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EC number: 267-956-0 | CAS number: 67953-76-8
In order to reduce the number of animals used, a combined dietary chronic toxicity and carcinogenicity study in rats has been carried out using a protocol similar to OECD 453. Four satellite groups of 10 animals of each sex (dose and control groups) were fed diets containing 0-10000 ppm disodium etidronate and used to provide blood and urine samples during the first 26 weeks of the study. After the first 26 weeks of the study all surviving rats in the satellite groups were killed for interim examination. The results of the interim report for the satellite groups are reported separately because juvenile rats during their growth phase seem to be more susceptible to effects of HEDP related to perturbations of iron homeostasis than adult rats. The doses quoted in the interim report (0, 500, 2000, and 10000 ppm corresponding to 0, 41, 169, 817 mg/kg bw/d for males and 0, 50, 195 and 1000 mg/kg bw/d for females) take into account the higher feed intake as a function of bodyweight during the first few weeks of the study. A decrease in red blood cell parameters was seen in the top dose group for both sexes, and for males at 169 mg/kg by week 12 although some improvement was noted from the week 7 values. Blood smears indicated prolonged anaemia in both sexes at the top dose, with a slight retardation of bone marrow development. Severe pallor of the skin of the top dose group animals and slight pallor in the mid dose rats was seen. A pale color was also noted for organs well supplied with blood (spleen and kidneys). These observations are consistent with perturbation of iron homeostasis. During week 25, values relating to red cell parameters among rats receiving 2000 ppm were similar to control values. For rats receiving 10000 ppm the packed cell volume and haemoglobin concentrations were only marginally lower than control values although the differences attained a level of statistical significance. The NOAEL for juvenile rats is assigned to the lowest dose group (500 ppm) where no indication of anaemia was seen.
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