SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:Betamethasone Liquid Formulation

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub: Pharmaceuticalstance/Mixture
Recommended restrictions
on use:Not applicable

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
30 Hudson Street, 33nd floor
07302 Jersey City, New Jersey, U.S.A
Telephone:+1-551-430-6000

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008)
Reproductive toxicity, Category 1B
H360D: May damage the unborn child.
Specific target organ toxicity - repeatedH372: Causes damage to organs through proexposure, Category 1
longed or repeated exposure.
Long-term (chronic) aquatic hazard, CatH410: Very toxic to aquatic life with long lastingegory 1effects.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

DangerHazard statements:

H360D May damage the unborn child.
1 / 21SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

H372 Causes damage to organs through prolonged or repeated exposure.
H410 Very toxic to aquatic life with long lasting effects.
Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P264 Wash skin thoroughly after handling.
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.

Hazardous components which must be listed on the label:betamethasone
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
Ecological information: The substance/mixture does not contain components considered to haveendocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
Toxicological information: The substance/mixture does not contain components considered tohave endocrine disrupting properties according to REACH Article 57(f) or Commission Delegatedregulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

SECTION 3: Composition/information on ingredients
3.2 Mixtures
Components
Chemical namebetamethasone

CAS-No.
EC-No.
Index-No.
Registration number
378-44-9
206-825-4

2 / 21

Classification

Concentration(% w/w)

Acute Tox. 2; H330
Repr. 1B; H360D
STOT RE 1; H372
(Pituitary gland,
Immune system,
muscle, thymus
gland, Blood, Adrenal gland)
Aquatic Chronic 1;>= 0,3 - < 1

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016
H410

M-Factor (Chronic
aquatic toxicity):
1.000
specific concentration limit
STOT RE 1; H372>= 0,01 %Repr. 1B; H360D>= 0,01 %Benzalkonium chloride

8001-54-5

Acute Tox. 3; H301
Acute Tox. 2; H330
Acute Tox. 3; H311
Skin Corr. 1; H314
Eye Dam. 1; H318
Aquatic Acute 1;
H400
Aquatic Chronic 2;
H411
EUH071>= 0,0025 - <0,025

M-Factor (Acuteaquatic toxicity):
100
Acute toxicity estimate
Acute oral toxicity:
240 mg/kg
Acute inhalation
toxicity (dust/mist):
0,0501 mg/l
Acute dermal toxicity: 704 mg/kg
For explanation of abbreviations see section 16.

SECTION 4: First aid measures
4.1 Description of first aid measures
General advice: In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.

3 / 21SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

Protection of first-aiders:

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).

If inhaled:

If inhaled, remove to fresh air.
Get medical attention.

In case of skin contact:

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.

In case of eye contact:

Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.

If swallowed:

If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.

4.2 Most important symptoms and effects, both acute and delayed
Risks: May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:

None known.

5.2 Special hazards arising from the substance or mixture
Specific hazards during fire- : Exposure to combustion products may be a hazard to health.
fighting
Hazardous combustion products:

No hazardous combustion products are known

4 / 21SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016:

In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
6.2 Environmental precautions
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.

6.3 Methods and material for containment and cleaning up
Methods for cleaning up: Soak up with inert absorbent material.
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.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handlingTechnical measures:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
5 / 21SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

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.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Keepareas and containers
tightly closed. Store in accordance with the particular national
regulations.
Advice on common storage

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

:

No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
Components
betamethasone

CAS-No.

Value type (Formof exposure)378-44-9
TWA
Further information: Skin
Wipe limit

6 / 21

Control parametersBasis

1 µg/m3 (OEB 4)Internal

10 µg/100 cm²Internal

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

8.2 Exposure controls
Engineering measures
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect 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 biosafety cabinet, 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
Eye/face protection: Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Skin and body protection::

Respiratory protection:

Consider double gloving.
Work uniform or laboratory coat.
Additional body garments should be used based upon the task
being performed (e.g., sleevelets, apron, gauntlets, disposable
suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to NS EN 143
Particulates type (P)Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: liquid
Colour:colourless

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flammability (solid, gas):

Not applicable
7 / 21SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Flash point:

No data available

Auto-ignition temperature:

No data available

Decomposition temperature:

No data available

pH:6,8 - 7,2

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

No data available

Relative density:

No data available

Density:

No data available

Relative vapour density:

No data available

Particle characteristics
Particle size:

Not applicable:Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Evaporation rate:

No data available

9.2 Other information
Explosives

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.

