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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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Chromosome aberrations and sister chromatid exchanges in Chinese hamster ovary cells: Evaluation of 108 chemicals
Author:
Galloway S.M. et al.
Year:
1987
Bibliographic source:
Environ.Molec.Mutag. 10 Suppl.10,|1-175 (1987)
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Principles of method if other than guideline:
Method: other: after Galloway, S.M. et al.: Environ. Mutagen. 7, 1-51
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Details on mammalian cell type (if applicable):
Cloned Chinese hamster ovary cells (CHO-W-B1) were cultured in Mc-Coy's 5a medium with 10% fetal calf serum, L-glutamine, and antibiotics.
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver
Test concentrations with justification for top dose:
1510 - 4030 µg/mL (without S9)
6040 - 10100 µg/mL (with S9)
Doses were chosen for the aberration test based on a preliminary test of cell survival 24 hr after treatment.
Vehicle / solvent:
Water, dimethyl sulfoxide (DMSO), ethanol, or acetone, in that order of preference.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: triethylenemielamine, mitomycin C. or cyclophosphamide

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion