Tridecan-1-ol

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:

2018

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

Test material information

Constituent 1

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

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.