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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier
Trade name:

Mometasone Metered Dose Inhaler 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)
Aerosols, Category 3
H229: Pressurised container: May burst if heated.
Long-term (chronic) aquatic hazard, CatH411: Toxic to aquatic life with long lasting effects.
egory 22.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

Warning

Hazard statements

:

H229

Pressurised container: May burst if heated.
1 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

Precautionary statements:

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

H411

Toxic to aquatic life with long lasting effects.

Prevention:
P210
Keep away from heat, hot surfaces, sparks, open
flames and other ignition sources. No smoking.
P251
Do not pierce or burn, even after use.
P273
Avoid release to the environment.
Response:
P391
Collect spillage.
Storage:
P410 + P412 Protect from sunlight. Do not expose to temperatures exceeding 50 °C/ 122 °F.

Additional Labelling
Contains fluorinated greenhouse gases. (HFC-227ea)
2.5 % by mass of the contents are flammable.
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.
May displace oxygen and cause rapid suffocation.

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

Ethanol#

CAS-No.
EC-No.
Index-No.
Registration number
64-17-5
200-578-6
603-002-00-5

Classification

Concentration(% w/w)

Flam. Liq. 2; H225
Eye Irrit. 2; H319>= 1.8 - <= 2.5

specific concentration
limit
Eye Irrit. 2; H319>= 50 %
2 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Mometasone

83919-23-7

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

Repr. 1B; H360Df
STOT RE 2; H373
(Immune system,
Liver, Kidney, Skin)
Aquatic Chronic 1;
H410>= 0.08 - <=0.18

M-Factor (Chronic
aquatic toxicity): 100
For explanation of abbreviations see section 16.
# Voluntarily-disclosed substance

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.
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.
If not breathing, give artificial respiration.
If breathing is difficult, give oxygen.
Get medical attention immediately.

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: Gas reduces oxygen available for breathing.

3 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

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
If the temperature rises there is danger of the vessels bursting
due to the high vapor pressure.
Hazardous combustion products
5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods:

Carbon oxides
Fluorine compounds:

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: Evacuate personnel to safe areas.
Ventilate the area.
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).
4 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

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:
Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe vapours or spray mist.
Do not swallow.
Avoid contact with eyes.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
Keep away from heat, hot surfaces, sparks, open flames andother ignition sources. No smoking.
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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep tightly closed. Keep in a cool, well-ventilated place.
areas and containers
Store in accordance with the particular national regulations.
Do not pierce or burn, even after use. Keep cool. Protect fromsunlight.
5 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Advice on common storage

7.3 Specific end use(s)Specific use(s)Date of last issue: 26.09.2023
Date of first issue: 28.10.2014:

Do not store with the following product types:
Self-reactive substances and mixtures
Organic peroxides
Oxidizing agents
Flammable solids
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures, which in contact with water, emit
flammable gases
Explosives
Gases

:

No data available
No data available

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

CAS-No.

Value type (Formof exposure)64-17-5
OELV - 15 min(STEL)
83919-23-7
TWA
Further information: Skin
Wipe limit

Control parameters

Basis

1,000 ppm

IE OEL

1 µg/m3 (OEB 4)Internal

10 µg/100 cm²Internal

Derived No Effect Level (DNEL) according to Regulation (EC) No. 1907/2006:
Substance name

End UseExposure routes

EthanolWorkers

Inhalation

Workers

Skin contact

Consumers

Inhalation

Consumers

Skin contact

Consumers

Ingestion

Workers

Inhalation

Consumers

Inhalation

1,1,1,2,3,3,3Heptafluoropropane

6 / 22

Potential health effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemic
effects
Long-term systemicValue
950 mg/m3
343 mg/kg
bw/day114 mg/m3
206 mg/kg
bw/day87 mg/kg
bw/day61279 mg/m3
6533 mg/m3

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014
effects

Predicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:
Substance name
Ethanol

Environmental Compartment
Fresh water
Freshwater - intermittent
Marine water
Sewage treatment plant
Fresh water sediment
Marine sedimentSoil

1,1,1,2,3,3,3-Heptafluoropropane

Oral (Secondary Poisoning)
Fresh waterIntermittent use/release
Sewage treatment plant
Fresh water sediment

