Fluticasone propionate (cas 80474-14-2) MSDS

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GlaxoSmithKline (919) 483-2100
PO Box 13398 (919) 483-2700 (24 hour contact)
5 Moore Drive
RTP, NC 27709 Effective Date: 5/20/97

MATERIAL SAFETY DATA SHEET
SECTION 1: CHEMICAL SUBSTANCE

Flonase? Nasal Spray, 0.05% w/w
PRODUCT NAME:

COMMON NAME: fluticasone propionate

CHEMICAL NAME: S-fluoromethyl 6??,9??-difluoro-11??-hydroxy-16??-methyl-3-oxo-17??-
propionyloxyandrosta-1,4-diene-17??-carbothioate

Flonase? (fluticasone propionate) Nasal Spray, 0.05% w/w; Flonase Nasal Spray
SYNONYMS:

SUBSTANCE CLASS: Anti-inflammatory corticosteroid.

SECTION 2: HAZARDOUS INGREDIENTS

NAME CAS/EINECS/ELINCS # % GW LIMITS OTHER LIMITS
(mcg/m3) (mcg/m3)
w/v or w/w
fluticasone propionate 80474-14-2
3 mcg/m3 Not established
(pure substance)
OEL

SECTION 3: HAZARDS IDENTIFICATION

THE RISK OF HEALTH HAZARDS MAY BE REDUCED WHEN FLONASE? IS HANDLED IN UNIT DOSAGE FORM.

May cause sensitization (allergy) by skin contact or inhalation.
Possible risk of birth defects to the unborn child.

See also Section 11: ??Toxicological Information??.

SECTION 4: FIRST AID MEASURES

If in Eyes: Flush with large amounts of cool water for at least 15 minutes. Obtain medical attention.

If On Skin: Wash affected areas with soap and water after removing contaminated clothing. Obtain medical
attention if contamination is significant and/or a skin reaction is evident.

If Inhaled: If not breathing, give artificial respiration or CPR. If breathing is difficult, give oxygen. Obtain medical
attention and remove to fresh air.


TO THE BEST OF OUR KNOWLEDGE THE INFORMATION CONTAINED HEREIN IS ACCURATE AS OF THE DATE HEREOF. ANY DETERMINATION AS TO THE
SUITABILITY OF THE PRODUCT FOR ANY PARTICULAR PURPOSE, ITS SAFE USE OR DISPOSAL SHALL BE THE RESPONSIBILITY OF THE USER. THE
INFORMATION CONTAINED HEREIN IS IN NO WAY INTENDED TO SUPPLEMENT, MODIFY OR SUPERSEDE THE INFORMATION PROVIDED IN THE PRODUCT
PACKAGE INSERT WITH RESPECT TO THE USE OF THE PRODUCT FOR MEDICAL PURPOSES. PLEASE REFER TO THE PRODUCT PACKAGE INSERT FO INFORMATION REGARDING THE USE OF THE PRODUCT FOR MEDICAL PURPOSES.
Flonase? Nasal Spray Effective Date: 05/20/97

SECTION 5: FIRE / EXPLOSION HAZARDS & FIRE-FIGHTING MEASURES

FLASHPOINT/TEST METHOD: Not Applicable (powder).

LEL/ UEL: Not Determined.

STORAGE OR HANDLING CONDITIONS TO BE AVOIDED: Extreme heat (See Section 10, ??Stability &
Reactivity??).

EXTINGUISHING MEDIA: Water Spray, Multipurpose Dry Chemical.

SPECIAL FIRE-FIGHTING PROCEDURES: Wear full protective clothing and use self-contained
breathing apparatus (SCBA).

SECTION 6: SPILL AND LEAK PROCEDURES

SPILL RESPONSE PROCEDURES (Liquid, Solid, Gas/Vapor):

Protective equipment may be necessary for spills. (See Section 8, ??Exposure Controls / Personal Protection?? for
guidance).

For small quantities associated with normal therapeutic use, collect spillage and transfer to a closed waste container
for disposal. For large or bulk quantities, collect spillage by carefully sweeping or wiping and place in a labeled,
sealed container for disposal. Wash spill area (floor or other contact surfaces) with a suitable cleaning solvent, like
dimethyl sulfoxide.

SECTION 7: HANDLING AND STORAGE

HANDLING: Avoid contact with eyes, skin, and clothing.

STORAGE: Store between 39 and 86??F.

SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION

ENGINEERING CONTROLS: No special ventilation requirements.

PERSONAL PROTECTION:

Respiratory: Not required under normal conditions of use and storage. See Section 5 - ?? /Fire
Explosion Hazards & Fire-Fighting Measures?? for respiratory protection in the event of a
fire.

Eye: Workers should wear adequate eye protection to prevent eye contact..

