SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Section 1: Identification
Product identifier:

Mometasone / Formoterol Metered Dose Inhaler Formulation

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
Manufacturer or supplier's details
Company: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

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

E-mail address

EHSSTEWARD@organon.com:

Section 2: Hazard identification
Classification of the substance or mixture
Aerosols: Category 3
Long-term (chronic) aquatic
hazard:Category 2

GHS Label elements, including precautionary statements
Hazard pictograms:

Signal word:

Warning

Hazard statements:

H229 Pressurised container: May burst if heated.
H411 Toxic to aquatic life with long lasting effects.

Precautionary statements:

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.
1 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Response:
P391 Collect spillage.
Storage:
P410 + P412 Protect from sunlight. Do not expose to temperatures exceeding 50 °C/ 122 °F.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
Other hazards which do not result in classification
May displace oxygen and cause rapid suffocation.
Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical name
Ethanol#
Mometasone
Formoterol# Voluntarily-disclosed substance

CAS-No.
64-17-5
83919-23-7
43229-80-7

Concentration (% w/w)
1.8>= 0.087 -<= 0.17>= 0.0009 -<= 0.0087

Section 4: First-aid measures
Description of necessary 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.
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.

2 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Most important symptoms and effects, both acute and delayed
Risks: Gas reduces oxygen available for breathing.
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).
Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.
Section 5: Fire-fighting measures
Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

:

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

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:

Fluorine compounds
Carbon oxides

Special protective actions for fire-fighters
Special protective equipment : In the event of fire, wear self-contained breathing apparatus.
for firefighters
Use personal protective equipment.
Specific extinguishing meth- : Use extinguishing measures that are appropriate to local cirods
cumstances 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
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).
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 oil
3 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

barriers).
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.
Methods and materials 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.
Section 7: Handling and storage
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.

Conditions for safe storage, including any incompatibilities
Conditions for safe storage: Keep tightly closed.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
Do not pierce or burn, even after use.
Keep cool. Protect from sunlight.
4 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

Materials to avoid

SDS Number:
75390-00023:

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Do not store with the following product types:
Strong oxidizing agents

Section 8: Exposure controls/personal protection
Control parameters
Occupational Exposure Limits
Components

CAS-No.

Value type
(Form ofexposure)
64-17-5
PEL (long
term)
STEL
83919-23-7
TWA
Further information: Skin
Wipe limit
43229-80-7
TWA

Ethanol

Mometasone

Formoterol

Wipe limit

Control parameters / Permissible
concentration
1,000 ppm
1,880 mg/m3
1,000 ppm
1 µg/m3 (OEB 4)Basis

10 µg/100 cm²
0.05 µg/m3 (OEB5)
0.5 µg/100 cm²Internal
Internal

SG OELACGIHInternal

Internal

Individual protection measures, such as personal protective equipment (PPE)Skin 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.
Filter type
: Self-contained breathing apparatus
Section 9: Physical and chemical properties
Appearance:

aerosol

Colour:white to off-white

Odour

:

No data available

Odour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

-16.5 °C

Flash point:

No data available

5 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

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

Vapour pressure:

3,900 hPa (20 °C)

Relative vapour density:

5.9

Relative density:

5.9

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition 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.

Molecular weight:

No data available

Particle characteristics
Particle size:

No data available:::

Not classified as a reactivity hazard.
Stable under normal conditions.
If the temperature rises there is danger of the vessels bursting
due to the high vapor pressure.
Can react with strong oxidizing agents.

Section 10: Stability and reactivity
Reactivity
Chemical stability
Possibility of hazardous reactions

6 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

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

Section 11: Toxicological information
Information on likely routes of :exposure

Inhalation
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
Exposure time: 4 h
Test atmosphere: dust/mist

Acute toxicity (other routes of :administration)

Formoterol:
Acute oral toxicity:

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

LD50 (Rat): 3,130 mg/kg
LD50 (Mouse): 6,700 mg/kg

Acute inhalation toxicity:

LC50 (Rat): 1.5 mg/l
7 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Exposure time: 4 h
Test atmosphere: dust/mist
Acute dermal toxicity:

Acute toxicity (other routes of :administration)

Remarks: No data available
LD50 (Rat): 1,000 mg/kg
Application Route: Subcutaneous
LD50 (Mouse): 640 mg/kg
Application Route: Subcutaneous

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

Formoterol:
SpeciesResultRemarks:::

RabbitNo skin irritationslight irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Ethanol:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

Mometasone:
SpeciesResult::RabbitNo eye irritation

Formoterol:
SpeciesResult::RabbitNo eye irritation
8 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

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

Mometasone:
Test Type
Exposure routes
Species
Assessment
ResultRemarks

:
:
:
:
:
:

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.

Formoterol:
Test Type
Exposure routes
SpeciesResult::::Maximisation Test
DermalGuinea pig
Not a skin sensitizer.

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

9 / 21SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

Mometasone:
Genotoxicity in vitro

SDS Number:
75390-00023:

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

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
Result: negative
Test Type: unscheduled DNA synthesis assay
Species: Rat
Cell type: Liver cells
Result: negative

Germ cell mutagenicity Assessment
Formoterol:
Genotoxicity in vitro:

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

:

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Chromosomal aberration
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Application Route: Oral
Result: negative
Test Type: Micronucleus test
10 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Species: Rat
Application Route: Oral
Result: negative
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

Formoterol:
Species
Application RouteExposure time
LOAEL
Target Organs
Remarks

:
:
:
:
:
:

Rat
Oral
2 Years
0.5 mg/kg body weight
Ovary
The mechanism or mode of action may not be relevant in humans.

