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EC number: 203-998-8 | CAS number: 112-70-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Data is from CCRIS
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Genetic toxicity study in vitro for Tridecanol
- Author:
- CCRIS
- Year:
- 2 018
- Bibliographic source:
- CCRIS
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of Tridecanol in Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA /PKM101 by AMES test.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tridecan-1-ol
- EC Number:
- 203-998-8
- EC Name:
- Tridecan-1-ol
- Cas Number:
- 112-70-9
- Molecular formula:
- C13H28O
- IUPAC Name:
- tridecan-1-ol
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): tridecan-1-ol
- Molecular formula : C13H28O
- Molecular weight : 200.37 g/mol
- Smiles notation (if other than submission substance): C(CCCCCCO)CCCCCC
- InChl (if other than submission substance): 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1-TRIDECANOL
- Common name : tridecan-1-ol
- Molecular formula : C13H28O
- Molecular weight : 200.37 g/mol
- Smiles notation : C(CCCCCCO)CCCCCC
- InChl : 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Substance type: Organic
- Physical state: Solid
Method
- Target gene:
- Histidine for Salmonella typhimurium and tryptophan Escherichia coli
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA/PKM101
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver, induced with PHenobarbital AND BETA-Naphthoflavone
- Test concentrations with justification for top dose:
- 0, 0.61-10000 µg/plate
- Vehicle / solvent:
- Vehicle
- Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: Preincubation method - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Evaluation was done considering a dose dependent increase in the number of revertants/plate.
- Statistics:
- Not specified
Results and discussion
Test results
- Species / strain:
- bacteria, other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA/PKM101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: No mutagenic effect were observed.
Applicant's summary and conclusion
- Conclusions:
- Test substance was evaluated for its mutagenic potential in Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA/PKM101 by AMES test. The test result was considered to be negative in all strain in the presence and absence of metabolic activation S9.
- Executive summary:
Genetic toxicity in vitro study was assessed for test substance. For this purpose AMES test was performed similar to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan).The test material was exposed to Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA /PKM101 in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0, 0.61-10000µg/plate. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore test substance was considered to be non mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA/ PKM101 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.
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