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EC number: 817-761-7 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Dec 2002 - 13 Jan 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Directive 2000/32/EC
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- EC Number:
- 817-761-7
- Cas Number:
- 765293-81-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- Test material form:
- other: waxy solid
Constituent 1
Method
- Target gene:
- his operon for S. typhimurium strains and trp operon for E. coli strains.
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- Cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbitone / β-naphthoflavone.
- Test concentrations with justification for top dose:
- Preliminary toxicity study: 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate in TA 100 and WP2 uvr A with and without metabolic activation
Experiment 1 and experiment 2: 50, 150, 500, 1500 and 5000 µg/plate in all strains with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tetrahydrofuran
- Justification for choice of solvent/vehicle: The test substance is soluble in tetrahydrofuran at 200 mg/mL, but insoluble in water, acetone, ethanol, DMSO and dimethyl formamide at 50 mg/mL, tetrahydrofuran is an acceptable vehicle for use in this test system.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tetrahydrofuran
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: The main assay was performed twice and each carried out in triplicates.
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the growth of the bacterial background lawn - Evaluation criteria:
- The test material is considered positive in this test system, if the test material have induced a reproducible, dose-related and statistically significant increase in the revertant count in at least one strain of bacteria.
- Statistics:
- Mean values and standard deviations were calculated. Dunnett's method of linear regression was used for statistical analysis.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA98 and TA100
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: An oily precipitate was observed at and above 500 µg/plate, this did not prevent the scoring of revertant colonies.
HISTORICAL CONTROL DATA
- Positive historical control data: see table 6
- Negative (solvent/vehicle) historical control data: see table 6
Any other information on results incl. tables
Table 1 Spontaneous mutation rates (concurrent negative controls)
Experiment 1
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
72 90 (91) 112 |
13 13 (13) 13 |
34 31 (31) 29 |
33 17 (91) 20 |
8 9 (9) 9 |
Experiment 2
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
68 70 (72) 78 |
15 7 (12) 13 |
18 17 (18) 20 |
12 17 (19) 29 |
7 8 (6) 4 |
Table 2 Test results: Experiment 1 – without metabolic activation
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
||
- |
0 (vehicle control) |
103 93 (89) 72 15.8# |
21 17 (22) 29 6.1 |
26 36 (32) 33 5.1 |
24 22 (30) 45 12.7 |
7 16 (9) 5 5.9 |
- |
50 |
81 90 (78) 63 13.7 |
12 14 (13) C 1.4 |
