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EC number: 202-764-2
CAS number: 99-54-7
RS-Freetext:Total mated females on study: 25/groupAll dams survived to scheduled sacrifice.CLINICAL OBSERVATIONS:10 mg/kg bw: significantly reduced food consumption on gd 6-10;30 mg/kg bw: significantly reduced food consumption for gd 6-10100 mg/kg bw: urogenital staining increasing number of dams with duration of pregnancy (3/25 to 16/25) and wet/matted fur (5/25 gd6-13); significantly reduced mean bodyweights on gd 10 (267.8g versus 284.5g of controls), gd 13(284.8g versus 302.3g of controls) and gd 16 (307.7g [approx.5 %] versus 324.4g of controls); significantly reduced food consumption on gd 6-10 and gd10-13Mean body weight change: gd 6-10, dose-related:control 8.4 g/dam, 10 mg-gr.: 6.2 g/dam, 30 mg-g.: 4.0 g/dam (significant,p<=o.05), 100 mg-gr.: -4.4 g/dam (significant,p<=0.01), corresponding to a significant body weight loss of approximately 5 % POST MORTEM FINDINGS:controls: hydronephrosis of the kidneys in 1/23 rat10 mg-group: hydronephrosis of the kidneys in 1/25 rat100 mg-groups: hydronephrosis of the kidneys in 3/25 ratsMATERNAL REPRODUCTIVE DATANo adverse effects on:pregnancy rates (Total pregnant females: control, low, mid, high dose: 23/25, 25/25, 23/25, 24/25), live or dead foetuses/dam, late resorptions/dam, total implants/dam, or corpora lutea/dam or preimplantation loss100 mg: increased mean early resorptions (1.1/dam versus 0.5/dam in controls FETAL DATAcontrol, low, mid, high dose:Total number of litters examined (no of fetuses): 23(323), 25(353), 23(340), 24(339)no of examined viscerally: 22(160), 25(176), 23(170), 24(169)no examined skeletally: 23(163), 25(177), 23(170), 24(170)No adverse effects on foetal body weights or sexdistribution.Total number with malformation: 2(4), 3(4), 4(6), 5(9)No statistically significant differences for the incidenceof total or individual malformations. Findings observed in multiple foetuses in treated rats includedanophthalmia/Microphthalmia (100 mg: 4 in 3 litters; 10 mg: 2 in 2 litters, control: 1 in 1 litter), small oral opening (100mg: 2 in 2 litters), skull misshapen (100 mg: 2 in 2 litters), nasal passages misshapen (100 mg: 2 in 2 litters and gastroschesis (100 mg: 2 in 2 litters). None of these findings were seen in mid-dosed rats For variations dilated ureters were elevated in mid- andhigh-dosed rats: control, low mid, high dose (7 fetuses in 3 litters, 8 fetuses in 4 litters, 17 fetuses in 9 litters 15 fetuses in 10 litters.)Dilated ureters are regarded to be of low concern (ECETOC Monograph No. 31, 2003).
Pregnant female Sprague-Dawley rats were orally applied with 0, 10, 30,
or 100 mg/kg bw/day 1,2 -dichloro-4-nitrobenzene dissolved in corn oil
by gavage resulting in developmental effects (significant increase in
dilated ureters) in the presence of maternal toxicity (significantly
reduced body weight gain on gd 6 -10). The NOAEL for maternal toxicity
and developmental toxicity is 10 mg/kg bw/d (Monsanto 1987)
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