Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ames test:

A reverse gene mutation assay has been conducted in line with Guidance for Screening Mutagenicity Testing of Chemicals (Japan) and OECD Test Guidelines 471 and 472, using the pre-incubation method. Strains TA100, TA1535, TA98, TA1537 of S. typhimurium and Escherichia coli Wp2 uvrA were exposed to a structural analogue of the substance, tetrahydromethylphthalic anhydride (MTHPA), in DMSO at concentrations of 0, 62.5, 125, 250, 500, 1000, 2000 ug/plate (-S9 mix) and 0, 156, 313, 625, 1250, 2500, 5000 ug/plate (+S9 mix) in the presence and absence of mammalian metabolic activation (S9 mix, Rat liver, induced with Phenobarbital and 5,6-benzoflavone). Tetrahydromethylphthalic anhydride was tested up to limit concentration (5000 µg/plate). No cytotoxicity occurred. The test chemical did not induce mutations in the S. typhimurium and E. coli strains.


Short description of key information:
Genotoxicity in-vitro: Bacterial reverse mutation - Negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on results of the three different in vitro genetic toxicity studies, tetrahydromethylphthalic anhydride (MTHPA) was not classified and labelled as genotoxic according to Directive 67/548/EEC (DSD) and to Regulation 1272/2008/EC (CLP).