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EC number: 285-203-4 | CAS number: 85049-34-9
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:
- 05 Jun - 09 Aug 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- 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)
- Version / remarks:
- adopted May 26, 1983 (2)
- 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)
- Version / remarks:
- adopted March 2, 1983
- 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:
- Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol
- EC Number:
- 284-864-6
- EC Name:
- Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol
- Cas Number:
- 84988-75-0
- IUPAC Name:
- Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol
- Details on test material:
- - Test Material: Fatty acids, C14-18 and C16-18 unsatd., esters with propylene glycol
- Lot/batch No.: 0130
- Expiration date of the lot/batch: 1992-07-16
- Storage condition of test material: at room temperature
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 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Other confounding effects: Contamination of 1 plate of strain TA98 in the second experiment (1000 µg/plate), therefore only 2 individual values were used for calculation of the mean number of revertant colonies at this concentration.
COMPARISON WITH HISTORICAL CONTROL DATA:
- see Table 1 and Table 2 under "Any other information on results incl. tables". - Remarks on result:
- other: all strains/cell types tested
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 |
9.7 ± 3.1 |
97.7 ± 2.1 |
6.3 ± 3.2 |
6.7 ± 1.2 |
46.7 ± 3.2 |
– |
Solvent control |
7.7 ± 3.5 |
94.3 ± 17.4 |
8.0 ± 1.7 |
7.3 ± 2.3 |
46.3 ± 6.0 |
– |
8 |
8.3 ± 2.1 |
70.0 ± 7.8 |
9.0 ± 1.0 |
6.7 ± 1.2 |
33.7 ± 0.6 |
– |
40 |
11.0 ± 2.7 |
74.3 ± 3.2 |
7.3 ± 2.1 |
5.3 ± 0.6 |
40.3 ± 4.9 |
– |
200 |
12.0 ± 4.6 |
67.3 ± 11.2 |
6.3 ± 1.2 |
5.7 ± 1.2 |
37.3 ± 3.2 |
– |
1000 |
10.0 ± 4.0 |
62.7 ± 10.8 |
10.3 ± 1.2 |
4.3 ± 1.5 |
42.7 ± 3.1 |
– |
5000 |
9.0 ± 1.7 |
83.0 ± 6.9 |
5.7 ± 1.5 |
4.3 ± 0.6 |
48.3 ± 3.5 |
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) |
744.7 ± 49.3 |
894.0 ± 62.0 |
939.7 ± 181.4 |
1541.0 ± 96.0 |
1410.7 ± 154.4 |
|
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) |
9.0 ± 1.7 |
88.7 ± 17.7 |
7.0 ± 2.7 |
10.3 ± 1.5 |
46.0 ± 8.7 |
|
+ |
Negative control |
5.7 ± 0.6 |
80.3 ± 15.3 |
8.7 ± 2.9 |
11.3 ± 2.3 |
53.3 ± 3.2 |
+ |
Solvent control |
9.7 ± 4.6 |
80.3 ± 14.4 |
9.3 ± 1.2 |
13.7 ± 2.3 |
44.3 ± 6.7 |
+ |
8 |
12.3 ± 3.1 |
82.3 ± 12.1 |
7.7 ± 3.5 |
14.7 ± 2.9 |
49.7 ± 4.2 |
+ |
40 |
