SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

SECTION 1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Mometasone Metered Dose Inhaler Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: Avenida 16 de Septiembre No. 301
Xaltocan - Xochimilco Mexico 16090
Telephone: +52 55 57284444
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS Classification
Aerosols:

Category 3

Reproductive toxicity:

Category 1B

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H229 Pressurised container: May burst if heated.
H360Df May damage the unborn child. Suspected of damaging
fertility.

Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
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.
P280 Wear protective gloves/ protective clothing/ eye protection/
face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
1 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

P405 Store locked up.
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
May displace oxygen and cause rapid suffocation.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Ethanol#
Mometasone# Voluntarily-disclosed substance

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

Concentration (% w/w)>= 1.8 -<= 2.5>= 0.08 -<= 0.18

SECTION 4. 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:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

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.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
May damage the unborn child. Suspected of damaging fertility.
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.

:

SECTION 5. FIRE-FIGHTING MEASURES
2 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

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:

Carbon oxides
Fluorine compounds

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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

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

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

Methods and materials forcontainment and cleaning up:

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

SECTION 7. HANDLING AND STORAGE
3 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Technical measures:

Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

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 vapors 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.
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.
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

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

CAS-No.

Ethanol

64-17-5

Mometasone

Value type
(Form ofexposure)
VLE-CT

Control parameters / Permissible
concentration
1,000 ppm

STEL
83919-23-7
TWA
Further information: Skin
Wipe limit

1,000 ppm
1 µg/m3 (OEB 4)

NOM-010STPS-2014
ACGIH
Internal

10 µg/100 cm²Internal

4 / 17

Basis

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or
exposure assessment demonstrates exposures outside therecommended guidelines, use respiratory protection.
Filter type
: Self-contained breathing apparatus
Skin and body protection: Skin should be washed after contact.
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

Aerosol containing a dissolved gas

Color

:

white to off-white

Odor

:

odorless

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

-16 °CFlash point:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

1 g/cm³

Solubility(ies)
Water solubility:

insoluble:

No data available:

No data available

Partition coefficient: noctanol/water
Autoignition temperature

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SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

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 size:

No data available

SECTION 10. STABILITY AND REACTIVITY
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.

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: vapor

Mometasone:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
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SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

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)

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

Mometasone:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
7 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

Components:
Ethanol:
Test Type
Routes of exposure
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative

Mometasone:
Test Type
Routes of exposure
Species
Assessment
ResultRemarks

:
:
:
:
:
:

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

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
8 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

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:

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
May damage the unborn child. Suspected of damaging fertility.
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 fetal
weight.
Result: No effects on fertility., Effect on reproduction capacity.
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SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

Effects on fetal development

SDS Number:
25996-00023:

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

Test Type: Embryo-fetal development
Species: Mouse
Application Route: Subcutaneous
Embryo-fetal toxicity.: LOAEL: 0.06 mg/kg body weight
Result: Embryotoxic effects., Teratogenicity anddevelopmental toxicity
Test Type: Embryo-fetal development
Species: Rat
Application Route: Dermal
Embryo-fetal toxicity.: LOAEL: 0.3 mg/kg body weight
Result: Embryo-fetal toxicity.
Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Dermal
Embryo-fetal toxicity.: LOAEL: 0.15 mg/kg body weight
Result: Embryo-fetal toxicity., Malformations were observed.
Test Type: Embryo-fetal development
Species: Rat
Application Route: Subcutaneous
Embryo-fetal toxicity.: LOAEL: 0.15 mg/kg body weight
Result: Effects on newborn.
Test Type: Embryo-fetal development
Species: Rabbit
Application Route: Oral
Embryo-fetal toxicity.: LOAEL: 0.7 mg/kg body weight
Result: Embryo-fetal 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:
Routes of exposure
Target Organs
Assessment:::

inhalation (dust/mist/fume)
Immune system, Liver, Kidney, Skin
May cause damage to organs through prolonged or repeated
10 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

exposure.
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

11 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

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
Ecotoxicity
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 other:

EC50 (Daphnia magna (Water flea)): > 5 mg/l
12 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

aquatic invertebrates

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

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.

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.
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

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SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

Stability in water

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014:

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

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

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

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 INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Packing group
LabelsEnvironmentally hazardous

:
:
:
:
:
:

UN 1950
AEROSOLS
2.2
Not assigned by regulation
2.2
noIATA-DGR
14 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

UN/ID No.
Proper shipping nameClass
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

:
:
:
:
:
:

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

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
NOM-002-SCT
UN number
Proper shipping nameClass
Packing group
Labels:::::UN 1950
AEROSOLS
2.2
Not assigned by regulation
2.2

Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or
mixtureNOM-165-SEMARNAT-2013, Norm establishing a list of substances subject to report for theRegistry of Emissions and Pollutant Transfer
Components
CAS-No.
MPU (kg/year)
Transfer/Release(kg/year)
1,1,1,2,3,3,3431-89-0
2500 kg/year
100 kg/year
Heptafluoropropane
MPU: Applicable reporting threshold when the substance, pure or in mixture in a composition of
more than 1% by weight, is used for industrial activities at facilities that are subject to report orare produced by themFederal Law for the control of chemical precursors,: Not applicableessential chemical products and machinery for
producing capsules, tablets and pills.
15 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

International Regulations
Montreal Protocol

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014:

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

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Revision Date
Date format::

26.09.2023
dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
NOM-010-STPS-2014: Mexico. Norm NOM-010-STPS-2014 on Chemicals Polluting
the Work Environment - Identification, Assessment and Control - Appendix 1 Occupational Exposure Limits
ACGIH / STEL
: Short-term exposure limit
NOM-010-STPS-2014 / VLE- : Short term exposure limit value
CT
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 Tempera16 / 17

SAFETY DATA SHEET
Mometasone Metered Dose Inhaler Formulation
Version
4.12

Revision Date:
26.09.2023

SDS Number:
25996-00023

Date of last issue: 20.03.2023
Date of first issue: 28.10.2014

ture; 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

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

The information is considered as correct, but not exhaustive, and will be used only as a guide,
which is based in the current knowledge of the substance or mixture, and is applicable to proper
safety precautions for the product.
MX / Z8

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