SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Mometasone / Formoterol Metered Dose Inhaler Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

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

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

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

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

2. HAZARDS IDENTIFICATIONGHS classification of chemical productAerosols: Category 3
Long-term (chronic) aquatic
hazard:Category 2

Hazardous to the ozone layer:

Category 1

GHS label elements
Hazard pictograms:

Signal word:

Warning

Hazard statements:

H229 Pressurised container: May burst if heated.
H411 Toxic to aquatic life with long lasting effects.
H420 Harms public health and the environment by destroying
ozone in the upper atmosphere.

Precautionary statements:

Prevention:
1 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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 40 °C/ 104 °F.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
P502 Refer to manufacturer or supplier for information on recovery or recycling.
Other hazards which do not result in classification
Important symptoms and out- : May displace oxygen and cause rapid suffocation.
lines of the emergency assumed
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
1,1,1,2,3,3,3-Heptafluoropropane

CAS-No.
431-89-0

Ethanol#

64-17-5

Mometasone
Formoterol# Voluntarily-disclosed substance

83919-23-7
43229-80-7

Concentration (% w/w)>= 98.05 - <= 98.09
1.8

ENCS No.
2-37632-202>= 0.087 - <= 0.17>= 0.0009 - <= 0.0087

4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
If not breathing, give artificial respiration.
If breathing is difficult, give oxygen.
Get medical attention immediately.
In case of contact, immediately flush skin with soap and plentyof water.
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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayedProtection of first-aiders:

Notes to physician::

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Gas reduces oxygen available for breathing.

First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Exposure to combustion products may be a hazard to health.
If the temperature rises there is danger of the vessels bursting
due to the high vapor pressure.

Hazardous combustion products:

Fluorine compounds
Carbon oxides

Specific extinguishing methods:

Special protective equipment
for firefighters:

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

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

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

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.

:

3 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Prevent spreading over a wide area (e.g. by containment or oilbarriers).
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

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

Handling
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
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.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.

Storage
Conditions for safe storage:

7. HANDLING AND STORAGE

Keep tightly closed.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Materials to avoid:

Do not pierce or burn, even after use.
Keep cool. Protect from sunlight.
Do not store with the following product types:
Oxidizing solids
Oxidizing liquids

Packaging material:

Unsuitable material: None known.

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

CAS-No.

Ethanol
Mometasone

64-17-5
STEL
83919-23-7
TWA
Further information: Skin
Wipe limit
43229-80-7
TWA

Formoterol

Value type
(Form ofexposure)

Wipe limit

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

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

ACGIH
Internal

Internal

Personal protective equipment
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
Skin and body protection: Skin should be washed after contact.
9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

aerosol

Colour:white to off-white

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:-16.5 °C

Flammability (solid, gas):

Not applicable

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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

Flammability (liquids)

SDS Number:
75385-00023:

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

No data available

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit:

No data available

Flash point:

No data available

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

3,900 hPa (20 °C)

Density and / or relative density
Relative density:
Density

5.9:

No data available

Relative vapour density:

5.9

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

10. STABILITY AND REACTIVITY

6 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Reactivity
Chemical stability
Possibility of hazardous reactions:::

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.

Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

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

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
1,1,1,2,3,3,3-Heptafluoropropane:
Acute inhalation toxicity: LC50 (Rat): > 788696 ppm
Exposure time: 4 h
Test atmosphere: gas
Method: OECD Test Guideline 403
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
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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

Remarks: No data available

Acute toxicity (other routes of :administration)

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.

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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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

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.

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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Germ cell mutagenicity
Not classified based on available information.
Components:
1,1,1,2,3,3,3-Heptafluoropropane:
Genotoxicity in vitro: Test Type: In vitro mammalian cell gene mutation test
Result: negative
Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: inhalation (gas)Result: negative

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
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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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
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

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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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:
1,1,1,2,3,3,3-Heptafluoropropane:
Effects on fertility: Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: inhalation (vapour)
Result: negative
Remarks: Based on data from similar materials
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: inhalation (gas)Method: OECD Test Guideline 414
Result: negative

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
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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

weightResult: No effects on fertility, Effect on reproduction capacity
Effects on foetal development:

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

Effects on foetal development:

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

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 ob13 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

served.
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.
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.

