Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Gene mutation has been investigated in bacteria using strains ofSalmonella typhimuriumandEscherichia coli, in accordance with OECD/EU test methods. Five tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA were used and experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone. The substance, 1, 2, 3, 6 tetrahydrophthalic anhydride (THPA), did not induce reverse mutation in the tester strains, neither in the absence nor presence of S9 metabolism.

Tetrahydrophthalic anhydride (THPA) has been assayed for the ability to cause chromosomal damage in cultured human lymphocytes followingin vitrotreatment in the absence and presence of S9 metabolic activation. Methods used were in accordance with OECD/EU test methods. The substance does not induce chromosomal aberrations in human lymphocytes.

Tetrahydrophthalic anhydride was examined for mutagenic activity by assaying for the induction of 5‑trifluorothymidine resistant mutants in mouse lymphoma L5178Y cells afterin vitrotreatment using OECD/EU test methods. It was concluded that the substance does not induce mutation at the TK locus of L5178Y mouse lymphoma cellsin-vitro.

 

REACH Regulation 1907/2006 (Annex VIII, 8.4 Column 2) states that appropriatein vivomutagenicity studies should be considered in those cases of a positive result in any of the in vitro genotoxicity studies. In vitro investigations were negative and in vivo studies are therefore regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.


Short description of key information:
Negative findings in bacterial reverse mutation test, chromosome aberration test and gene mutation test in mammalian cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Non classification is justified based on negative findings in 3 separate and key in-vitro tests for gene mutation / mutagenicity.