Registration Dossier
Registration Dossier
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EC number: 268-369-2 | CAS number: 68082-25-7 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid triethanol amine salt and SDA Reporting Number: 04-006-14.
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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- EC Number:
- 268-369-2
- EC Name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- Cas Number:
- 68082-25-7
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- Test material form:
- liquid
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 liver microsomal fraction and S9 Mix
- Test concentrations with justification for top dose:
- The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment. 5000 μg/plate was selected as the maximum concentration. The concentration range covered two logarithmic decades. Two independent experiments were performed with the following concentrations:
Experiment I:
10.0, 31.6, 100, 316, 1000 and 2500 μg/plate
Experiment II:
5.0, 15.8, 50.0, 158, 500, 1580 and 5000 μg/plate - Vehicle / solvent:
- The test item was dissolved in Ethanol and diluted prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Remarks:
- A. dest., Eurofins Munich, Lot No. 170220
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol, AppliChem Lot No. 5Y103701
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine; 2-aminoanthracene
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:
- no 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no 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:
- no 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, TEA Trioleate did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, TEA Trioleate is considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
The test item TEA Trioleate was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I and II) using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments:
Experiment I:
10.0, 31.6, 100, 316, 1000 and 2500 μg/plate
Experiment II:
5.0, 15.8, 50.0, 158, 500, 1580 and 5000 μg/plate
Precipitation of the test item was observed in all tester strains used in experiment I and II (with and without metabolic activation). In experiment I precipitation of the test item was found at concentrations of 1000 μg/plate and higher (with and without metabolic activation). In experiment II precipitation of the test item was found at a concentration of 5000 μg/plate (with and without metabolic activation).
Toxic effects of the test item were noted in some tester strains evaluated in experiment I and II.
In experiment I toxic effects of the test item were observed in tester strain TA 100 at concentrations of 1000 μg/plate and higher (without metabolic activation). In tester strain TA 1535 toxic effects of the test item were noted at a concentration of 2500 μg/plate (without metabolic activation). In tester strain TA 1537 toxic effects of the test item were observed at a concentration of 2500 μg/plate (with metabolic activation).
In experiment II toxic effects of the test item were noted in tester strain TA 1537 at concentrations of 1580 μg/plate and higher (without metabolic activation).
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with TEA Trioleate at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II.
All criteria of validity were met.
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