Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

The very low potential for systemic toxicity after oral dosage is adequately documented in the range-finder study for the 28-day study in rats (MHLW 1996). Here, no mortality was observed after repeated dosing of 2000 mg/kg bw; enlargement of the cecum was the sole effect observed. In a study with very limited documentation, a LD50 of 11700 mg/kg bw in rats was reported, supporting the assessment of a very low toxic potential of the substance.

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 toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 Classification, Labelling, 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 toxicity under Regulation (EC) No. 1272/2008.