TOXICOLOGY OF DIETHYLENE GLYCOL BUTYL ETHER .4. DERMAL SUBCHRONIC REPRODUCTION STUDY IN RATS

The subchronic and reproductive toxicity of diethylene glycol butyl et her (DGBE) by the dermal route was evaluated in Sprague-Dawley rats us ing a novel combined protocol. DGBE was administered dermally at 10 or 30% v/v in aqueous solutions or undiluted (100%) for 13 weeks under o cclusion, 6 hr/day, 5 days/week at a maximum attainable volume of 2 mL /kg. Satellite groups of male and female rats were treated with the to p dose of DGBE for 13 weeks, mated, and the females were treated throu gh day 20 of gestation and allowed to deliver and nurse their offsprin g through day 21 of lactation (weaning). DGBE produced dermal irritati on, which was dependent on concentration in incidence, severity, and t ime of onset and was more severe in females than in males. No correspo nding histopathology was evident. The only suggestion of a systemic ef fect was a slightly increased incidence of urinary occult blood at stu dy termination in the females receiving the 30% or 100% DGBE dose. The re was no evidence of histopathologic changes in the testes, and vagin al cytology indicated no adverse effect on estrous cycling. There were no effects on reproductive performance of the DGBE-treated males and females. Litters delivered by treated females contained the same numbe r of live pups as control litters and the growth and survival of pups within the treated litters was comparable to control. No reproductive or systemic toxicity was observed at the highest dose tested-2 g/kg/da y.