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EC number: 465-070-0 | CAS number: 518048-03-8
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:
- other information
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: AMES Test
- Principles of method if other than guideline:
- Purpose : to assess the potential of compounds to induce gene mutations in bacteria. Reversion to prototrophy is measured by plating treated (generally with doses ranging from 100 to 6000 µg/plate) bacteria on plates made with chemically defined media that lack either histidine or tryptophan. Only those cells which are capable of synthesizing histidine or tryptophan can form visible colonies.
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 465-070-0
- EC Name:
- -
- Cas Number:
- 518048-03-8
- Molecular formula:
- C16H19FN403
- IUPAC Name:
- 2-(2-aminopropan-2-yl)-N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
- Details on test material:
- L-000900405-000M004
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9
- Test concentrations with justification for top dose:
- 0 - 100µg - 300µg - 1000µg - 3000µg - 6000µg
- Vehicle / solvent:
- Dimethyl Sulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- Liver microsomal enzymes from rats pretreated with xenobiotics.
- Evaluation criteria:
- Strains do not produce any 2-fold or greater increases in revertants relative to the solvent control.
Results and discussion
Any other information on results incl. tables
| Conc./Plate | TA100 + (S-9) | TA100 - (S-9) | TA1535 +(S-9) | TA1535 - (S-9) | TA97a + (S-9) | TA97a - (S-9) | TA98 + (S-9) | TA98 - (S-9) | WP2 + (S-9) | WP2 - (S-9) |
| 0 µg | 194.6 | 201.9 | 24.2 | 23.0 |
185.7 |
267.9 |
45.2 |
49.4 |
85.8 |
95.6 |
100 µg |
197.3 |
202.7 |
26.7 |
29.7 |
188.0 |
297.7 |
46.0 |
50.7 |
100.7 |
114.0 |
300 µg |
198.3 |
200.3 |
22.0 |
25.3 |
199.7 |
299.0 |
50.0 |
42.7 |
86.7 |
91.7 |
1000 µg |
192.7 |
218.7 |
24.7 |
23.7 |
194.7 |
268.7 |
49.0 |
53.3 |
94.3 |
92.3 |
3000 µg |
216.7 |
244.3 |
32.3 |
26.7 |
208.3 |
313.7 |
50.0 |
44.7 |
96.3 |
94.3 |
6000 µg |
222.7 |
210.0 |
23.7 |
21.0 |
229.0 |
330.3 |
41.3 |
39.7 |
54.0 |
55.3 |
DMSO 100 µL |
194.6 |
201.9 |
24.2 |
23.0 |
185.7 |
267.6 |
45.2 |
49.4 |
85.8 |
95.6 |
2AA 1.0µg |
201.0 |
964.7 |
27.7 |
108.7 |
198.3 |
600.3 |
49.0 |
586.3 |
|
|
2AA 2.0µg |
206.3 |
2053.7 |
25.3 |
245.0 |
196.7 |
1291.7 | 62.3 | 1345.3 | 85.7 | 336.0 |
| 2AA 5.0µg | 91.7 | 1097.0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance is not detectably mutagenic in bacteria and is considered negative in this assay system.
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