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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 />

systemic toxicity: NOAEL(male, female): 1000 ppm<br />

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

Flag : Critical study for SIDS endpoint<br />

06.02.2004 (150)<br />

Type : Sub-chronic<br />

Species : rat<br />

Sex : male/female<br />

Strain : Sprague-Dawley<br />

Route of admin. : gavage<br />

Exposure period : 13 weeks<br />

Frequency of treatm. : 7 days/week<br />

Post exposure period : no<br />

Doses : 0, 50, 175, 600 mg/kg bw/day dissolved in corn oil<br />

Control group : yes, concurrent vehicle<br />

NOAEL : 50 mg/kg bw<br />

Method : other: see freetext ME<br />

Year : 1986<br />

GLP : yes<br />

Test substance : other TS: p-cresol, purity: 99.9 %<br />

Method : 30 rats/sex/dose,<br />

additional 10 rats/sex/dose for baseline clinical pathology<br />

interim kill at week 7<br />

bws were recorded on test day1 and weekly thereafter; individual food<br />

consumption data were collected weekly;<br />

moribund/mortality check twice daily (moribund rats were killed and<br />

necropsied); physical examination weekly; ophthalmologic examination<br />

during quarantine period and in test week 13<br />

HAEMATOLOGY<br />

haemoglobin, haematocrit, prothrombine time (PT), erythrocyte count,<br />

reticulocyte count, total and differential leucocyte count, activated partial<br />

thromboplastin time (APTT)<br />

CLINICAL CHEMISTRY<br />

sodium, chloride, potassium. direct and total bilirubin, alkaline<br />

phosphatase, total cholesterol, albumin, CO2, SGPT, SGOT, glucose,<br />

BUN, globulin (calculated), total protein, creatinine, Albumin/Globulin ratio<br />

(calculated<br />

URINALYSIS<br />

appearance, volume, colour, specific gravity, pH, protein, glucose, ketone,<br />

bilirubin, urobilinogen, haemoglobin, microscopic examination<br />

PATHOLOGY<br />

determination of weights of:<br />

heart, liver, spleen, brain, kidneys, gonads, adrenals, thyroid/parathyroid<br />

examination of all control rats and high dose rats at study termination as<br />

well as those that died during the study:<br />

all gross lesions,<br />

brain (3 levels), spleen, bone (with marrow), skeletal muscles, salivary<br />

gland. mammary gland, thymus, thyroid (with parathyroid), lungs (with<br />

mainstem bronchi), trachea, liver, urinary bladder, testes, prostate, ovaries,<br />

corpus and cervix uteri, eye, pituitary gland, lymph node, spinal cord, heart,<br />

aorta, siatic nerve, pancreas, oesophagus, kidneys, small and large<br />

intestine, adrenals, stomach<br />

STATISTICAL ANALYSIS<br />

One-way Analysis of Variance tests with Dunnett's t-test<br />

Result : 600 mg/kg: 3 females died within the first 3 days of dosing. Overt signs of<br />

toxicity at this dose included lethargy, tremors, convulsions and coma.<br />

BODY WEIGHT was sign. reduced (p

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