1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

Endpoint summary

Additional information

When tested up to dose levels of 5000 µg/plate, Perkalink 900 was not mutagenic in the Ames test. In contrast, Perkalink 900 showed clastogenic activity in the in vitro chromosome aberration test both the presence and absence of metabolic activation. However, in the in vivo micronucleus test, at levels up to 3000 mg/kg bw, even in the presence of some evidence of bone marrow toxicity as evidenced by depression of bone marrow proliferation, frequencies of micronucleated polychromatic erythrocytes in animals killed 24, 48 or 72 hours after administration of Perkalink 900 were similar to those in concurrent controls. It was concluded that, under the conditions of this in vivo test, there was no evidence of induced chromosomal or other damage leading to micronucleus formation in polychromatic erythrocytes of mice after oral administration of Perkalink 900. Finally, Perkalink 900 was not genotoxic in the DNA repair assay using hepatocytes obtained from male rat liver following in vivo exposure to the test substance at a level up to 2000 mg/kg bw..

Short description of key information:
Two in vitro and two in vivo genotoxicity studies were available: an Ames test, a chromosome aberration test in vitro, a micronucleus test in vivo and a DNA repair test (UDS) in vivo.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the overal picture of genotoxicity tests with Perkalink 900, with 2 negative in vivo tests, Perkalink 900 does not need classification for genotoxicity.