SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

SECTION 1. IDENTIFICATION
Product name:Betamethasone Injection Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: 30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302
Telephone: 1-551-430-6000
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Reproductive toxicity: Category 1BSpecific target organ toxicity- repeated exposure:

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

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

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.

Precautionary Statements:

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 vapors.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical attention.
1 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
Polyethylene glycol
25322-68-3
Benzyl alcohol
100-51-6
Betamethasone
378-44-9
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 1 - < 5>= 0.1 - < 1>= 0.1 - < 1

SECTION 4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayedProtection 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 soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
Flush eyes with water as a precaution.
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.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
2 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

Carbon dioxide (CO2)
Dry chemical
None known.

:

Exposure to combustion products may be a hazard to health.

:

Carbon oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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

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

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

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Prevent spreading over a wide area (e.g., by containment or
oil barriers).
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Soak up with inert absorbent material.
For large spills, provide diking or other appropriate
containment to keep material from spreading. If diked material
can be pumped, store recovered material in appropriate
container.
Clean up remaining materials from spill with suitable
absorbent.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
3 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Do not get on skin or clothing.
Do not breathe mist or vapors.
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.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

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

CAS-No.

Value type
(Form ofexposure)
25322-68-3
TWA (aerosol)
100-51-6
TWA
378-44-9
TWA
Further information: Skin
Wipe limit

Polyethylene glycol
Benzyl alcohol
Betamethasone

Engineering measures:

Control parameters / Permissible
concentration
10 mg/m³

Basis

10 ppm
1 µg/m3 (OEB 4)US WEELInternal

10 µg/100 cm²Internal

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

Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) and4 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

use NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Hygiene measures:

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.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

liquidColor:

No data available

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

No data available

5 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

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.

Particle characteristics
Particle size:

Not applicable

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

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

:::

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

6 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

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

Acute toxicity estimate: 57.14 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Calculation method

Polyethylene glycol:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 423
Remarks: Based on data from similar materials

Acute dermal toxicity:

LD50 (Rat): > 2,000 mg/kg
Remarks: Based on data from similar materials

Benzyl alcohol:
Acute oral toxicity:

LD50 (Rat): 1,620 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 4.178 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403

Betamethasone:
Acute oral toxicity:

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

Components:

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:
Polyethylene glycol:
Species
Method::RabbitOECD Test Guideline 404
7 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

ResultRemarks::

No skin irritation
Based on data from similar materials

Benzyl alcohol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Betamethasone:
SpeciesResult::RabbitMild skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Polyethylene glycol:
SpeciesResult
MethodRemarks::::

RabbitNo eye irritation
OECD Test Guideline 405
Based on data from similar materials

Benzyl alcohol:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

Betamethasone:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Polyethylene glycol:
Test Type
Routes of exposure
SpeciesResultRemarks:::::

Maximization Test
Skin contact
Guinea pig
negative
Based on data from similar materials

8 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Benzyl alcohol:
Test Type
Routes of exposure
Species
MethodResult:::::Maximization Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative

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

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

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Based on data from similar materials

Benzyl alcohol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
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.

9 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Carcinogenicity
Not classified based on available information.
Components:
Benzyl alcohol:
Species
Application RouteExposure time
MethodResult

:
:
:
:
:

Mouse
Ingestion
103 weeks
OECD Test Guideline 451
negative

IARC

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.

OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as a known or anticipated carcinogen by NTP.

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

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Effects on fetal development:

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

Betamethasone:
Effects on fetal development:

Species: Rabbit
Application Route: Intramuscular
Developmental Toxicity: LOAEL: 0.05 mg/kg body weight
Result: Fetotoxicity., Malformations were observed.
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.42 mg/kg body weight
Result: Malformations were observed.
Species: Mouse
Application Route: Intramuscular
Developmental Toxicity: LOAEL: 1 mg/kg body weight
Result: Malformations were observed.
10 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

Reproductive toxicity - Assessment

SDS Number:
1267898-00018:

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

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

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Causes damage to organs (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) through prolonged or repeated exposure.
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:
Benzyl alcohol:
Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
1.072 mg/l
inhalation (dust/mist/fume)
28 Days
OECD Test Guideline 412

Betamethasone:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

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

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.05 %
Skin contact
8 Weeks
thymus glandSpecies
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

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

:
:
:
:

Dog
0.05 mg/kg
Oral
28 d
11 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

Target Organs

SDS Number:
1267898-00018:

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Blood, thymus gland, Adrenal gland

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Betamethasone:
Inhalation
Skin contact::

Target Organs: Adrenal gland
Symptoms: Redness, pruritis, Irritation

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Polyethylene glycol:
Toxicity to fish:

LC50 (Poecilia reticulata (guppy)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials

Benzyl alcohol:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): 460 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 230 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 770
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 310
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

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

NOEC (Daphnia magna (Water flea)): 51 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Betamethasone:
Toxicity to daphnia and otheraquatic invertebrates:

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

Toxicity to algae/aquatic:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 34
12 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

plantsDate of last issue: 09/30/2023
Date of first issue: 02/12/2017

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

Persistence and degradability
Components:
Polyethylene glycol:
Biodegradability:

Result: rapidly degradable
Remarks: Based on data from similar materials

Benzyl alcohol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 92 - 96 %Exposure time: 14 d

Polyethylene glycol:
Partition coefficient: noctanol/water:log Pow: < 3

Benzyl alcohol:
Partition coefficient: noctanol/water:log Pow: 1.05

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

Bioaccumulative potential
Components:

13 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

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

Contaminated packaging:

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

SECTION 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

14 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
UN/ID/NA number
Proper shipping name

:
:

Class
Packing group
LabelsERG Code
Marine pollutant
Remarks

:
:
:
:
:
:

UN 3082
Environmentally hazardous substance, liquid, n.o.s.
(Betamethasone)
9
III
CLASS 9171
yes(Betamethasone)
Above applies only to containers over 119 gallons or 450
liters.
Shipment by ground under DOT is non-regulated; however it
may be shipped per the applicable hazard classification tofacilitate multi-modal transport involving ICAO (IATA) or IMO.

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, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
Listed substances in the product are at low enough levels to not be expected to exceed the RQ
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

SARA 313:

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
Water
Disodium hydrogenorthophosphate7732-18-5
7558-79-4

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

not determined
15 / 17

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

IECSC

:

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

not determined

SECTION 16. OTHER INFORMATION
Further information
NFPA 704:

HMIS® IV:
Flammability

HEALTH1
Health00Special hazard*

3

FLAMMABILITY

1

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
US WEEL: USA. Workplace Environmental Exposure Levels (WEEL)US WEEL / TWA: 8-hr TWA
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Betamethasone Injection Formulation
Version
6.0

Revision Date:
04/06/2024

SDS Number:
1267898-00018

Date of last issue: 09/30/2023
Date of first issue: 02/12/2017

Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

04/06/2024

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release andshall not be considered a warranty or quality specification of any type. The information provided
relates only to the specific material identified at the top of this SDS and may not be valid when the
SDS material is used in combination with any other materials or in any process, unless specified
in the text. Material users should review the information and recommendations in the specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
US / Z8

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