Registration Dossier
Registration Dossier
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EC number: 203-571-6 | CAS number: 108-31-6
Carcinogenicity
Administrative data
Description of key information
Maleic anhydride has low concern for carcinogenicity
Key value for chemical safety assessment
Justification for classification or non-classification
According to Directive 67/548/EEC, no classification is proposed for this substance based on the tests results.
Additional information
An oral feeding carcinogenicity study has been conducted for maleic anhydride and another one for maleic acid. Both studies are likely to reflect the toxicity of maleic acid since maleic anhydride is rapidly hydrolyzed to maleic acid in the body, particularly by the oral route of exposure.
Maleic anhydride
Maleic anhydride Male and female rats were exposed to 0, 10, 32, or 100 mg/kg/day maleic anhydride in feed, seven days a week for two years. There was only marginal toxicity, which was evidenced by small (<6%), but dose-related, decrease in body weights of male rats fed 32 and 100 mg/kg/day compared to the controls. The female rats fed 32 and 100 mg/kg/day also had reduced body weights, but the reductions were smaller and of shorter duration than those observed in males. Food consumption was also slightly reduced during limited periods during the study for animals in the mid- and high- dose groups. There were no increases in tumor incidence that were considered related to maleic anhydride exposure. There was an unusually high incidence of uterine adenocarcinomas in this study. These lesions were present in similar numbers in control and treated animals (23/86 and 20/82, respectively). The report stated that “Uterine adenocarcinomas is not a common spontaneous lesion in this strain of rats,” although no historical control data was provided. It is unclear why the incidence of uterine adenocarcinomas was high in this particular study both in the controls and the treated animals. But, it does not appear to be related to exposure to maleic anhydride. The authors speculated that this may have been related to altered hormonal status caused by the continuous light exposure since there were problems with the animal room lighting control system which resulted in exposure to continuous light for an unknown period.
Maleic acid
In a two-year chronic feeding study, Osborne-Mendel rats were fed 0, 0.5, 1.0, or 1.5% (0, 5000, 10000 and 15000 ppm) maleic acid in their diets for two years. These concentrations can be approximated to correspond with doses of (0, 250, 500 and 750 mg/kg/day) assuming a 0.4 kg rat eats 20g food/day. Concentrations of 1.0 and 1.5% maleic acid retarded the growth rate of rats and all concentrations of maleic acid increased mortality rate. However, no treatment-related increase in tumors was reported (Fitzhugh and Nelson, 1947).
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