Registration Dossier
Registration Dossier
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EC number: 215-951-9 | CAS number: 1459-93-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Dimethyl isophthalate was tested in two bacterial mutagenicity assays, and found to be negative. While DMIP was reported in a non-GLP study to result in an increase in chromosomal aberrations in Chinese Hamster lung cells, careful review of the experimental procedure found that concurrent toxicity controls were not run (Chung, 2007). When the study was repeated in an OECD compliant protocol under GLP with concentrations associated with low to moderate toxicity as noted by mitotic indices, there were no increased rates of chromosomal aberrations (Royand Jois, 2013). DMTP was negative in numerous in vitro genotoxicity studies (see toxicology review by BG Chemie, 2005). An in vivo micronucleus study showed positive results with DMTP, but the study was confounded with excessive toxicity of the DMSO vehicle. A later micronucleus study by the U.S. National Toxicology Program (NTP) showed no increase in polychromatic erythrocytes after exposure of mice to DMTP (BG Chemie, 2005). The substance is evaluated as non-genotoxic.
Justification for selection of genetic toxicity endpoint
Guideline study under GLP
Short description of key information:
Not mutagenic in bacteria, not clastogenic or mutagenic in mammalian cells.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The substance does not induce mutations or chromosome breakage, and it is evaluated to be non-mutagenic and non-genotoxic. According to Regulation EC No. 1272/2008, the substance is not classified.
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