Species
Application RouteExposure time
LOAEL
Target Organs
Remarks

:
:
:
:
:
:

Mouse
Oral
18 month(s)2 mg/kg body weight
Adrenal gland, Liver, Uterus (including cervix)
The mechanism or mode of action may not be relevant in humans.

Carcinogenicity - Assessment:

Limited evidence of carcinogenicity in animal studies

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
11 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Result: negative
Mometasone:
Effects on fertility

Effects on foetal development:

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
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

Formoterol:
Effects on fertility:

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

:

Test Type: Fertility/early embryonic development
Species: Rat
12 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Application Route: Oral
Fertility: NOAEL: 3 mg/kg body weight
Result: No effects on fertility
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 0.2 mg/kg body weight
Result: Embryo-foetal toxicity, No malformations were observed.
Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 3 mg/kg body weight
Result: Malformations were observed.
Test Type: Embryo-foetal development
Species: Rat
Application Route: inhalation (dust/mist/fume)Developmental Toxicity: NOAEL: 1.2 mg/kg body weight
Result: No embryo-foetal toxicity
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 60 mg/kg body weight
Result: Embryo-foetal toxicity, No malformations were observed.

Reproductive toxicity - Assessment:

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

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

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

Formoterol:
Exposure routes
Target Organs
Assessment:::

Ingestion, inhalation (dust/mist/fume)Cardio-vascular system, Central nervous system
Causes damage to organs.

STOT - repeated exposure
Not classified based on available information.

13 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

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.

Formoterol:
Exposure routes
Target Organs
Assessment:::

Ingestion, inhalation (dust/mist/fume)
Heart
Causes damage to organs through prolonged or repeatedexposure.

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 Route

:
:
:

Dog
0.0005 mg/l
inhalation (dust/mist/fume)

Repeated dose toxicity
Components:

14 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Exposure timeTarget Organs

:
:

90 d
Adrenal gland, Lungs, Lymph nodes, spleen, Bone marrow,
Kidney, thymus gland, Liver

Formoterol:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
>= 1.5 mg/kg
Inhalation
13 Weeks
Heart

Species
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.14 mg/kg
Inhalation
13 Weeks
Heart

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.003 mg/kg
Oral
1 yr
Heart

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
0.3 mg/kg
Oral
1 yr
Heart

Aspiration toxicity
Not classified based on available information.
Components:
Mometasone:
Not applicable
Experience with human exposure
Components:
Mometasone:
Inhalation:

Skin contact:

Formoterol:
Inhalation:

Symptoms: allergic rhinitis, Headache, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, Back pain,
musculoskeletal pain, immune system effects, indigestion
Symptoms: Dermatitis, Itching
Target Organs: Heart
Symptoms: Palpitation, Tremors, Dizziness, Headache, dry
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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

mouth, Nausea, Fatigue
Further information
Components:
Mometasone:
Remarks:

Dermal absorption possible

Section 12: Ecological information
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 daphnia and other :aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

Mometasone:
Toxicity to fish:

NOEC (Daphnia magna (Water flea)): 9.6 mg/l
Exposure time: 9 d
EC50 (Pseudomonas putida): 6,500 mg/l
Exposure time: 16 h

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
16 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

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 fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 0.00014
mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210

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

NOEC (Daphnia magna (Water flea)): 0.34 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211
Remarks: No toxicity at the limit of solubility

M-Factor (Chronic aquatic
toxicity)
Toxicity to microorganisms

:

100

:

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

Formoterol:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 120 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 114 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): 94 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 30
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
17 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

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 Pow: 0.41:

log Koc: 4.02

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

Partition coefficient: noctanol/water
Formoterol:
Partition coefficient: noctanol/water
Mobility in soil
Components:
Mometasone:
Distribution among environmental compartments
Other adverse effects
No data available

18 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Section 13: Disposal considerations
Disposal methods
Waste from residues:

Contaminated packaging:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
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
International Regulations
UNRTDGUN numberUN proper shipping name
Transport hazard class(es)Packing group
LabelsEnvironmental hazards

:
:
:
:
:
:

UN 1950
AEROSOLS
2.2
Not assigned by regulation
2.2
no

:
:
:
:
:
:

UN 1950
Aerosols, non-flammable
2.2
Not assigned by regulation
Non-flammable, non-toxic Gas
203

:

203

IMDG-CodeUN number
Proper shipping name::

Transport hazard class(es)Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 1950
AEROSOLS(Mometasone)
2.2
Not assigned by regulation
2.2
F-D, S-U
yes

IATA-DGR
UN/ID No.
UN proper shipping name
Transport hazard class(es)Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

Transport in bulk according to IMO instruments
Not applicable for product as supplied.
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

19 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
Section 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
Workplace Safety and Health Act and Workplace Safety and Health (General Provisions) Regulations: This product is subjected to the SDS, labelling, PEL and other requirements in the
Act/Regulations.
Environmental Protection and Management Act and: Hydrofluorocarbons
Environmental Protection and Management (Hazardous Substances) Regulations
Fire Safety (Petroleum and Flammable Materials)
Regulations:

Not applicable

Montreal Protocol:

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

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

not determined

IECSC

:

not determined

Revision Date:

06.04.2024

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/

Section 16: Other information

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

dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
SG OEL: Singapore. Workplace Safety and Health (General Provisions)
Regulations - First Schedule Permissible Exposure Limits of
Toxic Substances.
ACGIH / STEL
SG OEL / PEL (long term)::

Short-term exposure limit
Permissible Exposure Level (PEL) Long Term

20 / 21

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
4.0

Revision Date:
06.04.2024

SDS Number:
75390-00023

Date of last issue: 30.09.2023
Date of first issue: 16.03.2015

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance 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.
SG / EN

21 / 21