Registration Dossier
Registration Dossier
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EC number: 203-825-6 | CAS number: 111-01-3
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:
- 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
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:
- 2,6,10,15,19,23-hexamethyltetracosane
- EC Number:
- 203-825-6
- EC Name:
- 2,6,10,15,19,23-hexamethyltetracosane
- Cas Number:
- 111-01-3
- Molecular formula:
- C30H62
- IUPAC Name:
- 2,6,10,15,19,23-hexamethyltetracosane
- Test material form:
- other: liquid
Constituent 1
Method
- Target gene:
- histidine
Species / strainopen allclose all
- Species / strain / cell type:
- bacteria, other: S. typhimurium TA 97a
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix fraction
- Test concentrations with justification for top dose:
- 50, 100, 500, 1000 and 5000µg/plate of 50 mg/ml squalane solution prepared in acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- 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, other: TA1535, TA98, TA100, TA97a
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
There is no significant difference between the number of spontaneaous reversions, the number of reversions obtained in the positive controls (with or without metabolic activation), and the mean of corresponding experimental historic values obtained in the laboratory.
There is no evidence of any increase of number of revertant colonies in the presence of the test substance (5000, 1000, 500, 100 and 50 µg) with or without metabolic activation for bacterial strains in Salmonella typhimurium TA1535, TA97a, TA98, TA100 and Escherichia coli WP2(uvrA).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance does not indice reverse mutation on four salmonella typhimurium strains and one Escherichia coli strain according to the OECD guideline n°471 . - Executive summary:
Assessment of mutagenic activity of squalane was conduced on "Salmonella typhimurium his-" and "Escherichia coli WP2(uvrA)" strains according to the OECD guideline n°471.
There is no significant difference between the number of spontaneaous reversions, the number of reversions obtained in the positive controls (with or without metabolica cativation), and the mean of corresponding experimental historic values obtained in the laboratory.
There is no evidence of any increase of number of revertant colonies in the presence of the test substance (5000, 1000, 500, 100 and 50 µg) with or without metabolic activation for bacterial strains in Salmonella typhimurium TA1535, TA97a, TA98, TA100 and Escherichia coli WP2(uvrA).
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