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EC number: 700-128-3 | CAS number: -
A 28-day oral toxicity study was performed with Reaction Product of Bisphenol A (BADGE) with IPDA in male and female CRL (WI) Wistar rats. Dose levels administered in this study were selected from a preceding 14-day dose-range-finding toxicity study performed in the same strain of rats (LAB study code: 07/523-100PE).
A control and three dose groups (n= 5 animals per group and sex) were involved in the study. The test item was administered in concentrations of 0 mg/mL, 5 mg/mL, 16 mg/mL and 40 mg/ml prepared in Polyethylene glycol 400 corresponding to 0 mg/kg bw/day 25 mg/kg bw/day, 80 mg/kg bw/day and 200 mg/kg bw/day doses at a 5 mL/kg bw treatment volume.
Stability and homogeneity of test item in this vehicle was analytically proven. Reaction Product of Bisphenol A (BADGE) with IPDA was stable at concentrations of 0.5 mg/mL and 50 mg/mL in this vehicle at room temperature for 72 hours (92 % and 101 %, respectively; LAB study code 07/523-316AN). Analytical control of dosing solutions was conducted on days 3 and 25. The measured concentrations ranged from 91 % to 105 % of nominal concentrations.
General clinical observations were made once daily. A detailed clinical examination was made before the first treatment, then once a week outside the home cage. A functional observation battery was conducted on the last day of the treatment period. Body weight and food consumption were measured weekly. Clinical pathology examinations and gross necropsy were conducted at the end of the treatment period. The absolute and relative organ weights of adrenals, brain, epididymides, heart, liver, kidney, spleen, testes, and thymus were determined. A full histopathological examination was performed on the preserved organs and tissues of the animals of Groups 1 and 4.
No mortality occurred during the study.
Clinical observations :
There were no test item related clinical signs during the treatment period. The behaviour and the general condition of the test animals were normal during the study. There was no treatment-related effect on motor activity or in the functional observation battery tests across groups of treated male and female animals and no findings indicative for neurotoxicity were observed.
Body weight and Food consumption :
There were no significant differences in the body weight and body weight gain and in the mean daily food consumption between the control and test item treated groups.
Clinical pathology :
Haematology revealed marginal changes in the mean ratio of neutrophil cells and in the ratio of lymphocytes at 200 mg/kg bw/day male and female animals and in a single female animal at 80 mg/kg bw/day. The mean values of changes were within historical control ranges and thus not considered adverse toxicological effects. At the clinical chemistry examinations, a slightly elevated activity of alanine aminotransferase was observed in male and female animals at 200 mg/kg bw/day, but within the historical control ranges and with no correlations in organ weight or histopathology. Therefore, this variation was not considered toxicologically relevant.
Organ pathology :
Specific alterations related to treatment with the test item were not observed at the necropsy, organ weight or histopathology examinations.
Reaction Product of Bisphenol A (BADGE) with IPDA caused no adverse toxic effects in male or female CRL:(WI) BR rats after 28-day subsequent oral (by gavage) administration at 25 mg/kg bw/day, 80 mg/kg bw/day or 200 mg/kg bw/day.
However, a slight statistically significant test item influence was found on the white blood cell picture in male animals at 200 mg/kg bw/day. Changes in the female 200 mg/kg bw/day dose group were comparable, but not statistically significant. Similar changes were also observed in one single female animal at 80 mg/kg bw/day.
At 200 mg/kg bw/day, test item related changes in enzyme activity of alanine aminotransferase were observed.
At 25 mg/kg bw/day, there were no test item related effects.
The no observed effect level (NOEL) was 25 mg/kg bw/day.
The no observed adverse effect level (NOAEL) was 200 mg/kg bw/day.
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