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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 companied 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 macroscopic examination).
Dimetol was administered by diet to male and female Wistar Han rats at dose levels of 1000, 3000 and 10000 ppm. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating, during postcoitum, and at least 4 days of lactation (for 39-57 days).
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 macroscopic examination). Reproductive results: No reproductive toxicity was observed up to the highest dose level tested (10000 ppm). Developmental results: No developmental toxicity was observed up to the highest dose level tested (10000 ppm)
Based on these results, a parental No Observed Adverse Effect Level (NOAEL) of 3000 ppm was determined and a reproductive and developmental NOAEL of at least 10000 ppm was derived. When corrected for mean test article intake, the parental NOAEL of 3000 ppm corresponds to 228-231 mg/kg for males and 251-382 mg/kg for females. The reproductive and developmental NOAEL of 10000 ppm corresponds to 714-734 mg/kg for males and 830-1216 mg/kg for females..
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