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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study without detailed documentation For read-across justification refer to section 13.

Data source

Reference
Reference Type:
publication
Title:
Genotoxicity of Iron Chelators in L5178Y Mouse Lymphoma Cells
Author:
Whittaker P
Year:
2001
Bibliographic source:
Environmental and Molecular Mutagenesis 38:347-356 (2001)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
not specified
GLP compliance:
no
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Reference substance name:
Disodium dihydrogen ethylenediaminetetraacetate
EC Number:
205-358-3
EC Name:
Disodium dihydrogen ethylenediaminetetraacetate
Cas Number:
139-33-3
IUPAC Name:
disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Details on test material:
no further data

Method

Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9
Test concentrations with justification for top dose:
250, 500, 1000, 1500, 2000 µg/ml
Vehicle / solvent:
water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: - S9: ethyl methane sulfonate; + S9: 3-methylcholanthrene

Results and discussion

Test resultsopen allclose all
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 2000 µg/ml
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: mouse lymphoma L5178Y cells
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Mutagenicity and Cytotoxicity of Na2EDTA

Concentration [µg/ml] S9 Relative growth Mutant frequency/ 106survivors
0 - 100 24
250 - 95.5 27
500 - 79.5 27
1000 - 87 20
1500 - 83.5 30
2000 - 65.5 29
0.25 µg/ml EMS - 42 693
0 + 100 48
250 + 78.5 55
500 + 95.5 56
1000 + 80.5 47
1500 + 107 40
2000 + 87.5 42
5 µg/ml MCA + 22 542

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative