Registration Dossier
Registration Dossier
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EC number: 913-635-1 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Primary mutagenicity screening of food additives currently used in Japan
- Author:
- Ishidate, M., Jr., Sofumi, T., Yoshikawa, K., Hayashi, M.,|Nohmi, T., Sawada, M. and Matsuoka, A.
- Year:
- 1 984
- Bibliographic source:
- Fd Chem. Toxic., 22, 623-636
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only with metabolic activation
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Calcium chloride
- EC Number:
- 233-140-8
- EC Name:
- Calcium chloride
- Cas Number:
- 10043-52-4
- Molecular formula:
- CaCl2
- IUPAC Name:
- calcium dichloride
- Details on test material:
- Test substance: Supplied from the Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan,
where the purity and quality of the sample was checked. The purity of CaCl2 used was 74.5%.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94, TA98
- Metabolic activation:
- with
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- max 5.0 mg/plate
- Details on test system and experimental conditions:
- Ames test
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94, TA98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with metabolic activation
Negative in the test conditions. - Executive summary:
in a Ames test (similar to OECD 471 guideline), performed in the following TA strains: TA 92, TA 1535, TA 100, TA 1537, TA 94 and TA 98 calcium chloride did not induce mutation in bacteria in presence of metabolic activation.
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