Sodium feredetate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed according to methods similar to OECD471, non-GLP. However the reporting of results for EDTA-FeNa is limited.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Genotoxicity of Iron Compounds in Salmonella fyphimurium and L5 178Y Mouse Lymphoma Cells

Author:

Dunkel, V.C., San, R.H.C., Seifried, H.E., Whittaker, P.

Year:

1999

Bibliographic source:

Environmental and Molecular Mutagenesis 33:28-41

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Ames te al. 1975 and Yahagi et al. 1977

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium feredetate

EC Number:

239-802-2

EC Name:

Sodium feredetate

Cas Number:

15708-41-5

Molecular formula:

C10H12N2O8FeNa

IUPAC Name:

iron(3+) sodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate

Details on test material:

Substance: Sodium iron (III) EDTA
Molecular formula: NaFeEDTA (Hamp-ene, 13% Fe)
Purity: 98%
Supplier: W.R. Grace & Co.

Method

Target gene:

Histidine operon

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 102

Species / strain 3

Species / strain / cell type:

S. typhimurium, other: TA 97a

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

up to 10,000 µg/Fe plate = 75,397.76 µg EDTA-FeNa/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: distilled water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

distilled water

True negative controls:

no

Positive controls:

yes

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: triplicate

NUMBER OF CELLS EVALUATED: all plates were examined for revertant colonies

DETERMINATION OF CYTOTOXICITY
- Method: growth rate

Evaluation criteria:

The criteria used to evaluate a test stipulated that a test article must induce at least a doubling in the mean number of revertants per plate of at least
one tester strain (TA97a, TA98, TA100, TA102, and TA1535) for it to be considered positive. This increase in the mean revel (ants per plate must be accompanied by a dose response to increasing concencmtions of the test chemical. If the stody shows a dose-response, but with a less than 3-fold increase on TA1537 or TA1538, the response must be confirmed in it repeat experiment.

Statistics:

Not applicable

Results and discussion

Test results

Species / strain:

other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

EDTA-FeNa tested up to 10,000 µg/plate Fe in the plate incorporation and pre-incubation Ames test dit not result in an increased number of revertant colonies in strains S. typhimurium strains TA 98, 97a., 100, 102, 1537, 1538.

Executive summary:

EDTA-FeNa tested up to 10,000 µg/plate Fe in the plate incorporation and pre-incubation Ames test dit not result in increased number of revertant colonies in strains S. typhimurium strains TA 98, 97a., 100, 102, 1537, 1538.