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EC number: 217-895-0 | CAS number: 2001-94-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of 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 with acceptable restriction (limited documentation)
- Justification for type of information:
- Read across is based on a structurally similar material. An analogue justification is attached in section 13 of dataset.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- uninduced and arochlor induced liver S9 mix of male Fischer 344 rats, B6C3F1 mice, and Syrian hamsters
- Test concentrations with justification for top dose:
- 10; 33; 100; 333; 1000; 3333; 10000 µg/plate
- Vehicle / solvent:
- dest. water
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: - S9 mix: 2-Nitrofluorene; n-Methyl-N`-nitro-N-nitrosoguanidine; +S9: 2-aminoanthracene; 2-2(furyl)-3-(5-nitro-2-furyl)acrylamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
NUMBER OF REPLICATIONS:
3
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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
- Species / strain:
- E. coli WP2 uvr A
- 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: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Conclusions:
- Interpretation of results (migrated information):
negative - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of 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 with acceptable restrictions
- Justification for type of information:
- Read across is based on a structurally similar material. An analogue justification is attached in section 13 of dataset.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- NTP-Standard Protocol
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
- 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
- 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
- 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)
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative - Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of 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 with acceptable restrictions
- Justification for type of information:
- Read across is based on a structurally similar material. An analogue justification is attached in section 13 of dataset.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- NTP-Standard Protocol
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from the livers of either Aroclor 1254-induced or non-induced male Fischer 344 rats
- Test concentrations with justification for top dose:
- 3000, 4000, 5000 µg/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: - S9 mix: methyl methanesulfonate; + S9 mix: methylcholanthrene
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- 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'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Referenceopen allclose all
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 | ||||||||||||
Tables: Results of the mouse lymphoma test with Na3EDTA
Nonactivation Trial: 1 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | AVG Mutant Frequency | ||
µg/mL | Efficiency | Growth | |||||
Vehicle Control: | H2O | 0 | 64 | 87 | 113 | 59 | 69 |
63 | 112 | 132 | 70 | ||||
65 | 108 | 133 | 68 | ||||
64# | 92 | 148.5 | 78 | ||||
Test Chemical: | 60 | 65 | 107 | 177 | 91 | 83 | |
74 | 109 | 165 | 74 | ||||
70 | 58 | 110 | 97 | 56 | 68 | ||
67 | 113 | 162 | 81 | ||||
80 | 67 | 100 | 131 | 65 | 59 | ||
63# | 116 | 99 | 52 | ||||
90 | 58 | 86 | 119 | 69 | 72 | ||
63 | 93 | 140 | 75 | ||||
100 | 71 | 111 | 142 | 67 | 73 | ||
66 | 101 | 159 | 80 | ||||
Positive Control: | MMS | 15 | 49 | 42 | 293 | 198 | 181* |
53 | 45 | 261 | 164 | ||||
Trial Notes: | |||||||
Nonactivation Trial: 2 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | AVG Mutant Frequency | ||
µg/mL | Efficiency | Growth | |||||
Vehicle Control: | FOP | 0 | 78 | 103 | 24 | 10 | 18 |
93 | 91 | 50 | 18 | ||||
103 | 104 | 57 | 18 | ||||
84 | 102 | 63 | 25 | ||||
Test Chemical: | 1000 | 80 | 42 | 61 | 25 | 23 | |
76 | 51 | 45 | 20 | ||||
2000 | 87 | 53 | 52 | 20 | 21 | ||
88 | 52 | 61 | 23 | ||||
3000 | 79 | 38 | 47 | 20 | 21 | ||
77 | 50 | 50 | 22 | ||||
4000 | 93 | 32 | 80 | 29 | 27 | ||
65 | 30 | 49 | 25 | ||||
5000 | 79 | 23 | 49 | 21 | 22 | ||
76 | 29 | 54 | 24 | ||||
Positive Control: | MMS | 15 | 52 | 25 | 146 | 93 | 93* |
38 | 18 | 107 | 93 | ||||
Trial Notes: | |||||||
Nonactivation Trial: 3 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | AVG Mutant Frequency | ||
µg/mL | Efficiency | Growth | |||||
Vehicle Control: | FOP | 0 | 69 | 94 | 88 | 43 | 38 |
62 | 109 | 48 | 26 | ||||
58 | 87 | 79 | 46 | ||||
76 | 110 | 84 | 37 | ||||
Test Chemical: | 1000 | 61 | 59 | 95 | 52 | 57 | |
55 | 60 | 101 | 61 | ||||
