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EC number: 701-162-1
CAS number: -
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
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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