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EC number: 938-445-6 | CAS number: -
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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 - 2013
- 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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
- EC Number:
- 938-445-6
- Molecular formula:
- C16H37NO4S - C34H72NO12S
- IUPAC Name:
- Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
- Test material form:
- solid: compact
- Details on test material:
- - Name of test material (as cited in study report): DE07_2012_001_PLSW
- Physical state: solid
- Lot/Batch No. PU20740016, PU20740019
- Expiration date of lot/batch: 14/03/2014
- Storage condition of test materilal: common room light, room temperature
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): DE07_2012_001_PLSW
- Substance type: Alkylsulfate/alkylethersulfate
- Chemical name: Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
- CAS: n/a
- Physical state: ivory paste-like solid at 20 °C
- Batch No.: PU20740016, PU20740019
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions
Method
- Target gene:
- his- / his+ reversions
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix (rat liver, induced with phenobarbital and 5,6-benzoflavone)
- Test concentrations with justification for top dose:
- Dose-finding study:
3.16, 10.0, 31.6, 100, 316, 2500, 5000 μg/plate (TA 98, TA 100)
Doses: 3.16, 10.0, 31.6, 100, 316, 2500, 5000 μg/plate
Main study:
-S9 mix: 0, 31.6, 100, 316, 1000, 2500, 5000 μg/plate (all strains)
+S9 mix: 0, 31.6, 100, 316, 1000, 2500, 5000 μg/plate (all strains)
The test item was tested in a pre-experiment eith the following concentrations:
3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate
The test item concentration to be applied in the main experiments were choosen according to the results of the pre-experiment. 5000 µg/plate was selected as the maximum concentration. The concentration range covered two logarithmic decades. Three independent experiments were performed with the following concentrations:
3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- dist. Water
Controls
- Untreated negative controls:
- yes
- Remarks:
- dist. water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dist. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-Nitro-o-phenylenediamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- Procedures:
Pre-incubation method
Plate incorporation method
For each strain and dose level, including controls, three plates were used.
Number of replicates: 3
Positive controls:
-S9 mix; Sodium azide (TA 100, TA 1535), 4-nitro-o-phenylene-diamine (TA 98, TA 1537), methylmethanesulfonate (TA 102)
+S9 mix; 2-Aminoanthracene (for all strains) - Evaluation criteria:
- To be considered positive if:
- a clear and dose related increase in the number of revertants accours and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows;
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control. - Statistics:
- no data
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- a slight toxic effect oberved in tester strain TA 1535 at a concentration of 5000 µg/plate (+ S9 mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No biological relevant increases in revertant colony numbers of any of the five strains were observed in the test with either the non-activation method (-S9 mix) or the activation method (+S9 mix).
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 Revertants per plate (mean of 3 plates, data of experiment 1 of 3 shown)
Concentration µg/plate |
TA 98 |
TA100 |
TA1535 |
TA1537 |
TA102 |
|||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
|
Negative control |
25 |
32 |
106 |
128 |
5 |
6 |
7 |
9 |
309 |
177 |
31.6 |
19 |
33 |
108 |
113 |
9 |
11 |
9 |
12 |
239 |
220 |
100.0 |
14 |
30 |
116 |
119 |
8 |
6 |
14 |
14 |
256 |
191 |
316 |
22 |
30 |
125 |
122 |
8 |
5 |
7 |
11 |
252 |
182 |
1000 |
20 |
24 |
127 |
125 |
8 |
5 |
9 |
7 |
297 |
158 |
2500 |
27 |
28 |
115 |
117 |
12 |
5 |
11 |
13 |
268 |
207 |
5000 |
22 |
22 |
114 |
105 |
17 |
4 |
17 |
11 |
341 |
193 |
4-NOPD/NaN3 (10µg)/MMS ()* | 382 | - | 711 | - | 387 | - | 30 | - | 1784 | - |
2-AA (2.5 µg)** | - | 2500 | - | 2004 | - | 66 | - | 210 | - | 379 |
* positive control with 4-Nitro-o-phenylene-diamine (4-NOPD, 10 µg (TA 98) and 40 µg (TA 1537)), sodium azide (NaN3, 10 µg (TA 100, TA 1535)) or Methylmethansulfonate (MMS, 1µL (TA 102))
** positive control with 2-Aminoanthracene (2-AA, 2.5 µg (TA 98, TA 100, TA 1535, TA 1537) and 10 µg (TA 102))
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test material was considered to be non-mutagenic to Salmonella typhimurium under the conditions of the test. - Executive summary:
The test item did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at concentrations up to and including 5000 µg/plate. It is concluded that the test substance is negative for mutagenicity in bacteria under the conditions of the test.
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