OECD SIDS 5. TOXICITY
ID: 79-50-5 DATE: 18.01.2006
by treatment up to and including 1000 mg/kg bw/d. Statistically significant increased (relative) food consumption was observed on days 1-7 of the post-mating period in males at 40 mg/kg bw/d. This finding was not considered to be an adverse effect. No explanation for this increase can be given.
Clinical laboratory investigations Haematology: Haematological parameters of treated rats were considered not to have been affected by treatment. Clinical Biochemistry: The serum potassium level of males of the highest dose group was statistically significantly increased when compared to the control group. The statistically significantly increased serum sodium level of males of the highest dose group was considered to have arisen as a result of slightly low control values and thus considered to be of no toxicological significance. The values of glucose and inorganic phosphate achieving a level of statistical significance in treated males when compared to the control group, were considered to be of no toxicological significance as no clear dose-response relationship was observed.
Macroscopic examination Macroscopic observations at necropsy did not reveal any alterations that were considered to have arisen as a result of treatment. Incidental findings included pelvic dilation of both kidneys, yellowish soft nodule at the tail of the left epididymis, dark red discolouration of the right clitoral gland, watery-clear cyst at the right ovary, haemorrhagic/clotted blood in the right uterus horn, enlarged spleen, many dark red foci on the right clitoral gland, uterus enlarged with greenish contents, hard and dark red discolouration of the papillary process of the liver, alopecia and gray-white discolouration of the medulla of the kidney. These findings are occasionally seen among rats used in these types of studies and in the absence of correlated microscopic findings they were considered changes of no toxicological significance.
Organ weights No treatment-related changes were present. Males of the 200 mg/kg bw/d dose group showed statistically significantly decreased absolute and relative adrenals weight and females of the 40 mg/kg bw/d dose group showed statistically significantly increased relative adrenals weight. In the absence of a dose-response relationship, these findings were considered to be caused by chance and not related to treatment.
Microscopic examination Microscopic findings: There were no treatment-related findings. Staging of spermatogenesis: The assessment of the integrity of the spermatogenetic cycle did not provide any evidence of impaired spermatogenesis.
Reproduction Reproduction parameters were unaffected by treatment up to 1000 mg/kg bw/d. Of the control group, two females were non-pregnant. Of the 40 mg/kg bw/d dose group, one female did