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Fluoxetine Hydrochloride Oral
Solution
Eli Lilly and Company Effective Date: 27-Aug-2005
Material Safety Data Sheet
Section 1 - Chemical Product and Company
Manufacturer's Emergency Phone:
Manufacturer:
1-317-276-2000
Eli Lilly and Company
CHEMTREC:
Lilly Corporate Center
1-800-424-9300 (North America)
Indianapolis, IN 46285
1-703-527-3887 (International)
Common Name: Fluoxetine Hydrochloride Oral Solution
Chemical Name: Benzenepropanamine, N-methyl-gamma-[4-(trifluoromethyl)phenoxy]-,
hydrochloride
Chemical Name 2: (+-)-N-Methyl-3-phenyl-3-[(alpha,alpha,alpha-trifluoro-p-tolyl)oxy]propylamine
hydrochloride
Synonym(s): Fluoxetine HCl; Fluoxetine Hydrochloride; Fluoxetine; 110140 Formulation
Trademarks(s): Adzac; Alvenin; Branfluoxe; Erocap; Fluctine; Fluoxeren; Fluctin; Foncin; Fonzac;
Profac; Prenu; Praxin; Nuzac; Lovan; Lonparin; Levilin; Ladose; Zolovan; Sertax; Sarazac; Sarafem;
Prozyn; Fontex; Flutin; Debiton; Prozac
Lilly Item Code(s): MS5120; UC5017; UC5932; UC5982; VF0271
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Fluoxetine Hydrochloride 56296-78-7 0.35
Sucrose 57-50-1 47
Glycerin 56-81-5 15
Ethyl Alcohol 64-17-5 0.23
N&A Mint 587.207/SE NA 0.17
Benzoic Acid 65-85-0 0.04
Water 7732-18-5 36
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or
greater) not listed above.
Exposure Guidelines:
Fluoxetine hydrochloride - LEG 30 micrograms/m3 TWA for 12 hours. LEG 50 micrograms/m3 TWA
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for 8 hours.
Sucrose - PEL 5 mg/m3 TWA (respirable) and 15 mg/m3 TWA (total). TLV 10 mg/m3 TWA.
UK - Exposure Standard 10 mg/m3 TWA, 20 mg/m3 STEL.
Ireland - Occupational Exposure Limit 10 mg/m3 TWA, 20 mg/m3 15-minute STEL.
Italy - Occupational Exposure Limit 10 mg/m3 TWA.
France - Occupational Exposure Limit 10 mg/m3 (VME) TWA.
Spain - Occupational Exposure Limit 10 mg/m3 (VLA-ED) TWA.
Glycerin (mist) - PEL 5 mg/m3 TWA (respirable) and 15 mg/m3 TWA (total). TLV 10 mg/m3 TWA.
UK - Exposure Standard 10 mg/m3 TWA.
Ireland - Occupational Exposure Limit 10 mg/m3 TWA.
Italy - Occupational Exposure Limit 10 mg/m3 TWA.
France - Occupational Exposure Limit 10 mg/m3 (VME) TWA.
Spain - Occupational Exposure Limit 10 mg/m3 (VLA-ED) TWA.
Ethyl alcohol - PEL and TLV 1000 ppm (1900 mg/m3) TWA.
UK - Workplace Exposure Limit 1000 ppm (1920 mg/m3) TWA.
Ireland - Occupational Exposure Limit 1000 ppm (1900 mg/m3) TWA.
Italy - Occupational Exposure Limit 1000 ppm TWA.
France - Occupational Exposure Limit 1000 ppm (1900 mg/m3) (VME) TWA, 5000 ppm (9500 mg/m3)
(VLE) STEL.
Spain - Occupational Exposure Limit 1000 ppm (1910 mg/m3) (VLA-ED) TWA.
Germany - TRGS 900 Limit Value 500 ppm (960 mg/m3), 15-minute limit not to exceed 4 times
MAK.
Section 3 - Hazards Identification
Appearance: Clear colorless solution
Physical State: Liquid
Odor: Mint-like
Emergency Overview
Emergency Overview Effective Date: 27-Aug-2005
Lilly Laboratory Labeling Codes:
Health 1 Fire 1 Reactivity 0
Primary Physical and Health Hazards: Nervous System and Liver Effects.
