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EC number: 236-244-1 | CAS number: 13254-34-7
Accuracy and homogeneity of diets were demonstrated by analyses.
Parental toxicity was evident at 10000 ppm and was characterized by lower body weight gains for males Day 8 of the premating period onwards. Palatability issues of the test diet likely contributed to
the lower gains as food consumption was lower during the first week of treatment. Males and females at this dose level had higher absolute and relative liver weights with relative liver weights approximately 16% and 20% higher for males and females than controls, respectively. At the microscopic examination, cortical hyaline droplets representing alpha2uglobulin were recorded at an increased incidence and severity in the kidneys of males treated at 10000 ppm. These changes resulted from the increased/altered liver metabolism resulting in excessive accumulation of alpha- 2uglobulin in the renal proximal tubular epithelial cells and are regarded as specific to the male rat. Alpha-2uglobulin does not occur in the human kidney and that this finding does not indicate any potential risk to human health. This was accompanied by an increased incidence and severity of corticomedullary tubular basophilia and in one instance by granular casts. These granular casts are considered to be indicative of primary tubular injury and therefore this finding was considered to be adverse.
There were no relevant microscopic findings noted for females at 10000 ppm.
No treatment-related changes were noted in any of the remaining parental parameters investigated in this study (i.e. clinical appearance, functional observations, clinical laboratory investigations and
No reproductive toxicity was observed up to the highest dose level tested (10000 ppm).
No developmental toxicity was observed up to the highest dose level tested (10000 ppm)
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