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Toxicological information

Carcinogenicity

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Description of key information

No studies are available. The available data from genetic toxicity and sub-chronic toxicity studies do not suggest a concern for carcinogenicity and it is proposed that testing shall be waived on the basis that sufficient information is available on the end-point by reference to structurally related substances.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data are available on the chronic toxicity or carcinogenicity of trimellitic anhydride (TMA). Adequate testing for genetic toxicity in vitro has revealed no evidence of genotoxicity, suggesting that the substance is not a genotoxic carcinogen. Numerous sub-chronic toxicity studies are available for the substance and do not indicate any pre-neoplastic effects. The endpoint of concern for this substance is clearly identified as respiratory sensitisation. Read-across studies for the hydrolysis product trimellitic acid similarly do not indicate any concerns and demonstrate very low sub-chronic toxicity.

 

TMA is a cyclic anhydride and many cyclic anhydrides have a similar structure, containing a bicyclic ring structure with the carboxylic acid anhydride group being the reactive and toxicologically functional moiety. The bicyclic ring structure may be saturated or partially unsaturated and may contain substituted methyl derivatives. Substances with substituted methyl groups may exist as several isomeric forms.

 

While little information on the carcinogenicity of cyclic anhydrides is available, long-term feeding studies of phthalic anhydride in rodents has revealed no evidence of carcinogenicity [Kluwe WM, McConnell EE, Huff JE, Haseman JK, Douglas JF, Hartwell WV (1982); Carcinogenicity testing of phthalate esters and related compounds by the National Toxicology Program and the National Cancer Institute. Environmental Health Perspectives, 45: 129–133; Shelby MD, Stasiewicz S (1984) Chemicals showing no evidence of carcinogenicity in long-term, two-species rodent studies: The need for short-term test data. Environmental Mutagenesis, 6: 871–878;

Kluwe WM (1986) Carcinogenic potential of phthalic acid esters and related compounds: Structure activity relationships. Environmental Health Perspectives, 65: 271–278; Haseman JK, Huff JE, Zeiger E, McConnell EE (1987) Comparative results of 327 chemical carcinogenicity studies. Environmental Health Perspectives, 74: 229–235].

 

The available data do not suggest a concern and it is proposed that testing shall be waived on the basis that sufficient information is available on the end-point.

Justification for classification or non-classification

No classification is proposed. There is no evidence from genetic toxicity or sub-chronic toxicity studies that the substance is likely to be carcinogenic.