Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Additional information

Concerning urea, positive results obtained in vitro are associated with concentrations well in excess of the recommended limit concentrations and are not considered to be of biological relevance. A positive result in vivo is also associated with an excessive dose level. Considering the physiological role and presence of substantial quantities of urea in the human body, it is not considered likely that this substance is genotoxic. Further testing for genotoxicity is not proposed.

Short description of key information:
An Ames’s test in S. typhimurium according to OECD TG 471 (with and without metabolic activation) is negative. No other data are available with Uronium hydrogen sulphate.
As Uronium hydrogen sulphate readily degrades to urea and sulfuric acid and/or sulfate ions in the human body, the results obtained with these substances are considered:
- Sulfates (as calcium salt): no positive results were obtained in-vitro (Ames, mouse lymphoma assay) or in-vivo (micronucleus test) ;
- Urea: urea is considered extremely unlikely to be genotoxic. Negative results are reported in three Ames tests. Positive results are reported in assays for mutagenicity and clastogenicity in mammalian cells, however the value of these studies are limited by the extremely high test concentrations. A positive result is reported in a mouse bone marrow assay of unconventional design, however this study is not considered to be reliable.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is proposed for genotoxicity. Based on the data on urea sulfate and its degradation products (sulfates and urea), the substance is considered extremely unlikely to be genotoxic.