Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Salmonella Typhimurium /Eschericia coli Reverse Mutation Assay (OECD 471): positive

In vitro Micronucleus Assay in V79 cells (OECD 487): positive

Additional information

Methacrolein was tested in an Salmonella Typhimurium /Eschericia coli Reverse Mutation Assay (OECD 471). Strains tested are TA 1535, TA 100, TA 1537, TA 98 and E.coli WP2 uvrA in a dose range of 10 µg - 5200 µg/plate (SPT), with and without metabolic activation. Under the experimental conditions of this study, the test substance Methacrolein is mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the presence of metabolic activation (BASF, 2018).

Methacrolein was testd in an in vitro Micronucleus Assay in V79 cells (OECD 487). The exposure time were 4 and 24 hours in a dose range of 1.5 - 24.0 µg/mL with and without metabolic activation.Thus, under the experimental conditions described, Methacrolein is considered to have a chromosome-damaging (clastogenic) effect or to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells in the absence and the presence of metabolic activation (BASF, 2018).

Justification for classification or non-classification

Based on the available studies data on genetic toxicity properties the test item would have to be classified and labelled as suspected of causing genetic defects (cat. 2, H341) according to Regulation (EC) No 1272/2008 (CLP).