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EC number: 613-333-7 | CAS number: 63705-03-3
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. No E. coli strain or equivalent S. typhimurium strain was tested; lack of data on test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no E. coli strain or equivalent S. typhimurium strain was tested; lack of data on test substance
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3-dihydroxypropan-2-yl 16-methylheptadecanoate; 2-hydroxy-3-[(16-methylheptadecanoyl)oxy]propyl 16-methylheptadecanoate; 2-hydroxy-3-{2-hydroxy-3-[(16-methylheptadecanoyl)oxy]propoxy}propyl 16-methylheptadecanoate; 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl 16-methylheptadecanoate; 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl hexadecanoate
- EC Number:
- 613-333-7
- Cas Number:
- 63705-03-3
- Molecular formula:
- Unspecified
- IUPAC Name:
- 1,3-dihydroxypropan-2-yl 16-methylheptadecanoate; 2-hydroxy-3-[(16-methylheptadecanoyl)oxy]propyl 16-methylheptadecanoate; 2-hydroxy-3-{2-hydroxy-3-[(16-methylheptadecanoyl)oxy]propoxy}propyl 16-methylheptadecanoate; 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl 16-methylheptadecanoate; 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl hexadecanoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Appearance: viscous, amber-coloured liquid
- Analytical purity: no data
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and 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:
- 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/bidistilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (2 µg/plate; TA 1535, TA 100); 9-Aminoacridine (80 µg/plate; TA 1537); 4-Nitro-o-phenylenediamine (40 µg/plate; TA 1538, TA 98); +S9: 2-Aminoanthracene (2.5 µg/plate for TA 1535, TA 1537; 5 µg/plate for TA 98, TA 100, TA 1538)
- 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 - 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 (all other strains) increases in mean revertant numbers must be observed at more than one dose level. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and 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 examined
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY: The results show that no cytotoxicity was caused by the test substance.
- 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 result of experiment 1
Bacterial Reverse Mutation Assay, mean revertants colonies/plate |
|||||
EXPERIMENT 1 |
|||||
S9-Mix
|
Without
|
||||
Test item (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA1537 |
TA 1538 |
Negative control |
18.0 ± 3.5 |
102.3 ± 15.3 |
9.5 ± 2.4 |
5.0 ± 1.2 |
11.8 ± 3.2 |
8 |
13.6 ± 5.0 |
106.6 ± 13.0 |
7.3 ± 1.5 |
6.0 ± 2.0 |
