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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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).