Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cobaltate(2-)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Chromosome Aberration

Author:

National Toxicology Program (U.S. Department of health and Human Services)

Year:

1984

Bibliographic source:

NTP-Webpage http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm

Materials and methods

Principles of method if other than guideline:

NTP-Standard Protocol

GLP compliance:

no

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium hydrogen ethylenediaminetetraacetate

EC Number:

205-758-8

EC Name:

Trisodium hydrogen ethylenediaminetetraacetate

Cas Number:

150-38-9

Molecular formula:

C10H16N2O8.3Na

IUPAC Name:

trisodium hydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate

Details on test material:

no data

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced male Sprague Dawley rat liver S9 enzymes and cofactor mix

Test concentrations with justification for top dose:

50; 75; 100 µg/ml

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: -S 9: Mitomycin C; + S9: Cyclophosphamide

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: strain/cell type: Chinese hamster Ovary (CHO)

Any other information on results incl. tables

Table 1: Results of the Chromosome Aberrations Test for Na3EDTA.
Study Result: Negative
Activation	Trial	Trial Call
No Activation	1	Negative
Induced Rat Liver S9	2	Negative
Trial #:1   Activation: No Activation   Date: 10/17/1984   Harvest Time: 13.5 hrs   Trial Call: Negative
		Dose	Total Cells Examined	Total Aberrations			Complex Aberrations			Simple Aberrations			Other Abs.
		µg/mL		No. of	Abs	% Cells	No. of	Abs	% Cells	No. of	Abs	% Cells	No. of	Abs	% Cells
				Abs.	Per	With	Abs.	Per	With	Abs.	Per	With	Abs.	Per	With
					Cell	Abs.		Cell	Abs.		Cell	Abs.		Cell	Abs.
Abs: Aberrations
Vehicle Control:	Dimethylsulfoxide	10	100	1	0.01	1	0	0	0	1	0.01	1	0	0	0
Positive Control:	Mitomycin C	0.25	100	29	0.29	26	24	0.24	22	5	0.05	5	0	0	0
		1	50	31	0.62	46	24	0.48	44	7	0.14	14	0	0	0
Test Chemical:	Ethylenediamine tetraacetate, trisodium salt (EDTA)	25	100	1	0.01	1	0	0	0	1	0.01	1	0	0	0
		50	100	2	0.02	2	1	0.01	1	1	0.01	1	0	0	0
		75	100	5	0.05	5	3	0.03	3	2	0.02	2	0	0	0
		100	100	1	0.01	1	0	0	0	1	0.01	1	0	0	0
	Trend:			1.106			1.331			0.333
	Probability:			0.134			0.092			0.37
Trial #:2   Activation: Induced Rat Liver S9   Date: 10/31/1984   Harvest Time: 14.0 hrs   Trial Call: Negative
		Dose	Total Cells Examined	Total Aberrations			Complex Aberrations			Simple Aberrations			Other Abs.
		µg/mL		No. of	Abs	% Cells	No. of	Abs	% Cells	No. of	Abs	% Cells	No. of	Abs	% Cells
				Abs.	Per	With	Abs.	Per	With	Abs.	Per	With	Abs.	Per	With
					Cell	Abs.		Cell	Abs.		Cell	Abs.		Cell	Abs.
Abs: Aberrations
Positive Control:	Cyclophosphamide	15	100	55	0.55	40	29	0.29	22	26	0.26	22	0	0	0
Vehicle Control:	Dimethylsulfoxide	10	100	3	0.03	3	2	0.02	2	1	0.01	1	0	0	0
Test Chemical:	Ethylenediamine tetraacetate, trisodium salt (EDTA)	25	100	1	0.01	1	1	0.01	1	0	0	0	0	0	0
		50	100	4	0.04	4	2	0.02	2	1	0.01	1	1	0.01	1
		75	100	4	0.04	4	2	0.02	2	2	0.02	2	0	0	0
		100	100	3	0.03	3	1	0.01	1	2	0.02	2	0	0	0
	Trend:			0.686			-0.156			1.164
	Probability:			0.247			0.562			0.122

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
negative