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Nizatidine Capsules
Effective Date: 04-May-2000
Eli Lilly and Company
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: Nizatidine Capsules
Chemical Name: 1,1-Ethenediamine, N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]
ethyl]-N'-methyl-2-nitro-
Chemical Name 2: N-[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-
nitro-1,1-ethenediamine
Synonym(s): Nizatidine Capsule Mix; Nizatidine Formulation; 139037 Formulation; 3144; 3145
Trademarks(s): Averati; Averaty; Averity; Nizatt; Nizatto; Naxidine; Bonaxid; Nizaxid; Axid; Acinon;
Antizid; Axid AR; Bonacid; Calmaxid; Cronizat; Distaxid; Naxidin; Nizax; Nizid; Panaxid; Tazac;
Zanizal
Lilly Item Code(s): B01975; CK0895; CK0897; CK0920; CK0921; CK0944; CK0974; ID0620;
ND0896; ND0898; ND0904; ND0984; ND1051; PU3143; PU3144; PU3145; QA443K; QA447J;
SA0905; SA0916; SA0935; SA0936; SA0953; SA0954; SA0961; UC5401; UC5402; UC5983;
UC5984; UC7208; UC7209; UC9529; UC9530; UC9557; UC9558; VF0176; VF0177; VF0219;
VF0220; VF0354
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Nizatidine 76963-41-2 45 - 82
Excipients NA 18 - 55
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or
greater) not listed above.
Exposure Guidelines: Nizatidine - LEG <100 micrograms/m3 TWA for 12 hours.
Section 3 - Hazards Identification
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Appearance: Capsules containing white to off-white powder
Physical State: Solid
Odor: Mild sulfur-like
Emergency Overview
Special
A = Allergen
Emergency Overview Effective Date: 04-May-2000
Lilly Laboratory Labeling Codes:
Health 2 Fire 1 Reactivity 0 Special A
Primary Physical and Health Hazards: Not hazardous if intact. Irritant (eyes). Allergen.
Caution Statement: Intact Nizatidine Capsules are not considered to be a health hazard. The
contents of Nizatidine Capsules may be irritating to the eyes and causes allergic reactions.
Routes of Entry: Inhalation and skin contact.
Effects of Overexposure: Capsules are intended for human consumption under guidance of a
physician. Capsules are not considered hazardous under normal handling procedures. Allergic reaction
has been reported with occupational exposure to nizatidine, including watery eyes, sneezing, congestion,
and shortness of breath. Based on animal studies, nizatidine may be irritating to the eyes.
Medical Conditions Aggravated by Exposure: Known sensitization or allergy to nizatidine.
Carcinogenicity: Nizatidine - Not listed by IARC, NTP, ACGIH, or OSHA. Not considered
carcinogenic in animal studies conducted by Lilly Research Laboratories.
Section 4 - First Aid Measures
Eyes: Hold eyelids open and flush with a steady, gentle stream of water for 15 minutes. See an
ophthalmologist (eye doctor) or other physician immediately.
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.
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Section 5 - Fire Fighting Measures
Flash Point: Not applicable
UEL: No applicable information found
LEL: No applicable information found
Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon.
Unusual Fire and Explosion Hazards: As a finely divided material, may form dust mixtures in air
which could explode if subjected to an ignition source.
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). Vacuum material with appropriate dust collection filter in place. Be
aware of potential for dust explosion when using electrical equipment. If vacuum is not available,
lightly mist material and remove by sweeping or wet wiping.
Section 7 - Handling and Storage
Storage Conditions: Controlled Room Temperature: 15 to 30 C (59 to 86 F). Warehouse: 10 to 40 C
(50 to 104 F).
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
Filled capsules are not considered hazardous under normal handling procedures and protective
equipment is not required. The following are recommended for manufacturing or other situations where
exposure to contents may occur.
Respiratory Protection: Use an approved respirator.
Eye Protection: Chemical goggles and/or face shield.
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.
