Registration Dossier
Registration Dossier
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EC number: 228-973-9 | CAS number: 6381-77-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Two in vitro and two in vivo studies indicated that the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) was not mutagenic.
Justification for selection of genetic toxicity endpoint
No endpoint was selected as all studies were negative.
Short description of key information:
In vitro:
Gene mutation (Bacterial Reverse Mutation Assay/Ames test): the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) was not mutagenic in the strains S. typhimurium TA92, TA94, TA98, TA100, TA1535, and TA1537 in the presence and absence of Polychlorinated biphenyls-treated Fischer rat liver S9 metabolic activation. (Similar/equivalent to OECD 471).
Chromosome aberration (in vitro mammalian chromosome aberration): the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) was concluded to be negative for the induction of chromosome aberrations in the presence and absence of Polychlorinated biphenyls-induced Wistar rat S9 metabolic activation in Chinese hamster lung (CHL) cells. (Similar/equivalent to OECD 473).
In vivo:
Chromosome aberration (Dominant lethal assay): the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) was not mutagenic to the rat by the dominant lethal procedure.
Chromosome aberration (heritable translocation assay): the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) did not induce heritable translocation heterozygosity.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available information in the dossier, the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) does not need to be classified for germ cell mutagenicity when the criteria outlined in Annex I of 1272/2008/EC are applied.
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