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Diss Factsheets

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:
2004

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

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
465-070-0
EC Name:
-
Cas Number:
518048-03-8
Molecular formula:
C16H19FN403
IUPAC Name:
2-(1-amino-1-methylethyl)-N-(4-fluorobenzyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
Details on test material:
L-000900405-000M004

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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