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EC number: 281-978-8 | CAS number: 84082-30-4
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
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- 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:
- Rape oil, sulfated, sodium salt
- EC Number:
- 281-978-8
- EC Name:
- Rape oil, sulfated, sodium salt
- Cas Number:
- 84082-30-4
- Molecular formula:
- not available (substance is a UVCB)
- IUPAC Name:
- Rape oil, sulfated, sodium salt
- Details on test material:
- - Name of test material : CP12
- Physical state: Liquid
- Lot/batch No.: 0012
- Expiration date of the lot/batch: 2015-08-01
- Storage condition of test material: Room temperature
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 5000 , 2500, 1250, 625 ,313 and 156 µg/plate
- Vehicle / solvent:
- The substance was found to be sufficiently soluble in water for the highest concentration to be tested of 5000 μg/plate.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9, strains TA1535 and TA100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9, strain TA1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9, strain TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9, strain WP2
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoantracene
- Remarks:
- with S9, all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation) and preincubation
DURATION
- Preincubation period: 30minutes
- Exposure duration: 72 hours
SELECTION AGENT (mutation assays): Histidine requirement (S. thyphimurium) or tryptophan requirement (E. coli)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: Reduction in number of spontaneous revertants, thinning of background lawn or microcolony formation - Evaluation criteria:
- For a test to be considered valid, the mean of the vehicle control revertant colony numbers for each strain should lie within or close to the current historical control range of the laboratory unless otherwise justified by the Study Director. Also, the positive control compounds must induce an increase in mean revertant colony numbers of at least twice the concurrent vehicle controls.
For the tested substance to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels. - Statistics:
- The mean number and standard deviation of revertant colonies were calculated for all groups. The “fold-increases” relative to the vehicle controls were calculated in order to compare the means for all treatment groups with those obtained for the vehicle control groups.
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:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No
- Effects of osmolality: No
- Precipitation: No
- Other confounding effects: None
RANGE-FINDING/SCREENING STUDIES: Toxicity screening at concentration range of 50.0 - 5000 microgram/plate showed no toxicity
COMPARISON WITH HISTORICAL CONTROL DATA: Results show that mean plate counts for untreated and positive control plates fell within the test laboratory's acceptance criteria based on historical control data. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
ASSAY I
With (+) or |
Dose (µg/plate) |
Number of revertants Mean (±SD) |
||||
without(-) |
Base-pair substitution type |
Frameshift type |
||||
S9 mix |
TA100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
|
|
Untreated |
132 (±11.1) |
20 (±1.2) |
30 (±2.8) |
29 (±2.7) |
18 (±1.7) |
|
156 |
|
|
|
|
15 (±2.6) |
S9 mix |
313 |
168 (±4.9) |
22 (±3.0) |
30 (±1.5) |
32 (±0.9) |
20 (±1.5) |
(-) |
625 |
156 (±4.5) |
24 (±3.5) |
34 (±2.0) |
30 (±1.2) |
17 (±2.0) |
|
1250 |
145 (±9.6) |
27 (±1.0) |
31 (±2.1) |
31 (±2.9) |
17 (±1.9) |