25 26 (24) 20 3.2 |
23 17 (21) 23 3.5 |
9 8 (9) 9 0.6 |
- |
150 |
74 65 (74) 82 8.5 |
11 9 (11) 14 2.5 |
26 23 (22) 17 4.6 |
26 22 (22) 18 4.0 |
7 19 (10) 5 7.6 |
- |
500 |
82 P 86 P (81) 76 P 5.0 |
9 P 12 P (10) 9 P 1.7 |
26 P 20 P (23) 24 P 3.1 |
24 P 28 P (24) 19 P 4.5 |
12 P 9 P (10) 8 P 2.1 |
- |
1500 |
61 P 67 P (68) 77 P 8.1 |
20 P 16 P (15) 9 P 5.6 |
22 P 20 P (22) 24 P 2.0 |
26 P 20 P (24) 26 P 3.5 |
6 P 8 P (7) 7 P 1.0 |
- |
5000 |
89 P 70 P (83) 89 P 11.0 |
12 P 21 P (16) 15 P 4.6 |
24 P 34 P (28) 25 P 5.5 |
22 P 23 P (28) 40 P 10.1 |
13 P 7 P (11) 14 P 3.8 |
Positive controls S9-Mix - |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentration (µg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
No. colonies per plate |
295 333 (339) 390 47.8 |
441 410 (422) 416 16.4 |
742 727 (732) 727 8.7 |
126 142 (127) 114 14.0 |
3102 3064 (3068) 3039 31.7 |
|
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine; 4NQO:4-nitroquinoline-1-oxide; 9AA: 9-Aminoacridine; P: Precipitate; #: Standard deviation
Table 3 Test results: Experiment 1 – with metabolic activation
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
||
+ |
0 (vehicle control) |
110 90 (95) 86 12.9# |
9 18 (15) 19 5.5 |
23 44 (39) 49 13.8 |
57 32 (39) 29 15.4 |
7 8 (10) 16 4.9 |
+ |
50 |
90 87 (85) 79 5.7 |
12 19 (15) 13 3.8 |
31 22 (27) 27 4.5 |
37 31 (30) 21 8.1 |
17 7 (11) 8 5.5 |
+ |
150 |
77 99 (93) 102 13.7 |
13 8 (13) 19 5.5 |
34 25 (27) 21 6.7 |
38 24 (28) 22 8.7 |
11 9 (10) 11 1.2 |
+ |
500 |
92 P 85 P (90) 92 P 4.0 |
13 P 18 P (14) 11 P 3.6 |
36 P 37 P (36) 34 P 1.5 |
35 P 29 P (29) 22 P 6.5 |
9 P 8 P (8) 6 P 1.5 |
+ |
1500 |
69 P 83 P (82) 95 P 13.0 |
16 P 12 P (14) 15 P 2.1 |
37 P 23 P (27) 22 P 8.4 |
32 P 19 P (28) 32 P 7.5 |
4 P 2 P (4) 7 P 2.5 |
+ |
5000 |
112 P 97 P (106) 108 P 7.8 |
16 P 21 P (19) 21 P 2.9 |
32 P 28 P (31) 33 P 2.6 |
24 P 25 P (27) 31 P 3.8 |
5 P 9 P (8) 11 P 3.1 |
Positive controls S9-Mix + |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentration (µg/plate) |
1 |
2 |
10 |
5 |
2 |
|
No. colonies per plate |
1302 1338 (1347) 1401 50.1 |
326 632 (528) 626 175.0 |
798 846 (838) 869 36.2 |
224 230 (238) 260 19.3 |
478 500 (494) 504 14.0 |
|
BP: Benzo(a)pyrene; 2AA: 2-Aminoanthracene; P: Precipitate; #: Standard deviation
Table 4 Test results: Experiment 2 – without metabolic activation
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
||
- |
0 (vehicle control) |
120 74 (88) 70 27.8# |
17 13 (14) 11 3.1 |
16 12 (17) 23 5.6 |
31 26 (28) 27 2.6 |
8 7 (7) 6 1.0 |
- |
50 |
72 84 (73) 63 10.5 |
16 14 (15) 14 1.2 |
18 22 (22) 25 3.5 |
18 24 (21) 20 3.1 |
6 5 (7) 9 2.1 |
- |
150 |
85 77 (76) 67 9.0 |
9 11 (9) 8 1.5 |
25 24 (21) 13 6.7 |
29 17 (23) 22 6.0 |
15 8 (10) 8 4.0 |
- |
500 |
75 P 86 P (80) 80 P 5.5 |
11 P 7 P (12) 18 P 5.6 |
11 P 19 P (17) 21 P 5.3 |
18 P 24 P (22) 23 P 3.2 |
7 P 11 P (7) 3 P 4.0 |
- |
1500 |
95 P 100 P (98) 98 P 2.5 |
14 P 19 P (15) 11 P 4.0 |
19 P 18 P (19) 21 P 1.5 |
25 P 19 P (26) 34 P 7.5 |
7 P 4 P (6) 7 P 1.7 |
- |
5000 |
