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EC number: 947-453-9 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Reliability of the original study was established to be R2: purity below 80 %; strains tested may not detect certain oxidising mutagens, cross-linking agents and hydrazines. Justification for read-across is detailed at section 13.
- Justification for type of information:
- Justification for read-across is detailed at section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Similar Substance 02
- IUPAC Name:
- Similar Substance 02
Constituent 1
Method
- Target gene:
- his
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- experiment 1: 100, 500, 2500, 5000 μg/plate.
experiment 2: 500, 2500, 5000, 7500 μg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene; 2.5 µg dissolved in DMSO
- Remarks:
- With metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 4-nitro-o-phenylenediamide
- Remarks:
- Without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar, plate incorporation.
- Duration: 48 h at 37 °C
NUMBER OF REPLICATIONS: 3 test plates per dose or per control.
DETERMINATION OF CYTOTOXICITY: relative total growth. - Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control),
- dose-response relationship,
- reproducibility of the results.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- From 500 µg onwards
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- From 5000 µg onward.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
| Dose µg/plate | metabolic activation | TA98 | TA100 | TA1535 | TA1537 | TA1538 | |||||||||||||||||||
| 1st exp(a) | 2nd exp(b) | 1st exp(a) | 2nd exp(b) | 1st exp(a) | 2nd exp(b) | 1st exp(a) | 2nd exp(b) | 1st exp(a) | 2nd exp(b) | ||||||||||||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | ||||||
| 0 | + | 44,5 | 7,7 | 47,0 | 8,5 | 109,0 | 2,6 | 107,5 | 9,2 | 17,8 | 3,8 | 17,5 | 0,7 | 9,5 | 0,6 | 7,5 | 0,7 | 24,8 | 1,7 | 31,5 | 2,1 | ||||
| 20 | + | 48,3 | 7,4 | 119,3 | 10,3 | 14,8 | 6,8 | 9,5 | 1,3 | 28,3 | 2,2 | ||||||||||||||
| 100 | + | 46,8 | 5,9 | 46,0 | 0,0 | 117,3 | 5,3 | 114,5 | 6,4 | 14,0 | 1,6 | 15,5 | 4,9 | 7,5 | 2,4 | 11,5 | 2,1 | 24,3 | 3,8 | 25,0 | (c) | ||||
| 500 | + | 53,0 | 3,6 | 44,0 | 8,5 | 146,0 | 15,4 | 148,5 | 17,7 | 14,0 | 2,4 | 15,0 | 7,1 | 7,0 | 2,2 | 8,5 | 0,7 | 24,8 | 6,2 | 22,0 | 4,2 | ||||
| 2500 | + | 46,8 | 7,1 | 46,0 | 1,4 | 254,0 | 19,9 | 238,0 | 7,1 | 15,5 | 3,3 | 21,0 | 4,2 | 26,5 | 7,3 | 36,5 | 7,8 | 20,3 | 3,0 | 23,0 | 9,9 | ||||
| 5000 | + | 45,0 | 4,1 | 42,5 | 4,9 | 354,3 | 28,7 | 306,0 | 12,7 | 18,5 | 3,1 | 32,5 | 6,4 | 45,0 | 5,5 | 58,0 | 11,3 | 18,3 | 2,9 | 27,5 | 12,0 | ||||
| 7500 | + | 64,0 | 17,0 | 378,5 | 34,6 | 28,5 | 3,5 | 69,0 | 19,8 | 27,5 | 0,7 | ||||||||||||||
| 10 µg 2-Aminoanthracene | + | 1625,0 | 132,3 | 1725,0 | 134,4 | 2187,5 | 165,2 | 2450,0 | 141,4 | 300,8 | 57,5 | 394,5 | 29,0 | 291,3 | 18,2 | 240,0 | 15,6 | 1622,5 | 84,2 | 1420,0 | 84,9 | ||||
| 0 | - | 29,3 | 4,9 | 24,5 | 0,7 | 99,5 | 15,5 | 106,5 | 10,6 | 15,3 | 2,1 | 16,0 | 1,4 | 8,8 | 2,6 | 6,5 | 0,7 | 13,3 | 2,6 | 11,5 | 0,7 | ||||
| 20 | - | 30,7 | 5,8 | 100,0 | 15,6 | 13,3 | 1,3 | 7,0 | 1,8 | 11,3 | 2,5 | ||||||||||||||
| 100 | - | 31,5 | 5,9 | 29,5 | 2,1 | 102,8 | 4,9 | 106,5 | 2,1 | 15,3 | 3,4 | 16,5 | 3,5 | 7,5 | 2,5 | 7,0 | 1,4 | 12,5 | 1,0 | 13,5 | 2,1 | ||||
| 500 | - | 43,0 | 12,9 | 39,5 | 9,2 | 134,0 | 11,2 | 153,5 | 33,2 | 17,0 | 3,9 | 20,0 | 2,8 | 13,0 | 4,2 | 11,0 | 2,8 | 11,3 | 2,2 | 17,0 | 2,8 | ||||
| 2500 | - | 70,0 | 8,3 | 78,0 | 5,7 | 289,8 | 30,4 | 318,5 | 85,6 | 21,3 | 0,5 | 19,5 | 2,1 | 38,0 | 7,5 | 33,0 | 5,7 | 15,0 | 2,2 | 27,5 | 7,8 | ||||
| 5000 | - | 78,3 | 16,2 | 86,5 | 4,9 | 415,5 | 60,7 | 411,0 | 62,2 | 23,5 | 5,4 | 32,0 | (c) | 55,8 | 8,7 | 63,5 | 9,2 | 15,0 | 2,2 | 27,5 | 7,8 | ||||
| 7500 | 95,5 | 9,2 | 571,5 | 94,0 | 41,0 | 8,5 | 80,0 | 8,5 | 26,3 | 5,6 | 37,5 | 0,7 | |||||||||||||
| 5 µg MNNG | - | 1875,0 | 199,4 | 1845,0 | 21,2 | 1317,5 | 357,6 | 1595,0 | 176,8 | 58,0 | 1,4 | ||||||||||||||
| 10 µg 4-Nitro-o-phenylendiamin | - | 623,5 | 67,7 | 907,0 | 258,8 | 358,5 | 146,8 | 642,0 | 70,7 | ||||||||||||||||
| 100 µg 9-amninoacridine | - | 698,3 | 50,3 | 787,5 | 7,8 | ||||||||||||||||||||
Applicant's summary and conclusion
- Conclusions:
- Positive induction of mutation frequence.
- Executive summary:
The test was performed according to OECD 471 on five strains of S. typhimurium (TA1535; TA1537; TA98; TA100 and TA1538). A deviation from the guideline was present, since the E.coli strains or the S.typhimurium TA102, as recommended, were not evaluated. These strains should be used in order to evaluate certain oxidising mutagen, cross-linking agents and hydrazines.
The test substance showed a strain-dependent weak to moderate mutagenic effect without metabolic activation from 2500 μg/plate onward. In presence of metabolic activation no mutagenic effect was observed for TA1535, TA1538 and TA98 and a weak mutagenic effect for TA100 and TA1537 (> 2500 μg/plate). With metabolic activation, no or only weak mutagenic activity was determined.
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