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EC number: 286-490-9 | CAS number: 85251-77-0
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 based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- June 20th, 1990 - June 29th, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance 91744-13-7. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Glycerides, C14-18 and C16-22-unsatd. mono- and di-
- EC Number:
- 294-574-1
- EC Name:
- Glycerides, C14-18 and C16-22-unsatd. mono- and di-
- Cas Number:
- 91744-13-7
- IUPAC Name:
- 91744-13-7
- Details on test material:
- - Name of test material (as cited in study report): Glyceride, C14-18 and C16-22 unsaturated, mono- and di-
- Batch number: charge 0189-0-040
- Physical state: clear, yellow-brown liquid
- Analytical purity: approx. 100 %
- Receipt of test substance: March 20th, 1990
- Stability: not given
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:
- Aroclor 1254 induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 0, 8, 40, 200, 1000, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/bidist. water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: Sodium azide (TA 100 and 1535), 9-aminoacridine (TA1537), 4-nitro-o-phenylendiamine (TA98 and 1538); +S9: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation);
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
- Method: background lawn and/or reduced number of revertants versus negative control
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:
- cytotoxicity
- Remarks:
- at 5000 µg/plate in TA1535
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Ames Test Results - experiment 1
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 1535 |
TA 1538 |
TA 100 |
TA98 |
TA1537 |
||
- |
Negative control (water) |
8.3 |
11.0 |
72.7 |
28.0 |
7.7 |
- |
0 (Solvent control) |
8.0 |
11.0 |
80.3 |
27.7 |
6.3 |
- |
8 |
11.3 |
11.7 |
69.7 |
31.3 |
8.7 |
- |
40 |
9.0 |
11.0 |
71.7 |
28.0 |
6.7 |
- |
200 |
11.3 |
8.3 |
60.0 |
34.0 |
5.0 |
- |
1000 |
8.3 |
6.7 |
55.0 |
24.0 |
4.7 |
- |
5000 |
3.7* |
6.3 |
56.7 |
25.0 |
4.7 |
Positive controls - S9 |
Name |
SA |
4NP |
SA |
4NP |
9AA |
Concentrations (μg/plate) |
2 |
40 |
2 |
40 |
80 |
|
Number of colonies/plate |
251.0 |
1262.7 |
207.0 |
762.3 |
581.7 |
|
+ |
Negative control (water) |
9.7 |
14.7 |
69.3 |
26.7 |
6.7 |
+ |
0 (Solvent control) |
9.0 |
14.7 |
79.7 |
29.0 |
9.0 |
+ |
8 |
9.7 |
18.7 |
75.0 |
32.3 |
9.0 |
+ |
40 |
9.7 |
11.7 |
79.0 |
30.7 |
8.0 |
+ |
200 |
11.7 |
13.7 |
68.0 |
30.0 |
11.0 |
+ |
1000 |
10.3 |
16.0 |
73.3 |
28.3 |
7.7 |
+ |
5000 |
3.7* |
12.7 |
53.7 |
24.3 |
6.3 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
5 |
5 |
5 |
2.5 |
|
Number of colonies/plate |
135.7 |
1403.3 |
1509.0 |
1799.7 |
1654.3 |
|
* Partial inhibition of bacterial background lawn
SA = Sodium azide
4NP = 4-nitro-o-phenylendiamine
9AA = 9-aminoacridine
2AA = 2-Aminoanthracene
Table 2: Ames Test Results - experiment 2
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 1535 |
TA 1538 |
TA 100 |
TA98 |
TA1537 |
||
- |
Negative control (water) |
10.7 |
12.3 |
67.7 |
28.7 |
6.3 |
- |
0 (Solvent control) |
11.7 |
13.0 |
72.3 |
29.3 |
6.3 |
- |
8 |
10.3 |
14.0 |
68.7 |
28.0 |
5.7 |
- |
40 |
13.7 |
8.3 |
75.7 |
26.0 |
7.0 |
- |
200 |
7.3 |
8.0 |
54.7 |
24.7 |
4.3 |
- |
1000 |
7.3 |
8.0 |
53.7 |
26.3 |
4.0 |
- |
5000 |
2.7* |
8.3 |
46.3 |
28.7 |
1.7 |
Positive controls - S9 |
Name |
SA |
4NP |
SA |
4NP |
9AA |
Concentrations (μg/plate) |
2 |
40 |
2 |
40 |
80 |
|
Number of colonies/plate |
274.0 |
1410.0 |
192.0 |
738.0 |
646.7 |
|
+ |
Negative control (water) |
13.0 |
19.7 |
78.7 |
37.7 |
10.3 |
+ |
0 (Solvent control) |
14.3 |
20.7 |
82.7 |
40.0 |
9.0 |
+ |
8 |
13.7 |
20.7 |
76.0 |
32.7 |
9.7 |
+ |
40 |
14.7 |
16.3 |
85.0 |
35.7 |
10.0 |
+ |
200 |
11.7 |
16.0 |
75.3 |
38.7 |
7.7 |
+ |
1000 |
13.7 |
18.7 |
72.0 |
36.3 |
6.7 |
+ |
5000 |
7.7 |
14.3 |
61.3 |
34.7 |
3.3 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
5 |
5 |
5 |
2.5 |
|
Number of colonies/plate |
218.3 |
1413.3 |
1280.3 |
1637.0 |
1993.3 |
|
* Partial inhibition of bacterial background lawn
SA = Sodium azide
4NP = 4-nitro-o-phenylendiamine
9AA = 9-aminoacridine
2AA = 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative Loxiol P 1141 was not mutagenic in 5 different Salmonella typhimurium strains.
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