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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Several genotoxicity studies are available for EDTA-compounds.
Link to relevant study records
in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not many details available; however, together with the data of other metal-chelates sufficient information available
equivalent or similar to guideline
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
only strains TA97 and TA102 tested
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 97
Metabolic activation:
with and without
Metabolic activation system:
Test concentrations with justification for top dose:
0, 0.1, 0.5, 1, 5 and 10 mg/plate
Untreated negative controls:
Negative solvent / vehicle controls:
Positive controls:
Positive control substance:
other: 9-AA (TA97, -S9), 2-AA (TA97, TA102, +S9), MMC (TA102, -S9)
10 mg/plate (distilled water)
Species / strain:
other: TA97 and TA102
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
Untreated negative controls validity:
not examined
Positive controls validity:
Remarks on result:
other: all strains/cell types tested
Migrated from field 'Test system'.
Interpretation of results (migrated information):

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Although not many genotoxicity studies have been carried out with EDTA-CaNa2, several genotoxicity studies are available for other EDTA-compounds such as EDTA-Na2H2, EDTA-Na3H and severl metal-chelates. None of these showed genotoxic activity (see also read across document in section 13).

Justification for selection of genetic toxicity endpoint
One of the very few genotoxicity studies carried out with EDTA-CaNa2

Justification for classification or non-classification

Based on the absence of genotoxic effects, EDTA-CaNa2 does not need classification for this endpoint.