2000 | 68 | 73 | 111 | 55 | 49 | ||
61 | 61 | 77 | 42 | ||||
3000 | 62 | 64 | 110 | 59 | 60 | ||
52 | 50 | 95 | 61 | ||||
4000 | 61 | 45 | 74 | 40 | 42 | ||
61 | 51 | 81 | 45 | ||||
5000 | 50 | 34 | 68 | 45 | 46 | ||
55 | 37 | 77 | 47 | ||||
Positive Control: | MMS | 15 | 23 | 24 | 163 | 235 | 217* |
26 | 23 | 156 | 200 | ||||
EMS | 250 | 41 | 61 | 427 | 347 | 325* | |
52 | 59 | 474 | 302 | ||||
Trial Notes: | |||||||
Induced S9 Trial: 1 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | AVG Mutant Frequency | ||
µg/mL | Efficiency | Growth | |||||
Vehicle Control: | FOP | 0 | 108 | 93 | 101 | 31 | 36 |
102 | 109 | 98 | 32 | ||||
109 | 101 | 119 | 36 | ||||
97 | 97 | 130 | 45 | ||||
Test Chemical: | 1000 | 105 | 74 | 137 | 43 | 47 | |
100 | 78 | 152 | 51 | ||||
2000 | 82 | 58 | 101 | 41 | 42 | ||
97 | 67 | 126 | 43 | ||||
3000 | 99 | 56 | 159 | 54 | 44 | ||
109 | 62 | 113 | 35 | ||||
4000 | 99 | 55 | 106 | 36 | 38 | ||
85 | 45 | 101 | 40 | ||||
5000 | 77 | 36 | 124 | 54 | 55 | ||
85 | 36 | 145 | 57 | ||||
Positive Control: | MCA | 2.5 | 72 | 44 | 615 | 286 | 305* |
70 | 40 | 680 | 323 | ||||
Trial Notes: | |||||||
Induced S9 Trial: 2 Experiment Call: Negative and Non-Toxic | |||||||
Conc. | Cloning | Relative Total | Mutant Colonies | Mutant Frequency | AVG Mutant Frequency | ||
µg/mL | Efficiency | Growth | |||||
Vehicle Control: | FOP | 0 | 60 | 96 | 36 | 20 | 20 |
64 | 110 | 35 | 18 | ||||
56 | 92 | 48 | 29 | ||||
66 | 103 | 25 | 13 | ||||
Test Chemical: | 1000 | 52 | 61 | 41 | 26 | 21 | |
63 | 75 | 31 | 16 | ||||
2000 | 67 | 63 | 56 | 28 | 27 | ||
62 | 61 | 48 | 26 | ||||
3000 | 61 | 40 | 41 | 22 | 31 | ||
71 | 48 | 85 | 40 | ||||
4000 | 66 | 41 | 56 | 28 | 29 | ||
57 | 35 | 51 | 30 | ||||
5000 | 70 | 34 | 65 | 31 | 28 | ||
59 | 36 | 45 | 25 | ||||
Positive Control: | MCA | 2.5 | 34 | 19 | 231 | 229 | 232* |
34 | 17 | 237 | 236 | ||||
Trial Notes: | |||||||
Footnotes: | |||||||
Asterisks(*) indicate significant responses. | |||||||
r = rejected value due to quality control criteria | |||||||
# = reduced sample size because of the loss of one culture dish due to contamination | |||||||
MMS = methyl methanesulfonate | |||||||
MCA = methylcholanthrene | |||||||
DMSO = dimethylsulfoxide (solvent) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In vitro:
Na3EDTA was negative in a reverse gene mutation assay using bacteria Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 as well as E. Coli WP2uvrA without and with uninduced and arochlor induced liver S9 from male Fischer 344 rats, B6C3F1 mice or Syrian hamsters. The substance was tested up to concentrations of 10000 µg/plate (Dunkel 1985).
Similar results were obtained by Zeiger (1988), who tested up to 10000 µg/plate Na3EDTA on Salmonella typhimurium strains TA97, TA98, TA100, TA1535, and TA1537 with and without Arochlor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers S9 mix.
Several mammalian cell line gene mutations assays are available. In a mouse lymphoma assay with Na3EDTA the mutant frequency was not increased at concentrations of 3000, 4000, 5000 µg/ml and a treatment time of 4 h. The assay was conducted with and without metabolic activation and no cytotoxicity was detected (NTP, 1984).
Another mouse lymphoma assay with Na2EDTA was also negative at concentrations of 250, 500, 1000, 1500 and 2000 µg/ml with and without metabolic activation. However, 2000 µg/ml Na2EDTA reduced the relative growth to 65.5% compared to the control in cells without metabolic activation. This was not the case if cells were treated with S9 mix (Whittaker, 2001).
Additionally, in a chromosome aberration test Na3EDTA was tested negative (NTP, 1984).
Cell transformation assays with Na2 and Na3 salts of EDTA were negative. One test was performed on SHE cells with exposure of up to 100 µg/ml for 24 h or 150 µg/ml Na2EDTA for up to 7 days without metabolic activation (LeBoef, 1996).
Additionally a cell transformation assay using BALB/c-3T3 cells was performed without metabolic activation. Cells were exposed to up to up to 770 µg/ml Na3EDTA for 48 h without metabolic activation (Matthews, 1993).
Short description of key
information:
Concerning free edetic acid only few studies are available,
therefore data from EDTA sodium salts have also been considered. Na
salts of EDTA were tested negative in several ames tests. Na salts of
EDTA were tested negative in several mouse lymphoma assays.
Endpoint Conclusion: No adverse
effect observed (negative)
Justification for classification or non-classification
Based on the results obtained in the toxicity studies and taking into account the provisions laid down in Regulation EC 1272/2008, classification is not fulfilled with respect to genetic toxicity.
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