9.6 ± 0.57 |
40 |
16.0 ± 3.0 |
99.0 ± 2.0 |
7.6 ± 3.5 |
7.0 ± 2.0 |
9.0 ± 1.0 |
200 |
21.0 ± 2.0 |
100.6 ± 8.0 |
10.3 ± 5.0 |
7.6 ± 3.5 |
11.6 ± 0.57 |
1000 |
20.6 ± 3.5 |
92.3 ± 3.2 |
7.6 ± 1.1 |
7.0 ± 1.7 |
8.0 ± 2.0 |
5000 |
20.0 ± 5.2 |
104.0 ± 11.0 |
8.6 ± 1.5 |
6.3 ± 2.5 |
10.6 ± 0.57 |
Sodium azide |
--- |
492.0 ± 9.8 |
576.6 ± 31.6 |
--- |
--- |
9-Aminoacridine |
--- |
--- |
--- |
372.0 ± 43.3 |
--- |
4-Nitro-o-phenylenediamine |
807.0 ± 92.6 |
--- |
--- |
--- |
1970.6 ± 92.0 |
S9-Mix
|
With
|
||||
Test item (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA1537 |
TA 1538 |
Negative control |
25.0 ± 6.2 |
121.5 ± 11.6 |
8.5 ± 1.6 |
7.0 ± 2.0 |
19.8 ± 4.0 |
8 |
22.0 ± 1.7 |
118.3 ± 13.6 |
10.0 ± 3.6 |
6.0 ± 2.6 |
17.0 ± 4.0 |
40 |
19.3 ± 2.5 |
115.0 ± 3.0 |
10.3 ± 0.57 |
5.0 ± 2.6 |
15.6 ± 3.2 |
200 |
30.0 ± 0.0 |
122.6 ± 3.7 |
8.0 ± 0.0 |
5.3 ± 2.3 |
19.0 ± 8.0 |
1000 |
23.3 ± 2.0 |
117.3 ± 7.0 |
9.6 ± 2.3 |
10.0 ± 1.0 |
10.3 ± 2.0 |
5000 |
31.3 ± 8.0 |
126.3 ± 1.5 |
11.6 ± 3.7 |
6.0 ± 1.0 |
15.6 ± 1.5 |
2-Aminoanthracene |
790.0 ± 2.6 |
1074.0 ± 39.8 |
80.3 ± 12.7 |
57.6 ± 3.2 |
1097.6 ± 82.0 |
Table 2: Test result of experiment 2
Bacterial Reverse Mutation Assay, mean revertants colonies/plate |
|||||
EXPERIMENT 2 |
|||||
S9-Mix
|
Without
|
||||
Test item (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA1537 |
TA 1538 |
Negative control |
27.6 ± 2.5 |
97.1 ± 7.3 |
8.8 ± 2.6 |
8.6 ± 1.7 |
12.5 ± 3.7 |
8 |
21.3 ± 4.1 |
98.6 ± 3.0 |
6.3 ± 2.0 |
8.6 ± 0.57 |
11.0 ± 0.0 |
40 |
24.6 ± 12.0 |
111.0 ± 14.4 |
7.3 ± 0.57 |
9.0 ± 2.0 |
7.3 ± 3.2 |
200 |
22.6 ± 0.57 |
99.6 ± 0.57 |
8.3 ± 5.7 |
7.3 ± 5.0 |
9.3 ± 4.1 |
1000 |
26.3 ± 6.8 |
99.6 ± 15.9 |
8.6 ± 3.5 |
6.6 ± 0.57 |
10.3 ± 2.0 |
5000 |
17.3 ± 1.1 |
90.6 ± 4.0 |
4.6 ± 1.1 |
5.6 ± 0.57 |
10.6 ± 0.57 |
Sodium azide |
--- |
537.6 ± 25.5 |
591.3 ± 32.3 |
--- |
--- |
9-Aminoacridine |
--- |
--- |
--- |
578.0 ± 61.0 |
--- |
4-Nitro-o-phenylenediamine |
1242.6 ± 30.2 |
--- |
--- |
--- |
2475.3 ± 75.0 |
S9-Mix
|
With
|
||||
Test item (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA1537 |
TA 1538 |
Negative control |
30.1 ± 4.1 |
104.0 ± 8.1 |
9.1 ± 3.0 |
6.0 ± 1.8 |
15.3 ± 1.8 |
8 |
32.3 ± 3.5 |
113.0 ± 1.7 |
7.6 ± 0.57 |
6.3 ± 3.0 |
18.0 ± 2.6 |
40 |
31.3 ± 7.5 |
103.6 ± 4.0 |
8.6 ± 2.3 |
11.0 ± 2.6 |
18.3 ± 4.0 |
200 |
30.3 ± 0.57 |
115.3 ± 10.4 |
7.6 ± 2.3 |
6.6 ± 3.2 |
13.0 ± 3.4 |
1000 |
31.0 ± 1.0 |
101.6 ± 2.5 |
8.0 ± 1.7 |
8.6 ± 2.0 |
15.3 ± 1.1 |
5000 |
26.6 ± 1.5 |
108.0 ± 5.5 |
6.3 ± 1.1 |
9.3 ± 3.0 |
14.0 ± 5.0 |
2-Aminoanthracene |
755.0 ± 205.6 |
878.0 ± 81.2 |
101.0 ± 2.0 |
52.0 ± 14.1 |
1343.0 ± 80.7 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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