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EC number: 701-162-1 | CAS number: -
Correction of the obtained NOAEL/LOAEL of the read-across supporting substance
The registration substance is a weak acid and the read-across supporting substance is the corresponding weak base. When dissolved in water the read-across supporting substance will be converted to the registration substance
Since the conversion from salt to acid form is likely to occur already in the gastro-intestinal tract when given orally to the animals, there should be no bioavailability difference based on the molar dose. The obtained NOAEL of the read-across supporting substance should be therefore corrected, considering the molecular mass difference (420 g/mol vs ca. 530 g/mol). In the presented key study, the applied doses were 8, 40, 200 mg/kg bw, corresponding to 6, 30 and 160 mg/kg bw for the registration substance. For the DNEL derivation the dose levels of 6 mg/kg bw as LOAEL will be used.
TTC for Cramer II/III (EFSA Journal 2012; 10(7):2750) is to be applied for the general population for oral routes.
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