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EC number: 701-263-0
CAS number: -
Dermal application of DGEBPA to pregnant rabbits produced maternal
toxicity as exhibited by a dose-related increase in erythema, fissuring,
hemorrhage and edema at the site of application. Pregnant rabbits in the
300 mg/kg/day treatment group exhibited moderate to severe erythema,
fissures, hemorrhage and slight edema resulting in a maximum mean skin
irritation/damage score of 2.7 for erythema/eschar, 2.6 or greater for
erythema and/or edema is considered to represent significant maternal
toxicity in the rabbit by the Test Rules Development Branch, U.S.E.P.A.
(Locke, 1985). The degree of erythema, fissuring and hemorrhage observed
in high dose rabbits clearly meets and exceeds the standard for adequate
maternal toxicity communicated by the Test Rules Development Branch,
U.S.E.P.A. and represents a type of damage to the integument which
dramatically altered the integrity of the skin. In general, the skin
lesions observed in rabbits in the 100 mg/kg/day dose group were less
severe than the lesions observed in rabbits in the high dose group and
did not develop to the extent which would result in a mean skin
irritation/damage score of 2.0 or greater. However, the individual skin
response in rabbits in the 100 mg/kg/day dose group showed considerable
variation with some rabbits in this group developing lesions of similar
severity to that observed in rabbits from the 300 mg/kg/day dose group.
The average dermal response of rabbits in the 30 mg/kg/day dose group
was characterized as barely perceptible erythema and was
indistinguishable from erythema caused by the occlusive bandages/jacket
used to hold the test material in place. Since most pregnant control
rabbits showed similar low levels of skin erythema, the skin response
observed in rabbits from the 30 mg/kg/day dose group was not considered
toxicologically significant. No other treatment-related clinical signs
or systemic toxicity were observed in this study.
Although dermal exposure of pregnant rabbits to 300 mg DGEBPA/kg body
weight/day produced maternal toxicity, no indication of embryo/fetal
toxicity or teratogenicity was observed at any dose level tested. The
statistically significant decrease in pregnancy rate and deviation from
a binomial distribution of the fetal sex ratio observed in the 30
mg/kg/day dose group were considered random events in view of the lack
of a dose-response for these parameters. A small number of fetuses
scattered throughout the dose levels exhibited malformations. Although
the majority of these malformations occurred in the DGE BPA exposure
groups, the frequency of specific malformations were low and did not
show a dose-response. In addition, most of the malformations observed
also occurred at low frequencies in historical control New Zealand White
rabbit data generated in this laboratory and thus were not considered
due to exposure to DGEBPA.
Diglycidyl ether of bisphenol A (DGEBPA) was tested for its embryo/fetal
toxicity and teratogenicity in pregnant rabbits. DGEBPA was applied
daily to the backs (clipped free of hair) of New Zealand White rabbits
at dose levels of 0 (polyethylene glycol, vehicle control), 30, 100 or
300 mg/kg body weight/day at a dose volume of 1 ml/kg body weight/day on
days 6 through 18 of gestation. Twenty six inseminated rabbits were used
per dose group resulting in a minimum of 20 pregnant rabbits per
exposure level. An occlusive bandage of absorbent gauze and
non-absorbent cotton was placed over the dosing area on the back of each
rabbit. The bandage was held in place for a minimum of 6 hours/day using
a lycra/spandex jacket. Following the occlusion period the bandage and
jacket were removed.
Maternal toxicity was observed among pregnant rabbits in the 300 mg/kg
dose group as evidenced by moderate to severe erythema, fissures,
hemorrhage and slight edema at the exposure site. Similar, but less
severe skin lesions were observed in pregnant rabbits in the 100
mg/kg/day exposure group. Skin effects (slight erythema) observed in
pregnant rabbits in the 30 mg/kg/day dose group were not considered
toxicicologically significant. No evidence of embryo/fetal toxicity or
teratogenicity was observed at any dose level resulting in a
embryo/fetal no-observed-effect level of 300 mg/kg body weight/day.
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