OECD SIDS 5. TOXICITY
ID: 79-50-5 DATE: 18.01.2006
Frequency of treatment: Doses:
Control Group: NOAEL Maternal Toxity: NOAEL Teratogenicity: Result:
mean treatment duration for females was 43 days once daily
(controls, vehicle only = milli-U water), 40, 200
and 1000 mg/kg bw/d yes, concurrent vehicle = 1000 mg/kg bw = 1000 mg/kg bw no developmental toxic effects noted up to the highest dose of 1000 mg/kg bw/d
Year: GLP: Test substance:
other: OECD Guideline 422, "Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test", 22-Mar-1996 2003 yes as prescribed by 1.1 - 1.4
Please see 5.8.1, Toxicity to Fertility (same study). For general results regarding test substance analysis, please see 5.8.1 (same study).
Mortality No unscheduled deaths occurred during the study period.
Clinical signs Females of the highest dose group showed aggressive and restless behaviour during days 5 to 15 of treatment. Incidental findings that were noted included scabs, wound, hunched posture, piloerection, broken upper incisors, broken tail apex, and alopecia at several parts of the body. These findings are commonly noted in rats of this age and strain which are housed and treated under the conditions in this study. At the incidence observed, these were considered signs of no toxicological significance.
Functional observations No changes were observed in hearing ability, pupillary reflex, static righting reflex and grip strength in the animals treated with dl-lactone, when compared to control animals. The variation in motor activity did not indicate a relation with treatment. Females of the highest dose group showed a decreased motor activity at the low sensors when compared to the control group. Since this change occurred in the absence of similar changes of the high sensors, they were considered to be of no toxicological relevance. Body weight Body weights and body weight gain were unaffected by treatment up to and including 1000 mg/kg bw/d. Males of the 200 mg/kg bw/d dose group showed statistically significant decreased body weights on day 1 of the mating period. In the absence of a clear dose response relationship, this finding was considered to be of no toxicological relevance. On day 8 of the pre-mating period, males of the highest dose group showed a statistically significant increased body weight gain. As this finding was very slight and not considered to be adverse, it was considered to be of no toxicological significance.
Food consumption Food consumption and relative food consumption were unaffected