Caution Statement: Effects of exposure to Fluoxetine Hydrochloride Oral Solution may include
tremors, drowsiness, and liver tissue changes.
Routes of Entry: Inhalation and skin contact.
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Effects of Overexposure: Contact dermatitis (rash) has been reported with occupational exposure to
fluoxetine hydrochloride. The most common adverse events reported with therapeutic administration
include nausea, decreased appetite, anxiety, tremors, drowsiness, and sweating. The most common
signs and symptoms associated with non-fatal overdosage were seizures, drowsiness, nausea, increased
heart rate, and vomiting.
Medical Conditions Aggravated by Exposure: Acute overdose after sustained therapeutic exposure to
fluoxetine hydrochloride has resulted in seizures. The potential for aggravation of a seizure disorder has
not been ruled out.
Carcinogenicity:
Fluoxetine hydrochloride - Not listed by IARC, NTP, ACGIH, or OSHA. The dietary administration to
rats and mice for 2 years at doses of up to 10 and 12 mg/kg/day produced no evidence of
carcinogenicity.
Remaining ingredients - Not listed by IARC, NTP, ACGIH, or OSHA.
Section 4 - First Aid Measures
Eyes: Flush eyes with plenty of water. Get medical attention.
Skin: Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin with
plenty of soap and water. Get medical attention if irritation develops.
Inhalation: Move individual to fresh air. Get medical attention if breathing difficulty occurs. If not
breathing, provide artificial respiration assistance (mouth-to-mouth) and call a physician immediately.
Ingestion: Do not induce vomiting. Call a physician or poison control center. If available, administer
activated charcoal (6-8 heaping teaspoons) with two to three glasses of water. Do not give anything by
mouth to an unconscious person. Immediately transport to a medical care facility and see a physician.
Notes to Physician:
Fluoxetine hydrochloride - Cardiac and vital signs monitoring is recommended, along with general
symptomatic and supportive measures. No specific antidote is known. Forced diuresis, dialysis,
haemoperfusion, and exchange transfusion are unlikely to be of benefit. In limited human overdose
experience, seizures have been reported. Appropriate seizure precautions are advised for any patient
regularly taking fluoxetine who has been exposed to an acute overdose. Based on experience in
animals, which may not be relevant to humans, fluoxetine-induced seizures that fail to remit
spontaneously may respond to diazepam.
Section 5 - Fire Fighting Measures
Flash Point: No applicable information found
UEL: No applicable information found
LEL: No applicable information found
Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon.
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Unusual Fire and Explosion Hazards: None known.
Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.
Section 6 - Accidental Release Measures
Spills: Wear protective equipment, including eye protection, to avoid exposure (see Section 8 for
specific handling precautions). Prevent further migration into the environment. Use
absorbent/adsorbent material to solidify liquids.
Section 7 - Handling and Storage
Storage Conditions: Controlled Room Temperature: 15 to 30 C (59 to 86 F).
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
Under normal use and handling conditions, no protective equipment is required. The following is
recommended for a production setting:
Respiratory Protection: Use an approved respirator.
Eye Protection: Safety glasses.
Ventilation: Laboratory fume hood or local exhaust ventilation.
Other Protective Equipment: Chemical-resistant gloves and body covering to minimize skin
contact. If handled in a ventilated enclosure, as in a laboratory setting, respirator and goggles or face
shield may not be required. Safety glasses are always required.
Section 9 - Physical and Chemical Properties
Appearance: Clear colorless solution
Odor: Mint-like
Boiling Point: No applicable information found
Melting Point: Not applicable
Specific Gravity: 1.20 to 1.30
pH: 2.5 to 4.5
Evaporation Rate: No applicable information found
Water Solubility: Soluble
Vapor Density: No applicable information found
Vapor Pressure: No applicable information found
Section 10 - Stability and Reactivity
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Stability: Stable at normal temperatures and pressures.
Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid,
etc.).
