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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)

Data source

Reference
Title:
No information
Author:
European Commission
Year:
2006
Bibliographic source:
SCCP/1008/06

Materials and methods

Test guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
no
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)
Metabolic activation:
without
Test concentrations with justification for top dose:
1500/1700/1900 microgram/ml
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
True negative controls:
no
Positive controls:
yes

Results and discussion

Test results
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
at the higest dose only
Cytotoxicity / choice of top concentrations:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive without metabolic activation