Registration Dossier
Registration Dossier
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EC number: 918-939-8 | CAS number: 1180558-15-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Two studies with dietary administration to rats (30 days) and male mice (3 weeks) were conducted on the racemic free-acid analogue, however the corresponding reports are not available. The only available data is from a briefly summarised secondary source, and as such is considered to be unreliable and inadequate for risk assessment and classification purposes.
Two long term feeding studies with rats (2 years) and mice (18 months) were conducted with the racemic free-acid analogue (see also section 7.7). The dose levels were 0.1, 0.3, 1.0 and 3.0 mg/kg bw/day. The following results were reported:
rat: NOAEL for toxicity (based on increased mortality and microscopic liver changes, both confined to males at 3.0mg/kg bw/day): 1 mg/kg bw/day. Mouse: NOAEL for toxicity (based on hepatocytic enlargement at 3.0mg/kg bw/day): 1 mg/kg bw/day
Justification for classification or non-classification
Based on the read-across 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 read-across 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.
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