Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Using 2-(2-butoxyethoxy)ethyl acetate (DEGBEA) , no evidence of mutation was observed in a guideline and GLP (OECD471) bacterial reverse mutation “Ames” study using the Salmonella typhimurium strains TA98, TA100, TA1535, TA1337 and TA1538 with and without metabolic activation. The study was carried out at plate concentrations up to the maximum recommended of 10000ug/plate. There was no evidence for cytotoxicity either at this level. In a separate study, no evidence of mutation was observed in a guideline (OECD472) and GLP bacterial reverse mutation study using E Coli and DEGBEA with and without metabolic activation. The study was carried out at plate concentrations up to the maximum recommended of 10000ug/plate. There was no evidence for cytotoxicity either at this level. Overall, this provides data for all currently required bacterial strains to show that DEGBEA is negative in the bacterial reverse mutation assay(Hoechst, 1988).

There is no further data available on DEGBEA. There is however data on the metabolite of DEGBEA, 2-(2-butoxyethoxy)ethanol (DEGBE). A justification for read across to this substance is included as a separate document within the IUCLID dossier.

The lack of genotoxic potential of DEGBE (and hence DEGBEA) in the bacterial reverse mutation study was confirmed in a recent reverse mutation assay using bacteria strains S. typhimurium strains TA98, TA100, TA1535, TA1537 and E coli WP2uvrA. Tthere was no evidence of mutation with and without metabolic activation up to the maximum dose which did not cause significant cell toxicity (Envigo, 2017).

In an in vitro cytogenicity assay using Chinese Hamster Ovary cells with and without metabolic activation, there was no evidence of cytogenic properties when tested at doses up to those that cause cytotoxicity (Thompson, 1984).

In a GLP and guideline in vitro forward gene mutation assay at the HGPRT locus of CHO cells, DEGBE did not elicit a positive response when tested up to the maximum recommended dose of 5000ul/ml with and without S9 metabolic activation (Lindscombe, 1987).

In a rat hepatocyte unscheduled DNA synthesis assay, DEGBE did not induce any activity when tested at doses up to a level that caused overt cytotoxicity (Thompson, 1984)


Short description of key information:
Reverse mutation in Salmonella bacteria (5 strains), with and without metabolic activation (Ames): negative
Cytogenicity assay, CHO cells with and without metabolic activation: negative with surrogate substance.
Gene mutation assay, HGPRT locus of CHO cells with and without metabolic activation: negative with surrogate substance

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Evidence suggests no significant genotoxic potential.