Value
0.96 mg/l
2.75 mg/l
0.79 mg/l
580 mg/l
3.6 mg/kg dryweight (d.w.)
2.9 mg/kg dryweight (d.w.)
0.63 mg/kg dryweight (d.w.)
380 mg/kg food
0.1 mg/l
1 mg/l1.73 mg/l
1.3 mg/kg

8.2 Exposure controls
Personal protective equipment
Skin and body protection: Skin should be washed after contact.
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to I.S. EN 137
Filter type
: Self-contained breathing apparatus

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: Aerosol containing a dissolved gas
Colour:white to off-white

Odour

:

odourlessOdour Threshold:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

-16 °C

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Upper explosion limit / Upper:

No data available
7 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

flammability limit

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:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

insoluble

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Relative density:

No data available

Density:

1 g/cm³

Relative vapour density:

No data available

Particle characteristics
Particle size:

No data available:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Evaporation rate:

No data available

Molecular weight:

No data available

9.2 Other information
Explosives

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
8 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: If the temperature rises there is danger of the vessels bursting
due to the high vapor pressure.
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.
Components:
Ethanol:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Method: OECD Test Guideline 401

Acute inhalation toxicity:

LC50 (Rat): 124.7 mg/l
Exposure time: 4 h
Test atmosphere: vapour

Mometasone:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
LD50 (Mouse): > 2,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 3.3 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Remarks: No mortality observed at this dose.
LC50 (Mouse): > 3.2 mg/l
9 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

Exposure time: 4 h
Test atmosphere: dust/mist
Acute toxicity (other routes of :administration)

LD50 (Rat): 300 mg/kg
Application Route: Subcutaneous
Symptoms: Breathing difficulties

Skin corrosion/irritation
Not classified based on available information.
Components:
Ethanol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Mometasone:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Ethanol:
Species
MethodResult:::RabbitOECD Test Guideline 405
Irritation to eyes, reversing within 21 days

Mometasone:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Ethanol:
Test Type
Exposure routes
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative
10 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

Mometasone:
Test Type
Exposure routes
Species
Assessment
ResultRemarks

SDS Number:
25990-00024

:
:
:
:
:
:

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

Maximisation Test
DermalGuinea pig
Does not cause skin sensitisation.
negative
The results of a test on guinea pigs showed this substance tobe a weak skin sensitiser.

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

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Genotoxicity in vivo:

Test Type: Rodent dominant lethal test (germ cell) (in vivo)
Species: Mouse
Application Route: Ingestion
Result: equivocal

Mometasone:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosomal aberration
Test system: Chinese hamster lung cells
Result: negative
Test Type: Chromosomal aberration
Test system: Chinese hamster ovary cells
Result: positive
Test Type: Mouse Lymphoma
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Application Route: Oral
Result: negative
Test Type: Chromosomal aberration
Species: Rat
Cell type: Bone marrow
11 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

Result: negative
Test Type: unscheduled DNA synthesis assay
Species: Rat
Cell type: Liver cells
Result: negative
Germ cell mutagenicity- Assessment:

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

Carcinogenicity
Not classified based on available information.
Components:
Mometasone:
Species
Application RouteExposure time
Dose
Result

:
:
:
:
:

Rat
Inhalation
2 Years
0.067 mg/kg body weight
negative

Species
Application RouteExposure time
Dose
Result

:
:
:
:
:

Mouse
Inhalation
19 Months
0.160 mg/kg body weight
negative

Reproductive toxicity
Not classified based on available information.
Components:
Ethanol:
Effects on fertility:

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

Mometasone:
Effects on fertility:

Test Type: Fertility
Species: Rat
Application Route: Subcutaneous
Fertility: NOAEL: 0.015 mg/kg body weight
Symptoms: Reduced embryonic survival, Reduced foetal
weightResult: No effects on fertility, Effect on reproduction capacity:

