MATERIAL SAFETY DATA SHEET - Pfizer

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MATERIAL SAFETY DATA SHEET Material Name: Simethicone Oral Suspensions/Drops Page 4 of 7 Revision date: 16-Apr-2008 Version: 1.0 _______________________________________________________________________________________________________ 11. TOXICOLOGICAL INFORMATION General Information: The information included in this section describes the potential hazards of the individual ingredients. Acute Toxicity: (Species, Route, End Point, Dose) Sodium benzoate Rat Oral LD50 4,070 mg/kg Mouse Oral LD50 1600 mg/kg Sorbic acid Rat Oral LD50 7360 mg/kg Mouse Oral LD50 3200 mg/kg Citric acid Rat Oral LD50 3000 mg/kg Sodium cyclamate Rat Oral LD50 1280 mg/kg Sodium saccharin Mouse Oral LD50 17.5 g/kg Rat Oral LD50 14.2 - 17 g/kg Rat Intraperitoneal LD50 7100 mg/kg Hypromellose Rat Oral LD50 > 10,000 mg/kg Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable at the highest dose used in the test. Irritation / Sensitization: (Study Type, Species, Severity) Citric acid Eye Irritation Rabbit Severe Skin Irritation Rabbit Mild Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) Sodium benzoate 10 Day(s) Rat Oral 27370 mg/kg LOAEL Liver, Blood 10 Day(s) Mouse Oral 45 g/kg LOAEL Liver, Kidney, Blood, Ureter, Bladder Sodium saccharin 36 Week(s) Rat Oral 756 g/kg LOAEL Kidney, Ureter, Bladder 54 Day(s) Rat Oral 32400 mg/kg LOAEL Immune system Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s)) Sodium benzoate Embryo / Fetal Development Rat Oral 44 g/kg LOEL Developmental toxicity Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. See below : _______________________________________________________________________________________________________ PZ00809
MATERIAL SAFETY DATA SHEET Material Name: Simethicone Oral Suspensions/Drops Page 5 of 7 Revision date: 16-Apr-2008 Version: 1.0 _______________________________________________________________________________________________________ 11. TOXICOLOGICAL INFORMATION Sodium cyclamate IARC: Group 3 (Not Classifiable) Sodium saccharin IARC: Group 3 (Not Classifiable) 12. ECOLOGICAL INFORMATION Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be avoided. 13. DISPOSAL CONSIDERATIONS Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. 14. TRANSPORT INFORMATION Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. _______________________________________________________________________________________________________ PZ00809
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MATERIAL SAFETY DATA SHEET - Pfizer

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