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Toxicological information

Genetic toxicity: in vitro

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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:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.