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EC number: 203-306-4 | CAS number: 105-54-4
In a repeated-dose inhalation toxicity study, groups of 30 Sprague-Dawley rats of each sex were exposed to concentrations of 0.06, 0.2 or 0.8 mg/l WTPM of smoke from test cigarettes containing Ethyl butyrate(as flavoring agent) together by over 100 other additives. The animals were exposed by nose-only inhalation for 1 h/day, 5 day/week for 13 consecutive weeks or for 13 weeks of recovery from smoke exposure. In addition, groups of 30 rats/sex were exposed to same concentration of smoke from reference cigarettes, similar to the test cigarettes but without flavoring agent or to filtered air only (shame control). Test animals were observed for mortality and moribundity as well as for clinical signs. Individual body weights were recorded biweekly. Respiratory function measurements including Tidal volume (TV), respiratory rate (RR) and minute volume (MV) were measured in 4 rats/sex/group. Samples for blood test and blood clinical chemistry was also collected. At the end of the study, test animals were subject to gross pathological and histopathological examination. In addition, cell proliferation rates were measured on respiratory tract tissues collected from 10 rats of each sex from each exposure group. As seen by the results, no significant mortality occurred, and the exposure-related adverse clinical signs were absent. Minor clinical observations were noted in low incidence. The mean body weights were consistently decreased in male rats exposed to 0.8 mg/l of reference cigarette smoke and in males exposed to all 3 concentrations of test cigarette smoke compared to sham controls. The mean body-weights of all female smoke-exposed was comparable to shame control females through the study, and at the end of 13 week of recovery period, the mean body weight of all the test- and reference smoke-exposed animals were similar to sham control weights. Comparison of organ weights in rats indicated no consistent differences between smoke-exposed group and shame control or between the test and reference smoke-exposed groups at either the interim sacrifice or the recovery sacrifices. Reductions in Respiratory rate (RR) and/or Tidal volume (TV) resulted in consistently lower Minute volume (MV) in rats exposed to test or reference cigarette smoke compared to sham controls, as excepted. Also, there was no consistent difference in MV between groups of rats exposed to test and reference cigarette smoke.Exposure to smoke from both reference or test cigarettes induced increases in blood carboxyhemoglobin (COHb)) and plasma nicotine level, decreases in minute volume, differences in body or organ weights compared to air controls, and a concentration-related hyperplasia, squamous metaplasia, and inflammation in the respiratory tract. All these effects were greatly decreased or absent following the recovery period. Comparison of rats exposed to similar concentrations of test and reference cigarette smoke indicated no difference at any concentration. Thus, the results did not indicate any consistent differences in toxicological effects between smoke from cigarettes containing the flavoring or casing ingredients and reference cigarettes. Therefore, the NOAEL for the test chemical was considered to be 0.06 mg/L when male and female Sprague-Dawley rats were exposed by inhalation of cigarette smoke for 13 weeks.
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