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- W1525605715 abstract "The developmental toxicity of butyl benzyl phthalate was investigated inthe rat in an alternative study design using ten treatment groups. Theeffect of exposure period was studied, and a comparison of reaction totreatment in pregnant versus non-pregnant females was made. Theclassical data analysis via no-observed-adverse-effect-levels (NOAEL) wascompared to an alternative benchmark approach, in which critical effectdosages (CED) are derived. In addition, a pilot study was carried out inyoung males to assess the testicular toxicity of the compound. Thisreport describes the results obtained, together with an initial analysisof the data. A more extensive data analysis will be presented in aconsecutive report. Comparison of the lowest NOAEL with the lowest CEDshows that in both analyses liver effects determine maternal toxicity,with liver weight at NOAEL=450 mg/kg body weight/day (mkd) and serum atALAT CED20=456 mkd. For embryo toxicity, fetal testicular effects appearcritical in both analyses, with fetal testicular weight at NOAEL<270 mkd(lowest dose tested) and fetal testicular caudal migration at CED01=164mkd. As embryotoxicity was observed at dosages without observed maternaltoxicity, BBP appeared as a specific embryotoxic compound. Mostsensitive male toxicity appears at testis atrophy: NOAEL=750 mkd andtestis weight reduction: CED10=576 mkd. The effects reported in theliterature were generally reproduced. In addition, in the present study,critical adverse effects were observed on maternal serum ALAT levels andon fetal testis weight and descent, both found only after long exposure. End points which are either reversible or affected in the later phase ofexposure appear more likely to be affected after the long exposureregimen. Liver enzyme changes and hematological parameters appear moresensitive in pregnant than in non-pregnant animals. The data setcollected in this study will be instrumental for further development anddiscussion of the alternative benchmark approach for human riskassessment." @default.
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- W1525605715 date "1999-11-30" @default.
- W1525605715 modified "2023-09-23" @default.
- W1525605715 title "Developmental and testicular toxicity of butyl benzylphthalate in the rat and the impact of study design" @default.
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