11.3 ± 4.6 |
92.0 ± 11.8 |
6.3 ± 0.6 |
13.0 ± 4.2 |
47.7 ± 4.0 |
+ |
200 |
8.0 ± 2.0 |
84.3 ± 4.9 |
8.0 ± 1.0 |
16.3 ± 1.5 |
53.3 ± 4.0 |
+ |
1000 |
10.0 ± 2.0 |
70.7 ± 9.7 |
9.3 ± 3.8 |
13.0 ± 1.0 |
50.5 ± 3.5C |
+ |
5000 |
10.0 ± 3.6 |
74.7 ± 11.0 |
7.0 ± 1.7 |
13.0 ± 3.0 |
54.0 ± 7.0 |
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) |
213.3 ± 19.8 |
230.0 ± 4.6 |
283.3 ± 27.8 |
1434.0 ± 68.9 |
1307.6 ± 68.3 |
|
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) |
186.3 ± 19.4 |
1328.3 ± 166.5 |
52.3 ± 1.5 |
1711.3 ± 25.0 |
1587.7 ± 237.7 |
|
SA = sodium azide
4NPD = 4-nitro-o-phenylendiamine
9AA = 9-aminoacridine
2AA = 2-Amino-anthracene
C = Contamination, only 2 individual values
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 |
13.3 ± 1.5 |
117.7 ± 10.0 |
7.7 ± 2.9 |
9.0 ± 4.4 |
33.0 ± 1.0 |
– |
Solvent control |
10.3 ± 5.8 |
111.7 ± 5.0 |
7.3 ± 0.6 |
9.3 ± 1.5 |
30.0 ± 6.3 |
– |
8 |
11.3 ± 2.3 |
118.3 ± 12.5 |
7.3 ± 1.5 |
13.0 ± 2.0 |
32.0 ± 12.5 |
– |
40 |
14.0 ± 2.7 |
105.0 ± 17.4 |
9.3 ± 0.6 |
9.3 ± 0.6 |
25.0 ± 6.2 |
– |
200 |
13.0 ± 1.0 |
97.7 ± 2.9 |
8.0 ± 1.7 |
7.7 ± 2.1 |
32.0 ± 6.6 |
– |
1000 |
13.3 ± 2.1 |
111.7 ± 9.0 |
9.7 ± 4.0M |
8.7 ± 4.0 |
41.3 ± 4.2 |
– |
5000 |
12.0 ± 1.0 |
125.3 ± 4.9 |
7.3 ± 2.1 |
11.0 ± 4.6 |
30.7 ± 2.5 |
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) |
807.3 ±10.6 |
945.3 ± 37.5 |
1156.0 ± 216.5 |
2159.3 ± 106.6 |
226.7 ± 24.7 |
|
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) |
12.3 ± 5.5 |
110.3 ± 13.1 |
9.3 ± 3.8 |
22.0 ± 6.1 |
29.3 ± 3.8 |
|
+ |
Negative control |
12.3 ± 5.8 |
121.7 ± 10.3 |
9.3 ± 2.3 |
14.0 ± 7.2 |
39.7 ± 3.1 |
+ |
Solvent control |
12.3 ± 3.1 |
120.3 ± 17.0 |
8.7 ± 1.2 |
11.3 ± 1.5 |
45.0 ± 1.0 |
+ |
8 |
15.0 ± 3.5 |
122.3 ± 12.7 |
6.7 ± 2.5 |
9.7 ± 1.2 |
40.1 ± 2.3 |
+ |
40 |
13.3 ± 2.3 |
123.0 ± 7.6 |
8.7 ± 5.0 |
13.7 ± 6.7 |
41.3 ± 8.3 |
+ |
200 |
16.0 ± 3.0 |
122.3 ± 13.3 |
9.0 ± 3.6 |
9.7 ± 6.4 |
45.0 ± 10.2 |
+ |
1000 |
16.0 ± 4.6 |
104.0 ± 19.3 |
8.3 ± 1.2 |
12.3 ± 3.2 |
41.7 ± 6.4 |
+ |
5000 |
16.0 ± 1.7 |
95.0 ± 8.5 |
11.7 ± 3.5 |
12.0 ± 5.6 |
39.0 ± 13.1 |
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) |
232.0 ± 15.1 |
286.0 ± 29.2 |
748.0 ± 139.2 |
455.3 ± 14.2 |
531.3 ± 22.7 |
|
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) |
131.0 ± 5.2 |
1735.0 ± 84.5 |
81.3 ± 8.4 |
585.3 ± 32.1 |
594.3 ± 56.6 |
|
SA = sodium azide
4NPD = 4-nitro-o-phenylendiamine
9AA = 9-aminoacridine
2AA = 2-Amino-anthracene
M = Manual evaluation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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