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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
Study period:
1984
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Primary mutagenicity screening of food additives currently used in Japan
Author:
Ishidate M
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:
Material was supplied from the Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan. Purity and quality of the sample was checked. The purity of CaCl2 used was 74.5%.

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:
other: Chinese hamster lung fibroblasts (V79)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks on result:
not measured/tested

Applicant's summary and conclusion