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Description of key information

LD50 oral (rat) > 2000 mg/kg, based on available studies.

Key value for chemical safety assessment

Additional information

Two studies were available concerning acute oral toxicity.

One of them (CIT, 2003) was with reliability 1 according to Klimisch cotation criteria and was selected as key study. The other one (Rhône-Poulenc, 1977) was with reliability 2 and was selected as supporting study.

The summary of the key study is the following:

In an acute oral toxicity study (CIT, 2003), groups of Sprague-Dawley rats (male/female) were given a single administration of Guetol by gavage, at doses of 200 and 2000 mg/kg in corn oil.Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item.

Mortality occured in 1/3 female given 2000 mg/kg on day 2.

Clinical signs observed were hypoactivity, sedation, piloerection and dyspnea. They were fully reversible within 6 days.

Body weight in animals given 2000 mg/kg bw were reduced during the first week of the study, compared to the historical controls.

Under these experimental conditions, the LD50 by oral route was determined to be higher than 2000 mg/kg bw.

Based on these results, Guetol is considered as not harmful by oral route,according EC classification criteria (CLP 1272/2008).

The LD50 obtained in the second study was 2180 mg/kg bw, and supported the result obtained in the key study.

Justification for classification or non-classification

Based on the two available studies and according to EU classification criteria, guetol is not classified for acute toxicity by oral route.