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DL-LACTONE CAS N°:79-50-5 - page 102 / 113

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OECD SIDS 5. TOXICITY

102

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

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 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

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