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

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 />

164<br />

CRITERIA FOR POSITIVE RESULT:<br />

in general:<br />

dose-related increase in the mean revertants per plate of at least one tester<br />

strain with a minimum of two increasing concentrations of test article<br />

S.typh.TA1<strong>53</strong>5 and TA1<strong>53</strong>7:<br />

increase in mean revertants at the peak of the dose response is equal or<br />

greater than three times the mean vehicle control value S.typh.TA98 and<br />

TA100:<br />

increase in mean revertants at the peak of the dose response is equal or<br />

greater than two times the mean vehicle control value<br />

Result : 1) o-toluidine was negative in all tester strains without or with metabolic<br />

activation<br />

Positive controls were functional<br />

2) o-toluidine did cause positive responses with strain TA98 in the<br />

presence of aroclor-induced rat liver-S9 and Norharman.<br />

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

only 4 strains used<br />

Flag : Critical study for SIDS endpoint<br />

24.05.2004 (164)<br />

Type : Ames test<br />

System of testing : Salmonella typhimurium TA 97, TA 98, TA 100, TA 1<strong>53</strong>5<br />

Test concentration : 0, 33, 100, 333, 500, 1000, 2000, 3333 µg/plate in DMSO<br />

Cycotoxic concentr. : > 3333 µg/plate<br />

Metabolic activation : with and without<br />

Result : negative<br />

Method : other: preincubation method according to Ames, Mutat. Res. 31,347(1975);<br />

Maron, Mutat. Res.113,173(1983), see also freetext TC<br />

Year : 1985<br />

GLP : no data<br />

Test substance : other TS: o-toluidine, no data on purity<br />

Result : o-Toluidine was without significant activity without S9-mix<br />

with S9 mix of rats and hamsters with one exception:<br />

o-Toluidine induced a dose-related increase of revertants in TA100 only in<br />

the presence of 30% hamster liver S9-mix<br />

Test condition : Salmonella strains were used in a 20 min preincubation procedure without<br />

metabolic activation and with Aroclor-1554-induced S9 from male Sprague-<br />

Dawley rats(10%, 30%) and Syrian hamsters (10%, 30%).<br />

Dosing:<br />

<strong>Chemicals</strong> were tested under code at a minimum of five doses up to a toxic<br />

dose or the limit of solubility, to a maximum dose of 10 mg per plate.<br />

Evaluation:<br />

A positive response was defined as a dose-related increase over the<br />

controlregardless of its magnitude.<br />

In the first experiment the concentration of S9-mix was 10%.<br />

If all tests (non activation, rat S9 and hamster S9 were negative, they were<br />

repeated, with 30% S9-mix.<br />

If the repeat test was also negative, the chemical was declared<br />

nonmutagenic.<br />

If a positive result was seen, only the strain-activation combination giving<br />

the positive result, was repeated.<br />

If an equivocal or weak response was seen, only that strain-activation<br />

combination was repeated;<br />

Concurrent positive and negative controls were run.<br />

negative control: solvent = DMSO<br />

positive controls:<br />

without S9-mix:<br />

<strong>UNEP</strong> PUBLICATIONS

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