Octan-3-ol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Genotoxicity of microbial volatile organic compounds

Author:

Daisuke Nakajima, Riri Ishii, Shiho Kageyama, Yoshik Onji, Shigeru Mineki, Nobuhisa Morooka, Kosuke Takatori, Sumio Goto

Year:

2006

Bibliographic source:

Journal of Health Science, 52 (2) 148-153 (2006)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Ames assay was performed to determine the mutagenic nature of 3-octanol

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Octan-3-ol

EC Number:

209-667-4

EC Name:

Octan-3-ol

Cas Number:

589-98-0

Molecular formula:

C8H18O

IUPAC Name:

octan-3-ol

Test material form:

liquid

Details on test material:

- Name of test material: 3-Octanol
- IUPAC name: Octan-3-ol
- Molecular formula: C8H18O
- Molecular weight: 130.229 g/mole
- Smiles : C([C@@H](CC)O)CCCC
- Inchl: 1S/C8H18O/c1-3-5-6-7-8(9)4-2/h8-9H,3-7H2,1-2H3
- Substance type: Organic
- Physical state: Colorless Liquid

Specific details on test material used for the study:

- Name of test material: 3-octanol
- IUPAC name: Octan-3-ol
- Molecular formula: C8H18O
- Molecular weight: 130.229 g/mole
- Smiles : C([C@@H](CC)O)CCCC
- Inchl: 1S/C8H18O/c1-3-5-6-7-8(9)4-2/h8-9H,3-7H2,1-2H3
- Substance type: Organic

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98 and TA100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

The S9 mix was prepared with freeze dried material containing a set of cofactors and S9 solution

Test concentrations with justification for top dose:

Dose levels up to seven different strengths

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (AF2, without S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: Duplicate

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Yes, microscopic examination of plate surface was done as needed to determine inhibited bacterial growth

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

The plates were observed for revertant colonies

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98 and TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

No data

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

3-octanol did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Executive summary:

Ames assay was performed to determine the mutagenic nature of 3-octanol. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used at dose levels up to seven different strengths. Each dose was tested in duplicate by the pre-incubation method including a pre-incubation for 20 mins. The plates were observed for revertant colonies after 48 hrs expression period. Concurrent solvent and positive control plates were also included in the study.3-octanol did not induce gene mutation inSalmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.