Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Chromosome aberration tests with Chinese Hamster cells in vitro with and without metabolic activation - a comparative study on mutagens and carcinogens
Author:
Ishidate M
Year:
1980
Bibliographic source:
Arch. Toxicol. Suppl 4., 41-44, Springer Verlag

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
CHL cells were treated at different doses for 24 and 48 hours without a metabolic activation system and for 3 hours with S-9 mix from liver homogenate of Wistar rats preterated with PCB. After an additional culture for 24 hours, chromosome preparations were made.
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
See also SIDS Initial Assessment.

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix from liver homogenated of Wistar rats treated with PCB
Test concentrations with justification for top dose:
no data

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
not specified
Genotoxicity:
ambiguous
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
D20 = ca. 10E-1 mg/mL
D20: dose (mg/mL) at which chromosome aberrations were detected in 20 % of metaphases observed.
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): Ambiguous
In Chinsese hamster lung fibroblast cells chromosome aberrations were detected in 20 % of metaphases observed at a concentration range of ca. 10E-1 mg/mL.