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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Carcinogenicity

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Administrative data

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

Justification for classification or non-classification

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

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.