Ehs.lilly.com

Cephalexin Capsules and
Eli Lilly and Company
Material Safety Data Sheet
Section 1 - Chemical Product and Company
Manufacturer's Emergency Phone:
Manufacturer:
CHEMTREC:
Common Name: Cephalexin Capsules and Tablets
Chemical Name: 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2R)-aminophenylacetyl]
amino]-3-methyl-8-oxo-, monohydrate, (6R,7R)-
Chemical Name 2: 7-(D-alpha-Amino-alpha-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid
monohydrate
Synonym(s): Cephalexin M. F. Blend; Cephalexin; Cephalexin Monohydrate; Cephalexin Capsule Mix;
Cephalexin Monohydrate Capsule Mix; 066873 Formulation; H69; H71; 4202; 4203; Cefalexina
Capsules
Trademarks(s): Branfalexina; Kefalex; Falex; Keferol; Keflex Package; L-Keflex; Orex; Orakef;
Kefloridina; Keflex KX; Keflex; Keforal
Lilly Item Code(s): AH0377; AH0378; CAP3001L; MS5062; MS5063; ND0711; ND0720; ND0730;
ND0753; ND0762; ND0832; ND0833; ND0834; ND0861; ND0862; ND0868; ND0877; PU0401;
PU0402; PU0403; PU3001; PU3069; PU3070; PU3140; PU3141; PU3246; QA432Z; QA433Y;
QA455Z; QA476X; QD471R; TA1872; TA1894; TA1895; TA1896; TA4053; TA4090; TA4091;
TA4202; TA4203; TA4210; TA4211; UC5010; UC5011; UC5346; UC5347; UC5348; UC5349;
UC5376; UC5377; UC5930; UC5931; UC5938; UC5939; UC5942; UC5943; UC5944; UC5945;
UC5961; UC5962; UC5970; UC5974; UC5975; UC5976; UC5977; UC5978; UC5979; UC8932;
UC8933; UC8945; UC8946; UC9555; UC9556; UE0001; UE0002; UF0015; UF0016; UG9027;
VF0072; VF0077; VF0079; VF0084; VF0085; VF0090; VF0092; VF0100; VF0101; VF0122; VF0142;
VF0143; VF0155; VF0159; VF0160; VF0223; VF0224; VF0225; VF0226; VF0227; VF0254; VF0255;
VF0256; VF0257; VF0264; VF0265; VF0273; VF0288; VF0289; VF0291; VF0292; VL0257
See attached glossary for abbreviations. Section 2 - Composition / Information on Ingredients
Ingredient
Concentration %
file://Z:\Legacy\EXTRACT 30NOV2006\MSDS_html\4271800.html Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or greater) not listed above. Exposure Guidelines: Cephalexin monohydrate - LEG <100 micrograms/m3 TWA for 12 hours.
Section 3 - Hazards Identification
Appearance: White or colored powder finished as capsules or coated tablets
Physical State: Solid
Odor: Odorless
Emergency Overview
Emergency Overview Effective Date: 23-Apr-1994
Lilly Laboratory Labeling Codes:
Health 1
Reactivity 0
Special A
Primary Physical and Health Hazards: Not hazardous if intact. Severe Allergen.
Caution Statement: Intact Cephalexin Capsules and Tablets are not considered to be a health hazard.
Cephalexin Capsules and Tablets contains cephalexin which causes severe allergic reactions.
Routes of Entry: Inhalation and skin contact.
Effects of Overexposure: Capsules and tablets are intended for human consumption under guidance of
a physician. Capsules and tablets are not considered hazardous under normal handling
procedures. Allergic reactions to cephalexin monohydrate have been reported. Allergic reactions to
contents of capsules or to the powder used to make the tablets may include rash, nasal congestion,
cough, dry throat, and eye irritation.
Medical Conditions Aggravated by Exposure: Hypersensitivity to penicillin or cephalosporin.
Carcinogenicity: Cephalexin monohydrate - No carcinogenicity data found. Not listed by IARC, NTP,
ACGIH, or OSHA.
Section 4 - First Aid Measures
Eyes: Flush eyes with plenty of water. Get medical attention.
file://Z:\Legacy\EXTRACT 30NOV2006\MSDS_html\4271800.html 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.
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).
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information. Filled capsules and compressed tablets 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.
file://Z:\Legacy\EXTRACT 30NOV2006\MSDS_html\4271800.html 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.
