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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 />

168<br />

The positive control was functional<br />

(2) o-toluidine hydrochloride was tested negative in TA 98 with and without<br />

metabolic activation systems; o-toluidine hydrochloride was tested negative<br />

in TA 100 in the absence of S9-mix and in the presence of 30 % S9-mix<br />

prepared from rat liver but yielded positive results in the presence of 30 %<br />

S9-mix from hamster liver.<br />

The positive controls were functional.<br />

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

only 4 strains used, no cytotox. concentration given, no information on GLP<br />

Flag : Critical study for SIDS endpoint<br />

11.08.2004 (171)<br />

Type : HGPRT assay<br />

System of testing : Chinese hamster V 79 cells<br />

Test concentration : Trial 1: see freetext TC Trial 2: see freetext TC<br />

Cycotoxic concentr. : with and without serum: preliminary cytotoxicity study, with different doses<br />

and exposure times with and without S9-mix<br />

Metabolic activation : with and without<br />

Result : negative<br />

Method : other: as described by McMillan and Fox (1979)<br />

Year : 1985<br />

GLP : no data<br />

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

Result : Trial 1:<br />

Little evidence of toxicity (except at very high concentrations) was<br />

observed<br />

Trial 2:<br />

o-Toluidine did not induce increases in mutant frequencies over control<br />

levels<br />

Positive controls were functional<br />

Test condition : METHOD:<br />

1. INHIBITION OF COLONY FORMING ABILITY<br />

Cells were exposed to the test substance in the presence and in the<br />

absence of serum and in the presence and absence of S9-mix;<br />

exposure time: 1 hour<br />

doses:<br />

highest non-tox.dose:<br />

with and without serum, +/-S9-mix, 0.1mg/ml;<br />

conc. for 50 % kill:<br />

with Serum, +/-S9-mix: >3mg/ml, without Serum: -S9-mix, 3mg/ml, +S9mix,<br />

2mg/ml<br />

2. MUTATION ASSAY<br />

Thioguanine was used to select for HGPRT-deficient mutants.<br />

Exposure to the testsubstance was for 60 min. in the absence of serum<br />

and in the presence and absence of S9-mix.<br />

Doses tested were chosen to include at least one that induced<br />

measureable cytytotoxicity in colony forming assay and one higher dose.<br />

without serum, +/- S9-mix: 0, 0.25, 0.30, 0.50, 1.00, 2.00 mg/ml<br />

expression time: 5, 8, 12 days<br />

CONTROLS<br />

Positive control<br />

cyclophosphamide and ethylmethansulfonate in the presence and in the<br />

absence of S9 mix, respectively<br />

negative control<br />

Solvent: DMSO<br />

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