Registration Dossier

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.