Butyl glycollate

Endpoint summary

Additional information

Butyl glycollate (96%) was investigated for its potential mutagenic activity in the in vitro reverse gene mutation assay in bacteria with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA in the absence and presence of a metabolic activation (S9-mix).

No bacteriotoxicity was observed up to the highest concentration of 15000 µg/plate ±S9-mix. In the absence of metabolic activation no increase in the number of revertants was observed expect for Salmonella typhimurium strain TA 100. However, the increase was not concentration dependent and could generally only be observed at concentrations exceeding the current limit concentration of 5000 µg/plate. In the presence of a metabolic activation no increase in the number of revertant colonies was observed at any bacterial tester strains. Thus, an ambiguous result was observed –S9-mix, while butyl glycollate was clearly not mutagenic in the presence of metabolic activation in bacteria strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coli WP2 uvrA in the presence of metabolic activation. A weak indication of

mutagenicity, if any, was observed in the absence of metabolic activation at high doses in one bacterial strain

only (Mueller W, 1988).

A more recent in vitro bacterial reverse gene mutation test with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium revealed clearly no mutagenic potential of butyl glycollate (98.1%) the absence and presence of metabolic activation (Mueller W, 1996).

The potential clastogenic potential of butyl glycollate (97.3%) was investigated in V79 Chinese hamster in the absence and presence of a metabolizing system. No cytotoxicity was observed up to the highest achievable dose level (1320 µg/ml, about 0.1 mM) for the test system). Butyl glycollate (97.3%) did not induce chromosomal aberrations in V79 Chinese hamster cells, neither in the presence nor in the absence of a metabolic activation system (Mueller W, 1989).

Butyl glycollate (97.9%) was investigated for its potential mutagenic activity in the in vitro mammalian cell gene mutation test with L5178Y mouse lymphoma cells in the absence and presence of S9-mix. No cytotoxicity was observed and neither +S9-mix nor –S9-mix any induction in the mutation frequency was observed as indicated by the absence of altered incidences in large and small colonies. Thus, butyl glycollate (97.9%) was not mutagenic in the in vitro mammalian cell gene mutation test with mouse lymphoma L5178Y cells when tested up to limit dose of 1333 µg/ml (corresponding to about 0.01 M, Verspeek-Rip CM, 2010)).

In summary, Butyl glycollate (Polysolvan O) was investigated in the complete test battery of mutagenicity tests in vitro currently required (bacterial reverse gene mutation test, mammalian chromosomal aberration test, mammalian gene mutation test). An ambiguous result was obtained in one Ames test as Salmonella typhimurium strain TA100 showed an increased number of revertants in the absence but not in the presence of metabolic activation. Moreover, the increase was not concentration dependent and could only be observed at concentrations above the current limit concentration. All other tester strains were clearly negative. No mutagenic effect was observed in the presence of metabolic activation in all bacterial strains. A subsequently performed Ames test was clearly negative with/without metabolic activation including Salmonella typhimurium strain TA100. Thus, butyl glycollate is finally considered to reveal no mutagenic potential in bacteria. In mammalian cell systems in vitro, butyl glycollate (Polysolvan O) showed no clastogenic activity and no potential to induce gene mutations, both in the presence or absence of metabolic activation. Finally, butyl glycollate (Polysolvan O) was shown to possess no mutagenic/clastogenic potential in vitro.

Short description of key information:
Butyl glycollate (Polysolvan O) was finally considered to reveal no mutagenic potential in bacteria and were negative in mammalian cell systems with regards to gene mutation and chromosome aberration.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, classification as a genotoxic substance is not triggered according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.