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EC number: 305-769-9 | CAS number: 95009-41-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 26 Mar - 05 Apr 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions. No S. typhimurium TA102 or E. coli strain was included.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no S. typhimurium TA102 or E. coli strain was included
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- no S. typhimurium TA102 or E. coli strain was included
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Decanoic acid, mixed diesters with octanoic acid and propylene glycol
- EC Number:
- 271-516-3
- EC Name:
- Decanoic acid, mixed diesters with octanoic acid and propylene glycol
- Cas Number:
- 68583-51-7
- IUPAC Name:
- 68583-51-7
- Details on test material:
- - Name of test material (as cited in study report): [trade name], Decanoic acid, mixed diesters with octanoic acid and propylene glycol
- Analytical purity: 100%
- Physical state: colourless liquid
- Lot/batch No.: 3409
- Production date: November 04, 1990
- Expiration date of the lot/batch: May 04, 1992
- Storage condition of test material: at room temperature
- Stability:
Pure: 18 months
In Solvent: not given
- Receipt of the test substance: February 08, 1991
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
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Standard I nutrient broth for microbiology
- Additional strain / cell type characteristics:
- other: rfa-; uvrB- (R+ for TA98 and TA100)
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Standard I nutrient broth for microbiology
- Additional strain / cell type characteristics:
- other: rfa-; uvrB-
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- First and second experiment: 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Suspension medium Tween 80/bidest. water
- Justification for choice of solvent/vehicle: According to the author, the suspension medium was chosen based on the solubility properties preliminary tested before start of the study.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tween 80/bidest. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (2 µg/plate, ±S9, TA1535 and TA100); 9-Aminoacridine (80 µg/plate, ±S9, TA1537); 4-Nitro-o-phenylendiamine (40 µg/plate, ±S9,TA98 and TA1538); 2 Amino-anthracene (2.5 or 5 µg/plate, ±S9, TA1535 and TA1357; TA100, TA1538 and TA98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments - Evaluation criteria:
- The test material may be considered positive in this test system if a combination of the following criteria are met:
- the plate background of non-reverted bacteria does not show any growth reduction versus the respective negative controls.
- the spontaneous mutation rates of each tester strain per plate are within the characteristic spontaneous mutation range.
- the positive controls show mutation rates exceeding the control values of TA100 at least two fold and those of the other strains at least by the factor 3.
- at more than one dose tested, at least a two-fold (or more) increase in comparison with the negative controls in the tester strain TA100. For the other strains, an increase in the mutation rate of more than 3 above the corresponding negative controls. - Statistics:
- Mean values and standard deviation were calculated.
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:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
- see Table 1 and Table 2 - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
COMPARISON WITH HISTORICAL DATA
Table 1. Characteristic spontaneous mutation range of the test batches without S9-mix.
Tester strains |
TA1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
Historical laboratory values (Mean values) Extreme values |
6 1-25 |
87 35-201 |
7 1-24 |
15 6-27 |
20 5-39 |
Ames et al.* (Mean values) Extreme values |
20 5-50 |
160 60-220 |
7 3-25 |
25 5-40 |
40 15-75 |
*Ames, BN, McCann, J, Yamasaki, E 1977, ´Methods for detecting carcinogens and mutagens with the Salmonella/mammalian microsome mutagenicity test.`in Kilbey et al. Handbook of Mutagenicity Test Procedures, Elsevier, Amsterdam, pp. 1 -17.
Table 2. Characteristic spontaneous mutation range of the test batches containing S9-mix.
Tester strains |
TA1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
Historical laboratory values (Mean values) Extreme values |
8 1-25 |
105 54-252 |
6 1-23 |
