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EC number: 222-048-3 | CAS number: 3327-22-8
From EU RA, 2008
In group 2, which was the only treated group, clinical symptoms included slightly red discoloured salivation, alopecia in the fore legs or neck. One female performed strenuous respiration, tremor and piloerection on day 20. Two females died 10 minutes after the second administration and were replaced by spare animals. However, the authors did not consider this substance related. Neither the food consumption nor the bodyweight development was affected significantly by the treatment. The reflexes, eyes, hearing and teeth had no abnormalities. Haematological parameters of the treated group had no statistically significant changes when compared to the control group. Clinical chemistry showed a slightly but statistically significantly decreased (-26 %) glucose value to control group. The female rats had a decreased creatinine concentration while the creatinine kinase (202 %) and aspartate aminotransferase (ASAT) values were slightly increased but were within the normal range of this strain of rats. The change in ASAT was only slight (22 %) but significant. The creatine kinase values, which are known to vary over a wide range, were within the historical controls. No morphological changes were found to correlate with the increased creatine kinase values. Urinalysis did not produce any substance-related findings. The only statistically significant, although slight, change in organ weights was a decrease of absolute (-16 %) and relative body weight (-14 %) heart weight in males and a 20 % increase of relative kidney weight in males. Females had no statistically significant changes in their organ weights. In the macroscopical examination of the necropsy, focal alopecia of the forepaws (1 male) and neck (1 female) and reddening of the proximal parts of the small intestine or the glandular stomach was seen. The latter finding was only observed in the animals that died on day 2 of the study for non-substance related reasons. Microscopically, slight or moderate vacuolisation of proximal tubule cells of the inner cortical and outer medullar region of the kidney were seen in 5/10 male animals but not in females. This was not observed in control animals. In addition, this region had minimal tubular hyperplasia (4/5 males, 2/5 females) and minimal or slight hypertrophy (5/5 males 0/5 females). Control animals had no hyperplasia or hypertrophy. The female rat with alopecia was diagnosed to have moderate atrophy of hair glands and sebaceous glands in the affected skin areas. The causes of the two deaths of the female rats in the group 2 were unresolved by the necropsy examination.
In a short-term repeated toxicity study, the test item CHPTAC was applied by gavage to young adult Bor:WISW rats (5/sex/dose) at dose levels of 0 and 1085 mg/kg bw. Slight morphological findings in the kidney (fine, diffuse vacuolisation of tubular cells, slight tubular cell hyperplasia and hypertrophy) were observed. The findings were more pronounced in males than in females. Based on these kidney changes, the LOAEL for CHPTAC after oral administration is 1085 mg/kg bw/day.
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