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EC number: - | CAS number: 1474044-66-0
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:
- 10 October 2012-10 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alkane C6-C8 (even numbered), 1-sulphonic acid, sodium salt
- Cas Number:
- 1474044-66-0
- Molecular formula:
- CnH(2n+1)O3Na where n=6 or 8
- IUPAC Name:
- Alkane C6-C8 (even numbered), 1-sulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Bio-Terge PAS 7S-DRY
- Physical state: solid
- Analytical purity: >98%
- Lot/batch No.: PG12122011 (dried from industrial lot 7476775)
- Expiration date of the lot/batch: 12 December 2013
- Stability under test conditions: stable
- Storage condition of test material: Controlled room temperature (15-25 °C, < 70 % RH)
Constituent 1
Method
- Target gene:
- Histidine and Tryptophan
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 rat liver induced with phenobarbital/β-naphthoflavone
- Test concentrations with justification for top dose:
- Range-finding test (TA 98, TA100): 5000; 2500; 1000; 316; 100; 31.6 and 10 μg/plate
Main tests: 5000; 1581; 500; 158.1; 50; 15.81 and 5 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: Substance is soluble in water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylenediamine; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) Experiment 1; preincubation Experiment 2
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: Triplicate plates per duplicate experiment
DETERMINATION OF CYTOTOXICITY
- Method: evaluation of background lawn of bacteria - Evaluation criteria:
- Criteria for a Positive Response:
A test item is considered mutagenic if:
- a dose–related increase in the number of revertants occurs and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
An increase is considered biologically relevant if:
- the number of reversions is more than two times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA98, TA100 and Escherichia coli WP2 uvrA bacterial strains;
- the number of reversions is more than three times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA1535 and TA1537 bacterial strains.
According to the OECD guidelines, statistical method may be used as an aid in evaluating the test results. However, statistical significance should not be the only determining factor for a positive response.
Criteria for a Negative Response:
A test article is considered non-mutagenic if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation. - Statistics:
- Not applicable.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: None
- Effects of osmolality: None
- Evaporation from medium: None
- Water solubility: Soluble
- Precipitation: None
- Other confounding effects:
RANGE-FINDING/SCREENING STUDIES: Range-finder experiment performed to set the dose levels for the two main experiments.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes, all control data within the historical ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxicity varied slightly between bacterial strains; more toxic to strains TA1535 and TA1537.
Any other information on results incl. tables
Summary Table of the Initial Mutation Test and Complementary Initial Mutation Test
Concentrations |
Mean |
Salmonella typhimuriumtester strains |
Escherichia coli |
||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
|||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
Untreated control |
Mean |
25.7 |
20.7 |
99.0 |
120.3 |
37.0 |
22.0 |
7.0 |
6.3 |
28.0 |
37.0 |
MF |
0.99 |
0.98 |
0.99 |
0.99 |
1.19 |
1.43 |
1.17 |
1.19 |
0.79 |
0.81 |
|
DMSO control |
Mean |
27.3 |
18.7 |
-- |
112.7 |
-- |
21.0 |
8.3 |
8.7 |
-- |
44.3 |
MF |
1.05 |
0.89 |
-- |
0.93 |
-- |
1.37 |
1.39 |
1.63 |
-- |
0.97 |
|
Distilled water control |
Mean |
26.0 |
21.0 |
100.3 |
121.7 |
31.0 |
15.3 |
6.0 |
5.3 |
35.7 |
45.7 |
MF |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
|
5000 |
Mean |
20.7 |
30.0 |
99.0 |
127.3 |
21.0 |
14.3 |
4.3 |
8.0 |
37.0 |
38.3 |
MF |
0.79 |
1.43 |
0.99 |
1.05 |
0.68 |
0.93 |
0.72 |
1.50 |
1.04 |
0.84 |
|
1581 |
Mean |
16.3 |
29.7 |
101.3 |
122.7 |
17.0 |
10.3 |
5.7 |
6.3 |
31.7 |
36.3 |
MF |
0.63 |
1.41 |
1.01 |
1.01 |
0.55 |
0.67 |
0.94 |
1.19 |
0.89 |
0.80 |
|
500 |
Mean |
18.3 |
22.3 |
98.7 |
114.0 |
20.7 |
16.3 |
4.3 |
7.0 |
37.3 |
35.7 |
MF |
0.71 |
1.06 |
0.98 |
0.94 |
0.67 |
1.07 |
0.72 |
1.31 |
1.05 |
0.78 |
|
158.1 |
Mean |
17.0 |
24.7 |
101.7 |
112.3 |
18.3 |
14.0 |
7.7 |
6.7 |
33.7 |
40.7 |
MF |
0.65 |
1.17 |
1.01 |
0.92 |
0.59 |
0.91 |
1.28 |
1.25 |
0.94 |
0.89 |
|
50 |
Mean |
17.0 |
23.3 |
107.3 |
117.3 |
17.0 |
12.3 |
5.7 |
9.7 |
30.0 |
42.3 |
MF |
0.65 |
1.11 |
1.07 |
0.96 |
0.55 |
0.80 |
0.94 |
1.81 |
0.84 |
0.93 |
|
15.81 |
Mean |
16.0 |
28.7 |
106.7 |
119.7 |
15.3 |
17.0 |
6.0 |
9.7 |
36.3 |
42.3 |
MF |
0.62 |
1.37 |
1.06 |
0.98 |
0.49 |
1.11 |
1.00 |
1.81 |
1.02 |
0.93 |
|
5 |
Mean |
22.7 |
30.3 |
109.3 |
131.7 |
16.7 |
19.0 |
6.0 |
9.7 |
36.7 |
37.7 |
MF |
0.87 |
1.44 |
1.09 |
1.08 |
0.54 |
1.24 |
1.00 |
1.81 |
1.03 |
0.82 |
|
NPD (4µg) |
Mean |
321.0 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
MF |
11.74 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
|
2AA (2µg) |
Mean |
-- |
2276.0 |
-- |
2111.3 |
-- |
201.0 |
-- |
213.0 |
-- |
-- |
MF |
-- |
121.93 |
-- |
18.74 |
-- |
9.57 |
-- |
24.58 |
-- |
-- |
|
2AA (50µg) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
247.7 |
MF |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
5.59 |
|
SAZ (2µg) |
Mean |
-- |
-- |
1210.7 |
-- |
1173.3 |
-- |
-- |
-- |
-- |
-- |
MF |
-- |
-- |
12.57 |
-- |
37.85 |
-- |
-- |
-- |
-- |
-- |
|
9AA (50µg) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
466.7 |
-- |
-- |
-- |
MF |
-- |
-- |
-- |
-- |
-- |
-- |
56.00 |
-- |
-- |
-- |
|
MMS (2µL) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
1203.3 |
-- |
MF |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
33.74 |
-- |
|
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test item had no mutagenic activity in the applied bacterium tester strains under the test conditions used in this study.
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