|
2500 |
142 (±7.4) |
24 (±2.1) |
33 (±1.7) |
32 (±2.2) |
18 (±1.5) |
|
5000 |
128 (±5.5) |
17 (±1.0) |
30 (±2.2) |
26 (±0.6) |
18 (±1.7) |
|
Untreated |
162 (±4.2) |
19 (±0.3) |
33 (±1.9) |
45 (±2.3) |
25 (±0.9) |
|
313 |
176 (±8.1) |
21 (±2.7) |
34 (±0.7) |
46 (±2.2) |
22 (±1.5) |
S9 mix |
625 |
167 (±2.4) |
23 (±2.3) |
35 (±0.7) |
41 (±5.2) |
20 (±2.6) |
(+) |
1250 |
158 (±5.0) |
21 (±1.2) |
36 (±1.2) |
47 (±4.1) |
23 (±2.9) |
|
2500 |
158 (±7.4) |
21 (±0.9) |
35 (±2.0) |
42 (±2.8) |
24 (±2.0) |
|
5000 |
161 (±5.9) |
21 (±3.2) |
36 (±1.5) |
50 (±2.3) |
16 (±0.7) |
+ve control |
Chemical |
SA |
SA |
MMS |
2NF |
9-AA |
S9 mix(-) |
Doseµg/plate |
1.0 |
1.0 |
500 |
2.0 |
50 |
|
Colonies/plate |
617 (±21.9) |
494 (±10.1) |
173 (±7.9) |
138 (±4.1) |
215 (±12.5) |
+ve control |
Chemical |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
S9 mix(+) |
Doseµg/plate |
1.0 |
1.0 |
10 |
1.0 |
1.0 |
|
Colonies/plate |
1234 (±42.8) |
107 (±5.2) |
264 (±17.3) |
535 (±36.4) |
118(±4.1) |
SA = sodium azide; MMS = methylmethanesulphonate; 2NF = 2-nitrofluorene; 9-AA = 9-aminoacridine; 2-AA = 2-aminoanthracene
ASSAY II
With (+) or |
Dose (µg/plate) |
Number of revertants Mean (±SD) |
||||
without(-) |
Base-pair substitution type |
Frameshift type |
||||
S9 mix |
TA100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
|
|
Untreated |
145 (±2.9) |
19 (±1.0) |
29(±1.2) |
30 (±0.9) |
21 (±0.9) |
|
156 |
140 (±9.8) |
19 (±1.7) |
27 (±1.5) |
26 (±2.6) |
19 (±1.7) |
S9 mix |
313 |
127 (±3.6) |
16 (±1.8) |
34 (±2.3) |
26 (±1.5) |
18 (±1.5) |
(-) |
625 |
123 (±7.1) |
16 (±2.1) |
27 (±2.7) |
30 (±2.9) |
16 (±0.9) |
|
1250 |
103 (±9.3) * |
17 (±1.5) |
34 (±2.4) |
30 (±0.9) |
12 (±1.8) * |
|
2500 |
107 (±4.3) * |
25 (±1.9) |
28 (±2.0) |
33 (±2.0) |
6 (±22.3 * |
|
5000 |
86 (±3.8) * |
17 (±1.5) |
30 (±0.3) |
30 (±3.5) |
6 (±1.8) * |
|
Untreated |
130 (±2.3) |
17 (±2.0) |
34 (±1.2) |
43 (±1.9) |
24 (±1.2) |
|
156 |
118 (±2.0) |
18 (±0.9) |
36 (±1.7) |
45 (±2.0) |
26 (±2.8) |
|
313 |
128 (±5.5) |
23 (±1.5) |
36 (±1.9) |
50 (±2.8) |
25 (±0.6) |
S9 mix |
625 |
126 (±8.2) |
19 (±2.1) |
37 (±0.6) |
45 (±2.6) |
26 (±1.5) |
(+) |
1250 |
101 (±3.4) * |
18 (±1.5) |
35 (±2.1) |
38 (±2.3) |
23 (±2.3) |
|
2500 |
100 (±6.0) * |
18 (±1.7) |
29 (±2.8) |
38 (±0.9) |
21 (±1.9) |
|
5000 |
106 (±5.2) * |
21 (±0.7) |
34 (±0.7) |
42 (±1.8) |
14 (±0.7) * |
+ve control |
Chemical |
SA |
SA |
MMS |
2NF |
9-AA |
S9 mix(-) |
Doseµg/plate |
1.0 |
1.0 |
500 |
2.0 |
50 |
|
Colonies/plate |
662 (±32.1) |
492 (±41.1) |
197 (±12.2) |
147 (±4.2) |
167 (±53.8) |
+ve control |
Chemical |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
S9 mix(+) |
Doseµg/plate |
2.0 |
1.0 |
20 |
2.0 |
1.0 |
|
Colonies/plate |
912 (±44.6) |
107 (±5.3) |
240 (±11.9) |
636 (±39.7) |
112 (±10.1) |
SA = sodium azide; MMS = methylmethanesulphonate; 2NF = 2-nitrofluorene; 9-AA = 9-aminoacridine; 2-AA = 2-aminoanthracene; * = thinning of background lawn
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It is concluded that the substance showed no evidence of mutagenic activity in this bacterial system under the test conditions employed. - Executive summary:
Gene mutation has been investigated in bacteria using strains of Salmonella typhimurium and Escherichia coli, in accordance with OECD/EU test methods. Five tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA were used and experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbital and 5,6-benzoflavone. The tested substance did not induce reverse mutation in the tester strains, neither in the absence nor presence of S9 metabolism.
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