Registration Dossier

Administrative data

Description of key information

The substance did not cause mortality upon oral or dermal exposure of rats at the limit dose of 2000 mg/kg bw as tested in GLP compliant studies performed according to OECD testing guidelines 401 and 402, respectively (Ciba-Geigy 1992 a and b).

Key value for chemical safety assessment

Additional information

Upon an acute oral administration and a 14 day post-treatment observation period, the LD50 and LD0 of > 2000 mg/kg bw was determined for male and female rats (Ciba-Geigy 1992a). The study followed OECD testing guideline 401 and GLP.. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests and the animals recovered within 4 to 6 days. No deviations from normal morphology were found in all animals at necropsy.

Upon an acute dermal administration and a 14 day post-treatment observation period, the LD50 and LD0 of > 2000 mg/kg bw was determined for male and female rats (Ciba-Geigy 1992b). The study followed OECD testing guideline 402 and GLP.. Piloerection was seen, being a common symptom in acute tests and the animals recovered within 2 days. No deviations from normal morphology were found in all animals at necropsy.

No experimental data is available regarding acute inhalation toxicity.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008.