1-Octanol, reaction products with epichlorohydrin and 2-mercaptoethanol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

473-730-4

EC Name:

-

Cas Number:

928768-73-4

Molecular formula:

C13H28SO3

IUPAC Name:

1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol

Test material form:

liquid: viscous

Details on test material:

Batch number: 20074-10142005

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Test concentrations with justification for top dose:

Short Term Treatment Test - Experiment 1

Group Final Concentration of Test Material (µg/ml)
6(18)-hour without S9 0*, 10.31 ,20.63*, 41.25*, 82.5*, 123.75, 165, MMC 0.1 *
6(18)-hour with S9 0*, 20.63,41.25*, 82.5*, 165*, 247.5, 330, CP 5.0*


Continuous Treatment Test - Experiment 2 and Short Term

Group Final Concentration of Test Material (µg/ml)
24-hour 0*, 5.15, 10.31*, 20.63*, 30.94*, 41.25*, 82.5 MMC 0.05*
6(18)-hour with S9 0*, 10.31,20.63*, 41.25*, 82.5*, 165,247.5, CP 5.0*


* Dose levels selected for metaphase analysis
MMC = mitomycin C
CP = cyclophosphamide

Details on test system and experimental conditions:

The Chinese Hamster Lung (CHL, also known as CHL/IU) cell line, isolated by Koyama et al (1970) and cloned by Ishidate and Sofbni (1985), was used. The CHL cell line has an average generation time of approximately 17 hours when growing under normal experimental conditions.

Cells were grown in Eagle's Minimal Essential Medium (MEM) with HEPES buffer and Earle's Salts and supplemented "in-house" with 10% foetal bovine serum and antibiotics, at 37°C with 5% C02 in air.

Cultures were established 16 to 72 hours prior to treatment using the appropriate number of cells per flask depending on the pre-exposure culture period. The cells were exposed to at least three doses of the test material, vehicle and positive controls both with and without metabolic activation. All exposures were performed in duplicate (A + B) and cultures were maintained at 37°C in a humidified atmosphere of 5% C02 in air.

Statistics:

The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells was compared, where necessary, with the concurrent vehicle control value using Fisher's Exact test.

Results and discussion

Test results

Key result

Species / strain:

mammalian cell line, other: Chinese Hamster Lung (CHL, also known as CHL/IU)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test material did not induce any statistically significant, dose-related increases in the frequency of cells with structural or numerical chromosome aberrations either in the presence or absence of a liver enzyme metabolising system or after various exposure times. The test material was therefore considered to be non-clastogenic to CHL cells in vitro.

Executive summary:

The test material did not induce any statistically significant, dose-related increases in the frequency of cells with structural or numerical chromosome aberrations either in the presence or absence of a liver enzyme metabolising system or after various exposure times. The test material was therefore considered to be non-clastogenic to CHL cells in vitro.