Registration Dossier
Registration Dossier
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EC number: 247-728-7 | CAS number: 26479-35-6
Carcinogenicity
Administrative data
Description of key information
Data waiver.
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
Genotoxicity assays on potassium allophonate were performed according to OECD Guidelines and showed a lack of genotoxicity. No carcinogenicity data are available for potassium allophonate. However, given the negative in vitro and in vivo genotoxicity results for potassium allophonate and a lack of neoplasia/hyperplasia in a read-across repeated dose study on urea, it is unlikely that potassium allophonate is carcinogenic.
Additional information
According to Column 2 of the Registration, Evaluation and Authorisation of Chemicals (REACH) regulation, Annex X, a carcinogenicity study may be required 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. Based on the available data, potassium allophonate would not classify as a mutagen. No hyperplasia and/or pre-neoplastic lesions were identified in the read-across repeated-dose oral toxicity study (Fleischman et al., 1980) on urea.
Reference:
Fleischman, R. W. Baker, J. R. Hagopian, M. Wade, G. G. Hayden, D. W. Smith, E. R. Weisburger, J. H. Weisburger, E. K. 1980. Carcinogenesis bioassay of acetamide, hexanamide, adipamide, urea and P-tolylurea in mice and rats. Journal of Environmental Pathology and Toxicology, 3(5-6): 149-70.
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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