Registration Dossier
Registration Dossier
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EC number: 203-571-6 | CAS number: 108-31-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Maleic anhydride and maleic acid were both negative in bacterial gene mutation tests. A single in vitro chromosomal aberration test with and without S-9 was positive for maleic anhydride. Because there is inadequate documentation on this study, it is unclear whether the results were due to maleic anhydride or to a change in pH due to the acidic environment resulted from the hydrolysis of maleic anhydride. Maleic anhydride was negative in an in vivo rat bone marrow chromosomal aberration test. Both maleic anhydride and maleic acid were not carcinogenic when given to rats in their diets for two years up to doses of 100 mg/kg/day.
Short description of key information:
Genetic toxicity in vitro (Bacterial reverse mutation assay): Negative;
Genetic toxicity in vitro (Cytogenetic): Positive;
Genetic toxicity in vivo (Chromosomal aberrations): Negative.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to Directive 67/548/EEC, no classification is proposed for this substance.
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