Registration Dossier
Registration Dossier
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EC number: 203-742-5 | CAS number: 110-16-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Wollny (2010), in vitro gene mutation test: Negative
Lake (1988), Ames test: Negative
Ishidate (1980), Ames test (maleic anhydride): Negative
Ishidate (1980), in vitro chromosome aberration test (maleic anhydride): Ambiguous results
Ishidate (1988), in vitro chromosome aberration test (maleic anhydride): Positive without metabolic activation
Yanasigawa (1987), inhibition of DNA synthesis: DNA synthesis was inhibited
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One Ames test and one in vitro gene mutation assay with maleic acid were negative and DNA sythesis was inhibited in another study.
One Ames test with maleic anhydride also gave negative results. One in vitro chromosome aberration study with maleic anhydride was performed only without a metabolising system and gave positive results, one other in vitro chromosome aberration study with maleic anhydride gave ambiguos results. In the SIDS report on maleic acid and maleic anhydride it is stated that "maleic anhydride is known to hydrolyze to maleic acid in aqueous media. Due to inadequate documentation on this study, it is unclear whether the results were due to the test material itself or a change in pH to an acidic environment, which could have resulted in a non-specific effect."
Overall, it is concluded that maleic acid does not have significant mutagenic potential.
Justification for classification or non-classification
No classification is derived from the results of the mutagenicity tests.
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