MATERIAL SAFETY DATA SHEET - Pfizer

MATERIAL SAFETY DATA SHEET
Material Name: Simethicone Oral Suspensions/Drops
Page 4 of 7
Revision date: 16-Apr-2008
Version: 1.0
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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 :
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PZ00809