Hazardous Decomposition: May emit toxic fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Acute Exposure
Oral:
Fluoxetine hydrochloride oral solution - Rat, 625 mg/kg, no deaths or toxicity.
Skin:
Fluoxetine hydrochloride oral solution - Rabbit, 1250 mg/kg, no deaths or toxicity.
Inhalation: No applicable information found.
Skin Contact:
Fluoxetine hydrochloride oral solution - Rabbit, nonirritant
Eye Contact:
Fluoxetine hydrochloride oral solution - Rabbit, slight irritant
Chronic Exposure
No data available for mixture or formulation. Data for ingredient(s) or related material(s) are
presented.
Target Organ Effects:
Fluoxetine hydrochloride - Liver effects (reversible increases in serum enzymes, slight hepatic fat
deposition, tissue changes).
Glycerin - Heart effects (increased weight), liver effects (increased weight), kidney effects (increased
weight, tissue changes).
Other Effects:
Fluoxetine hydrochloride - In a juvenile toxicology study in rats, where the exposure period corresponds
to human childhood and adolescence, administration of 30 mg/kg resulted in skeletal muscle
necrosis. Other findings in rats included necrosis of the testis and immaturity and inactivity of the
female reproductive tract. Following an approximate 11-week recovery period, sperm assessments
indicated an approximately 30% decrease in sperm concentrations without affecting sperm morphology
or motility. Microscopic evaluation indicated that testicular degeneration was irreversible. Delays in
sexual maturation occurred with administration of 10 or 30 mg/kg. The significance of these findings in
humans is unknown. Femur lengths at 30 mg/kg increased to a lesser extent compared with control
rats.
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Reproduction:
Fluoxetine hydrochloride - Two fertility studies conducted in adult rats indicated no adverse effects on
fertility. In embryo-fetal development studies in rats and rabbits, there was no evidence of
teratogenicity. However, in rat reproduction studies, an increase in stillborn pups, a decrease in pup
weight, and an increase in pup deaths during the first 7 days postpartum occurred following maternal
exposure to 7.5 mg/kg/day during gestation and lactation. There was no evidence of developmental
neurotoxicity in the surviving offspring of rats. The no effect dose for rat pup mortality was 5
mg/kg/day.
Data on a large number of exposed pregnancies in humans indicate no appearance of adverse effects on
pregnancy or on the overall health of the fetus/newborn child. However, a few epidemiological studies
have noted that some women treated with fluoxetine and other SSRIs late in the third trimester have had
newborns with increased complications that could be consistent with drug discontinuation syndrome
(e.g. transient jitteriness, difficulty feeding, tachypnea and irritability) and required prolonged
hospitalizations.
Sensitization:
Glycerin - Guinea pig, not a contact sensitizer.
Mutagenicity:
Fluoxetine hydrochloride - No genotoxic effects based on the following assays: bacterial mutation
assay, DNA repair assay in cultured rat hepatocytes, mouse lymphoma assay, and in vivo sister
chromatid exchange assay in Chinese hamster bone marrow cells.
Section 12 - Ecological Information
No environmental data for the mixture or formulation. The environmental information for ingredient(s)
or related material(s) are presented.
Ecotoxicity Data:
Fluoxetine hydrochloride
Rainbow trout 96-hour median lethal concentration: 1.57 mg/L
Daphnia magna 48-hour median effective concentration: 0.94 mg/L
Green algae (S. capricornutum) median effective concentration: 30.5 micrograms/L (average specific
growth rate)
Microorganisms:
fungus (Chaetomium globosum): MIC = 64 mg/L
mold (Aspergillus flavus): MIC = 64 mg/L
soil bacteria (Pseudomonas acidovorans): MIC = 1000 mg/L
N-fixing bacteria (Azotobacter chroococcum): MIC = 64 mg/L
blue-green algae (Nostoc sp.): MIC = 250 mg/L
Environmental Fate:
Fluoxetine hydrochloride
Dissociation constant (pKa): 8.7
Log Kow: 1.0, 1.8, 2.6 (pH 5, 7, 9)
Solubility (g/L): 15.0, 6.84, 5.47 (pH 5, 7, 9)
Light absorption (nm): none between 290 and 800
Hydrolysis rate (1/day): 0, 0, 0 (pH 5, 7, 9)
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Aerobic biodegradation half-life (days): not measurable
Environmental Summary:
Fluoxetine hydrochloride - Moderately toxic to fish and highly toxic to invertebrates and green
algae. No volatility expected. Low potential to bioaccumulate in aquatic organisms. Can be considered
persistent due to low rates of biodegradation and hydrolysis.
