Registration Dossier

Administrative data

Description of key information

Bisphenol A, a structural analog for 2-Acetone polymer with phenol (BPA-Tars) was assessed for systemic adverse effects in a manner similar to O.E.C.D. Test Guideline No. 408 90-day subchronic feeding study in rats.  

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
37 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Bisphenol A, a structural analog for 2 -Acetone polymer with phenol (BPA-Tars) was assessed for systemic adverse effects in a 90 -day subchronic feeding study with rats in a manner similar to O.E.C.D. Test guideline No. 408. On the basis of the results obtained it appears that Bisphenol A did not induce any signs of overt toxicity even at the top—dose level of 2500 ppm in the diet. The changes observed at this level which may be of toxicological relevance consisted of reduced body weight gain accompanied by decreased feed consumption. The increased incidence of alopecia was not accompanied by morphological changes. Since no changes of toxicological significance were found in the mid—dose group, 500 ppm is considered a no—toxic effect level. In this study this dose level was equivalent to a daily intake of approximately 37 mg Bisphenol /kg body weight/day. These data suggest that BPA-Tars would have a similar No Observed Adverse Effect Level (NOAEL) under the conditions of this study.

Justification for classification or non-classification

No signficant adverse systemic and/or target organ effects were observed. Therefore, no Classification and Labeling is required for repeated-dose target organ effects.