8 / 21SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

None known.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
Information on likely routes of : Inhalation
exposure
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:

LC50 (Rat): 0,4 mg/l
Exposure time: 4 h

Benzalkonium chloride:
Acute oral toxicity:

LD50 (Rat): 240 mg/kg

Acute inhalation toxicity:

LC50 (Rat, male): > 0,05 - 0,5 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403
9 / 21SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

Assessment: Corrosive to the respiratory tract.
Remarks: Based on data from similar materials
Acute dermal toxicity:

LD50 (Rat, female): 704 mg/kg

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

Benzalkonium chloride:
SpeciesResult::HumanCorrosive after 4 hours or less of exposure

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

Benzalkonium chloride:
SpeciesResult::RabbitIrreversible effects on the eye

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

Benzalkonium chloride:
Test Type
Exposure routes
Species:::

Human repeat insult patch test (HRIPT)
Skin contact
Humans
10 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

ResultSDS Number:
809716-00019:

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

negative

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

Germ cell mutagenicity- Assessment:

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

:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Benzalkonium chloride:
Genotoxicity in vitro

Test Type: In vitro mammalian cell gene mutation test
Method: OECD Test Guideline 476
Result: negative
Remarks: Based on data from similar materials
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
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
Remarks: Based on data from similar materials

Carcinogenicity
Not classified based on available information.

11 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

Components:
Benzalkonium chloride:
Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
Ingestion
2 Years
OECD Test Guideline 453
negative
Based on data from similar materials

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Skin contact
80 weeks
negative

Species
Application RouteExposure time
Result::::RabbitSkin contact
90 weeks
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:
betamethasone:
Effects on foetal development

Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0,42 mg/kg body weight
Result: Malformations were observed.
Species: Mouse
Application Route: Intramuscular
Developmental Toxicity: LOAEL: 1 mg/kg body weight
Result: Malformations were observed.
Reproductive toxicity - Assessment
Benzalkonium chloride:
Effects on fertility:

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

:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 416
Result: negative
Remarks: Based on data from similar materials

12 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

Effects on foetal development

SDS Number:
809716-00019:

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Ingestion
Method: OECD Test Guideline 414
Result: negative
Remarks: Based on data from similar materials

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Causes damage to organs through prolonged or repeated exposure.
Components:
betamethasone:
Target Organs:

Assessment:

Benzalkonium chloride:
Assessment:

No significant health effects observed in animals at concentrations of 100 mg/kg bw or less.

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

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

Repeated dose toxicity
Components:

13 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

Target Organs:

Blood, thymus gland, Adrenal gland

Benzalkonium chloride:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 100 mg/kg
Ingestion
12 WeeksAspiration toxicity
Not classified based on available information.
11.2 Information on other hazards
Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

Experience with human exposure
Components:
betamethasone:
Inhalation
Skin contact::

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

SECTION 12: Ecological information
12.1 Toxicity
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
14 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

Toxicity to fish (Chronic toxicity)

SDS Number:
809716-00019:

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

NOEC: 0,052 mg/l
Exposure time: 32 d
Species: Pimephales promelas (fathead minnow)
Method: OECD Test Guideline 210
NOEC: 0,07 µg/l
Exposure time: 219 dSpecies: Oryzias latipes (Japanese medaka)
Method: OECD Test Guideline 229

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

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

M-Factor (Chronic aquatic
toxicity)

:

1.000

:

LC50 (Pimephales promelas (fathead minnow)): 0,28 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 0,0056 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Chlorella pyrenoidosa (algae)): 0,09 mg/l
Exposure time: 72 h

M-Factor (Acute aquatic toxicity):

100

Toxicity to fish (Chronic toxicity):

NOEC: 0,032 mg/l
Exposure time: 34 dSpecies: Pimephales promelas (fathead minnow)

Benzalkonium chloride:
Toxicity to fish

12.2 Persistence and degradability
Components:
Benzalkonium chloride:
Biodegradability:

Result: Readily biodegradable.
Method: OECD Test Guideline 301D
Remarks: Based on data from similar materials:

log Pow: 2,1112.3 Bioaccumulative potential
Components:
betamethasone:
Partition coefficient: noctanol/water
Benzalkonium chloride:
15 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

Bioaccumulation:

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

Partition coefficient: noctanol/water:log Pow: 1,692
Remarks: Calculation

12.4 Mobility in soil
No data available
12.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.

12.6 Endocrine disrupting properties
Product:
Assessment:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
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 information
14.1 UN number or ID number
ADN:

UN 3082

ADR:

UN 3082

RID:

UN 3082

IMDG:

UN 3082
16 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

IATA

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016:

UN 3082ADN:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)

ADR:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)

RID:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)

IMDG

:

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,
N.O.S.
(betamethasone)

