Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
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

Constituent 1
Chemical structure
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 102
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.