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
Effects on fertility
Additional information
In a two-generation reproductive toxicity study, rats were dosed via gavage to 0, 20, 55 and 150 mg/kg/day maleic anhydride. The NOAEL for reproductive effects is 55 mg/kg/day (highest dose tested due to parental death at 150 mg/kg/day.) However, in the parental group adverse effects (mortality, body weight changes, and respiratory irritation) were observed at 150 mg/kg/day (the highest dose tested.) In addition, there were histopathological effects in the kidneys and bladder of the parental animals (first generation only) in all treated dose groups. The LOAEL for parental effects is 20 mg/kg/day.
Short description of key information:
NOAEL=55 mg/kg/day for reproductive effects in rat.
NOAEL=20 mg/kg/day for parental effects in rat.
Effects on developmental toxicity
Description of key information
NOAEL=140 mg/kg/day for developmental toxicity in rat.
Additional information
No developmental toxicity was observed when pregnant rats were dosed with maleic anhydride via gavage to 0, 30, 90 and 140 mg/kg/day. The dams in all dose groups either lost weight or failed to gain weight between days 6 and 9 of gestation; however, this effect was not statistically significant at any interval and was reversible. As a result, the NOAEL (maternal) was determined to be 140 mg/kg/day.
Justification for classification or non-classification
According to Directive 67/548/EEC, no classification is proposed for this substance.
Additional information
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