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EC number: 203-398-6
CAS number: 106-44-5
Maternal toxicity: mortality: 3/25 females at 450 mg/kg bw/day No abortions or early deliveries (1 litter at 30 mg/kg bw was fully resorbed) 450 mg/kg bw: decreased food consumption, stat. sign. reduction in periodic maternal body weight and weight gain during dosing, maternal gestational weight gain reduced when corrected for the weight of the gravid uterus and reduced maternal terminal bw, relative but not absolute liver weight was increased clin. signs of toxicity: hypoactivity, ataxia and tremors, prone position audible respiration and perioral wetness gestational parameters were unaffected by treatment except fetal body weight per litter were reduced at 450 mg/kg bw.
Fetal evaluations: No significant changes in the incidence of any individual malformation, malformation by category (external, visceral including craniofacial or skeletal) or total malformations for any dose group. 450 mg/kg bw: 7 skeletal variations exhibited sign. different incidences relative to those in the control groups: only 3 of these findings indicate slight fetotoxicity --incidence of cervical centrum 6 bilobed, --reduced number of ossified caudal segments, --unossified sternebrae, reduced incidence of unossified cervical centrum no. 7, poorly ossified parietal skull bone (30 mg/kg bw), reduced incidence of some (14) proximal phalanges of the hind limb unossified an increased incidence of of poorly ossified thoracic centrum number 13 (175 mg/kg bw/d) p-Cresol caused mild fetotoxicity at the 450 mg/kg, as seen by reduced ossification in three skeletal districts. In addition, fetal body weight was reduced at the 450 mg/kg dose level. There was no treatment-related increased incidence of malformations at any dosage.
Developmental toxicity study according to TSCA Health Effects Test guidelines for Specific Organ/Tissue Toxicity - Developmental Toxicity (EPA, 1984,1987):Administration of p-cresol by gavage to time-pregnant Sprague-Dawley rats during organogenesis at 0.0, 30.0, 175.0, or 450.0 mg/kg bw/d resulted in maternal toxicity at 450 mg/kg bw/d and included mortality, clinical signs of toxicity, reduced weight gain and food consumption during dosing and reduced gestational weight gain corrected for the gravid uterus . Slight developmental toxicity was observed at 450 mg/kg bw/d and included reduced ossification in three skeletal districts in addition with reduced fetal body weight. Thus, The NOAEL for maternal toxicity and developmental toxicity is 175 mg/kg bw/d.
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