Registration Dossier
Registration Dossier
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EC number: 205-633-8 | CAS number: 144-55-8
Genetic toxicity: in vitro
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:
- 2 018
- 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:
- 2 005
- 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:
- 1 980
- 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
- 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
Constituent 1
- 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
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