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EC number: 942-401-1 | CAS number: -
The endpoint conclusion was derived after evaluation of all data available on analogues. The worst case was selected for the endpoint conclusion. A summary of the evaluation is included in Section 13.
The subchronic study was conducted to evaluate the toxic effects of repeated administration of the read-across analogue test substance sodium iodide to Sprague-Dawley rats by the oral (drinking water) route. Rats were treated with 0, 1, 3, 10, and 100 mg/l of sodium iodide in the drinking water for 100 days.Treatment had no effect on body, brain, or heart weights in either sex, or on testes weights in male rats. Although differences in kidney and liver weights were noted, they did not appear to be treatment related. Thyroid weight in male rats was significantly increased with an increasing concentration of sodium iodide in the water. In contrast, thyroid weight decreased at the highest dose of sodium iodide in female rats. Hematocrit, hemoglobin, and blood urea nitrogen (BUN) values were relatively constant and did not vary with treatment. There were no significant differences in AST, ALT, cholesterol, and triglyceride values.Also there was a significant increase in T4/T3 ratios in female rats after 100 day of treatment with sodium iodide.The results of this study indicate that sodium iodide affect thyroid hormone status in substantially different ways. The highest concentration level of 100 mg/L was considered to be a LOAEL based on the results of the study. The NOAEL was set at 10 mg/L, corresponding to 1.8 mg sodium iodide/kg bw/day, or 1.53 mg I-/kg bw/day. These results can be read across to bismuth oxy-iodide bromide, applying a correction for molecular weight. The corresponding NOAEL for BiOI0.6Br0.4 was calculated to be 6.7 mg/kg bw/day.
Based on the available data, bismuth oxy-iodide bromide is not classified for effects after repeated dose exposure according to Regulation (EC) No 1272/2008.
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