Registration Dossier
Registration Dossier
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EC number: 273-105-4 | CAS number: 68937-98-4 This substance is identified by SDA Substance Name: C14-C18 and C12-C20 unsaturated alkyl alkene and C14-C18 and C12-C20 unsaturated alkyl hydroxy sulfonic acid sodium salt and SDA Reporting Number: 03-059-04.
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:
- 17 August 2017 - 18 September 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
- Report date:
- 2017
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
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Economy, Trade and Industry, Japanese Ministry of Health, Labour and Welfare and Japanese Ministry of Agriculture, Forestry and Fisheries, 24 November 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts
- EC Number:
- 273-105-4
- EC Name:
- Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts
- Cas Number:
- 68937-98-4
- IUPAC Name:
- Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Moisture content: 5% max
Constituent 1
Method
- Target gene:
- not specified
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction
- Test concentrations with justification for top dose:
- 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate
- Vehicle / solvent:
- - Vehicle: DMSO
- Justification for choice of solvent/vehicle: solubility
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: direct plate incorporation method
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 37 ± 3 °C for approximately 48 hours
- Rationale for test conditions:
- not specified
- Evaluation criteria:
- 1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- not specified
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- not specified
- Positive controls validity:
- valid
- Key result
- 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:
- not specified
- Positive controls validity:
- valid
- Key result
- 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:
- not specified
- Positive controls validity:
- valid
- Key result
- 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:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No biologically relevant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in both experiments.
Small, statistically significant increases in TA1535 revertant colony frequency (some of which were just in excess of the upper historical control limit) were observed in the absence and presence of S9-mix at 1500 μg/plate in the first mutation test. These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility and the maximum fold increase was only 1.5 times the concurrent vehicle controls. Further statistically significant increases in TA1535 revertant colony frequency were noted in Experiment 2 at 1500 μg/plate in the presence of S9-mix. However, these increases were accompanied by a weakened bacterial lawns and were, therefore, disregarded.
Applicant's summary and conclusion
- Conclusions:
- SORPOL 5115 was considered to be non-mutagenic under the conditions of this test.
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