Registration Dossier
Registration Dossier
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EC number: 202-180-8 | CAS number: 92-70-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Toxicity to reproduction: other studies
Additional information
When testing BONA in a one generation reproduction toxicity study in rats the outcome was as follows:
NOEL for systemic toxicity in P male: 12.5 mg/kg bw, based on forestomach lesions at 50 mg/kg bw.
NOEL for systemic toxicity P female: 50 mg/kg bw, based on forestomach lesions and adverse effects on bodyweight gain at 200 mg/kg/bw.
NOEL for reproductive toxicity P male 200 mg/kg bw (=highest dose tested).
NOEL for reproductive toxicity P female: 50 mg/kg bw, based on growth retardation of pups possibly related to suppressed lactation at 200 mg/kg/day.
NOEL for reproductive toxicity and teratogenicity F1 male/female: 50 mg/kg bw/day (=actual dose received by parental animals P), based on growth retardation (bodyweight of pups lower than concurrent controls) and malformations (in pups from a limited number of litters) at 200 mg/kg/day.
In summary, it can be stated that in this study male and female fertility (related to delivery performance) is not impaired. But there might be an effect via lactation causing a reduced body weight gain of the pups. Additionally malformations were observed in a limited number of litters appearing simultaneously with maternal toxicity at the highest dose tested.
In conclusion there are suspicious signs that the test item may cause harm via lactation and may cause malformations at doses associated with parenteral systemic toxicity. But for a final conclusion on classification without further testing available data alone were considered to be insufficient and not robust enough.
Justification for classification or non-classification
In summary, it can be stated that in this study male and female fertility (related to delivery performance) is not impaired. But there might be an effect via lactation causing a reduced body weight gain of the pups. Additionally malformations were observed in a limited number of litters appearing simultaneously with maternal toxicity at the highest dose tested.
In conclusion there are suspicious signs that the test item may cause harm via lactation and may cause malformations at doses associated with parenteral systemic toxicity. But for a final conclusion on classification without further testing available data alone were considered to be insufficient and not robust enough.
Additional information
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