Registration Dossier

Administrative data

Description of key information

Acute oral toxicity:
The test item was evaluated in an acute oral toxicity study in rats according to OECD guideline 401 and EPA OPPTS 870.1100 guideline. The results of this study indicate that the test item had no significant toxic effect in the rat following oral administration of a single dose at a Ievel of 5000 mg/kg. Thus the LD50 value for both, male and female animals was greater than 5000 mg/kg bw.
Acute dermal toxicity:
The test item was evaluated in an acute dermal toxicity study in rats according to EU method B.3 and OECD guideline 402. Under the experimental conditions the acute dermal LD50-value of the test item proved to be greater than 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Acute oral toxicity

The acute oral toxicity of the test item was tested in young Wistar rats according to OECD guideline 401 and EPA OPPTS 870.1100 guideline. The acute toxicity of the test item was investigated following administration of a single oral dose. The test item was administered by single gavage. Five animals were employed per sex and dose. No mortality occurred following dosing of the 10 animals at a Ievel of 5000 mg/kg. Observed clinical signs were limited to piloerection which was seen in male animals during the first week of the post -dose observation period. Changes in body weight were within the expected range and necropsy examination revealed no abnormalities. These results indicate that the test substance has no significant toxic effect in the rat following oral administration of a single dose at a Ievel of 5000 mg/kg bw.

Acute dermal toxicity

The acute dermal toxicity was tested in adult young Wistar rats according to EU method B.3 and OECD guideline 402 . The test item was administered as a single dermal dose to rats in a concentration of 5000 mg/kg bw. Five rats were used per sex. Neither male rats nor female rats died at this dose level nor did they show marked signs of toxicity during the study period. The post mortem inspection revealed no abnormalities.

Under the experimental conditions the dermal LD50 of the test item in rats was found to be above 5000 mg/kg bw.

Justification for classification or non-classification

Based on the results obtained in the oral toxicity study (LD50, rat = > 5000 mg/kg bw) the test item has not to be classified and labelled according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).

Based on the results obtained in the dermal toxicity study (LD50, rat = > 5000 mg/kg bw) the test item has not to be classified and labelled according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).