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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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