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Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
This key study comprised four individual studies to investigate the effects of multiple dosing by oral gavage in rats (15 and 150 mg/kg), the effects of concurrent administration of NaF (11.4 mg/kg) with EDITEMPA; the effects of a single dose by oral gavage in rats and mice, (15 and 150 mg/kg), the effects of concurrent administration of NaF (11.4 mg/kg) with EDITEMPA in male rats;the effects of 10 days treatment with EDITEMPA in the feed (15 and 150 mg/kg, and the effects of i.v. dosing (15 mg/kg) in rats and mice.

Key value for chemical safety assessment

Additional information

A MULTIPLE DOSING STUDY BY ORAL GAVAGE (15 and 150 mg/kg respectively, rats) were limited to accumulation of EDITEMPA in the bone. C-14 accumulation in blood and tissues was not apparent. Concurrent administration of NaF increased the absorption, uptake/retention of 14C by bone. SINGLE DOSES administered ORALLY BY GAVAGE to male and female SD rats and male B6C3F1 mice. The male mice & rats received single doses of 15 and 150 mg/kg, females were treated only with the high dose. The effect of concurrent administration of NaF (11.4 mg/kg) on the disposition and metabolism of EDITEMPA were studied in male rats treated orally at the high dose. These single ORAL GAVAGE studies indicate limited absorption of EDITEMPA (1 -3% in rats) and (2 -4% in mice). Excretion of 14C was limited. Large proportions of absorbed radioactivity were recovered in the bone. Disappearance from the bone occurred at a slow rate with a t 1/2 of 15 -26 days. The trabecular bone had the highest 14C levels. However concurrent dosing with NaF appears to increase absorption, uptake and/or retention of EDITEMPA. EDITEMPA does not appear to be metabolised very much. The results of the 10 days treatment with EDITEMPA in the feed (19 mg/kg (bw) and 196 mg/kg (bw) respectively) demonstrates that accumulation and retention is limited to the bone. Compared to multiple oral GAVAGE dosing, less absorption of the test compound was apparent, shown by lower blood and tissue levels. Treatment at low doses in feed or by gavage resulted in similar levels of 14C in the bone. However after high doses bone levels decreased three fold in animals fed with 14C EDITEMPA diets. Following i.v. administration (15 mg/kg) to rats and mice EDITEMPA has a high affinity for bone. The disappearance of 14C from bone is slow, as demonstrated by the long t ½ of 20 days (rats) and 26 days (mice). Data suggests that EDITEMPA is not metabolised to any great extent. The disposition in both mice and rats is similar.