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Carcinogenicity

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Description of key information

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

Key value for chemical safety assessment

Justification for classification or non-classification

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