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Toxicological information

Carcinogenicity

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Description of key information

One chronic study is available with EDTA-CaNa2 in rats, and two supporting chronic studies are available with EDTA-Na3H in rats and mice, respectively (see also read across document in section 13).

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study 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

No treatment-related tumours were observed following chronic exposure to either EDTA-CaNa2 or EDTA-Na3H. In addition, other chelates did not demonstrate any pre-neoplastic or neoplastic lesions in repeated dose toxicity studies.

Justification for classification or non-classification

Because no treatment-related tumours have been observed following chronic exposure to EDTA-CaNa2, and no treatment-related tumours have been observed following chronic exposure to EDTA-Na3H, and no such effects are expected for EDTA-CuNa2, this substance does not need classification for this endpoint.