Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

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.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
Sufficient details available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

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. 1272/2008.