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2525 West End Avenue, Suite 950 Nashville, TN 37203, USA Page 1 of 3 VERSION DATE: March 13, 2006; Valid Until Revised MATERIAL SAFETY DATA SHEET KRISTALOSE Cumberland Pharmaceuticals believes the information provided herein is accurate but makes no representations or warranties, either expressed or implied, and assumes no responsibility for any damage or injuries, which may result from use or reliance upon this information. Material Name: KRISTALOSE Chemical Formula: C12H22O11 Molecular Weight: 342.3 Synonyms: Lactulose, Lactulose Crystals, 4-O-β-D-Galactopyranosyl-D-fructofuranose. Characteristics: KRISTALOSE is an odorless, white crystalline powder which is freely soluble in water. General Use: KRISTALOSE in its finished dosage form is an oral solution intended for the treatment of constipation. While in its reconstituted finished dosage form KRISTALOSE is not regarded as OSHA hazardous. Emergency Telephone Number: 1-615-423-8460 KRISTALOSE CAS Number: 4618-18-2 SECTION I - PRODUCT IDENTIFICATION SECTION II - COMPOSITION SECTION III – HEALTH HAZARD DATA Presents little hazard to human health and the environment. Carcinogenicity: ACGIH, IARC, NTP, and OSHA do not list KRISTALOSE as a carcinogen. Teratogenic Effects: A study performed in rats, mice and rabbits using oral doses of up to three (3) or six (6) times the normal human oral dose revealed no evidence of harm to the fetus due to KRISTALOSE.There are no adequate data regarding the potential reproductive toxicity of KRISTALOSE in a non-rodent species or adequate studies in pregnant women. During pregnancy, KRISTALOSE should be used only if the potential benefit justifies the potential risks to the fetus. Target Organs: Skin, eyes, and respiratory tract. Primary Entry Routes: Inhalation, ingestion, and skin contact. Acute Effects: Eyes: KRISTALOSE may cause mild eye irritation. Skin: KRISTALOSE may cause allergic reactions including pain, burning, itching, rash, swelling, and hives. Respiratory tract: KRISTALOSE is a moderate respiratory hazard, and inhalation of the unfinished product may cause harmful effects to the respiratory tract. Hypersensitization is possible. For additional information, please contact: Quality Assurance, Cumberland Pharmaceuticals Inc., tele: 1-615-255-0068; fax: 1-615-255-0094. 2525 West End Avenue, Suite 950 Nashville, TN 37203, USA Page 2 of 3 Eyes: Gently lift eye lids and flush with water immediately for 15 minutes. Seek prompt medical attention and treatment. Skin: Remove contaminated clothing and wash affected area with copious amounts of water. Then wash with soap and water. Consult a physician if skin becomes irritated. Inhalation: Remove to fresh air immediately and keep at rest and warm. If Kristalose® is inhaled and discomfort occurs, consult a physician promptly. Ingestion: Promptly determine the amount ingested and wash the mouth with water. Consult poison control center or physician. AFTER ADMINISTERING FIRST AID, GET APPROPRIATE MEDICAL SUPPORT. Extinguishing Media: Use water spray, CO2, dry chemical powder, or polymer foam to extinguish. Hazardous Combustion: When heated to decomposition, KRISTALOSE emits toxic fumes. Personal Protective Equipment: Because fire may product toxic decomposition products, wear a self-contained breathing apparatus (SCBA) with a full facepiece operated in pressure-demand or positive-pressure mode. Chemically compatible gloves should also be used. Spill/Leak: If KRISTALOSE is accidentally released, sweep up the material gently to minimize the dust and place the remains in a plastic bag inside a fiber drum. Seal and label the drum with the pertinent information. The remaining traces can be washed down with water. Cleanup personnel should wear a self-contained breathing apparatus (SCBA) with a full facepiece operated in pressure-demand or positive-pressure mode. Chemically compatible gloves should also be used. Disposal must be conducted according to Federal, State and Local regulations. Storage Requirements: Keep closed in original packaging, Handling: KRISTALOSE For Oral Solution is a prescription product and should only be taken under the directions of a physician. Bulk handling requires no specific handling precautions. SECTION IV – FIRST AID MEASURES SECTION V – FIRE AND EXPLOSION DATA SECTION VI – SPILL AND LEAK MEASURES SECTION VII – HANDLING AND STORAGE SECTION VIII – SPECIAL PROTECTION DATA Skin Protection: When handling bulk quantities of KRISTALOSE, chemically-compatible, rubber gloves should be worn to avoid skin contact. Respiratory Protection: When working with KRISTALOSE a NIOSH-approved respirator with particulate filters should be worn to avoid inhalation of the material. Ventilation: Local exhaust systems should be provided to maintain airborne concentrations at levels that promote worker safety. Comments: Never eat, drink, or smoke around work areas, and practice good hygiene after using this material, especially before eating, drinking, or smoking, etc. For additional information, please contact: Quality Assurance, Cumberland Pharmaceuticals Inc., tele: 1-615-255-0068; fax: 1-615-255-0094. 2525 West End Avenue, Suite 950 Nashville, TN 37203, USA Page 3 of 3 Molecular Weight: 342.30 Bulk Density: N/A Appearance: White, crystalline powder Odor: Odorless Melting Point: 164 – 169 °C Solubility: Soluble in water Stability: Stable at storage temperatures of 20 – 25°C and under normal storage and handling conditions. Chemical Incompatibilities: Avoid interactions with oxidant substances Conditions to Avoid: N/A Hazardous Products of Decomposition: When heated to decomposition, acrid smoke and toxic fumes and gases are produced. Toxicity Data: Rat, oral, LD50: 15000 mg/kg body weight Mice, oral, LD50 : 20000 mg/kg body weight Ecotoxicity: Data not listed Environmental Effects: Data not listed Disposal: KRISTALOSE is biodegradable through an active sledge waste water treatment plant. To dispose, dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all applicable Federal, State and Local laws. . Shipping Name: Not regulated Hazard class: Not regulated No data given SECTION IX – PHYSICAL DATA SECTION X – REACTIVITY DATA SECTION XI – TOXICOLOGICAL DATA SECTION XII – ECOLOGICAL DATA SECTION XIII - DISPOSAL SECTION XIV – TRANSPORTATION INFORMATION SECTION XV – REGULATORY INFORMATION SECTION XVI – OTHER INFORMATION Disclaimer: While reasonable care and attention has been paid to the compilation of data in this material safety data sheet, Cumberland Pharmaceuticals Inc. extends no warranties and assumes no responsibility regarding the accuracy or suitability of such information as it pertains to the purchaser’s intended use. For additional information, please contact: Quality Assurance, Cumberland Pharmaceuticals Inc., tele: 1-615-255-0068; fax: 1-615-255-0094.