Clothing: Adequate protective clothing should be worn to prevent occupational skin contact.

Gloves: When routine handling or spill cleanup may result in skin contact, impermeable (e.g.,
latex) gloves should be worn.

WORK PRACTICES: Special care should be taken to ensure that contaminated clothing and equipment is
properly cleaned after use. Wash hands and other areas of skin contact thoroughly
after handling this material. Contaminated clothing should be cleaned or disposed of.




Flonase? Nasal Spray Effective Date: 05/20/97

SECTION 9: PHYSICAL / CHEMICAL PROPERTIES

APPEARANCE AND ODOR: White to off white cloudy suspension with a rose scent.

PHYSICAL STATE (liquid/solid/gas): Liquid.

MELTING POINT (deg. C): Not determined.

BOILING POINT (deg. C): Not determined.

VAPOR PRESSURE: Not determined.

VAPOR DENSITY (air = 1.0): Not determined

Not determined for Flonase? Nasal Spray. Fluticasone propionate the active
SOLUBILITY/MISCIBILITY (% w/v):
ingredient in Flonase? , is practically insoluble in water, slightly soluble in 95%
ethanol and methanol, and freely soluble in dimethyl sulfoxide and dimethyl
formamide.

SECTION 10: STABILITY AND REACTIVITY

CHEMICAL STABILITY: Stable.

CONDITIONS TO AVOID: Not determined.

INCOMPATIBILITY WITH OTHER MATERIALS: Not determined for Flonase? Nasal Spray. No known incompatibilities
have been identified for, fluticasone propionate the active ingredient in
Flonase? Nasal Spray.

Hazardous decomposition products of Flonase? Nasal Spray have not
HAZARDOUS DECOMPOSITION PRODUCTS:
been determined. Thermal decomposition products of fluticasone
propionate, the active ingredient in Flonase? Nasal Spray, include toxic
and/or corrosive oxides of nitrogen, hydrogen fluoride, and sulfur.

HAZARDOUS POLYMERIZATION: Will not occur.

SECTION 11: TOXICOLOGICAL INFORMATION

THE RISK OF HEALTH HAZARDS MAY BE REDUCED WHEN FLONASE? NASAL SPRAY IS HANDLED IN UNIT DOSAGE FORM.

The active component in Flonase? Nasal Spray is fluticasone propionate, a
PHARMACOLOGICAL ACTIVITY:
synthetic corticosteroid. Flonase? Nasal Spray is used medically for the
management of seasonal and perennial allergic inflammation of the nasal
passages.

OCCUPATIONAL EXPOSURE LIMITS: For fluticasone propionate, the active ingredient in Flonase? Nasal Spray, the
Glaxo Wellcome estimated safe working level is an eight hour time-weighted
average (TWA) of 3 mcg/m3 (includes a skin notation--skin contact can lead to
substantial absorption of fluticasone).

ACUTE TOXICITY: Overexposure to fluticasone propionate in the occupational setting may result in
the same adverse effects which have been observed when fluticasone is used
medically. (See ?? Repeat Dose Toxicity?? and ?? Clinical Safety?? below.) The
,
potential for allergic hypersensitivity (including sudden onset of itching, rashes,
hives, chest tightness, and wheezing) caused by inhalation of the formulated
product in the occupational setting may exist.



Flonase? Nasal Spray Effective Date: 05/20/97

SECTION 11: TOXICOLOGICAL INFORMATION (cont??
d)

REPEAT DOSE TOXICITY: Fluticasone propionate can be absorbed during skin contact and may be
absorbed following inhalation; it is poorly absorbed after ingestion. Repeated
skin contact may result in itching, burning, irritation, dryness, redness, and, less
frequently, thinning of the skin and increased ease of bruising. Chronic exposure
is normally required for systemic (affecting the whole body) reactions. In
medical use, excessive doses of steroids like fluticasone may lead to suppression
of growth in children or teenagers. Fluticasone propionate may also slow
healing of wounds, increase susceptibility to certain infectious diseases, increase
intraocular pressure, and contribute to development of cataracts and glaucoma.
Systemic effects of Flonase? Nasal Spray could also include suppression of the
adrenal cortex, a serious medical condition, which results in decreased ability to
respond to stress (such as serious illness, surgery, and infections). Depressed
adrenal gland function may also result in high blood sugar, sugar in the urine,
fluid and salt retention with swelling, abnormal fat deposition, weight gain,
increased appetite, and diabetes.

IRRITATION: Repeated skin contact may result in itching, burning, irritation, dryness or
redness of the skin.

SENSITIZATION: Repeated and frequent skin contact with fluticasone propionate at work may
lead to a rash which appears when exposure to this steroid ceases (for example,
while on vacation) and disappears upon return to work and re-exposure to
fluticasone. The occurrence of such symptoms indicates that work practices
require review and possible modification to reduce steroid contact with skin.

