Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Applying a weight-of-evidence approach 1,6-Hexanediol Diglycidylether (HDDGE) is not genotoxic. HDDGE was mutagenic only in the in vitro Ames/Salmonella gene mutation assay. When treatment was in vivo in rats and mice HDDGE induced no evidence of chromosome damage or repairable DNA damage.


Short description of key information:
1,6-Hexanediol Diglycidylether (HDDGE) was evaluated for genotoxic potential in the standard Ames/Salmonella gene-mutation assay and two in vivo tests. HDDGE was positive in the Ames/Salmonella mutation assay. However, HDDGE was negative for induction of chromosome damage in an oral mouse micronucleus test and an in vivo/in vitro rat hepatocyte UDS test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Data is insufficient for the Classification and Labeling of 1,6-Hexanediol Diglycidylether (HDDGE) as a Mutagen based on negative findings in two in vivo test for genotoxicity.