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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined. Only 4 Salmonella typhimurium strains tested.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1983
Reference Type:
other: NTP Annual Plan for Fiscal Year 1983
Title:
Unnamed
Year:
1983
Reference Type:
other: Internet Publication
Title:
Unnamed
Year:
1981
Reference Type:
publication
Title:
Unnamed
Year:
1988
Reference Type:
publication
Title:
Salmonella mutagenicity and rodent carcinogenicity: Quantitative structure -activity relationships
Author:
Blake B.W., et al.
Year:
1990
Bibliographic source:
Mutation Research, 241 (1990) 261-271

Materials and methods

Principles of method if other than guideline:
Bacterial reverse mutation assay (Ames test).
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chloro-p-toluidine
EC Number:
202-446-3
EC Name:
3-chloro-p-toluidine
Cas Number:
95-74-9
Molecular formula:
C7H8ClN
IUPAC Name:
3-chloro-4-methylaniline
Details on test material:
IUCLID4 Test substance: other TS: 3-chloro-p-toluidine; label purity: >99 %

Method

Target gene:
Ames test
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with and without
Test concentrations with justification for top dose:
0.0, 10.0, 33.0, 100.0, 333.0, 1000.0, 3333.0 µg/plate.
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
Ames test.

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Results:

       TA 100        TA1535        TA 1537        TA 98
 Dose  NA  RLI  KLI  NA RLI   KLI  NA  RLI  KLI  NA  RLI  KLI
0.0  109 +/- 6.2  155 +/- 3.4  158 +/- 12.6  24 +/- 0.9  28 +/- 6.3  24 +/- 3.4  7 +/- 1.2  9 +/- 1.5  16 +/-1.2  23 +/-5.7  22 +/-0.9  37 +/-2.4
10.0        27 +/- 2.7  32 +/- 0.7  32 +/- 2.7        29 +/-2.9  24 +/-1.5  35 +/-6.1
33.0  112 +/- 7.6  150 +/- 10.2  172 +/- 9.1  16 +/- 4.1  39 +/- 2.3  35 +/- 4.0  8 +/- 0.9  12 +/- 0.9 21 +/- 4.7   26 +/-1.5  21 +/-1.5  36 +/-2.2
100.0  122 +/- 10.0  140 +/- 2.6  172 +/- 14.2  25 +/- 3.5  35 +/- 1.3  28 +/- 3.0  5 +/- 0.9 10 +/- 1.2  12 +/- 1.8   23 +/-2.6  25 +/-2.5  31 +/-2.5
333.0  111 +/- 10.0  162 +/- 2.2  150 +/- 3.0  18 +/- 2.6  32 +/- 1.5  21 +/- 11.6  5 +/- 2.0  8 +/- 0.6  14 +/-2.3 18 +/- 4.5   20 +/-0.9  35 +/-3.5
1000.0   81 +/- 9.6  145 +/- 7.0  154 +/- 17.6   9 +/- 5.2  15 +/- 7.7  23 +/- 6.4  3 +/- 1.2  5 +/- 2.6  8 +/- 1.2  30 +/-5.5  8 +/-3.8  21 +/-8.3
 3333.0 POS  120 +/- 5.5  152 +/- 2.0  152 +/- 1.5        0 +/- 0.0  5 +/- 2.3  7 +/-2.0      
 POS  1268 +/- 11.3  2100 +/- 17.9  2458 +/- 49.7  1482 +/- 7.3  186 +/- 23.5  229 +/- 20.2  249 +/- 32.5  170 +/-12.1  100 +/-5.9  304 +/-46.9  1371 +/-78.6  2079 +/-50.4

Applicant's summary and conclusion

Executive summary:

In an Ames test the test substance was tested in following strains of Salmonella typhimurium with and without metabolic activation TA 98, TA 100, TA 1535, TA 1537. The test concentrations used were: 0.0, 10.0, 33.0, 100.0, 333.0, 1000.0, 3333.0 µg/plate.

The test substance did not prove to be mutagenic in the Ames test for the strains of Salmonella typhimurium tested.

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