Section 9 - Physical and Chemical Properties
Appearance: White or colored powder finished as capsules or coated tablets
Odor: Odorless
Boiling Point: Not applicable
Melting Point: No applicable information found
Specific Gravity: No applicable information found
pH: No applicable information found
Evaporation Rate: No applicable information found
Water Solubility: Slightly 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: May emit toxic fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Acute Exposure
No data are available for Cephalexin Capsules and Tablets. Toxicity data for cephalexin monohydrate
and cephalexin hydrochloride are presented.
Oral: Cephalexin monohydrate - Rat, 5000 mg/kg, no deaths, increased urine output, weight loss.
Monkey, 1000 mg/kg, no deaths, diarrhea.
Skin: Cephalexin monohydrate - Rabbit, 153 mg/rabbit, no deaths or toxicity.
Inhalation: Cephalexin hydrochloride - Rat, 1990 mg/m3 for 4 hours, no deaths.
file://Z:\Legacy\EXTRACT 30NOV2006\MSDS_html\4271800.html Intravenous: Cephalexin monohydrate - Rat, 700 mg/kg, no deaths or toxicity.
Dog, 100 mg/kg, no deaths, vomiting, tarry stools.
Skin Contact: Cephalexin monohydrate - Rabbit, nonirritant
Eye Contact: Cephalexin monohydrate - Rabbit, slight irritant
Chronic Exposure
No data are available for Cephalexin Capsules and Tablets. Toxicity data for cephalexin monohydrate
are presented.
Target Organ Effects: Cephalexin monohydrate - No effects identified in animal studies.
Other Effects: Cephalexin monohydrate - Salivation and vomiting.
Reproduction: Cephalexin monohydrate - No effects identified in animal studies.
Sensitization: Cephalexin monohydrate - No applicable information found.
Mutagenicity: Cephalexin monohydrate - Not mutagenic in bacterial cells.
Section 12 - Ecological Information
No applicable ecological information found. 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. file://Z:\Legacy\EXTRACT 30NOV2006\MSDS_html\4271800.html U.S. Regulations
Cephalexin monohydrate
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
Contains cephalexin monohydrate (C = 14-96%)
Xn (Harmful)
Xi (Irritant)
Risk Phrases
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 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 CompanyHazard Communication317-277-6029For additional copies contact: Eli Lilly and Company 1-800-LILLY-Rx (1-800-545-5979) GLOSSARY:
ACGIH = American Conference of Governmental Industrial HygienistsAIHA = American Industrial Hygiene AssociationBEI = Biological Exposure Index file://Z:\Legacy\EXTRACT 30NOV2006\MSDS_html\4271800.html CAS Number = Chemical Abstract Service Registry NumberCERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)CHAN = Chemical Hazard Alert NoticeCHEMTREC = Chemical Transportation Emergency CenterDOT = Department of TransportationEC = European CommunityEINECS = European Inventory of Existing Chemical SubstancesELINCS = European List of New Chemical SubstancesEPA = Environmental Protection AgencyHEPA = High Efficiency Particulate Air (Filter)IARC = International Agency for Research on CancerICAO/IATA = International Civil Aviation Organization/International Air Transport AssociationIEG = Lilly Interim Exposure GuidelineIMO = International Maritime OrganizationKow = Octanol/Water Partition CoefficientLEG = Lilly Exposure GuidelineLEL = Lower Explosive LimitMSDS = Material Safety Data SheetMSHA = Mine Safety and Health AdministrationNA = Not Applicable, except in Section 14 where NA = North AmericaNADA = New Animal Drug ApplicationNAIF = No Applicable Information FoundNCI = National Cancer InstituteNIOSH = National Institute for Occupational Safety and HealthNOS = Not Otherwise SpecifiedNTP = National Toxicology ProgramOSHA = Occupational Safety and Health AdministrationPEL = Permissible Exposure Limit (OSHA)RCRA = Resource Conservation and Recovery ActRQ = Reportable QuantityRTECS = Registry of Toxic Effects of Chemical SubstancesSARA = Superfund Amendments and Reauthorization ActSTEG = Lilly Short Term Exposure GuidelineSTEL = Short Term Exposure LimitTLV = Threshold Limit Value (ACGIH)TPQ = Threshold Planning QuantityTSCA = Toxic Substances Control ActTWA = Time Weighted Average/8 Hours Unless Otherwise NotedUEL = Upper Explosive LimitUN = United NationsWEEL = Workplace Environmental Exposure Level (AIHA) file://Z:\Legacy\EXTRACT 30NOV2006\MSDS_html\4271800.html

Source: http://ehs.lilly.com/msds/msds_cephalexin_capsules_and_tablets.pdf