Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Final Report on the Safety Assessment of Ascorbyl Palmitate, Ascorbyl Dipalmitate, Ascorbyl Stearate,Erythorbic Acid, and sodium Erythorbate
Author:
F. Alan Andersen
Year:
1999
Bibliographic source:
International Journal of Toxicology

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Litton Bionetics, Inc performed activation and non-activation suspernsion tests using homogenates of liver, lungs, and testes and suspensions from adult male ICR mice, Sprague-Dawley rats, and Macca mulatta primates. The indicator organisms were S. typhimurium strains TA-1535, TA-1537, and TA-1538, and Saccharomyces cerevisiae strain D4.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Results and discussion

Test results
Species / strain:
other: TA-1535,TA-1537,TA-1538 and Scccharomyces cerevisiae strain D4
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Remarks:
Not mentioned in the review article
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion