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Toxicological information

Genetic toxicity: in vitro

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: publication of acceptable quality standard

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Chromosome aberrations and sister chromatid exchanges in Chinese hamster ovary cells: Evaluations of 108 chemicals.
Author:
Galloway SM, Armstrong MJ, Reuben C, Colman S, Brown B, Cannon C, Bloom AD, Nakamura F, Ahmed M, Duk S, Rimpo J, Margolin BH, Resnick MA, Anderson B
Year:
1987
Bibliographic source:
Environ Molec Mutag 10, 1-175
Reference Type:
publication
Title:
Development of a standard protocol for in vitro cytogenetic testing with Chinese hamster ovary cells: Comparison of results for 22 compounds in two laboratories.
Author:
Galloway et al.
Year:
1985
Bibliographic source:
Galloway SM, Bloom AD, Resnick M, Margolin BH, Nakamura F, Archer P, Zeiger E (1985), Environ Mutagen 7: 1-51

Materials and methods

Principles of method if other than guideline:
Method: described in detail in Galloway et al. (1985), see reference above. According to a previous IUCLID dossier from 2008 (author unknown), the method would be similar to OECD TG 473.
GLP compliance:
not specified
Type of assay:
other: in vitro mammalian sister chromatid exchange, in vitro mammalian chromosome aberration

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance as stated in the publication: 2-ethoxyethanol

Method

Species / strain
Species / strain / cell type:
other: cloned Chinese hamster ovary cells (CHO-W-B1)
Metabolic activation:
with and without
Metabolic activation system:
S9 liver homogenate from male Sprague-Dawley rats
Test concentrations with justification for top dose:
Sister chromatid exchange (SCE): 951-9510 µg/mL (+/- S9 mix)
Chromosome aberration (ABS): 4780-9510 µg/mL (+/- S9 mix)

Results and discussion

Test resultsopen allclose all
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
SCE: stronger response without than with S9
Cytotoxicity / choice of top concentrations:
other: no information was given
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
chromosome aberration without S9
Cytotoxicity / choice of top concentrations:
other: no information was given
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
chromosome aberration with S9
Cytotoxicity / choice of top concentrations:
other: no information was given

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: SCE positive; ABS positive without metabolic activation, negative with metabolic activation

The test substance 2-ethoxyethanol showed a positive response in the sister chromatid exchange assay and in the chromosome aberration assay of cloned chinese hamster ovary cells (CGO-W-B1). Aberrations were only induced without the metabolic activation (S9 liver homogenate from male Sprague-Dawley rats), whereas SCEs were observed with and without the metabolic activation.

The test results point to in vitro mutagenicity of the test substance under the test conditions.