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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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OECD SIDS o-<strong>TOLUIDINE</strong><br />

5. TOXICITY ID: <strong>95</strong>-<strong>53</strong>-4<br />

DATE: 07.01.2005<br />

160<br />

- Number of animals: 5 per sex and dose<br />

ANIMAL MAINTENANCE<br />

- water provided ad libitum<br />

- air of the animal room at a temperature of 22-24°C, relative humidity: 45-<br />

55%, room air changed 15 times per hour<br />

- fluorescence lightening : 12 hour per day cycle<br />

ADMINISTRATION / EXPOSURE<br />

- Diet: presterilized Wayne Sterilizable Lab Meal with 4%<br />

fat, provided at libitum<br />

- Doses: 0-1000-2000-3000-4000-6000-6200-12500-25000 and<br />

50000 ppm (approximately 0-75-150-225-300-450-465-938-1875 and<br />

3750 mg/kg bw), prepared fresh every 1 to 1-1/2 weeks<br />

CLINICAL OBSERVATIONS AND FREQUENCY:<br />

- Clinical signs: daily<br />

- Mortality: twice daily<br />

- Body weight: twice per week<br />

NECROPSY:<br />

at the end of study, gross examination of spleen and kidneys<br />

Evaluation of the results: Ten percent depression in body weight was taken<br />

as the major criterion for the estimation of maximum tolerated dose<br />

Conclusion : Based on the data the low and high dose for a carcinogenesis bioassay<br />

were set on 3000 and 6000 ppm.<br />

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

dose finding study for cancerogenesis bioassay (see chapter 5.7)<br />

03.06.2004 (159)<br />

Type : Sub-chronic<br />

Species : mouse<br />

Sex : male/female<br />

Strain : B6C3F1<br />

Route of admin. : oral feed<br />

Exposure period : 7 weeks<br />

Frequency of treatm. : continuous<br />

Post exposure period : 1 week<br />

Doses : 0, 3100 - 50000 ppm (approximately 0, 465-7500 mg/kg bw/d see also<br />

freetext TC)<br />

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

Method : other: dose finding study for cancerogenesis bioassay<br />

Year : 1979<br />

GLP : no data<br />

Test substance : other TS: o-Toluidine hydrochloride, purity > 99%<br />

Result : MORTALITY<br />

- no animal died during the study<br />

TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:<br />

- Clinical signs:<br />

no clinical signs reported<br />

- Body weight:<br />

dose dependent reduced up to 63 % of the control<br />

- Gross pathology and Histopathology:<br />

50000 ppm:<br />

spleen - red pulp with pigment deposition, apparently<br />

lipofuscin,<br />

kidneys - similar pigmentation in trace up to small<br />

amounts in the tubular epithelium<br />

liver - trace amounts of pigment in Kupffer's cells of the<br />

hepatic sinusoids in both sex<br />

<strong>UNEP</strong> PUBLICATIONS

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