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EC number: 249-951-5 | CAS number: 29911-28-2
Groups of 12 male and 12 female Crl:CD(SD) rats were administered dipropylene glycol n-butyl ether (DPnB) daily, by gavage at dose levels of 0 (control), 100, 300, or 1000 mg/kg/day. Females were dosed once daily for two weeks prior to breeding, through breeding (two weeks), gestation (three weeks), and lactation up to postpartum day 4. Females were necropsied on postpartum day 5. Males were dosed for two weeks prior to breeding and continuing through breeding (two weeks) until necropsy (test day 29). Effects on reproductive function as well as general toxicity were evaluated. In addition, postmortem examinations included a gross necropsy of the adults with collection of organ weights and histopathologic examination of tissues. Litter size, pup survival, sex, body weight, and the presence of gross external abnormalities were also assessed. On the first day of dosing with 1000 mg/kg/day of DPnB, three females exhibited a transient, subtle, incoordinated gait which resolved within 1-2 hours after dosing and was not seen again for the remainder of the study. The only other treatment-related clinical observation was transient, post-dosing salivation (clear perioral soiling) noted sporadically in several high-dose males and females. This salivation was considered to be a local response to the taste of the test material, rather than evidence of toxicity. Treatment-related increases in the incidence of hepatocellular hypertrophy occurred in males of all dose groups, and in females given 300 or 1000 mg/kg/day DPnB. The hypertrophy corresponded with increased liver weights in the 1000 mg/kg/day males and females, and 300 mg/kg/day males (absolute and relative weights affected). These changes were considered to be an adaptive response associated with increased hepatic metabolism of DPnB. Treatment-related increases in absolute and relative kidney weights also were found in males and females given 1000 mg/kg/day. In addition, hyaline droplet formation in the proximal renal tubules was observed in males given 300 or 1000 mg/kg/day. Females given 1000 mg/kg/day had treatment-related higher mean absolute and relative kidney weights, but a histopathologic correlate to the higher kidney weights was lacking. There were no treatment-related effects on any reproductive parameters. The no-observed-adverse-effect level (NOAEL) for systemic toxicity was considered to be 100 mg/kg/day, based on very slight to slight hepatocellular hypertrophy with no corresponding increases in liver weights in low-dose males. The no-observed-effect level (NOEL) for reproductive effects was 1000 mg/kg/day, the highest dose tested. According to EU classification and labeling criteria, DPnB is not classified as a reproductive toxicant and is not required to be labeled.
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