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EC number: 242-362-4
CAS number: 18479-58-8
An oral feeding study with the test item in male and female Sprague Dawley rats similar to OECD 421 is currently running as a preliminary study to a extended one-generation reproductive toxicity study (basic design) according to OECD guideline 443. The nominal dose range was chosen between 0 and 15000 ppm, which is expected to result in actual achieved doses of approx. 225 to 886 mg/kg bw/day (as determined in a 21-day palatability study, please refer to section 7.5.1). Clinical signs, body weight, food consumption, hematology, gross pathology estrus cyclicity and number of implantation sites + mammary tissue appearance (for females whose litter die before day 21 of lactation) will be examined in the P0 generation. Litters will be evaluated for number and sex of pups, sex ratio, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical and behaviour abnormalities, anogenital distance (AGD) and gross evaluation of external genitalia. Reproductive indices and offspring viability indices will be calculated. This section will be updated with the results of the EOGRS soon as the study is finalized.
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