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Three Ames tests were performed covering Salmonella typhimurium as well as Escherichia coli strains without and with S9 metabolic activation: in none of the tested strains an increase of colonies at whatever dose could be found. The number of revertants was always similar to the control. In an in vivo micronucleus assay in mice, the test substance did not lead to an increase in the number of polychromatic erythrocytes containing either small or large micronuclei. Thus, phthalide has no chromosome-damaging (clastogenic) effect nor does it lead to any impairment of chromosome distribution in the course of mitosis (aneugenic activity) in bone marrow cells in vivo. There is no genotoxic effect for phthalide to be determined.

Short description of key information:
Three reliable in vitro (BASF 2005, BASF 1979 and Kuroda 1986) and one in vivo test (BASF 2005) for genetic toxicity are available. Of the Ames tests the latest BASF study (40M0360/054048, 2005) was taken as key study as S. typhimurium TA100, 1537 and 98 as well as E. coli WP2 uvrA were tested according to OECD guideline 471 and EPA OPPTS 870.5100 with and without metabolic activation at 55-5500 µg/plate and with all valid controls. This study confirmed the result of the other two showing no mutagenic capacity of the test substance. Also in the in vivo study (BASF 26M0360/054030, 2005), a micronucleus assay performed in mice treated orally with 187.5-750 mg/kg bw according to OECD guideline 474 and EPA OPPTS 870.5395, there was no genotoxic effects to be found.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification