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m-Cresol - ipcs inchem

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OECD SIDS<br />

p-CRESOL<br />

5. TOXICITY ID: 106-44-5<br />

DATE: 24.05.2004<br />

number of corpora lutea and number and status of implantation sites (i.e.<br />

resorptions, dead fetuses, live fetuses)<br />

live fetuses were dissected from uterus, counted and weighed, examined<br />

for external malformations and variations, and for visceral malformaltions<br />

and variations, and for soft tissue craniofacial malformations<br />

statistical analysis:<br />

Levene's test, ANOVA, pooled t-test, Kruskal-Wallis test, Mann-Whitney U-<br />

test, Fisher's exact test<br />

Result : Maternal toxicity:<br />

mortality: 3/25 females at 450 mg/kg bw/day<br />

No abortions or early deliveries (1 litter at 30 mg/kg bw was fully resorbed)<br />

450 mg/kg bw:<br />

decreased food consumption<br />

stat. sign. reduction in periodic maternal body weight and weight gain<br />

during dosing, maternal gestational weight gain reduced when corrected for<br />

the weight of the gravid uterus and reduced maternal terminal bw, relative<br />

but not absolute liver weight was increased<br />

clin. signs of toxicity: hypoactivity, ataxia and tremors, prone position<br />

audible respiration and perioral wetness<br />

gestational parameters were unaffected by treatment except fetal body<br />

weight per litter were reduced at 450 mg/kg bw.<br />

fetal evaluations:<br />

No significant changes in the incidence of any individual malformation,<br />

malformation by category (external, visceral including craniofacial or<br />

skeletal) or total malformations for any dose group.<br />

450 mg/kg bw:<br />

7 skeletal variations exhibited sign. different incidences relative to those in<br />

the control groups:<br />

incidence of cervical centrum 6 bilobed, reduced number of ossified caudal<br />

segments, unossified sternebrae, reduced incidence of unossified cervical<br />

centrum no. 7, poorly ossified parietal skull bone (30 mg/kg bw), reduced<br />

incidence of some (1-4) proximal phalanges of the hind limb unossified<br />

p-<strong>Cresol</strong> caused mild fetotoxicity at the 450 mg/kg, as seen<br />

by reduced ossification in three skeletal districts. In<br />

addition, fetal body weight was reduced at the 450 mg/kg dose<br />

level. There was no treatment-related increased incidence of<br />

malformations at any dosage.<br />

Reliability : (1) valid without restriction<br />

Flag : Critical study for SIDS endpoint<br />

06.02.2004 (169)<br />

Species : rabbit<br />

Sex : female<br />

Strain : New Zealand white<br />

Route of admin. : gavage<br />

Exposure period : days 6 - 18 of gestation<br />

Frequency of treatm. : daily<br />

Duration of test : until gd 29<br />

Doses : 0, 5, 50, 100 mg/kg bw in corn oil<br />

Control group : yes, concurrent vehicle<br />

NOAEL maternal tox. : = 5 mg/kg bw<br />

NOAEL teratogen. : = 100 mg/kg bw<br />

Result : see freetext ME<br />

Method : other: following the TSCA Health Effects Test guidelines for Specific<br />

Organ/Tissue Toxicity - Developmental Toxicity (EPA, 1984,1987)<br />

Year : 1988<br />

GLP : yes<br />

Test substance : other TS: p-cresol, purity = 98.93%<br />

280<br />

UNEP PUBLICATIONS

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