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EC number: 701-216-4 | CAS number: -
Table 1 Summary of urinary and faecal elimination.
Table 2 Summary of blood:tissue ratios at Day 10
RECOVERY DATA Individual total recovery = 81.85 - 88.55% Mean total recovery = 85.90% (SEM = 1.62)
AUTORADIOGRAPHY At 24 h, the major regions of localisation of 14C were: - gut contents - stomach contents - nasal turbinates - bone and bone marrow Radioactivity also observed in the kidney (no other tissues) and throughout all bones of the body (most intense in epiphyseal plate of the long bones and in nasal turbinates). At 10 d post-dose, intense localisation still apparent in bone, especially the epiphyseal plate of the long bones. Some low level deposition of 14C was present in stomach lining and the kidneys (no other tissues affected). (The authors note that this pattern is consistent with that reported for EHDP.)
In a well conducted and reported toxicokinetics study (reliability score 1), 150 mg/kg bw 14C-labelled ATMP was administered to male Sprague-Dawley rats and killed ten days later. Whole-body autoradiography was used to determine tissue distribution, and metabolism was studied using HPLC analysis. Total recovery was 86%. The majority of the dose (84.2%) was excreted in the faeces and only 1.1% was excreted in the urine. The amount of radioactivity in the urine was used to determine the extent of absorption by comparing urinary excretion between orally and intravenously dosed rats. Using this approach, absorption following administration of 14C-labelled ATMP was shown to be approximately 2.2%. The initial and terminal urinary half-lives were approximately 5 and 70 hours, respectively. The initial phase whole-body elimination half-life was 5.3 hours and the terminal half life was 299 hours. HPLC analysis of urine samples collected 24 hours after administration revealed the presence of the parent compound, the n-methyl derivative and an unidentified metabolite. Approximately 0.06% of the dose was found in the bone (femur, tibia and sternum) and 0.21% of the dose was found in the carcass. The overall tissue distribution confirmed that the highest levels of radioactivity were found in the bone. No significant signs of localisation in other tissues were evident ten days after administation. Overall, ATMP was poorly absorbed and rapidly eliminated after oral administration. The bone appeared to be the only tissue that demonstrated any significant amount of accumulation of ATMP-derived radioactivity.
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