IATA

:

Environmentally hazardous substance, liquid, n.o.s.
(betamethasone)

14.2 UN proper shipping name14.3 Transport hazard class(es)
Class
ADN

:

9

ADR

:

9

RID

:

9

IMDG

:

9

IATA

:

9

ADN
Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

III
M6
90
9

ADR
Packing groupClassification CodeHazard Identification Number
LabelsTunnel restriction code

:
:
:
:
:

III
M6
90
9
(-)

RID
Packing groupClassification CodeHazard Identification Number
Labels

:
:
:
:

III
M6
90
9

IMDG
Packing group:

III

Subsidiary risks

14.4 Packing group17 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

LabelsEmS Code

SDS Number:
809716-00019::

9
F-A, S-F

:

964

:
:
:

Y964
III
Miscellaneous

:

964

:
:
:

Y964
III
Miscellaneous

ADN
Environmentally hazardous

:

yes

ADR
Environmentally hazardous

:

yes

RID
Environmentally hazardous

:

yes

IMDG
Marine pollutant:

yes

IATA (Passenger)
Environmentally hazardous:

yes

IATA (Cargo)
Environmentally hazardous:

yes

IATA (Cargo)
Packing instruction (cargo
aircraft)Packing instruction (LQ)
Packing group
LabelsIATA (Passenger)
Packing instruction (passenger aircraft)
Packing instruction (LQ)
Packing group
LabelsDate of last issue: 30.09.2023
Date of first issue: 15.07.2016

14.5 Environmental hazards

14.6 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.
14.7 Maritime transport in bulk according to IMO instruments
Remarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
REACH - Restrictions on the manufacture, placing on: Conditions of restriction for the folthe market and use of certain dangerous substances,lowing entries should be considered:mixtures and articles (Annex XVII)
Number on list 75, 3
Substance(s) or mixture(s) are listed
here according to their appearance
in the regulation, irrespective of their
18 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016
use/purpose or the conditions of therestriction. Please refer to the conditions in corresponding Regulation todetermine whether an entry is applicable to the placing on the market ornot.
If you intend to use this product astattoo ink, please contact your vendor.

REACH - Candidate List of Substances of Very High: Not applicable
Concern for Authorisation (Article 59).
REACH - List of substances subject to authorisation: Not applicable(Annex XIV)
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
Regulation (EU) 2019/1021 on persistent organic pollu: Not applicabletants (recast)
Regulation (EU) No 649/2012 of the European Parlia: Not applicablement and the Council concerning the export and importof dangerous chemicals
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control ofmajor-accident hazards involving dangerous substances.
Quantity 1
Quantity 2
E1
ENVIRONMENTAL
100 t
200 t
HAZARDS
Other regulations:
Note the Working Environment Act § 4-1 and § 4-2 on requirements for the employer to protect
pregnant employees against discomfort and injury as a result of the work situation and theworking environment.
Note the regulation on organization, leadership and participation, chapter 12 on the work ofchildren and young people.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined15.2 Chemical safety assessment
A Chemical Safety Assessment has not been carried out.

SECTION 16: Other information
Other information:

Items where changes have been made to the previous version
are highlighted in the body of this document by two verticallines.

19 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Full text of H-Statements
H301
H311
H314
H318
H330
H360D
H372

:
:
:
:
:
:
:

H400
H410
H411
EUH071::::

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016

Toxic if swallowed.
Toxic in contact with skin.
Causes severe skin burns and eye damage.
Causes serious eye damage.
Fatal if inhaled.
May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
Very toxic to aquatic life.
Very toxic to aquatic life with long lasting effects.
Toxic to aquatic life with long lasting effects.
Corrosive to the respiratory tract.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Aquatic Acute: Short-term (acute) aquatic hazard
Aquatic Chronic: Long-term (chronic) aquatic hazard
Eye Dam.
: Serious eye damage
Repr.
: Reproductive toxicity
Skin Corr.
: Skin corrosion
STOT RE: Specific target organ toxicity - repeated exposure
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; 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; 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 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; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; 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; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of very high concern; TCSI - Taiwan Chemical Substance Inventory; TECI Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN
20 / 21

SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006, as amended byCommission Regulation (EU) 2020/878

Betamethasone Liquid Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
809716-00019

Date of last issue: 30.09.2023
Date of first issue: 15.07.2016- United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous
Goods; vPvB - Very Persistent and Very Bioaccumulative
Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

Classification of the mixture:

Classification procedure:

Repr. 1B

H360D

Calculation method

STOT RE 1

H372

Calculation method

Aquatic Chronic 1

H410

Calculation method

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 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.
NO / EN

21 / 21