Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: other: DNA demage, Mouse lymphoma assay
Type of information:
other: literature review
Adequacy of study:
key study
Study period:
2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data prepared by European Chemical Bureau.

Data source

Reference
Reference Type:
review article or handbook
Title:
European Risk Assessment Report CAS 60-00-4 EC 200-449-4 edetic acid (EDTA)
Author:
European Chemical Bureau Institute of Health and Consumer Protection
Year:
2004
Bibliographic source:
European Chemical Bureau Institute of Health and Consumer Protection

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: DNA damage; alkaline elution; V79 cells
Qualifier:
according to
Guideline:
other: Mouse lymphoma assay
GLP compliance:
not specified
Type of assay:
other: DNA damage; alkaline elution; V79 cells; Mouse lymphoma assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Any other information on results incl. tables

Mammalian cell culture tests were performed with EDTA (free acid). In a mouse lymphoma assay which was done only without metabolic activation, 2-fold to 6-fold increases of mutant frequencies were induced by EDTA at very high concentrations of 25 and 30 mmol/l and a treatment time of 4 hours; relative total growths at these concentrations were 57% and 16% respectively. The pH, measured in a parallel experiment where EDTA was dissolved in culture medium (pH of 7.2), was reduced to 5.8 at 30 mmol/l and to 6.1 at 20 mmol/l, when measured directly after preparation of the solution. Whether the mutagenic activity was due to pH effects or due to the high tested concentrations seems to be unclear (Wangenheim and Bolcsfoldi, 1988). In an alkaline elution assay with mouse lymphoma cells EDTA induced DNA single strand breaks in very high concentrations from 40 mmol/l upwards. Data on toxicity were not given; the assay was conducted without a metabolic activation system only (Garberg et al., 1988). In concentrations up to 30 mmol/l EDTA induced no effects with and without S-9 mix in alkaline elution assays with V79 cells (Swenberg et al., 1976; Swenberg, 1981).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: negative and positive but only at ery high concentrations

EDTA is not mutagenic for humans.
Executive summary:

Mutations and DNA damage were found in mouse lymphoma cells after exposure to very high concentrations. EDTA has a low mutagenic potential at extremely high doses. On the basis of the various negative findings and the assumption of a threshold mode-of action for aneugens, it can be concluded that EDTA is not mutagenic for humans.