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EC number: 205-381-9
CAS number: 139-89-9
Epidemiological and animal studies are not
available for the evaluation of the carcinogenic potential of Na3HEDTA.
Therefore the carcinogenicity studies with Na3EDTA have been used for
evaluation. (For read-across justification also refer to section 13). A
bioassay of Na3EDTA for possible carcinogenicity was conducted by
administration of test material in the diet to Fischer 344 rats and
B6C3F1 mice. Although, a variety of tumors occurred among test and
control animals of both species, no tumors were treatment related. Taking
together the negative results of the carcinogenicity study and as well
as the general non-mutagenicity after oral doses it can be concluded
that there is no concern on a carcinogenic potential of HEDTA and EDTA.
Negative findings were obtained for
structurally related substances in in tests for gene mutation /
mutagenicity in vitro and in vivo. In addition, in vivo carcinogenicity
studies in the rat and mouse have not revealed any statistical
significant increace in tumour type or incidence.
Non-classification is justified on the basis
of negative findings in accordance with Regulation (EC) No.
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