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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

Formoterol:
Exposure routes
Target Organs
Assessment

SDS Number:
75385-00023:::

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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

Repeated dose toxicity
Components:
1,1,1,2,3,3,3-Heptafluoropropane:
Species: Rat
NOAEL: 731.69 mg/l
Application Route: inhalation (gas)Exposure time: 13 Weeks
Method: OECD Test Guideline 413
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 time

:
:
:
:

Dog
0.0005 mg/l
inhalation (dust/mist/fume)90 d
15 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Target Organs:

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:

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

Skin contact:

Symptoms: Dermatitis, Itching

Formoterol:
Inhalation:

Target Organs: Heart
16 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Symptoms: Palpitation, Tremors, Dizziness, Headache, drymouth, Nausea, Fatigue
Further information
Components:
Mometasone:
Remarks:

Dermal absorption possible

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
1,1,1,2,3,3,3-Heptafluoropropane:
Toxicity to fish
: LC50 (Danio rerio (zebra fish)): > 200 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 200 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: Based on data from similar materials

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 114
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
NOEC (Pseudokirchneriella subcapitata (green algae)): 1.2
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

Toxicity to microorganisms:

EC50: > 173.1 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

Ethanol:
Toxicity to fish:

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

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

Toxicity to daphnia and otheraquatic invertebrates

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SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

Toxicity to algae/aquaticplantsSDS Number:
75385-00023:

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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
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)100:

18 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

Toxicity to microorganisms

SDS Number:
75385-00023:

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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

Persistence and degradability
Components:
1,1,1,2,3,3,3-Heptafluoropropane:
Biodegradability: Result: Not readily biodegradable.
Biodegradation: 1 %Exposure time: 28 d
Method: OECD Test Guideline 301D
Ethanol:
Biodegradability:

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

Mometasone:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 50 %19 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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

Hazardous to the ozone layer
Components:
1,1,1,2,3,3,3-Heptafluoropropane:
Ozone-Depletion Potential: Regulation: Japan.Enforcement Ordinance of the Law concerning the Protection of the Ozone Layer through the Controlof Specified Substances and other measures (Update: 201808-10)
Number: 6
Group: Annex F - Group I
Other adverse effects
No data available

20 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
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.

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Packing group
LabelsEnvironmentally hazardous

:
:
:
:
:
:

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

:
:

Class
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.
Proper shipping nameClass
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.

21 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, and variations in regional or country regulations.
ERG Code:126

15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Group 4, Alcohols, (400 litre), Hazardous rank II, (Remained chemical in a spray can after degassing falls under this group)
Chemical Substance Control Law
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Article 57-2 (Enforcement Order Table 9)
Chemical name
1,1,1,2,3,3,3-heptafluoropropane
Ethanol

Concentration (%)>=98.05 - <=98.09>0 - <10

Substances Subject to be Indicated Names
Article 57 (Enforcement Order Article 18)
Chemical name
1,1,1,2,3,3,3-heptafluoropropane
Ethanol

22 / 25

Remarks
From April 1st, 2026-

Remarks
From April 1st, 2026-

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Exempted from application of the High Pressure Gas Safety Act in accordance with Ministry of International Trade and Industry Notification No. 139 of 1997
Explosive Control Law
Not applicable
Vessel Safety Law
Gases (Article 2 and 3 of rules on shipping and storage of dangerous goods and its Attached Table 1)
Aviation Law
Gases (Article 194 of The Enforcement Rules of Aviation Law and its Attached Table 1)
Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Not applicable
23 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

International Regulations
Montreal Protocol

SDS Number:
75385-00023:

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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

16. OTHER INFORMATIONIn this SDS, if the concentration of substances subject to notification under the Industrial Safety
and Health Law is indicated as a range, it includes cases where it is a trade secret.
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/

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

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ACGIH / STEL:

Short-term exposure limit

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
24 / 25

SAFETY DATA SHEET

Mometasone / Formoterol Metered Dose Inhaler Formulation
Version
10.0

Revision Date:
2024/04/06

SDS Number:
75385-00023

Date of last issue: 2023/09/30
Date of first issue: 2015/03/16

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.
JP / EN

25 / 25