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EC number: 258-806-5 | CAS number: 53817-61-1
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
- Study period:
- 15 - 24 Sep 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted May 26, 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- dated Dec 29, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diisodecyl maleate
- EC Number:
- 258-806-5
- EC Name:
- Diisodecyl maleate
- Cas Number:
- 53817-61-1
- Molecular formula:
- C24H44O4
- IUPAC Name:
- 1,4-bis(2-methylnonyl) (2E)-but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: 100 %
Constituent 1
Method
- Target gene:
- his operon
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Phneobarbital/ beta-Naphthoflavone
- Test concentrations with justification for top dose:
- 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/ aqua bidest
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylenediamine (40 µg/plate, -S9, TA1538, TA 98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: + S9: 2-amino anthracene (2AA, 2.5 µg/plate: TA 1535, TA 1537; 5 µg/plate: TA 100, TA 1538, TA 98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn
NUMBER OF REPLICATIONS: triplicates each in two independent experiments - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met: For the test item to be considered mutagenic, two-fold (TA 100) or three-fold (other test strains used) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels.
All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: S. typhimurium TA 1535, TA 1537, TA1538, 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: the spontanous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Test Results of Experiment 1 (plate incorporation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
|
|
Base-pair substitution type |
Frameshift type |
|||
|
|
TA 100 |
TA 1535 |
TA 1538 |
TA 98 |
TA 1537 |
– |
0 (medium) |
129 |
11 |
10 |
18 |
19 |
– |
0 (solvent) |
133 |
14 |
8 |
19 |
16 |
– |
8 |
115 |
10 |
10 |
23 |
19 |
– |
40 |
131 |
9 |
9 |
25 |
12 |
– |
200 |
130 |
14 |
10 |
25 |
18 |
– |
1000 |
133 |
10 |
10 |
26 |
13 |
– |
5000 |
128 |
16 |
12 |
16 |
14 |
Positive controls, –S9 |
Name |
SA |
SA |
4NP |
4NP |
9AA |
Concentrations (μg/plate) |
2 |
2 |
40 |
40 |
80 |
|
Mean No. of colonies/plate (average of 3) |
735 |
583 |
2271 |
1686 |
1041 |
|
+ |
0 (medium) |
115 |
11 |
14 |
21 |
14 |
+ |
0 (solvent) |
103 |
11 |
12 |
25 |
11 |
+ |
8 |
134 |
13 |
14 |
26 |
13 |
+ |
40 |
117 |
8 |
16 |
24 |
15 |
+ |
200 |
119 |
12 |
14 |
27 |
12 |
+ |
1000 |
124 |
17 |
14 |
26 |
12 |
+ |
5000 |
120 |
12 |
11 |
28 |
10 |
Positive controls, + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
5 |
2.5 |
5 |
5 |
2.5 |
|
Mean No. of colonies/plate (average of 3) |
2557 |
180 |
2269 |
1985 |
152 |
|
4NP = 4-nitro-p-phenolenediamine
9AA = 9-aminoacridine
2AA = 2 -aminoanthracene
SA = sodium azide
Table 2: Test Results of Experiment 2 (plate incorporation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
|
|
Base-pair substitution type |
Frameshift type |
|||
|
|
TA 100 |
TA 1535 |
TA 1538 |
TA 98 |
TA 1537 |
– |
0 (medium) |
118 |
16 |
9 |
25 |
14 |
– |
0 (solvent) |
128 |
7 |
10 |
28 |
15 |
– |
8 |
119 |
18 |
11 |
28 |
15 |
– |
40 |
123 |
12 |
13 |
22 |
15 |
– |
200 |
114 |
14 |
11 |
23 |
16 |
– |
1000 |
137 |
12 |
12 |
26 |
14 |
– |
5000 |
131 |
11 |
6 |
24 |
19 |
Positive controls, –S9 |
Name |
SA |
SA |
4NP |
4NP |
9AA |
Concentrations (μg/plate) |
2 |
2 |
40 |
40 |
80 |
|
Mean No. of colonies/plate (average of 3) |
857 |
649 |
2159 |
1637 |
1069 |
|
+ |
0 (medium) |
136 |
18 |
16 |
29 |
14 |
+ |
0 (solvent) |
99 |
15 |
15 |
29 |
14 |
+ |
8 |
139 |
10 |
12 |
35 |
13 |
+ |
40 |
118 |
13 |
15 |
32 |
14 |
+ |
200 |
133 |
22 |
21 |
34 |
14 |
+ |
1000 |
133 |
12 |
13 |
30 |
14 |
+ |
5000 |
119 |
12 |
12 |
30 |
13 |
Positive controls, + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
5 |
2.5 |
5 |
5 |
2.5 |
|
Mean No. of colonies/plate (average of 3) |
501 |
144 |
1100 |
672 |
86 |
|
4NP = 4-nitro-p-phenolenediamine
9AA = 9-aminoacridine
2AA = 2 -aminoanthracene
SA = sodium azide
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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