Registration Dossier

Toxicological information

Carcinogenicity

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Description of key information

EDTA-MnNa2 has a wide dispersive use; however, EDTA-MnNa2 is not classified as mutagen category 3 and there is no evidence from repeated dose studies that EDTA-MnNa2 is able to induce hyperplasia and/or pre-neoplastic lesions.

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

In REACH Annex X column II it is stated: “A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if: the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and the substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.” EDTA-MnNa2 has a wide dispersive use; however, EDTA-MnNa2 is not classified as mutagen category 3 and there is no evidence from repeated dose studies that EDTA-MnNa2 is able to induce hyperplasia and/or pre-neoplastic lesions.

Justification for classification or non-classification

Based on the information indicated above, no classification is needed for EDTA-MnNa2 for this endpoint.