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EC number: 208-796-3
CAS number: 542-02-9
In order to avoid unnecessary animal testing one of the three
genetic toxicity tests (which are required by Annex VII and VIII of
REACH regulation) was read acrossed from Benzoguanamine. It was decided
to support the negative AMES test by the performance of a test according
to OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test) and
to propose a Read-Across approach for the endpoint "8.4.2. In
vitro cytogenicity study in mammalian cells or in vitro micronucleus
Justification for Read-Across:
Irrespective of metabolic
activation Acetoguanamine was not able to induce reverse mutations in Salmonella
typhimurium just as Benzoguanamine did not in the Ames test. The
molecule structure of Acetoguanamine supports the negative effect. It is
completely integrated in the structure of Benzoguanamine. There are no
additional functional groups which could be relevant regarding
structural alerts for mutagenicity. Since Benzoguanamine showed no
obvious potential to impact genomic integrity it can be assumed that
Acetoguanamine will show the same properties.
According to OECD TG 473 and GLP two tests
were performed with Benzoguanamine. In
the first test Benzoguanamine was tested for chromosomal aberation with
human lymphocytes cells in concentrations up to 2500 µg/mL with and
without metabolic activation system. There was no evidence for
cytotoxicity with metabolic activation system within and above the
solubility limit. Cytotoxicity was detected without metabolic activation
system within and above the solubility limit (Pateman 1993). In
the second test Benzoguanamine was tested for chromosomal abberation in
Chinese Hamster Lung (CHL) cells with and without metabolic activation
system. Cytotoxicity was observed without metabolic activation system.
Findings for cytoxicity with metabolic activation system was ambiguous
(Nakajima 1999). The cytogenetic effect observed in in vitro
assays however, could not be reproduced in the micronucleus tests in
vivo (Honarvar 2000).
In accordance to Directive 67/548/EEC,
respectively Regulation (EC) No 1272/2008, Acetoguanamine does not need
to be classified for genotoxicity.
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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