Lilly Aquatic Exposure Guideline (LAEG):
Fluoxetine hydrochloride
LAEG for Drinking Water: 11.2 micrograms/L
LAEG for Chronic Exposure of Aquatic Organisms: 1.2 micrograms/L
LAEG for Acute Exposure of Aquatic Organisms: 30.5 micrograms/L
Section 13 - Disposal Considerations
Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws
and regulations.
Section 14 - Transport Information
Regulatory Organizations:
DOT: Not Regulated
ICAO/IATA: Not Regulated
IMO: Not Regulated
Section 15 - Regulatory Information
Below is selected regulatory information chosen primarily for possible Eli Lilly and Company
usage. This section is not a complete analysis or reference to all applicable regulatory
information. Please consider all applicable laws and regulations for your country/state.
U.S. Regulations
Fluoxetine hydrochloride
TSCA - No
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
Remaining Ingredients
TSCA - Yes
CERCLA - Not on this list
SARA 302 - Not on this list
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SARA 313 - Not on this list
OSHA Substance Specific - No
EU Regulations
Risk Phrases
R 52/53 - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic
environment.
Safety Phrases
S 61 - Avoid release to the environment. Refer to special instructions/Safety data sheets.
Section 16 - Other Information
MSDS Sections Revised: Sections 3, 4, 11, 12 and 15.
Emergency Overview Sections Revised: Physical and health hazards and caution statement.
As of the date of issuance, we are providing available information relevant to the handling of this
material in the workplace. All information contained herein is offered with the good faith belief that it
is accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE
ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this
material, this safety data sheet is not intended to be a substitute for consultation with appropriately
trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which
may accompany the finished product.
For additional information contact:
Eli Lilly and Company
Hazard Communication
317-277-6029
For additional copies contact:
Eli Lilly and Company
1-800-LILLY-Rx (1-800-545-5979)
GLOSSARY:
ACGIH = American Conference of Governmental Industrial Hygienists
AIHA = American Industrial Hygiene Association
BEI = Biological Exposure Index
CAS Number = Chemical Abstract Service Registry Number
CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)
CHAN = Chemical Hazard Alert Notice
CHEMTREC = Chemical Transportation Emergency Center
DOT = Department of Transportation
EC = European Community
EINECS = European Inventory of Existing Chemical Substances
ELINCS = European List of New Chemical Substances
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EPA = Environmental Protection Agency
HEPA = High Efficiency Particulate Air (Filter)
IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association
IEG = Lilly Interim Exposure Guideline
IMO = International Maritime Organization
Kow = Octanol/Water Partition Coefficient
LEG = Lilly Exposure Guideline
LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
MSHA = Mine Safety and Health Administration
NA = Not Applicable, except in Section 14 where NA = North America
NADA = New Animal Drug Application
NAIF = No Applicable Information Found
NCI = National Cancer Institute
NIOSH = National Institute for Occupational Safety and Health
NOS = Not Otherwise Specified
NTP = National Toxicology Program
OSHA = Occupational Safety and Health Administration
PEL = Permissible Exposure Limit (OSHA)
RCRA = Resource Conservation and Recovery Act
RQ = Reportable Quantity
RTECS = Registry of Toxic Effects of Chemical Substances
SARA = Superfund Amendments and Reauthorization Act
STEG = Lilly Short Term Exposure Guideline
STEL = Short Term Exposure Limit
TLV = Threshold Limit Value (ACGIH)
TPQ = Threshold Planning Quantity
TSCA = Toxic Substances Control Act
TWA = Time Weighted Average/8 Hours Unless Otherwise Noted
UEL = Upper Explosive Limit
UN = United Nations
WEEL = Workplace Environmental Exposure Level (AIHA)
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