1,3-Benzenediol, 4-butyl-

Endpoint summary

Additional information

Salmonella typhimurium, Reverse Mutation Assay of 4 -butylbenzene-1,3 -diol was carried out in compliane with the OECD Guidelines for Testing of Chemicals (No 471, section 4, Health Effects) on conduct of Bacterial Reverse Mutation Test, adopted 21 July 1997, OPPTS Guideline 870.5100 and as per mutually agreed protocol. 4 -Butylbenzene-1,3 -diol was evaluated in the Ames/Salmonella Plate Incorporation Assay to determine its ability to induce reverse mutation at selected histidine loci in five tester strains of Salmonella typhimurium TA1535, TA97A, TA98, TA100 and TA102 in the presence and absence of metabolic activation system (S9). Based upon the preliminary tests conducted to assess the solubility/precipitation and cytotoxicity of the test substance, the tester strains were exposed to the test article in triplicate cultures at the doses of 500ug, 150ug, 50ug, 15ug and 5ug/plate, both with and without metabolic activation system (S9). Liver S9, induced in Sprague Dawley rats by phenobarbitone with B-naphthoflavone, was used for this purpose. Dimethyl sulfoxide was used as a vehicle. The exposed bacteria were plated onto minimal glucose agar medium supplemented with L-histidine. The plates were incubated at 37 deg C for 48-72 hours after which the histidine revertant colonies were counted and their frequency was compared with that in the vehicle control group. Concurrent negative control group and positive control groups were also included in the experiment, as specified by the test guideline. Results of this testindicated that the frequencies of histidine revertant colonies at all concentrations of 4 -butylbenzene-1,3 -diol in strains TA1535, TA97A, TA98, TA100 and TA102, with and without the presence of metabolic activation system, were comparable to those observed in the vehicle control group, as per criteria employed for evaluation of mutagenic potential, and this observation was confirmed by repetition of the experiments. Plate counts for the spontaneous histidine revertant colonies in the vehicle control groups were found to be within the frequency ranges expected from the laboratory historical control data at the test facility. They also compared well with the range reported in the literature. Concurrent positive controls demonstrated sensitivity of the assay with and without metabolic activation. It is concluded that, under the conditions of the study, 4 -butylbenzene-1,3 -diol is non-mutagenic in Salmonella typhimurium strains TA1535, TA97A, TA98, TA100 and TA102.

Short description of key information:
Results of this test indicated that the frequencies of histidine revertant colonies at all concentrations of 4-butylbenzene-1,3-diol in strains TA1535, TA97A, TA98, TA100 and TA102, with and without the presence of metabolic activation system, were comparable to those observed in the vehicle control group, as per criteria employed for evaluation of mutagenic potential, and this observation was confirmed by repetition of the experiments. Plate counts for the spontaneous histidine revertant colonies in the vehicle control groups were found to be within the frequency ranges expected from the laboratory historical control data at the test facility. They also compared well with the range reported in the literature. Concurrent positive controls demonstrated sensitivity of the assay with and without metabolic activation. It is concluded that, under the conditions of the study, 4-butylbenzene-1,3-diol is non-mutagenic in Salmonella typhimurium strains TA1535, TA97A, TA98, TA100 and TA102.

Endpoint Conclusion: No adverse effect observed (negative)