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EC number: 205-758-8 | CAS number: 150-38-9
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Basic data given: acceptable publication
- Principles of method if other than guideline:
- Method: other Fish, Acute Toxicity Test
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- not specified
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 24 h
- Hardness:
- 12 °dH
- Test temperature:
- 18 - 21 °C
- Details on test conditions:
- The fry were held in glass aquaria with aeration.
Sufficient oxygen content of the test water was ensured.
Tap water from the city of Hamburg was used in all experiments as test water.
3 animals were used per test concentration.
A second test series was run in parallel.
The fish were observed for at least 24 hours, in some cases even 48 hours and lethalities were recorded. - Duration:
- 24 h
- Dose descriptor:
- LC100
- Effect conc.:
- 860 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- The authors noted that the disodium salt of EDTA showed significantly less toxicity towards aquatic organisms compared to the corresponding acid EDTA which was presumably caused by a pH effect.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication
- Principles of method if other than guideline:
- The static water acute toxicity tests followed the methods described in the EPA publication, "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates, and Amphibians" (COMMITTEE ON METHODS FOR TOXICITY WITH AQUATIC ORGANISMS, 1975).
- GLP compliance:
- no
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- Lepomis macrochirus
- Details on test organisms:
- The test fish were obtained from the National Fish Hatchery at Hebron, Ohio, USA.
The fish had an average weight of 0.74 g (range 0.62-1.28 g) and an average total length of 34 mm (range 28-38 mm).
The fish were kept in a 16-h light/8-h dark cycle. Feed was stopped three days prior to the bioassay to empty the digestive tract. Fish were placed into the aquaria 24 h before adding the test material. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- Three different water types were used:
very soft water: 10-13 mg/L CaCO3, reconstituted from destilled water
medium hard water: 103 mg/L as CaCO3, dilution water from Lake Huron
very hard water: 280-320 mg/L CaCO3, reconstituted from destilled water - Test temperature:
- 22 +/- 1°C
- pH:
- Three different water types were used:
very soft water reconstituted from destilled water, start: pH 6.4 - 6.8, end: unknown but low
medium hard water dilution water from Lake Huron: start pH 7.6, end pH 4
very hard water reconstituted from destilled water: start pH 8.0 - 8.4, end pH 4 - Dissolved oxygen:
- start of test: 8.2 mg/L
end of test: 4.2 mg/L - Salinity:
- no data available
- Nominal and measured concentrations:
- no data available
- Details on test conditions:
- Water used came from Whitestone Point on the west side of Saginaw Bay, Lake Huron.
The water was sent through an activated charcoal bed to remove any free chlorine.
This water exhibits chemical characteristics in the following ranges:
total alkalinity: 85 mg/L as CaC03
specific conductivity: 1770 umhos/cm
resistivity: ca. 570 ohms/cm
This water passes the general requirements for dilution water as stated in COMMITTEE ON METHODS FOR TOXICITY WITH AQUATIC ORGANISMS (1975). In addition, VERSENE acid, VERSENE 100 were also tested for effect in very soft and hard waters. These waters were reconstituted distilled waters.
None of the products were neutralized prior to testing.
Bioassays were conducted by placing eight liters water in each vessel, a round glass aquarium measuring 22 cm deep with a 24.5 cm diameter, adding the fish, then aerating with plant air. If no deaths occurred in 24 h, the aerators were removed, and the test solution added with two liters of water for mixing, making a total of ten liters. Any vessel containing dead fish was cleaned, reset, and observed for another 24 h prior to compound addition. Ten fish were exposed to each concentration of the material. Between five and ten concentrations were set per product. Observations were made and recorded daily. - Reference substance (positive control):
- not specified
- Duration:
- 96 h
- Dose descriptor:
- other: NAEL
- Effect conc.:
- 24 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very soft water
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 41 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 34 - 62 mg/L, very soft water
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very soft water
- Duration:
- 96 h
- Dose descriptor:
- other: NAEL
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: medium hard water
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 159 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 136-204 mg/L, medium hard water
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 240 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: medium hard water
- Duration:
- 96 h
- Dose descriptor:
- other: NAEL
- Effect conc.:
- 420 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very hard water
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 532 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 473-598 mg/L, very hard water
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 750 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very hard water
- Details on results:
- Instead of the NOEC, in this study the NAEL (= no (observable) adverse effect level) is quoted.
- Results with reference substance (positive control):
- no data
- Sublethal observations / clinical signs:
Two products illustrate the effect of pH in medium hard water: VERSENE acid and VERSENE powder. The acid kills 100 % of the bluegill at 240 mg/L in water at a pH of 3.7.