112 P 110 P (110) 107 P 2.5 |
20 P 17 P (19) 21 P 2.1 |
24 P 25 P (22) 18 P 3.8 |
18 P 23 P (26) 38 P 10.4 |
11 P 5 P (7) 5 P 3.5 |
Positive controls S9-Mix - |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentration (µg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
No. colonies per plate |
529 501 (512) 507 14.7 |
373 376 (359) 328 26.9 |
867 872 (879) 897 16.1 |
105 124 (117) 121 10.2 |
1619 1518 (1896) 2552 570.1 |
|
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine; 4NQO:4-nitroquinoline-1-oxide; 9AA: 9-Aminoacridine; P: Precipitate; #: Standard deviation
Table 5 Test results: Experiment 2 – with metabolic activation
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
||
+ |
0 (vehicle control) |
87 87 (86) 83 2.3# |
13 14 (15) 18 2.6 |
24 20 (27) 36 8.3 |
38 36 (34) 28 5.3 |
12 14 (12) 11 1.5 |
+ |
50 |
113 84 (94) 85 16.5 |
15 20 (18) 18 2.5 |
26 26 (26) 27 0.6 |
31 42 (38) 41 6.1 |
12 14 (13) 13 1.0 |
+ |
150 |
87 86 (82) 72 8.4 |
22 22 (20) 17 2.9 |
18 35 (27) 28 8.5 |
42 36 (38) 36 3.5 |
9 14 (10) 8 3.2 |
+ |
500 |
100 P 78 P (90) 92 P 11.1 |
17 P 15 P (14) 9 P 4.2 |
28 P 23 P (24) 22 P 3.2 |
47 P 31 P (40) 41 P 8.1 |
13 P 9 P (10) 8 P 2.6 |
+ |
1500 |
85 P 80 P (80) 76 P 4.5 |
14 P 13 P (15) 19 P 3.2 |
36 P 23 P (32) 37 P 7.8 |
32 P 36 P (32) 28 P 4.0 |
14 P 7 P (12) 14 P 4.0 |
+ |
5000 |
112 P 82 P (93) 85 P 16.5 |
14 P 16 P (15) 15 P 1.0 |
33 P 11 P (26) 33 P 12.7 |
41 P 38 P (42) 46 P 4.0 |
15 P 7 P (10) 7 P 4.6 |
Positive controls S9-Mix + |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentration (µg/plate) |
1 |
2 |
10 |
5 |
2 |
|
No. colonies per plate |
947 1305 (1160) 1229 188.6 |
330 319 (312) 287 22.3 |
654 721 (707) 746 47.6 |
229 215 (230) 245 15.0 |
340 349 (370) 420 43.8 |
|
BP: Benzo(a)pyrene; 2AA: 2-Aminoanthracene; P: Precipitate; #: Standard deviation
Table 6 History profile of vehicle and positive control values
Combined vehicle and untreated control values 2001
Strain S9-Mix |
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Mean |
106 |
116 |
16 |
15 |
22 |
26 |
23 |
32 |
11 |
13 |
SD |
23 |
23 |
4 |
4 |
5 |
6 |
7 |
8 |
4 |
4 |
Min |
58 |
62 |
8 |
7 |
11 |
13 |
10 |
13 |
2 |
4 |
Max |
178 |
178 |
37 |
37 |
41 |
52 |
56 |
58 |
23 |
29 |
Values |
817 |
658 |
790 |
621 |
656 |
501 |
814 |
662 |
793 |
630 |
Positive control values 2001
Strain S9-Mix |
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Mean |
505 |
1582 |
431 |
336 |
685 |
756 |
140 |
303 |
1415 |
428 |
SD |
190 |
541 |
412 |
110 |
323 |
243 |
43 |
96 |
713 |
146 |
Min |
259 |
454 |
98 |
113 |
248 |
242 |
72 |
136 |
197 |
139 |
Max |
1829 |
2738 |
2039 |
990 |
1960 |
1340 |
362 |
679 |
3616 |
792 |
Values |
165 |
163 |
163 |
161 |
156 |
155 |
166 |
164 |
162 |
160 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation.
Based on the results of the conducted Ames test the test substance did not exhibit mutagenic properties in bacterial cells with and without metabolic activation tested up to the limit concentration.
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