Potassium carbamoylcarbamate

Endpoint summary

Additional information

Potassium allophonate was negative in an in vitro bacterial reverse mutation assay (Ames assay) performed according to GLP and OECD Testing Guideline 471 (Covance, 2012g). In this test, two bacterial species, Salmonella typhimurium and Escherichia coli, were tested at potassium allophonate concentrations up to 5000 µg/plate both in the presence and absence of a rat liver S9 microsomal fraction metabolic activation system. In an in vitro micronucleus assay performed according to GLP and OECD Testing Guideline 487, potassium allophonate was studied for its potential to induce micronuclei formation in human lymphocytes in the absence and presence of a rat liver S9 microsomal fraction metabolic activation system. Potassium allophonate did not induce biologically relevant micronuclei in cultured human peripheral blood lymphocytes when tested up to 10 mM in both the absence and presence of S9 and, therefore, the results of this test were determined to be negative. An in vitro mammalian cell gene mutation assay (MGMA), performed under GLP and according to OECD Testing Guideline 476, is available testing potassium allophonate. In this study, mouse lymphoma L5178Y cells were tested at concentrations of potassium allophonate up to 10 mM both in the absence and presence of a rat liver S9 microsomal fraction metabolic activation system. In this study, potassium allophonate did not induce mutation at the thymidine kinase locus when tested with and without metabolic activation; therefore, the results of this study were determined to be negative.

References:

Covance. 2012g. Reverse mutation in four histidine-requiring strains of Salmonella typhimurium and one tryptophan-requiring strain of Escherichia coli. Testing laboratory: Covance Laboratories Ltd, Otley Road, Harrogate, North Yorkshire HG3 1PY ENGLAND. Report no.: 8249504. Owner company: Kerr Fire Fighting Chemicals, Ashcroft Road, Knowsley Industrial Park, Kirby, Liverpool L33 7TS. Study number: 8249504. Report date: 2012-04-23.

Covance. 2012h. Mutation at the thymidine kinase (tk) locus of mouse lymphoma L5178Y cells (MLA) using the Microtitre fluctuation technique. Testing laboratory: Covance Laboratories Ltd Otley Road, Harrogate, North Yorkshire HG3 1PY ENGLAND. Report no.: 8251472. Owner company: Kerr Fire Fighting Chemicals, Ashcroft Road, Knowsley Industrial Park, Kirby, Liverpool L33 7TS. Report date: 2012-10-15.

Covance. 2012i. Induction of micronuclei in cultured human peripheral blood lymphocytes. Testing laboratory: Covance Laboratories Ltd Otley Road, Harrogate, North Yorkshire HG3 1PY ENGLAND. Report no.: 8251471. Owner company: Kerr Fire Fighting Chemicals, Ashcroft Road, Knowsley Industrial Park, Kirby, Liverpool L33 7TS. Report date: 2012-04-24.

Short description of key information:
Potassium allophonate was negative for mutagenicity in an in vitro micronucleus test according to Good laboratory Practices (GLP) and Organisation for Economic Co-operation and Development (OECD) Testing Guideline 487, an in vitro bacterial reverse mutation assay according GLP and OECD Testing Guideline 471 and an in vitro L5178Y TK+/- mouse lymphoma forward mutation assay according to GLP and OECD Testing Guideline 476.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Potassium allophonate was negative for mutagenicity in an in vitro micronucleus test according to GLP/OECD Testing Guideline 487, an in vitro bacterial reverse mutation assay according to GLP/OECD Testing Guideline 471 and an in vitro L5178Y TK+/- Mouse lymphoma forward mutation assay according to GLP/OECD Testing Guideline 476.Given the absence of positive results in mutagenicity assays, potassium allophonate is not considered genotoxic and therefore does not warrant classification for genetic toxicity.