Registration Dossier
Registration Dossier
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EC number: 202-446-3 | CAS number: 95-74-9
Genetic toxicity: in vitro
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:
- 1 983
- Reference Type:
- other: NTP Annual Plan for Fiscal Year 1983
- Title:
- Unnamed
- Year:
- 1 983
- Reference Type:
- other: Internet Publication
- Title:
- Unnamed
- Year:
- 1 981
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
- Reference Type:
- publication
- Title:
- Salmonella mutagenicity and rodent carcinogenicity: Quantitative structure -activity relationships
- Author:
- Blake B.W., et al.
- Year:
- 1 990
- 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
- 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 %
Constituent 1
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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