Additional Exposure Precautions: In production settings, airline-supplied, hood-type respirators are
preferred. Shower and change clothing if skin contact occurs.
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Section 9 - Physical and Chemical Properties
Appearance: Capsules containing white to off-white powder
Odor: Mild sulfur-like
Boiling Point: Not applicable
Melting Point: No applicable information found
Specific Gravity: Not applicable
pH: No applicable information found
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
Stability: Stable at normal temperatures and pressures.
Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid,
etc.).
Hazardous Decomposition: Will emit toxic fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Acute Exposure
Data for the active ingredient, nizatidine, are reported.
Oral: Nizatidine - Rat, median lethal dose 2109 mg/kg, convulsions, incoordination, tremors, diarrhea,
reduced activity.
Monkey, 1200 mg/kg, no deaths or toxicity.
Skin: Nizatidine - Rabbit, 200 mg/kg, no deaths or toxicity.
Inhalation: Nizatidine - Rat, 1540 mg/m3 for 4 hours, no deaths.
Intravenous: Nizatidine - Monkey, 200 mg/kg, no deaths, reduced activity, tremors, drooping eyelids,
vasodilation, and salivation.
Skin Contact: Nizatidine - Rabbit, nonirritant
Eye Contact: Nizatidine - Rabbit, irritant
Chronic Exposure
Data for the active ingredient, nizatidine, are reported.
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Target Organ Effects: Nizatidine - Nervous system effects (reduced activity), heart effects (decreased
heart rate), liver effects (liver enzyme changes, increased liver weight), kidney effects (increased kidney
weight), digestive effects (reduced gastric acid secretion, nausea/vomiting, diarrhea), eye effects
(contraction of pupils).
Other Effects: Nizatidine - Decreased body weight gain.
Reproduction: Nizatidine - No effects identified in animal studies.
Sensitization: No applicable information found.
Mutagenicity: Nizatidine - Not mutagenic in bacterial or mammalian cells.
Section 12 - Ecological Information
Data for the active ingredient, nizatidine, are reported.
Ecotoxicity Data: Nizatidine
Rainbow trout 96-hour median lethal concentration: > 988 mg/L
Daphnia magna 48-hour median effective concentration: 2176 mg/L
Green algae (S. capricornutum) median effective concentration: > 1074 mg/L (average specific growth
rate)
Microorganisms:
fungus (Chaetomium globosum): MIC > 1000 mg/L
mold (Aspergillus flavus): MIC > 1000 mg/L
soil bacteria (Comamonas acidovorans): MIC > 1000 mg/L
N-fixing bacteria (Azotobacter chroococcum): MIC > 1000 mg/L
blue-green algae (Nostoc sp.): MIC > 1000 mg/L
Environmental Fate: Nizatidine
Dissociation constants (pKa): 2.1, 6.52
Log Kow: -2.0, -0.6, -0.4 (pH 5, 7, 9)
Water solubility (g/L): > 100, 46.1, 26.7 (pH 5, 7, 9)
Light absorption (nm): 314 (pH 5, 7, 9)
Molar extinction coefficient (L/mole-cm): 16,546; 16,755; 18,380 (pH 5, 7, 9)
Hydrolysis: none measured after 5 days at 50 C (122 F) (pH 5, 7, and 9)
Aerobic biodegradation: none measured after 29 days
Environmental Summary: Nizatidine - Practically nontoxic to fish, invertebrates, green algae, and
microorganisms. No volatility expected. Low potential to bioconcentrate in aquatic
organisms. Persistence in the aquatic environment not expected due to the potential for photolysis.
Section 13 - Disposal Considerations
Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws
and regulations.
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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
Nizatidine
TSCA - No
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
EU Regulations
EC Classification
Xn (Harmful)
Xi (Irritant)
Risk Phrases
R 36 - Irritating to eyes.
R 42/43 - May cause sensitization by inhalation and skin contact.
Safety Phrases
S 36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
Section 16 - Other Information
MSDS Sections Revised: Section 1.
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
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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
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
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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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