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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 />

Remark : Dose selection was based on the results of a range-finding study.<br />

14 mated females/group, 28 control females, all females were weighed on<br />

gd 0, 6, 12, 18, 24 and 29, food consumption was measured throughout<br />

gestation, all females were examined daily for clinical signs, for mortality<br />

and morbidity<br />

sacrifice on gd 29:<br />

does were evaluated for body weight, liver and gravid uterine weight,<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 : mortality: 100 mg/kg bw: 5/14; 50 mg/kg bw: 2/14;<br />

all were pregnant<br />

1 control female aborted and one each at 5.0 and 50 mg/kg bw was<br />

removed due to dosing error<br />

gestational weights and weight changes were not stat. significant different<br />

among groups for periodic body weights or weight changes.<br />

50, 100 mg/kg bw: clinical signs included hypoactivity, gasping, cyanosis,<br />

laboured rapid and audible respiration and ocular discharge<br />

food consumption: no significant differences among groups for any time<br />

period measured; no treatment related gross lesions at necropsy of does<br />

maternal organ weights:<br />

no significant difference among the groups: terminal bw., gravid uterine<br />

weight, corrected bw. or weight change, absolute and relative liver weight<br />

gestational parameters:<br />

no significant difference for number of ovarian corpora lutea, number of<br />

implantations sites including total, nonviable (early or late resorptions or<br />

dead fetuses) or viable percent live fetuses per litter or fetal body weight<br />

per litter; sex ratio was significantly increased (more males) at 50 mg/kg bw<br />

but not at 100 mg/kg bw (considered due to biological variabilty)<br />

fetal evaluation:<br />

No significant differences among groups for any individual malformations,<br />

malformations by category or total malformations; no treatment-related<br />

significant differences for any individual external variations, variations by<br />

category or total variations.<br />

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

Flag : Critical study for SIDS endpoint<br />

06.02.2004 (170)<br />

5.8.3 TOXICITY TO REPRODUCTION, OTHER STUDIES<br />

Type : other<br />

In vitro/in vivo : In vivo<br />

Species : mouse<br />

Sex : male/female<br />

Strain : B6C3F1<br />

Route of admin. : oral feed<br />

Exposure period : 28 d<br />

Frequency of treatm. : continuously in diet<br />

Duration of test : 28 d<br />

Doses : 0, 300, 1000, 3000, 10000, 30000 ppm<br />

Control group : yes, concurrent no treatment<br />

Result : See freetxt RS<br />

Method : other: the reproductive organs were examined as part of the 28-day study,<br />

see chapter 5.4<br />

UNEP PUBLICATIONS 281

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