Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Second literature data reporting, hence K2.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Summarized data of genotoxicity tests for designated food additives in Japan
Author:
Masami Yamada and Masamitsu Honma
Year:
2018
Bibliographic source:
Yamada and Honma Genes and Environment (2018) 40:27
Report date:
2018
Reference Type:
publication
Title:
Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens I. Sensitivity, specificity and relative predictivity
Author:
Kirkland D, Aardema M, Henderson L, Müller L.
Year:
2005
Bibliographic source:
Mutat Res. 2005;584:1–256
Report date:
2005
Reference Type:
publication
Title:
Mutagenicity tests on food additives (series 1) - the collaborative study supported by the Ministry of Health and Welfare of Japan.
Author:
Ishidate M Jr, Yoshikawa K, Sofuni T.
Year:
1980
Bibliographic source:
Mutagen Toxicity. 1980;12:82–90
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hydrogencarbonate
EC Number:
205-633-8
EC Name:
Sodium hydrogencarbonate
Cas Number:
144-55-8
Molecular formula:
CH2O3.Na
IUPAC Name:
sodium hydrogen carbonate
Specific details on test material used for the study:
Raising agent, CAS 144–55-8, MW 84.01

Method

Species / strain
Species / strain / cell type:
not specified
Metabolic activation:
not specified

Results and discussion

Test results
Species / strain:
not specified
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified

Applicant's summary and conclusion

Executive summary:

A review of Ames test studies revelead negative results with exposure to sodium bicarbonate