18 3-48 |
27 7-76 |
STUDY RESULTS
Table 3. 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 ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
||
– |
Negative control |
11.7 ± 2.3 |
99.7 ± 11.7 |
6.7 ± 3.8 |
8.7 ± 0.6 |
22.7 ± 1.5 |
– |
Solvent control |
12.7 ± 5.5 |
113.3 ± 6.4 |
6.3 ± 1.5 |
11.30 ± 2.1 |
27.0 ± 3.5 |
– |
8 |
13.7 ± 1.5 |
103.3 ± 3.1 |
8.0 ± 3.6PM |
7.7 ± 1.5 |
30.0 ± 5.3 |
– |
40 |
9.3 ± 2.1 |
104.7 ± 12.0 |
6.3 ± 1.5 |
10.7 ± 3.8 |
26.3 ± 6.7 |
– |
200 |
8.7 ± 3.1 |
113.0 ± 7.0 |
8.0 ± 2.0 |
11.0 ± 2.0 |
26.0 ± 2.7 |
– |
1000 |
13.7 ± 4.2 |
104.7 ± 7.1 |
8.0 ± 3.0 |
13.3 ± 4.0 |
27.3 ± 3.5 |
– |
5000 |
9.7 ± 0.6 |
110.0 ± 8.9 |
7.0 ± 3.6 |
7.3 ± 2.3 |
24.3 ± 2.1 |
Positive controls, –S9 |
Name |
SA |
SA |
9AA |
4NPD |
4NPD |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
534.7 ± 38.4 |
324.0 ± 19.2 |
352.0 ± 57.1 |
1428.0 ± 19.0 |
699.0 ± 99.0 |
|
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Concentrations (μg/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
9.7 ± 0.6 |
110.7 ± 7.6 |
10.7 ± 2.1 |
18.7 ± 6.1 |
27.3 ± 1.2 |
|
+ |
Negative control |
12.7 ± 3.1 |
101.7 ± 7.8 |
9.3 ± 2.1 |
18.7 ±3.2 |
42.3 ± 5.0 |
+ |
Solvent control |
14.7 ± 3.5 |
107.0 ± 15.4 |
9.3 ± 3.2 |
15.3 ± 2.1 |
45.0 ± 5.0 |
+ |
8 |
14.0 ± 4.4 |
103.7 ± 23.0 |
8.0 ± 1.7 |
12.7 ± 2.1 |
42.7 ± 4.7 |
+ |
40 |
14.3 ± 2.1 |
104.3 ± 12.7 |
6.3 ± 1.2 |
15.7 ± 2.9 |
49.3 ± 2.1 |
+ |
200 |
11.7 ± 1.5 |
115.0 ± 10.4 |
7.0 ± 1.0 |
14.7 ± 4.7 |
38.7 ± 2.3 |
+ |
1000 |
16.0 ± 2.0 |
116.7 ± 11.9 |
5.3 ± 1.5 |
17.0 ± 2.0 |
45.3 ± 8.1 |
+ |
5000 |
6.3 ± 0.6 |
81.0 ± 4.6 |
6.3 ± 3.2 |
16.0 ± 2.7 |
31.3 ± 0.6 |
Positive controls, +S9 |
Name |
SA |
SA |
9AA |
4NPD |
4NPD |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
143.0 ± 17.8 |
180.3 ± 8.1 |
268.3 ± 18.5 |
1170.3 ± 84.0 |
617.3 ± 169.5 |
|
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Concentrations (μg/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
181.0 ± 19.3 |
1059.3 ± 129.7 |
95.7 ± 16.3 |
1219.7 ± 152.3 |
875.0 ± 40.5 |
|
SA = sodium azide
4NPD = 4-nitro-o-phenylendiamine
9AA = 9-aminoacridine
2AA = 2-Amino-anthracene
PM = in part manual evaluation
Table 4. 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 ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
||
– |
Negative control |
9.7 ± 1.5 |
88.3 ± 10.8 |
10.3 ± 4.0 |
9.7 ± 2.5 |
28.7 ± 2.5 |
– |
Solvent control |
8.3 ± 1.5 |
86.7 ± 19.7 |
8.7 ± 1.2 |
10.7 ± 1.2 |
26.3 ± 4.0 |
– |
8 |
9.3 ± 1.5 |
86.0 ± 3.5 |
7.3 ± 0.6 |
9.0 ± 1.0 |
24.7 ± 4.0 |
– |
40 |
10.3 ± 0.6 |
91.7 ± 18.3 |
8.7 ± 2.1 |
9.3 ± 1.5 |
27.0 ± 6.6 |
– |
200 |
6.7 ± 2.5 |
92.7 ± 4.5 |
9.3 ± 3.1 |
8.0 ± 2.7 |
20.7 ± 1.5 |
– |
1000 |
10.3 ± 3.1 |
92.7 ± 5.9 |
8.0 ± 4.6 |
8.7 ± 5.5 |
31.3 ± 1.2 |
– |
5000 |
7.7 ± 3.1PM |
92.3 ± 20.0 |
9.0 ± 4.0 |
8.7 ± 1.2 |
28.3 ± 5.1 |
Positive controls, –S9 |
Name |
SA |
SA |
9AA |
4NPD |
4NPD |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
357.3 ± 26.8 |
216.7 ± 15.3 |
692.0 ± 186.2 |
1242.3 ± 56.2 |
535.0 ± 49.7 |
|
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Concentrations (μg/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
9.3 ± 2.1 |
80.3 ± 8.2 |
6.7 ± 2.9 |
14.3 ± 2.5 |
32.3 ± 4.6 |
|
+ |
Negative control |
7.0 ± 2.7 |
72.3 ± 8.0 |
7.0 ± 1.0 |
12.7 ± 0.6M |
30.0 ± 7.6M |
+ |
Solvent control |
9.7 ± 2.3 |
80.0 ± 12.1 |
7.0 ± 1.0 |
10.7 ± 0.6M |
37.3 ± 4.7M |
+ |
8 |
6.7 ± 1.2 |
64.7 ± 5.5 |
8.7 ± 1.5M |
14.3 ± 1.5M |
36.3 ± 6.7M |
+ |
40 |
5.3 ± 0.6 |
72.3 ± 9.7 |
7.3 ± 1.2M |
11.7 ± 1.5M |
31.7 ± 3.2M |
+ |
200 |
8.7 ± 1.5 |
77.0 ± 14.8 |
7.7 ± 2.1M |
11.3 ± 2.5M |
30.7 ± 9.5M |
+ |
1000 |
7.7 ± 1.5 |
69.7 ± 4.0 |
6.0 ± 1.0M |
11.0 ± 1.0M |
30.7 ± 8.5M |
+ |
5000 |
5.0 ± 1.0 |
58.0 ± 2.0 |
3.3 ± 1.5M |
6.3 ± 0.6M |
22.7 ± 4.0M |
Positive controls, +S9 |
Name |
SA |
SA |
9AA |
4NPD |
4NPD |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
57.0 ± 3.6 |
98.0 ± 11.4 |
428.3 ± 29.3 |
986.0 ± 89.9M |
720.0 ± 16.0M |
|
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Concentrations (μg/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
90.3 ± 20.8 |
467.0 ± 22.5 |
105.3 ± 12.1 |
1072.0 ±57.7M |
909.3 ± 159.8M |
|
SA = sodium azide
4NPD = 4-nitro-o-phenylendiamine
9AA = 9-aminoacridine
2AA = 2-Amino-anthracene
M = manual evaluation
PM = in part manual evaluation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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