Registration Dossier

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.