Test Type: Embryo-foetal development
Species: Mouse

Effects on foetal development

12 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

Application Route: Subcutaneous
Embryo-foetal toxicity: LOAEL: 0.06 mg/kg body weight
Result: Embryotoxic effects., Teratogenicity and developmental toxicity
Test Type: Embryo-foetal development
Species: Rat
Application Route: Dermal
Embryo-foetal toxicity: LOAEL: 0.3 mg/kg body weight
Result: Embryo-foetal toxicity
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Dermal
Embryo-foetal toxicity: LOAEL: 0.15 mg/kg body weight
Result: Embryo-foetal toxicity, Malformations were observed.
Test Type: Embryo-foetal development
Species: Rat
Application Route: Subcutaneous
Embryo-foetal toxicity: LOAEL: 0.15 mg/kg body weight
Result: Effects on newborn
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Embryo-foetal toxicity: LOAEL: 0.7 mg/kg body weight
Result: Embryo-foetal toxicity, Malformations were observed.
Reproductive toxicity - Assessment:

Clear evidence of adverse effects on development, based onanimal experiments., Some evidence of adverse effects on
sexual function and fertility, based on animal experiments.

STOT - single exposure
Not classified based on available information.
Components:
Mometasone:
Remarks:

Based on available data, the classification criteria are not met.

STOT - repeated exposure
Not classified based on available information.
Components:
Mometasone:
Exposure routes
Target Organs
Assessment:::

inhalation (dust/mist/fume)
Immune system, Liver, Kidney, Skin
May cause damage to organs through prolonged or repeatedexposure.
13 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

Repeated dose toxicity
Components:
Ethanol:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
1,280 mg/kg
3,156 mg/kg
Ingestion
90 Days

Mometasone:
Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
0.005 mg/kg
0.3 mg/kg
Oral
30 d
Lymph nodes, Liver, Adrenal gland, Skin, thymus glandSpecies
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.5 mg/kg
Oral
30 d
Lymph nodes, Liver, Adrenal gland, Skin, thymus glandSpecies
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.00013 mg/l
inhalation (dust/mist/fume)
90 dAdrenal gland, Lungs, Lymph nodes, spleen, Bone marrow,
Kidney, Liver, thymus glandSpecies
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.0005 mg/l
inhalation (dust/mist/fume)
90 dAdrenal gland, Lungs, Lymph nodes, spleen, Bone marrow,
Kidney, thymus gland, Liver

Aspiration toxicity
Not classified based on available information.
Components:
Mometasone:
Not applicable

14 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

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:
Mometasone:
Inhalation:

Skin contact:

Symptoms: allergic rhinitis, Headache, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, Back pain,
musculoskeletal pain, immune system effects, indigestion
Symptoms: Dermatitis, Itching:

Dermal absorption possible

Further information
Components:
Mometasone:
Remarks

SECTION 12: Ecological information
12.1 Toxicity
Components:
Ethanol:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 1,000 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia (water flea)): > 1,000 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Chlorella vulgaris (Fresh water algae)): 275 mg/l
Exposure time: 72 h
EC10 (Chlorella vulgaris (Fresh water algae)): 11.5 mg/l
Exposure time: 72 h

Toxicity to microorganisms:

EC50 (Pseudomonas putida): 6,500 mg/l
Exposure time: 16 h

Toxicity to daphnia and other:

NOEC: 9.6 mg/l
15 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

aquatic invertebrates (Chronic toxicity)
Mometasone:
Toxicity to fish

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

Exposure time: 9 dSpecies: Daphnia magna (Water flea):

LC50 (Menidia beryllina (Silverside)): 0.11 mg/l
Exposure time: 96 h
Remarks: No toxicity at the limit of solubility
LC50 (Cyprinodon variegatus (sheepshead minnow)): > 5 mg/l
Exposure time: 7 dRemarks: No toxicity at the limit of solubility

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 5 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility
EC50 (Americamysis): > 5 mg/l
Exposure time: 96 h
Method: US-EPA OPPTS 850.1035
Remarks: No toxicity at the limit of solubility

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 3.2
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility

Toxicity to microorganisms:

EC50 : > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility
NOEC : 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
Remarks: No toxicity at the limit of solubility

Toxicity to fish (Chronic toxicity):

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

NOEC: 0.00014 mg/l
Exposure time: 32 d
Species: Pimephales promelas (fathead minnow)
Method: OECD Test Guideline 210
NOEC: 0.34 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility

16 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

M-Factor (Chronic aquatic
toxicity)

SDS Number:
25990-00024:

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

100

12.2 Persistence and degradability
Components:
Ethanol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 84 %Exposure time: 20 d

Mometasone:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 50 %Exposure time: 28 d
Method: OECD Test Guideline 314

Stability in water:

Hydrolysis: 50 %(12 d)
Method: OECD Test Guideline 111:

log Pow: -0.35:

Species: Lepomis macrochirus (Bluegill sunfish)
Bioconcentration factor (BCF): 107.1
Method: OECD Test Guideline 305:

log Pow: 4.68:

log Koc: 4.02

12.3 Bioaccumulative potential
Components:
Ethanol:
Partition coefficient: noctanol/water
Mometasone:
Bioaccumulation

Partition coefficient: noctanol/water
12.4 Mobility in soil
Components:
Mometasone:
Distribution among environmental compartments

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.
17 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

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.

