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m-Cresol - ipcs inchem

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OECD SIDS<br />

m-CRESOL<br />

5. TOXICITY ID: 108-39-4<br />

DATE: 24.05.2004<br />

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

NOAEL teratogen. : ca. 100 mg/kg bw<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: m-cresol, purity: 99.7 %<br />

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

14 mated females/group, 28 control females, all females were weighed ond<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 of status of implantation sites (i.g.<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 : >= 50 mg/kg: audible respiration and ocular discharge<br />

No embryotoxicity or teratogenicity was observed at any<br />

dosage employed.<br />

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

Flag : Critical study for SIDS endpoint<br />

06.02.2004 (158)<br />

Species : rat<br />

Sex : female<br />

Strain : Wistar<br />

Route of admin. : s.c.<br />

Exposure period : day 7 through day 17 of gestation<br />

Frequency of treatm. : daily<br />

Duration of test : until post partum<br />

Doses : 90 mg/kg bw/d (30 ml/kg bw 0.3 %)<br />

Control group : yes<br />

Result : m-cresol was used as the solvent at a concentration of 0.3<br />

%; no negative effects on F0- or F1-generation were observed<br />

when compared with control animals.<br />

Reliability : (3) invalid<br />

application route is not relevant for the human situation<br />

12.11.2002 (159)<br />

Species : rat<br />

Sex : female<br />

Strain : Wistar<br />

Route of admin. : s.c.<br />

Exposure period : day 17 of gestation until 21 days after birth<br />

Frequency of treatm. : daily<br />

Duration of test : until 8 w post partum<br />

Doses : 90 mg/kg bw/d (30 mg/kg 0.3 %)<br />

Control group : yes<br />

Result : m-cresol was used as the solvent at a concentration of 0.3<br />

%; no negative effects on F0-, F1- or F2-generation were<br />

observed when compared with controls (no fetotoxicity,<br />

normal postnatal development, normal behaviour and<br />

UNEP PUBLICATIONS 153

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