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EC number: 446-620-9
CAS number: 120983-72-4
Table 2: Summary of 4-weeks subacute inhalation toxicity (6 h/day on 5 days per week)
9d - 26d
2 / f
3 / f
4d - 26d
m = males, f = females, - not applicable, day 0: first exposure day
Values given in the Toxicological results' column are:
1 st = number of dead animals.
2nd = number of animals with signs
3rd = number of animals exposed.
Mortality did not occur in any of the exposure groups. Concentrations up to and including 1.5 mg/m3 were tolerated by all rats without clinical effects. At 5.63 mg/m3 some rats experienced mild and transient signs of respiratory tract irritation (serous nasal discharge, stridor, tachypnea, irregular breathing pattern, limp, ungroomed hair-coat, piloerection, mild hypothermia). In the rats of this group significantly decreased body weights and a decreased food consumption were observed. There was no evidence of hematological effects considered to be patho-diagnostically relevant. Clinical-pathology did not reveal any evidence of concentration- dependent effects considered to be causally related to the exposure to the test substance. There were no statistically significant or conclusive changes in absolute or relative organ weights up to and including 1.5 mg/m3. However, there was a trend of significantly decreased liver, spleen and thymus weights in rats of the high-level exposure group. In female rats of this group somewhat increased adrenal weights were observed. Collectively, the changes in body weights and food consumption are considered to be the major cause of the liver weight changes observed at 5.63 mg/m3, despite the somewhat increased hepatoquick and ALAT values observed in the female rats of this group. At the end of the 4-week exposure period, inflammatory as well as concentration dependent epithelial changes (metaplasia, necrosis) were observed in the upper respiratory tract (nasal cavity, pharynx, larynx) of rats exposed at 1.5 and 5.63 mg/m3. In none of the groups evidence of test substance-related findings were detected in the trachea or lung. Following the 6-week recovery period, epithelial metaplasia, necrosis and inflammatory findings were still detectable in the nasal cavity, however, the intensity of changes decreased appreciably as compared to the findings observed at the end of the exposure period. There was no effect on extrapulmonary organs. In summary, this study demonstrates that the outcome of study is governed by irritant-related effects at the portal-of-entry. The histopathological examinations showed a marked anterior-posterior gradient of intensity of changes. Based on the most sensitive endpoint, i.e., irritant-related changes occurring the upper, extrathoracic airways, the NO(A)EL is 0.411 mg/m3. At 1.5 mg/m3 histopathological whilst at 5.63 mg/m3 additional clinical evidence of upper respiratory tract irritation existed (mainly nasal discharge). The mildly affected organ weight (decreased liver, spleen and thymus weights) and increased adrenal weights at 5.63 mg/m3 are of unclear toxicological significance and may be associated to irritant-related stress (upper respiratory tract irritation). Taking all findings into account 0.411 mg/m3 constitutes the no-adverse-observed effect-level (NOAEL).
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