Registration Dossier
Registration Dossier
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EC number: 267-400-7 | CAS number: 67859-51-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not many details available; however, together with the data of other metal-chelates dufficient information available
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity test of food additives with Salmonella typhimurium TA97 and TA102 (III)
- Author:
- Fujita H, Nakano M, Sasaki M
- Year:
- 1 988
- Bibliographic source:
- Ann. Rep. Tokyo Metr. Res. Lab. PJI, 39, 343-350
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only strains TA97 and TA102 tested
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium calcium edetate
- EC Number:
- 200-529-9
- EC Name:
- Sodium calcium edetate
- Cas Number:
- 62-33-9
- Molecular formula:
- C10H12CaN2O8.2Na
- IUPAC Name:
- calcium disodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
- Details on test material:
- no data
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 0, 0.1, 0.5, 1, 5 and 10 mg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 9-AA (TA97, -S9), 2-AA (TA97, TA102, +S9), MMC (TA102, -S9)
- Remarks:
- 10 mg/plate (distilled water)
Results and discussion
Test results
- Species / strain:
- other: TA97 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
EDTA-CaNa2 did not induce mutagenicity in the Ames test using strains TA97 and TA102 - Executive summary:
A mutagenicity test was carried out with 28 food additives including EDTA-CaNa2 using Salmonella typhimurium strains TA97 and TA102 with and without metabolic activation. No mutagenicity was observed.
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