Sodium calcium edetate

Genetic toxicity: in vitro

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

Test material information

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 results

Test results 1

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

Test results 2

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/ 10^6survivors
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