Registration Dossier
Registration Dossier
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EC number: 239-407-5 | CAS number: 15375-84-5
Carcinogenicity
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.
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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