Registration Dossier
Registration Dossier
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EC number: 209-008-0 | CAS number: 552-30-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Ames test
Two studies were conducted to evaluate the mutagenic potential of trimellitic anhydride (TMA), and its ability to induce back-mutations at selected loci of several strains of Salmonella typhimurium, specifically, TA 98, TA 100, TA 1535, TA 1537 and TA 1538. This is indicative of a chemical's genotoxic potential. San & Wagner (1991) concluded that TMA did not cause a positive response when tested both in the presence and absence of metabolic activation in the form of S-9 reaction mixture (microsomal enzymes prepared form Aroclor-induced rat liver) . Similarly, San & Olson (1991) reported findings indicating that TMA did not cause a positive response with any of the tester strains, both in the presence and absence of metabolic activation.
Mammalian cell mutation
Two studies were included to assess the mutagenic potential of trimellitic anhydride, based upon its ability to induce forward mutations at the HGPRT locus of CHO cells. Based on the results of an experiment conducted by Bigger & Sigler (1991), the test article was found to be negative in both the absence and presence of exogenous metabolic activation in the form of S-9 reaction mixture (microsomal enzymes prepared form Aroclor-induced rat liver). In a separate study conducted by Jacobson-Kram & Sigler (1991), similar results were observed, with TMA negative in both the absence and presence of exogenous metabolic activation.
Clastogenicity
In a study in CHO cells conducted by Putman &Morris (1991), it was concluded that TMA did not increase the number of chromosome aberrations observed in either the non-activated or S-9 activated test system. In a separate study again conducted by Putman & Morris (1990) similar results were observed, concluding that trimellitic anhydride was negative in the CHO cytogenetics assay both in the presence and absence of metabolic activation.
Short description of key information:
No evidence of genetic toxicity was seen in two Ames tests, two mammalian mutation assays (CHO / HGPRT) or in two studies of clastogenicity in CHO cells.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The available studies do not indicate any potential for genetic toxicity. Therefore no classification is required for trimellitic anhydride under CLP.
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