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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 />

Test condition : ANIMALS<br />

obtained as 4-week -old weanlings , all within 3 days of the same age<br />

housed for 2 weeks before start of the study<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:<br />

45-55%, 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, 3100-6200-8000-10000-12500-20000-25000 and<br />

50000 ppm (approximately 0, 465-930-1200-1500-2400-3000- and 7500<br />

mg/kg bw/d), 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, kidneys and liver<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 1000 and 3000 ppm.<br />

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

dose finding study for carcinogenisis bioassay<br />

24.05.2004 (159)<br />

Type : Sub-chronic<br />

Species : rat<br />

Sex : no data<br />

Strain : no data<br />

Route of admin. : oral feed<br />

Exposure period : 91 days<br />

Frequency of treatm. : continuous<br />

Post exposure period :<br />

Doses : 15 - 24 mg/animal (reduced for toxicity at 7.5 - 12 mg/animal)<br />

Control group : no data specified<br />

Method : other: see TC<br />

Year :<br />

GLP : no<br />

Test substance : other TS: no data on purity<br />

Result : 3/10 animals showed changes in the mucous membrane of the bladder<br />

with metaplasia and early epithelial proliferation<br />

Test condition : 10 rats were given a basic diet of rice flour with addition of a slice of carrot<br />

about every other day, and o-toluidine was added to the rice flour.<br />

Reliability : (4) not assignable<br />

documentation insufficient for assessment<br />

18.12.2003 (160) (161)<br />

Type :<br />

Species : rat<br />

Sex : no data<br />

Strain : no data<br />

Route of admin. : dermal<br />

<strong>UNEP</strong> PUBLICATIONS 161

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