Registration Dossier
Registration Dossier
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EC number: 239-802-2 | CAS number: 15708-41-5
Carcinogenicity
Administrative data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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