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EC number: 247-956-7 | CAS number: 26748-47-0
Dose Formulation Analysis:
Concentration analysis of formulation samples was determined at three concentrations, for low dose group (LD, 25 mg/mL), for medium dose group (MD, 75 mg/mL) and for high dose group (HD, 250 mg/mL). Samples were taken in study week 1, week 3, week 5, and in the last week of the study.
Mean recoveries observed at the four sampling occasions were for LD group between 93.6 % and 95.0 % of nominal value, for MD group between 97.6 % and 101.0 %, and for HD group between 95.7% and 99.9 %. Overall recoveries of entire study observed in LD, MD and HD groups were 94.2 %, 99.6 %, and 97.6 % of nominal concentration, respectively.
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422), the test item1-methyl-1-phenylethyl peroxyneodecanoate (75.1 % peroxide) was administered to 10 male and female Wistar rats/dose in corn oil by gavage at dose levels of 0, 100, 300, or 1000 mg/kg bw/day. In addition, a second control group was included. Animals of this control group received 500 mg/kg bw/day of the phlegmatizer isododecane. The animals were treated with the test item formulation on 7 days per week for a period of 63 days, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 12 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days was completed. No adverse effects were found on male and female mortality, clinical observations, functional observations, body weight development (except HD males and females), food consumption (except HD females), estrous cyclicity, haematology and coagulation, clinical biochemistry, urinalysis and gross macroscopic findings at necropsy in all treatment groups.
In the high dose group treated with 1000 mg/kg bw/day treatment related effects on organ weights (liver, kidney, uterus with cervix weights, heart, spleen) and histopathology (liver) were observed. Based on the results, the NOAEL for repeated dose toxicity is considered to be 300 mg/kg bw/day. This study is classified as acceptable and satisfies the guideline requirement for an oral repeated dose toxicity study in rat.
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