Such acidity alone is lethal to bluegill (COMMITTEE ON WATER QUALITY CRITERIA, 1972). If the acid is made into the sodium salt, VERSENE powder, a 100 % mortality occurs at 521 mg/L. The resultant pH of 8.9 is not itself toxic to bluegill. A 50 % aqueous solution of this sodium salt, VERSENE 100, causes 100 % mortality at 1120 mg/L at a pH of 9.6. In hard water, total kill with the VERSENE acid occurs at 750 mg/L and pH 3.5 (again, a pH related kill), whereas VERSENE 100 killed all bluegill at 2400 mg/L and pH 9.8. A pH level of 9.5-10.0 may cause some mortality; values >10.0 are not tolerated by bluegill (COMMITTEE ON WATER QUALITY CRITERIA, 1972).
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The test results of H4EDTA show that there is a relation between water hardness and ecotoxicity. Tests performed in very soft (10-13 mg/l CaCO3) and medium hard water (103 mg/I CaCO3) showed a higher toxicity than those performed in very hard water. As the hardness increased, more of the chelator was converted to the Ca-complex, thus more chelating agent was required to exert a toxic effect-less uncomplexed EDTA is available. This was proofed by a reported LC50 of 2340 mg/L for Versene Ca (where EDTA is already complexed with Ca) in the same publication. Thus, it should be noted, that under test conditions (buffer capacity) pH 4 alone leads to toxicity in bluegill.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication
- Principles of method if other than guideline:
- The static water acute toxicity tests followed the methods described in the EPA publication, "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates, and Amphibians" (COMMITTEE ON METHODS FOR TOXICITY WITH AQUATIC ORGANISMS, 1975).
- GLP compliance:
- no
- Analytical monitoring:
- not specified
- Details on sampling:
- no data available
- Vehicle:
- not specified
- Test organisms (species):
- Lepomis macrochirus
- Details on test organisms:
- The test fish were obtained from the National Fish Hatchery at Hebron, Ohio, USA.
The fish had an average weight of 0.74 g (range 0.62-1.28 g) and an average total length of 34 mm (range 28-38 mm).
The fish were kept in a 16 -h light/8-h dark cycle. Feed was stopped three days prior to the bioassay to empty the digestive tract. Fish were placed into the aquaria 24 h before adding the test material. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no data available
- Hardness:
- Three different water types were used:
very soft water: 10-13 mg/L CaCO3, reconstituted from destilled water
medium hard water: 103 mg/L as CaCO3, dilution water from Lake Huron
very hard water: 280-320 mg/L CaCO3, reconstituted from destilled water - Test temperature:
- 22 +/- 1 °C
- pH:
- Three different water types were used:
very soft water reconstituted from destilled water, start: pH 6.4 - 6.8, end: 7.5
medium hard water dilution water from Lake Huron: start pH 7.6, end pH 9.5
very hard water reconstituted from destilled water: start pH 8.0 - 8.4, end pH 9.5 - Dissolved oxygen:
- start of test: 8.2 mg/L
end of test: 4.2 mg/L - Salinity:
- no data
- Nominal and measured concentrations:
- no data
- Details on test conditions:
- TEST WATER
Water used came from Whitestone Point on the west side of Saginaw Bay, Lake Huron.
The water was sent through an activated charcoal bed to remove any free chlorine.
This water exhibits chemical characteristics in the following ranges:
total alkalinity: 85 mg/L as CaCO3;
specific conductivity: 1770 µmhos/cm; and resistivity: ca. 570 ohms/cm (AMERICAN PUBLIC HEALTH ASSOCIATION 1975).
This water passes the general requirements for dilution water as stated in COMMITTEE ON METHODS FOR TOXICITY WITH AQUATIC ORGANISMS (1975).
None of the products were neutralized prior to testing.
Bioassays were conducted by placing eight liters water in each vessel, a round glass aquarium measuring 22 cm deep with a 24.5 cm diameter, adding the fish, then aerating with plant air. If no deaths occurred in 24 h, the aerators were removed, and the test solution added with two liters of water for mixing, making a total of ten liters. Any vessel containing dead fish was cleaned, reset, and observed for another 24 h prior to compound addition. Ten fish were exposed to each concentration of the material. Between five and ten concentrations were set per product. Observations were made and recorded daily. - Reference substance (positive control):
- not specified
- Duration:
- 96 h
- Dose descriptor:
- other: NAEL
- Effect conc.:
- 88 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very soft water
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 121 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 113-130 mg/L, very soft water
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 138 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very soft water
- Duration:
- 96 h
- Dose descriptor:
- other: NAEL
- Effect conc.:
- 669 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: medium hard water
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 792 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 754-831 mg/L, medium hard water
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 861 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: medium hard water
- Duration:
- 96 h
- Dose descriptor:
- other: NAEL
- Effect conc.:
- 1 380 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: hard water
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1 592 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 1493-1678 mg/L, hard water
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 1 846 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: hard water
- Details on results:
- Instead of the NOEC, in this study the NAEL (= no (observable) adverse effect level) is quoted.
