96 h
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 140 mg/l
Exposure time: 48 h
Method: DIN 38412

Toxicity to algae/aquaticplants:

ErC50 (Pseudokirchneriella subcapitata (green algae)): > 100
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
13 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

EC10 (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

NOEC (Daphnia magna (Water flea)): 25 mg/l
Exposure time: 21 d
EC10 (activated sludge): > 500 mg/l
Exposure time: 30 min
Method: OECD Test Guideline 209

Persistence and degradability
Components:
Disodium EDTA, dihydrate:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 2 %Exposure time: 28 d
Method: OECD Test Guideline 301D

Bioaccumulative potential
Components:
betamethasone:
Partition coefficient: noctanol/water:

Disodium EDTA, dihydrate:
Bioaccumulation:

Partition coefficient: noctanol/water:log Pow: 2.11

Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): < 500
Remarks: Based on data from similar materials
log Pow: -4.3

Mobility in soil
No data available
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available

14 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)
9
III
9
yes

:
:
:
:

UN 3082
Environmentally hazardous substance, liquid, n.o.s.
(betamethasone)
9
III
Miscellaneous
964

:

964

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)
9III
9
F-A, S-F
yes

Class
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
Environmentally hazardous

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.

15 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

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:171

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Priority Assessment Chemical SubstanceChemical name
Sodium salt of 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid

Number268

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
Not applicable
Substances Subject to be Indicated Names
Not applicable
Substances Subject to be Indicated Names
Not applicable

16 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

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
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
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
Miscellaneous dangerous substances and articles (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Miscellaneous dangerous substances and articles (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

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
Industrial waste
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SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

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

not determined

IECSC

:

not determined:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

16. OTHER INFORMATION
Further information
Sources of key data used tocompile the Safety Data
Sheet

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

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 Sub18 / 19

SAFETY DATA SHEET

Betamethasone Sodium Phosphate Formulation
Version
5.0

Revision Date:
2024/04/06

SDS Number:
3960234-00012

Date of last issue: 2023/09/30
Date of first issue: 2019/01/29

stances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
JP / EN

19 / 19