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Description of key information

Full details of these endpoints are provided in the IUCLID dossier and they are considered reliable. The substance is considered "Harmful if swallowed" (Acute tox 4).
Results are presented below:
Female animals: 1320 mg/kg body weight
Male animals did not react more sensitive

Key value for chemical safety assessment

Additional information

According to the key study and the directive 83/467/EC, the product has to be labelled as hazardous with R22 "Hazardous in case of digestion". The testing of acute toxicity of the substance in the Wistar rat gave the following dosage LD50:

Female animals: 1320 mg/kg body weight

Male animals did not react more sensitive

Mortality was observed by the 9th day after gavage

Animals showed besides from unspecific poisoning symptoms an influence movement of body and diarrhoea was observed. Surviving animals did not show symptoms anymor after the 8th day.

According to the supporting study, the acute oral toxicity of the substance was investigated in two of five male and five female CD rats. The animals were started overnight priot to dosing. The test material was administered at dosages of 2000 or 500 mg/kg, at a constant volume-dosage of 10 ml/kg in maize oil. Mortality and signs of reaction to treatment were recorded during a subsequent 14 -day observation period; the surviving animals were killed on the following day. All animals were subjected to necropsy.

Under the conditions of this study the acute oral medin lethal dosage (LD50) was 2116 mg/kg for male and female animals.

Accordingly, the substance was assigned to the class "low oral toxicity"

Justification for classification or non-classification