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EC number: 216-823-5
CAS number: 1675-54-3
There were no treatment-related
histopathologic effects in any organs or tissues of males or females
given 50 mg/kg/day.
A two-year oral gavage toxicity/oncogenicity
study of Bisphenol A Diglycidyl Ether (BADGE) was initiated in Fischer
344 rats. Groups of 65 Fischer 344 rats/dose level were dosed with BADGE
suspended in a Tween** 80 and methylcellulose vehicle at dose levels of
0, 50, 250 or 1000 mg/kg/day. The study was terminated on test days 99
(males) or 101 (females) due to excessive toxicity noted in rats given
250 or 1000 mg/kg/day. Standard toxicologic parameters consistent with
OECD guideline #408 were evaluated on a subset of ten rats/sex/dose
Progressive decreases in body weights and
feed consumption, relative to controls, occurred throughout the study in
males and females given 250 or 1000 mg/kg/day. By the end of the study,
body weights of males and females given 1000 mg/kg/day were 19.2 and
10.9% lower than controls, respectively, and body weights of males and
females given 250 mg/kg/day were 10.8 and 5.1% lower than controls,
respectively. Body weights of females given 50 mg/kg/day were 3.2% lower
than controls, while body weights of males given 50 mg/kg/day were
comparable to controls throughout the study.
Treatment-related alterations in hematology
(decreases in red blood cell count, hemoglobin concentration, and
hematocrit), clinical chemistries, urinalysis, and organ weights
occurred in rats given 250 or 1000 mg/kg/day. Some clinical chemistry
and urinalysis alterations were indicative of renal toxicity, while
organ weight alterations were reflective of lower feed consumption and
body weights. The only treatment-related clinical
pathology alteration in male and female rats
given 50 mg/kg/day was increased cholesterol. The only treatment-related
gross pathologic observation was increased size of the cecum in males
given 250 or 1000 mg/kg/day, and in females given 1000 mg/kg/day. Two
males and one female given 1000 mg/kg/day that died prior to study
termination had moderate to severe acute necrosis of renal proximal
tubules. Treatment related histopathologic effects in surviving animals
given 250 and/or 1000 mg/kg/day were noted in the adrenal glands, cecum,
ileum, kidneys, liver, testes, and uterus. Males and females given 50
mg/kg/day had no treatment-related histopathologic effects.
Based on alterations in body weights and
serum cholesterol in rats given 50 mg/kg/day, a no-observed-effect level
(NOEL) was not determined. However, since these alterations were not
associated with detrimental effects, the dose of 50 mg/kg/day was
interpreted to be the no-observed-adverse-effect level (NOAEL).
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