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EC number: 298-190-5 | CAS number: 93778-52-0
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:
- 2002-03-29 to 2002-04-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- 2-decyltetradecanoic acid
- EC Number:
- 298-190-5
- EC Name:
- 2-decyltetradecanoic acid
- Cas Number:
- 93778-52-0
- Molecular formula:
- C24H48O2
- IUPAC Name:
- 2-decyltetradecanoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Isocarb 24
- Substance type: Product
- Lot/batch No.: ISC2403, 04058/MA
- Physical state: crystalline at ambient conditions
Constituent 1
Method
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 homogenate
- Test concentrations with justification for top dose:
- 5000, 2500, 1250, 625 and 313 µg/plate.
- Vehicle / solvent:
- acetone
- Details on test system and experimental conditions:
- SYSTEM OF TESTING
- Species/cell type: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Deficiencies/Proficiencies: histidine auxotroph
- Metabolic activation system: rat liver S9 of Phenobarbital/beta-Naphthoflavone induced male Sprague-Dawley rats
ADMINISTRATION:
- Dosing:
experiment I and II:
313, 625, 1250, 2500 and 5000 µg/plate
- Number of replicates: 3
- Application:
Experiment I (plate-incorporation method): The first experiment was perfonned using a plate-incorporation method. The components of the assay (the tester strain bacteria, the test item and S9 mix or phosphate buffer) were added to molten overlay agar and vortexed. The mixture was
then poured onto the surface of a minimal medium agar plate, and allowed to solidify prior to incubation.
The overlay mixture was composed as follows:
(i) Overlay agar (held at 45°C) 2 ml
(ii) Test or control item solution 0.1 ml
(iii) S9 mix or phosphate buffer (pH 7.4, 0.1 M) O.S ml
(iv) Bacterial suspension 0.1 ml
Experiment II and III (pre-incubation method): Since acetone is known to be toxic at 50 Ill/plate when used for the pre-incubation method, 25
Ill/plate of solvent or test item solution were used.
The components were added in turn to an empty test-tube:
(i) Bacterial suspension 0.1 ml
(ii) Test item solution or its solvent 0.025ml
Positive control solution or its solvent O.OSOml
(iii) S9 mix or phosphate buffer (PH 7.4, 0.1 M) O.S ml
The incubate was vortexed and placed at 37°C for 30 minutes. Two ml of overlay agar was then added and the mixture vortexed again and poured onto the surface of a minimal medium agar plate and allowed to solidify. - Evaluation criteria:
- The test item is considered as a mutagen if at least a two-fold increases in mean revertant numbers are 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:
- regression analysis
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of result:
negative
The test item does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions. - Executive summary:
The test item was examined for mutagenic activity by assaying for reverse mutation to histidine prototrophy in the prokaryotic organism Salmonella typhimurium. The five tester strains TA1535, TA1537, TA98, TA100 and TA102 were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone. Test item solutions were prepared using acetone. In the toxicity test, the test item was assayed at a maximum dose-level of 5000 flg/plate and at four lower dose-levels spaced at approximately half-log intervals: 1580, 500, 158 and 50.0 flg/plate. No signs of toxicity were observed at any doselevel tested, in any tester strain, in the absence or presence of S9 metabolic activation. Two main experiments were performed. In Main Assay I, using the plate incorporation method, the test item was assayed at a maximum dose-level of 5000 flg/plate and at four lower dose-levels, separated by two-fold dilutions: 2500,1250,625 and 313 flg/plate. As no increases in revertant numbers were observed, all treatments of Main Assay II included a pre-incubation step and used the same dose-levels as Main Assay I. The test item did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose-level, in any tester strain, in the absence or presence of S9 metabolism. It is concluded that the test item does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions.
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