12.7 Other adverse effects
Global warming potential
Regulation (EU) No 517/2014 on fluorinated greenhouse gases
Product:
100-year global warming potential: 3,159

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.
Please ensure aerosol cans are sprayed completely empty(including propellant)
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 1950

ADR:

UN 1950

RID:

UN 1950

IMDG:

UN 1950

IATA:

UN 1950ADN:AEROSOLSADR:AEROSOLSRID:AEROSOLS

14.2 UN proper shipping name18 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

IMDG

:

AEROSOLS(Mometasone)

IATA

:

Aerosols, non-flammable

14.3 Transport hazard class(es)Class

Subsidiary risks

ADN

:

2

2.2

ADR

:

2

2.2

RID

:

2

2.2

IMDG

:

2.2

IATA

:

2.2

ADN
Packing groupClassification CodeLabels:::Not assigned by regulation
5A
2.2

ADR
Packing groupClassification CodeLabelsTunnel restriction code

:
:
:
:

Not assigned by regulation
5A
2.2
(E)

RID
Packing groupClassification CodeHazard Identification Number
Labels::::Not assigned by regulation
5A
20
2.2

IMDG
Packing group
LabelsEmS Code:::

Not assigned by regulation
2.2
F-D, S-U

:

203

:
:
:

Y203
Not assigned by regulation
Non-flammable, non-toxic Gas

:

203

:
:
:

Y203
Not assigned by regulation
Non-flammable, non-toxic Gas

14.4 Packing group

IATA (Cargo)
Packing instruction (cargo
aircraft)Packing instruction (LQ)
Packing group
LabelsIATA (Passenger)
Packing instruction (passenger aircraft)
Packing instruction (LQ)
Packing group
Labels
14.5 Environmental hazards

19 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

ADN
Environmentally hazardous

:

yes

ADR
Environmentally hazardous

:

yes

RID
Environmentally hazardous

:

yes

IMDG
Marine pollutant:

yes

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

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: Not applicablethe market and use of certain dangerous substances,mixtures and articles (Annex XVII)REACH - Candidate List of Substances of Very High: Not applicable
Concern for Authorisation (Article 59).
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
REACH - List of substances subject to authorisation: Not applicable(Annex XIV)
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
E2
ENVIRONMENTAL
200 t
500 t
HAZARDS
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined
20 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

15.2 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.

Full text of H-Statements
H225
H319
H360Df

:
:
:

H373

:

H410

:

Highly flammable liquid and vapour.
Causes serious eye irritation.
May damage the unborn child. Suspected of damaging fertility.
May cause damage to organs through prolonged or repeatedexposure if inhaled.
Very toxic to aquatic life with long lasting effects.

Full text of other abbreviations
Aquatic Chronic: Long-term (chronic) aquatic hazard
Eye Irrit.
: Eye irritation
Flam. Liq.
: Flammable liquids
Repr.
: Reproductive toxicity
STOT RE: Specific target organ toxicity - repeated exposure
IE OEL: Ireland. List of Chemical Agents and Carcinogens with Occupational Exposure Limit Values - Code of Practice, Schedule 1
and 2
IE OEL / OELV - 15 min: Occupational exposure limit value (15-minute reference peri(STEL)od)
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;
21 / 22

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

Mometasone Metered Dose Inhaler Formulation
Version
1.23

Revision Date:
06.04.2024

SDS Number:
25990-00024

Date of last issue: 26.09.2023
Date of first issue: 28.10.2014

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; TRGS - Technical Rule for Hazardous Substances; TSCA
- Toxic Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent andVery 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:

Aerosol 3

H229

Based on product data or assessment

Aquatic Chronic 2

H411

Calculation method

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.
IE / EN

22 / 22