Registration Dossier
Registration Dossier
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EC number: 200-529-9 | CAS number: 62-33-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 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
- 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
- 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
- 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)
- 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'.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
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.
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