Registration Dossier
Registration Dossier
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EC number: 202-180-8 | CAS number: 92-70-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
When testing BONA in a subacute oral toxicity study in rats the outcome was as follows: Bodyweight, food consumption and animal behavior were unaffected by treatment with the test substance and mortality, neurological impairment, eye opacities and pathological findings in oral cavity or teeth were not evident at all dose levels. At 12 mg/kg/day, no signs of toxicity attributable to treatment with the test substance were evident. At 60 mg/kg/day, male animals were unaffected by treatment, whereas a relationship of necrosis in the adrenal cortex in one female at 60 and one female at 300 mg/kg/day to treatment with the test item could not be entirely discounted. In addition, at 300 mg/kg/day a transient increase in water consumption, decreased serum phosphate levels and increased bilirubin concentrations in serum and urine were evident in both sexes and slightly increased liver to body weight ratios in females. Histopathological hepatic correlates were not evident.
The no-observed-effect-level (NOEL) was 60 mg/kg/day for male animals and 12 mg/kg/day for female animals.
Multi-focal or diffuse necrosis is an effects considered to support classification for specific target organ toxicity following repeated exposure. For a 28d study the guidance value for Cat 1 is ≤30 and for Cat 2 is >30 and ≤300 mg/kg bw.
Necrosis in the adrenal cortex was observed in one female at 60 and one female at 300 mg/kg/day in this study but not in male at any dose level. In another study (OECD 415) doses up to 200 mg/kg were tested for up to 11 (females) or 14 weeks (male). In this study no necrosis in the adrenal cortex were observed.
Since the effect was only seen in 2 of 20 animals in a single study and was not reproducible in a further study with comparable dose levels and a longer treatment period this findings were considered to be not significant and consequently insufficient to meet criteria for classification as Cat 2 STOT RE.
Justification for classification or non-classification
The low incidence of necrosis in the adrenal cortex and the fact that these effects were not reproducible in another study with comparable dose levels and a prolonged treatment period are indicative that these findings were rather incidental then treatment related. Consequently these findings were considered to be not robust enough to meet the requirements for classification as Cat 2 STOT RE.
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