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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: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Primary mutagenicity screening of food additives currently used in Japan
Author:
Ishidate, M., Jr., Sofumi, T., Yoshikawa, K., Hayashi, M.,|Nohmi, T., Sawada, M. and Matsuoka, A.
Year:
1984
Bibliographic source:
Fd Chem. Toxic., 22, 623-636

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
yes
Remarks:
no test with metabolic activation
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data.

Method

Species / strain
Species / strain / cell type:
other: Chinese hamster fibroblast cell line CHL
Metabolic activation:
without
Test concentrations with justification for top dose:
max. 4 mg/plate

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks on result:
other: all strains/cell types tested

Applicant's summary and conclusion