Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Mode of Action Analysis / Human Relevance Framework

Additional information

Two long term feeding studies with rats (2 years) and mice (18 months) were conducted with the racemate (for the corresponding study summaries see section 7.7). The dose levels were 0.1, 0.3, 1.0 and 3.0 mg/kg bw/day. The following results have been reported for the racemate:

rat: NOAEL for toxicity (based on increased mortality and microscopic liver changes, both confined to males): 1 mg/kg bw/day

mouse: NOAEL for toxicity (based on hepatocytic enlargement): 1 mg/kg bw/day

Two studies with dietary administration to rats (30 days) and male mice (3 weeks) were conducted, however the corresponding reports are not available. The only available data is from a brief summarised secondary source, and as such is considered to be unreliable and inadequate for risk assessment and classification purposes.

Justification for classification or non-classification

Based on the results of the chronic/carcinogenicity studies (rat, mouse), the substance does not meet the criteria for classification (harmful – danger of serious damage to health by prolonged exposure) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 3.2.3 and 3.2.4.

Based on the results of the chronic/carcinogenicity studies (rat, mouse), the substance does not meet the criteria for classification (specific target organ toxicity – repeated exposure) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.9.2.