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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 />

228<br />

No significant increase in MN frequency and no decrease in % PCEs was<br />

observed at any sampling time. the concurrent positive controls were<br />

functional.<br />

(2) multiple-treatment study:<br />

(2a) 1. trial<br />

In a first multiple treatment study no decrease of % PCEs was observed,<br />

but statistically significant increases of MNPCEs were induced at the high<br />

dose (800 mg/kg) 24 h after the last of 2 and 4 treatments. Since the<br />

mortality ratio after 4 injections was 3/6, this regimen was too toxic.<br />

(2b) 2. trial<br />

The experiment was repeated with similar results.<br />

A weak MNPCE increase was observed only at highly toxic dose (800<br />

mg/kg bw/day, 4 injections) which was statistically significant when<br />

compared to the concurrent control:<br />

800 mg/kg bw:<br />

4 injections, 24 hours after the last injection:<br />

mortality: 4/6<br />

MNPCE/1000 PCEs: 2/6 mice: 0.4 % and 51.9 % PCE<br />

1000 mg/kg bw:<br />

2 injections, 24 hours asfter the last injection:<br />

mortality: 6/6<br />

negative control:<br />

4 injections, 24 hours after the last injection:<br />

MNPCEs/1000 PCEs: 6/6 mice: 0.12 % and 40.0 % PCE<br />

historical control:<br />

number of mice: 111<br />

Number of PCEs observed: 111000<br />

Mean of MNPCEs/1000 PCE: 1.12 %(ranged: 0-6)<br />

Mean of % PCE: 46.5<br />

The positive control was functional.<br />

Test condition : TEST ORGANISMS:<br />

- Age: 6 weeks<br />

- No. of animals per dose: 6<br />

ADMINISTRATION:<br />

- Vehicle: olive oil<br />

- Administration volume: 10 ml/kg body weight<br />

- Duration of test:<br />

-----------1. single-treatment study:<br />

animals were killed 24, 48, 72 h after treatment with<br />

dose levels: 0, 200, 400, 800 mg/kg b.w.<br />

----------2. multiple-treatment study:<br />

animals were killed 24h after 2 or 4 injections of o-toluidine at dose levels<br />

of<br />

a)0, 50 (4 inj.), 100, 200, 400, 800 mg/kg bw/day<br />

b)0, 400, 600, 800,1000 mg/kg bw/day<br />

- Sampling times and number of samples:<br />

(1) 24, 48, 72 h for the single-treatment study<br />

(2) 24 after last injection for the multiple-treatment<br />

- 4 bone-marrow smears per animal<br />

- Control groups:<br />

negative controls: vehicle control group<br />

positive controls: treated with single i.p.injection of 2 mg Mitomycin C/kg<br />

bw; animals were killed 24h after<br />

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