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EC number: 700-684-7
CAS number: 80793-17-5
Table 1: Ophthalmic Examination in Males- Summary
*Day number relative to Start Date; total number of animals examined in
each group was 10
Group 1- 0 mg/m3 (0 ppm), Group 2 - 7118.61 mg/m3 (500 ppm), Group 3 -
14237.22mg/m3 (1000 ppm), Group 4 - 28474.44 mg/m3 (2000 ppm), Group 5 -
56948.88 mg/m3 (4000 ppm).
Table 2: Ophthalmic Examination in Females- Summary
Particulate opacity in lens
Focal opacity in lens
*Day number relative to Start Date; total number of animals examine in
each group was 10
Table 3: Necropsy Findings in Males - Summary
Table 4: Necropsy Findings in Females - Summary
Table 5: Histopathology Findings in Male Liver - Summary
Hypertrophy, hepatocyte; centrilobular
Necrosis, hepatocyte; focal
Cell infiltration, inflammatory; focal
Table 6: Histopathology Findings in Female Liver - Summary
The subchronic toxicity of AC-6000 was examined when it was repeatedly exposed to Crl:CD(SD) rats for 6 hours a day on 5 days a week for 13 consecutive weeks. The mean actual concentrations were 7628.30 mg/m3 (535.8 ppm), 14993.22 mg/m3 (1053.1 ppm), 29811.31 mg/m3 (2093.9 ppm) and 61370.96 mg/m3 (4310.6 ppm) in the AC-6000 7118.61 mg/m3 (500 ppm), 14237.22 mg/m3 (1000 ppm), 28474.44 mg/m3 (2000 ppm), and 56948.88 mg/m3 (4000 ppm) groups, respectively.
The test substance related effects were evident in the liver. The higher values of absolute and body weight-relative weight in the liver were noted in males exposed to AC-6000 56948.88 mg/m3 (4000 ppm) in comparison with those in the control group. Hypertrophy of centrilobular hepatocyte was observed in males and females exposed to AC-6000 56948.88 mg/m3 (4000 ppm) and in males exposed to AC-6000 28474.44 mg/m3 (2000 ppm). The ground glass cytoplasm was observed in the hypertrophic hepatocyte. It was considered that the hypertrophy of hepatocyte was originated as a result of adaptive changes by induction of drug metabolizing enzymes. There was a low value of potassium in the blood chemistry in males exposed to AC-6000 56948.88 mg/m3 (4000 ppm). Since there was no difference in the potassium range between this study and the background data of the test facility (mean ± 2S.D: 3.8-5.0 mmol/L, Annex 1), it was concluded that the changes were within the physiological fluctuation in the serum potassium. There were low values of absolute and body weight-relative weight in the adrenals in males exposed to AC-6000 56948.88 mg/m3 (4000 ppm). Since there were no abnormalities in the pathological examination, it was concluded that these changes did not have any toxicological significance. There were no changes attributable to the test substance in clinical sign, body weight, food consumption, ophthalmoscopy, urinalysis, hematology, or necropsy. Based on the results, it was concluded that the NOAEL of AC-6000 was 14237.22 mg/m3 (1000 ppm) for males and 28474.44 mg/m3 (2000 ppm) for females under the conditions of this study.
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