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EC number: 204-479-9 | CAS number: 121-54-0
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity
In a 28d feeding study, continuous feeding of benzethonium chloride to rats at various dietary levels up to 2500 ppm resulted in a number of changes (e.g. body weights, hematology, biochemistry, urinalysis, organ weights) in the top-dose group. From the results obtained in the present study it was concluded that the no-observed-effect level NOEL of benzethonium chloride was 500 ppm in the diet of rats for 4 weeks. This level was equivalent to an intake of about 40 mg benzethonium chloride/kg body weight/day.
In further subchronic studies, little or no toxic effects were found when Benzethonium Chloride was administered orally or percutaneously. The maximum tolerated dose of Benzethonium Chloride administered subcutaneously was 3.0 and 35 mg/kg in rats and mice, respectively. Chronic oral studies were also generally negative for toxic effects due to Benzethonium Chloride except for a slight increase in mortality and reduced body weight in rats at the high dietary concentration (5000 ppm) in one study. Greatly enlarged ceca were also noted in this latter study. In 1 of 2 chronic subcutaneous studies on Benzethonium Chloride, reduced weight gain was found at the high dose only, and a 13 percent incidence of sarcomas at injection sites was dose related.
Source:
CIR-Report (Lit: Journal of the American College of Toxicology, Volume 4, Number 5, 1985, Mary Ann Liebert, Inc., Publishers)
GLP-report (owner: Lonza)
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
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