- Results with reference substance (positive control):
- no data available
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The test results of Na4EDTA show that there is a relation between water hardness and ecotoxicity. Tests performed in very soft water (10-13 mg/L CaCO3) showed a higher toxicity than those performed in a medium hard water (103 mg/L CaCO3) or very hard water (280-320 mg CaCO3). The great variation in mortality resulted in LC50 values in a range of 121 mg/L (soft water) to 1592 mg/L (very hard water). The LC50 of 121 mg/L derived in very soft water which reflects spring water from lime-free geological zones is not considered as environmentally relevant as EDTA is not released to waters of such low hardness.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance.
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Refer to the Analogue Approach Justification document provided in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 41 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very soft water; source, RA-A, CAS 60-00-4, Batchelder & al., 1980, L. macrochirus, 96 h, RL2
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 159 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: medium hard water; source, RA-A, CAS 60-00-4, Batchelder & al., 1980, L. macrochirus, 96 h, RL2
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 532 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very hard water, source, RA-A, CAS 60-00-4, Batchelder & al., 1980, L. macrochirus, 96 h, RL2
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 121 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: very soft water; source, RA-A, CAS 64-02-8, Batchelder & al., 1980, L. macrochirus, 96 h, RL2
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 792 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: medium hard water; source, RA-A, CAS 64-02-8, Batchelder & al., 1980, L. macrochirus, 96 h, RL2
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1 592 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Na4EDTA
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: hard water; source, RA-A, CAS 64-02-8, Batchelder & al., 1980, L. macrochirus, 96 h, RL2
Referenceopen allclose all
Description of key information
LC50 (96 h) > 100 mg/L; read-across (Lepomis macrochirus)
Key value for chemical safety assessment
Additional information
Since no studies investigating the short-term toxicity trisodium
hydrogen EDTA (CAS 150-38-9) to fish are available, in accordance to
Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to structurally
related EDTA species was conducted. This read-across is justified in
detail in the overall summary (IUCLID Section 6.1) and within the
analogue justification in IUCLID Section 13.
Several studies on different species of edetic acid (EDTA) are
available. All studies were combined in a weight-of-evidence approach.
The toxicity of EDTA on fish highly depends on water hardness, pH and
metal speciation (EU Risk Assessment, 2004). Batchelder et al. (1980)
investigated the toxicity of EDTA complexes to bluegill sunfish (Lepomis
macrochirus) by taking into account the water hardness and pH of the
test medium. The results testing the acidic form of EDTA lead to a
decrease of pH in test medium < 4 with a LC100 of 240 mg/L. However, a
pH of 4 leads to toxicity in bluegill sunfish (Committee on water
quality criteria, 1972). Thus, the results testing the acidic form are
only considered to be related to the very low pH of the test medium
causing mortality.
The revealed LC50-values after 96 h resulting from test
media with different hardness are in a range of 41 mg/L to 1592 mg/L
(see table below).
EDTA Species |
LC50 [mg/L] |
Test conditions |
H4-EDTA |
41 |
Very soft water |
|
159 |
Medium hard water |
|
532 |
Very hard water |
Na4-EDTA |
121 |
Very soft water |
|
792 |
Medium hard water |
|
1592 |
Very hard water |
Two consequences can be drawn from the results of Batchelder et
al. First, the tests performed with the acid form lead to very low pH
values under test conditions causing mortality. The low LC50-value of 41
mg/L in very soft water can be explained by a surplus of un-complexed
EDTA which was present in the test media since species to be complexed
are limited in very soft water. In medium hard and hard water the
predominant species of EDTA is the complexed form. This effect is not
expected to occur in the environment since EDTA is not released to
waters of such low hardness (e.g. spring water from lime-free geological
zones). Therefore, the results derived by soft water hardness and/or
very low pH <4 are not relevant for the assessment.
One supporting study with disodium dihydrogen EDTA (CAS 139-33-3)
supports this conclusion with a LC100 (24 h) of 860 mg/L.
Consequently, the LC50 of EDTA is estimated to be higher 100 mg/L, due to the fact that this predicted value represents the lowest LC50 at acceptable pH which has been performed in natural non-synthetic water.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.