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Toxicological information

Neurotoxicity

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Description of key information

Specific studies on neurotoxicity are only available on BPA, for which a developmental neurotoxicity study according to OECD guideline 426 reported no evidence of developmental neurotoxicity.

Key value for chemical safety assessment

Additional information

For considerations on the analogue approach used please refer to the reporting form attached to section 13 of the IUCLID.

BPA:

A robust study in rats conducted under OECD and US EPA guidelines (Stump, 2009) reported no evidence of developmental neurotoxicity at any of the tested concentrations of BPA. BPA was continuously administered to rat dams during gestation and lactation via test diets containing 0, 0.15, 1.5, 75, 750, and 2250 ppm BPA. Reduced body weight and body weight gain was observed in dams and F1 males and females at 750 and 2250 ppm BPA. There were no effects observed at any exposure level in the neurobehavioural and neuropathological evaluations of F1 animals. A systemic NOAEL of 75 ppm (corresponding to 5.85 mg/kg/day during gestation and 13.1 mg/kg/day during lactation) for reduction in body weight and weight gain of dams and offspring was determined. A NOAEL for developmental neurotoxicity of 2250 ppm (corresponding to 164 mg/kg/day during gestation and 410 mg/kg/day during lactation) in offspring was determined, as there was no evidence of developmental neurotoxicity at any tested dose, including the highest dose of 2250 ppm BPA.

Justification for classification or non-classification

Classification not warranted based on the hazard profile of the constituents of the reaction mass.