Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
It was concluded that H-MI is not mutagenic in the bacterial reverse mutation assay (JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals) carried out under the experimental conditions.
The test material did not induce any statistically significant, dose-related increases in the frequency of cells with structural or numerical chromosome aberrations either in the presence or absence of a liver enzyme metabolising system or after various exposure times. The test material was therefore considered to be non-clastogenic to CHL cells in vitro (OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test)).
Short description of key information:
Two genetic toxicity studies have been conducted on the test material H-MI ammonium salt, both in vitro (Ames and Chromesome abberration).
All studies have been ranked 'reliability 1' according to the Klimisch et al scale as they were conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Negative results were indicated in both of the genetic toxicity studies.
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