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Toxicological information

Genetic toxicity: in vitro

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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:
1988
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

Constituent 1
Chemical structure
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

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.