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Key value for chemical safety assessment

Additional information

Resorcinol generally showed no evidence of activity in bacterial mutation assays. In mammalian cells in culture, it induced chromosome aberrations (breaks and micronuclei), but no SCE effects. In an in vitro Unscheduled Synthesis Assay in rat hepatocytes, resorcinol is negative. In an OECD TG 476 (in vitro thymidine kinase locus) under GLP conditions, resorcinol is positive without activation in the L5178Y mouse lymphoma cells; however, the observed induction of small colony mutants is associated with chromosome aberrations. A repeat of this study was conducted in 2009 with two experiments within the same study. Resorcinol was negative in the mouse lymphoma cells L5178Y, tested up to the limit concentration (1101 ug/mL), gave 37% and 26% relative survival with and without S-9 metabolic activation, respectively. In an OECD TG 487 (in vitro Micronucleus assay) under GLP conditions, resorcinol is positive with and without activation in female human lymphocytes. In an in vitro Syrian hamster embryo cell morphological transformation assay following OECD, FDA and MHLW guidelines under GLP conditions, resorcinol is negative. Several in vivo studies suggest that it does not induce micronuclei or SCE in mammals. Resorcinol was negative for inducing micronuclei in six in vivo micronucleus assays in which one study was conducted following OECD TG 474 under GLP conditions. In one of two NTP in vivo micronucleus assays, resorcinol was positive for inducing micronuclei. Resorcinol was negative in three sister chromatid exchange assays. In a transgenic mouse model, resorcinol was negative for activating RasH2. In studies to evaluate the effectiveness of the transgenic mouse model, resorcinol was negative in p53+/- while positive in Tg.AC. While resorcinol appears to induce chromosome aberrations in vitro, based on the weight of evidence, these findings suggest that resorcinol is not genotoxic in vivo. 


Short description of key information:
While resorcinol appears to induce chromosome aberrations in vitro, based on the weight of evidence, these findings suggest that resorcinol is not genotoxic in vivo.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

While resorcinol appears to induce chromosome aberrations in vitro,based on the weight of evidence, these findings suggest that resorcinol is not genotoxic in vivo.