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m-Cresol - ipcs inchem

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OECD SIDS<br />

m- / p-CRESOL MIXTURE<br />

5. TOXICITY ID: 15831-10-4<br />

DATE: 24.05.2004<br />

and liver.<br />

Microscopic changes which were characterized by average<br />

severity score based on scale of 1 to 4 (1=minimal, 2=mild,<br />

3=moderate, 4=marked) were reported from<br />

nose (contr., low dose to high dose, respiratory epithelium<br />

hyperplasia: male, 0/5, 300 and 1000 ppm: not performed,<br />

0/5, 1/5[1.0], 5/5[1.6]; female, 2/5[1.5], low dose: not<br />

performed, 0/5, 3/5[1.0], 3/5[1.7], 4/5[1.5]; olfactorium<br />

epithelium: at 30000 ppm, male, atrophy 2/5[1.0] and<br />

respiratory metaplasia 3/5 [1.3]; female, olfactory<br />

epithelium respiratory metaplasia at 30000 ppm, 2/5[1.0]),<br />

lung (bronchiolar hyperplasia, minimal in males and females<br />

at 30000 ppm),<br />

oesophagus (males, minimum hyperplasia and hyperkeratosis at<br />

30000 ppm),<br />

forestomach (males, at 30000 ppm, minimal hyperplasia of the<br />

squamous epithelium),<br />

bone marrow (minimal hypocellularity at 30000 ppm),<br />

atrophy of the ovary (mild) and uterus (moderate) at 30000<br />

ppm<br />

local toxicity:<br />

NOAEL(male): 3000 ppm; NOAEL(female): 1000 ppm systemic<br />

toxicity:<br />

NOAEL(male): 300 ppm; NOAEL(female): 1000 ppm<br />

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

Flag : Critical study for SIDS endpoint<br />

05.02.2004 (101)<br />

Type : Sub-acute<br />

Species : mouse<br />

Sex : male/female<br />

Strain : CD-1<br />

Route of admin. : oral feed<br />

Exposure period : 14 d<br />

Frequency of treatm. : daily<br />

Post exposure period : no<br />

Doses : 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0 % (target dose: 0, 375, 750, 1500, 2250,<br />

3000, 4500 mg/kg bw)<br />

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

Method : other: NTP continuous breeding protocol, task 1 see freetext ME<br />

Year : 1990<br />

GLP : yes<br />

Test substance : other TS: m-/p-cresol (60%/40%)<br />

Method : 48 male and 48 female mice: 8 per sex per dose, data<br />

collected included clinical signs, individual body weights,<br />

feed and water consumption, mortality data<br />

Result : mortality:<br />

3.0 %-gr.: 1/8 (12.5 %) males, 1/8 (12.5 %) females (due to<br />

indeterminant causes)<br />

Clinical signs:<br />

all mice in 3.0 %-, and some in 2.0 %- and 1.0 %-group:<br />

lethargy, hunched back, squinted eyes, rough coat<br />

dose related reduced feed consumption, water consumption and<br />

reduced body weight gain<br />

3 %-group: sign. terminal weight loss of males and females<br />

Reliability : (2) valid with restrictions<br />

preliminary dose range finding study for the two generation<br />

reproductive study: see also chapter 5.8.1<br />

04.09.2002 (102)<br />

362<br />

UNEP PUBLICATIONS

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