Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Two studies are available for acute oral toxicity: one in rats showing a combined oral LD50 equal to 3170 mg/kg bw with 95% confidence limits between 2260 and 4000 mg/kg bw, and one supporting study in mice showing an oral LD50 of 3600 mg/kg bw.
In an acute dermal toxicity study similar to OECD guideline 402, mortality was 0/5 male and 0/5 female at 2000 mg/kg bw and 4/5 males and 1/5 female at 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 170 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Two studies are available for acute oral toxicity: one in rats showing a combined oral LD50 equal to 3170 mg/kg bw with 95% confidence limits between 2260 and 4000 mg/kg bw, and one supporting study in mice showing an oral LD50 of 3600 mg/kg bw.

In an acute dermal toxicity study similar to OECD guideline 402, mortality was 0/5 male and 0/5 female at 2000 mg/kg bw and 4/5 males and 1/5 female at 5000 mg/kg bw.

Justification for classification or non-classification

LD50 in acute oral and dermal toxicity studies conducted similar to OECD guidelines were higher than 2000 mg/kg bw therefore the substance is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).