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EC number: 203-988-3 | CAS number: 112-59-4
Four groups, each consisting of 20 Fischer 344 rats per sex, were exposed for 6 hours per day, 5 days per week, for 14 weeks to the vapor of ethylene glycol hexyl ether) at target concentrations of 0 (control), 20, 40, or 85 ppm and followed by 4 week recovery period.. Actual mean concentrations obtained for this study were 20, 41, and 71 ppm ethylene glycol hexyl ether.
Rats were received from breeding Laboratories. Rats were kept for acclimatization for 5 days. At study initiation rats were of approximately 9 weeks old. Rats were housed 2/cage in stainless steel cages with wire mash bottoms. Rats were provided ad libitum feed and municipal water except during exposure. The animals were kept on a 12-hour photoperiod throughout the study.
Monitors for toxic effects included clinical observations, body weight, food and water consumption, ophthalmology, hematology, clinical chemistry, urinalysis, organ weights, and macroscopic and microscopic tissue evaluations.
The principal sign observed in males that was considered to be exposure related was a urogenital wetness in the 71 ppm group. Urogenital wetness was also observed in female rats, but in a dose-related manner among ethylene glycol hexyl ether-exposed groups. On a daily basis, the urogenital wetness was principally observed after the exposure rather than in the morning (before the exposure). The urogenital wetness was primarily observed beginning during week 6 of the study and continued until the termination of exposures. Also, beginning about week 9 and continuing until the termination of exposures, rats of the 71 ppm group were observed lying on their sides during the daily exposures. There were no significant signs observed during the recovery period. There were no mortalities during the study.
Consistent statistically significant decreases in body weight gain were observed in the 71 ppm males (weeks 5-12) and females (weeks 5-14), and in the 41 ppm females (weeks 6-12). There were no exposure-related decreases in body weight gain observed in any group during the recovery period. There were no statistically significant differences in absolute body weight for any of the groups at the end of the exposure or recovery period.
Statistically significant Increases in food and water consumption were observed in the 71 ppm males at the end of the exposure regimen (day 93). A significant increase in food consumption was observed in the 71 ppm females at the end of both the exposure regimen (day 94) and the recovery period (day 122). Other statistically significant differences were considered to be spurious as they were observed in the 20 ppm group with no effects observed in the 41 ppm group, i.e. no dose-response effect.
There were no exposure-related ocular effects observed during the study. There were no biologically significant alterations were observed in hematology parameters for rats monitored at 14 weeks or following a four week recovery period. There were no biologically significant alterations were observed in urinalysis parameters for rats monitored at 14 weeks or following a four week recovery period. There were no biologically significant alterations were observed in serum chemistry parameters for male rats monitored at 14 weeks or following a four week recovery period.
However, decreases in transaminases (AST and ALT) and sorbitol dehydrogenase (SDH), and Increases in alkaline phosphatase (ALP) were observed at the end of the exposure period for female rats exposed to 71 ppm ethylene glycol hexyl ether vapor. No similar effects were observed on these enzyme levels at the end of the recovery period for female rats exposed to 71 ppm of ethylene glycol hexyl ether vapor. However, there was a statistically significant increase in gamma-glutamyl-transferase for the 71 ppm females at the end of the recovery period.
Increased absolute and/or relative liver and kidney weights in both sexes of the 71 ppm group and, to a lesser extent, in the 41 ppm group. However, there were no exposure-related macroscopic or microscopic abnormalities found in this study. There were no exposure-related effects on the potential primary target tissues for glycol ethers of blood and testes. The changes observed at 41 ppm and below were not considered to be biologically significant, while the effects observed at 71 ppm, although not severe, were considered to be related to exposure to ethylene glycol hexyl ether vapor and thus to have biological relevance.
Based on the data from this study, 41 ppm is considered to be the concentration at which no biologically significant toxic effects were observed. Although the toxic effects observed at 71 ppm were generally mild, the spectrum of body weight, clinical chemistry, and organ weight effects, some of which persisted into the recovery period, are considered to be treatment related and thus to be biologically relevant in assessing potential health effects from this material.
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