REPRODUCTIVE EFFECTS: Fluticasone propionate has no effect on fertility and mating performance in
standard tests with rats. Many corticosteroids have been shown to cause birth
defects in studies with animals when administered systemically and topically.
Fluticasone propionate caused cleft palate and fetal growth retardation in mice,
rats, and rabbits when administered by subcutaneous injection. However,
adverse effects on fetal development were not seen when fluticasone was
administered by mouth. There are no adequate and well-controlled studies of
fluticasone propionate in pregnant women. Flonase? Nasal Spray should be used
during pregnancy only if the potential benefit justifies the potential risk to the
fetus. For recommended dosage and administration, Flonase? Nasal Spray is
classified as ??Pregnancy Category C?? Systemically administered corticosteroids
.
are excreted in human milk. It is not known whether fluticasone propionate is
excreted in human breast milk, but caution should be exercised when Flonase?
Nasal Spray is administered to a nursing woman.

Precautions should be taken to limit exposure to Flonase? Nasal Spray while
pregnant or nursing; medical evaluation of exposure and attention to
compliance with standard operating procedures and/or other workplace health
and safety directives is advised.

GENOTOXICITY: Fluticasone propionate was not mutagenic (causing change in the genetic
material) in standard tests with bacteria and did not cause chromosome breakage
in human cell cultures or mice.

CARCINOGENICITY: Animal studies conducted to date give no indication that fluticasone has cancer-
causing potential.

CLINICAL SAFETY: The formulated product is a potential inhalation hazard and may produce the
effects described in ??Repeat Dose Toxicity?? above.
,



Flonase? Nasal Spray Effective Date: 05/20/97

SECTION 11: TOXICOLOGICAL INFORMATION (cont??
d)

CLINICAL SAFETY (cont??
d): Individuals known to be hypersensitive to corticosteroids should not be exposed.

The immunosuppressive effects of fluticasone propionate may increase
susceptibility to viral diseases (such as chickenpox and measles) and other
infectious diseases. Intranasal use of fluticasone propionate has been associated
with localized fungal infections of the nose and pharynx in rare cases.

SECTION 12: ECOLOGICAL INFORMATION

ENVIRONMENTAL FATE: Fluticasone propionate compartmentalizes into the terrestrial environment.

ENVIRONMENTAL EFFECTS: Fluticasone propionate is not readily biodegradable in soils other than clay and is
unlikely to bioaccumulate. It is potentially toxicity to receptors in the terrestrial
environment at levels greater than 1000 mg/L.

ENVIRONMENTAL TEST RESULTS:

STUDY NAME RESULTS COMMENTS
Water Solubility: 69.5??g/L at 25??C
Hydrolysis Rate: Does not hydrolyze. Half life greater than one year
at 25??C
Vapor Pressure: 1.47X10-5 Torr at 25??C
n-Octanol/Water Partition Coefficient: 2.78 at pH 7
UV/Visible Spectrum: No absorbance
Aerobic Biodegradation (water) Not readily biodegradable <44% in 28 days
Aerobic Biodegradation (soil) Readily biodegradable in sandy loam
and silty clay >50%
Soil Absorption/Desorption: Very strong adsorption >25%
Subacute Toxicity to Earthworms >1000 mg/kg
Activated sludge respiration inhibition test >1000 mg/L
Acute toxicity to Daphnia EC50>0.55 mg/L at 48 hours No-effect at 0.19??g/L

SECTION 13: WASTE DISPOSAL

ROUTINE: Unused product should be disposed of at an approved facility in accordance with federal,
state and local regulations.

ACCIDENTAL RELEASE: Clean up spills immediately, observing precautions in Section 8 - ??Personal Protection?? Do
.
not flush to sewer. Avoid runoff into storm sewers and ditches which lead to waterways.

SECTION 14: TRANSPORTATION INFORMATION

Flonase? Nasal Spray, 0.05% w/w
Component 1 or Formulation 1:

US Department of Transportation
Proper Shipping Name: Not Regulated

IATA/ICAO
Proper Shipping Name: Not Regulated




Flonase? Nasal Spray Effective Date: 05/20/97

SECTION 14: TRANSPORTATION INFORMATION (cont??
d)

IMDG
Proper Shipping Name: Not Regulated


RQ: None Marine Pollutant: No

SECTION 15: REGULATORY INFORMATION

EC PACKAGING AND LABELING FOR SUPPLY: Not applicable.

OTHER LEGISLATION: Not determined.

SECTION 16: OTHER INFORMATION




REVISION DATE: 05/20/97 SUPERSEDES: 02/08/96