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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
according to the method described by Ames, B.N. et al.: Proc. Nat. Acad. Sci., 70, 2281-2285, 1973 and Ames, B.N. et al.: Mut. Res., 31, 347-364, 1975
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
6-amino-5-formamido-1,3-dimethyluracil
EC Number:
231-501-4
EC Name:
6-amino-5-formamido-1,3-dimethyluracil
Cas Number:
7597-60-6
Molecular formula:
C7H10N4O3
IUPAC Name:
N-(6-amino-1,3-dimethyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)formamide
Details on test material:
- Name of test material (as cited in study report): 1,3-Dimethyl-4-amino-5-formylaminouracil
- Substance No.: 80/205
- Physical state: solid
- Analytical purity: 98.5%
- Storage condition of test material: 4°C

Method

Target gene:
his
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9-mix
Test concentrations with justification for top dose:
20, 100, 500, 2500, 5000 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-Aminoanthracen; 10 µg/plate dissolved in DMSO for TA 100, TA 98, TA 1538, TA 1537 und TA 1535
Remarks:
with metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Methyl-N'-nitro-N-nitroso-guanidin (NNNG); 5 µg/plate dissolved in DMSO for TA 100 , TA 98 und TA 1535
Remarks:
without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-Nitro-o-pheny lendiamin; 10 µg/plate dissolved in DMSO for TA 1538
Remarks:
without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without metabolic activation

Migrated to IUCLID6: 100 µg/plate dissolved in DMSO for TA 1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h, 37°C

NUMBER OF REPLICATIONS: 4


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
The test chemical is considered positive in this assay if the following criteria are met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if:
- The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA 98, 100, 1535, 1537 and 1538

Any other information on results incl. tables

Reults:

Dose µg/plate metabolic activation  TA 98   TA 100   Ta 1535   TA 1537   TA 1538 
Trial 1 Trial 2 Trial 3 Trial 4 Trial 1 Trial 2 Trial 3 Trial 4 Trial 1 Trial 2 Trial 3 Trial 4 Trial 1 Trial 2 Trial 3 Trial 4 Trial 1 Trial 2 Trial 3 Trial 4
0 + 36 39 37 42 118 102 118 108 11 16 13 17 9 8 10 10 26 25 34 32
20 + 41 49 36 55 105 114 116 117 12 11 12 16 9 7 6 11 31 34 33 30
100 + 30 43 49 46 125 111 129 97 18 16 13 14 8 9 8 6 22 31 22 30
500 + 33 45 47 51 128 122 123 105 12 12 12 12 9 7 7 12 27 25 25 30
2500 + 38 35 42 50 109 124 120 86 12 7 15 11 8 8 7 11 26 31 25 15
5000 + 34 41 37 39 105 118 116 92 10 14 131 18 7 7 6 10 29 30 18 23
                       
10 µg 2-Aminoanthracene + 1190 920 1110 850 1580 1320 1360 1550 143 161 175 152 79 90 83 85 550 745 735 620
              12          
0 - 27 29 25 37 119 110 118 119 12 19 12 15 6 8 6 5 14 18 15 13
20 - 30 25 27 34 - 116 109 131 20 26 16 11 7 5 5 4 12 13 18 14
100 - 24 29 23 27 120 129 120 104 15 13 18 14 5 7 7 5 16 11 14 16
500 - 27 26 26 26 107 102 132 125 14 21 13 16 3 5 4 6 13 13 16 11
2500 - 24 24 26 18 112 116 123 116 18 15 15 19 6 5 5 8 14 12 16 16
5000 - 28 31 31 28 109 113 114 94 19 14 18 17 5 6 4 8 12 12 12 14
                       
5 µg MNNG - 640 - 375 405 2350 2050 2450 2450 2650 2400 2350 2900        
10 µg 4-Nitro-o-phenylendiamin -                 244 276 256 245
100 µg 9-amninoacridine -                         820 875 705 615        

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative