Alcohols, C16-17-branched and linear

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a test protocol that is comparable to the appropriate national standard method. It was not compliant with GLP. Read-across to registered substance is valid.

Data source

Reference

Reference Type:

publication

Title:

Evaluation of Di-(2-Ethylhexyl)phthalate and its major metabolites in the Ames Test and L5178Y Mouse Lymphoma mutagenicity assay

Author:

Kirby PE, Pizzarello RF et al

Year:

1983

Bibliographic source:

Environmental Mutagenesis 5 657-663 (1983)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexan-1-ol

EC Number:

203-234-3

EC Name:

2-ethylhexan-1-ol

Cas Number:

104-76-7

IUPAC Name:

2-ethylhexan-1-ol

Constituent 2

Reference substance name:

2-ethyl hexan-1-ol

IUPAC Name:

2-ethyl hexan-1-ol

Details on test material:

- Name of test material (as cited in study report): 2-ethylhexanol
- Substance type: monoconstituent substance
- Analytical purity: 99.7%
- Impurities (identity and concentrations): 0.3% 2-ethyl-4-methyl pentanol
- Composition of test material, percentage of components:
- Purity test date: 1983 - analysed by gas-liquid chromatography



- Molecular formula (if other than submission substance): 2-ethylhexanol
- Substance type: monoconstituent substance
- Physical state: liquid
- Analytical purity: 99.7%
- Impurities (identity and concentrations): 0.3% 2-Ethyl-4-methyl pentanol
- Purity test date: 1983 analysed by gas-liquid chromatography

Method

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S9

Test concentrations with justification for top dose:

10 concentrations at log intervals between 0.013 and 1.0 µl/ml

Vehicle / solvent:

not indicated

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 4hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 10-12days

SELECTION AGENT (mutation assays): TFT

NUMBER OF REPLICATIONS: single treatement per dose, 10 doses

NUMBER OF CELLS EVALUATED: 3 E+06 calls

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

A result was judged to be positive when a two-fold increase in the number of revertants relative to background was observed.

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

> 1.0 µl/ml

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without activation

2-Ethyl hexan-1-ol was tested for mutagenicity to mammalian cells in a valid study using a method similar to OECD TG 476 up to toxic concentrations. No increase in the number of revertants was observed. It was concluded that 2-Ethyl hexan-1-ol is negative for mutagenicity to mammalian cells under the conditions of the test. 2-Ethyl hexan-1-ol is closely related to the registered substance, decan-1-ol, and it is considered that read-across is valid.