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EDTA

1 CHEMICAL IDENTITY EDTA is mainly produced and used as acid (H4EDTA) and as sodium salt (Na4EDTA). In lower amounts, other salts or metal complexes are produced or used. The environmental exposure from the different uses of all EDTA species is overlapping. Despite the fact that EDTA is likely to occur in the environment in different chemical species, it is analysed as EDTA in environmental samples. For these reasons, one ERL derivation is performed for all species of EDTA.” (van Herwijnen and Fleuren, 2009).

Common name EDTA

Chemical name (IUPAC) [[2-(Bis-carboxymethyl-amino)-ethyl]-carboxymethyl-amino] acetic acid

Synonym(s)Ethylenediaminetetraacetic acidEDTA Edetic acid

Chemical class (when relevant) -

CAS number 60-00-4

EU number 200-449-4

Molecular formula C10H16N2O8

Molecular structure

Molecular weight (g.mol-1) 292.3

Common name Tetrasodium ethylenediaminetetraacetate

Chemical name (IUPAC) Tetrasodium [[2-(bis-carboxymethyl-amino)-ethyl]-carboxymethylamino]-acetate

Synonym(s)

Ethylenediaminetetraacetic acid tetrasodium saltSodium ededate; N,N’-1,2-Ethanediylbis[N-(carboxymethyl)glycine] tetrasodium saltEdetic acid tetrasodium saltNa4EDTA EDTA tetrasodium Edetate sodium

Chemical class (when relevant) -

CAS number 64-02-8

EU number 200-573-9

Molecular formula C10H12N2Na4O8

Molecular structure

Molecular weight (g.mol-1) 380.2

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2 EXISTING EVALUATIONS AND REGULATORY INFORMATION

Annex III EQS Dir. (2008/105/EC) Included

Existing Substances Reg. (793/93/EC)

1st List – Final Risk Assessment Report (E.C., 2004a)EU Risk Assessment Reports are finalised and publicly available for EDTA (E.C., 2004a) and Na4EDTA (E.C., 2004b).

Pesticides(91/414/EEC) Not relevant

Biocides (98/8/EC) Not notified

PBT substances

Industry commentno PBT, no vPvBEnhanced biodegradability according to the REACH Guidances, BCF between 1 and 2, acute and long-term tests on all three trophic levels were performed to examine the aquatic toxicity of EDTA. Neither acute nor long-term effects of EDTA on aquatic organisms were observed and EDTA is not classified as carcinogenic, mutagenic, or toxic for reproduction.CSTEE comment (CSTEE, 2003):“EDTA is not easily degraded. It is biodegraded in particular conditions that may occur in industrial treatment plants but that seem unlikely to occur in natural waters as well as in municipal treatment plants.”

Substances of Very High Concern (1907/2006/EC) No

POPs (Stockholm convention) No

Other relevant chemical regulation (veterinary products, medicament, ...)

Reg 1995/2/EEC, Annex 4 (as Na2CaEDTA, CAS 62-33-9)Reg 2002/72/EC, Annex 3

Endocrine disrupter

Not investigated within COMMISSION STAFF WORKING DOCUMENTS on implementation of the Community Strategy for Endocrine Disrupters (E.C., 2004c, E.C., 2007)Industry commentsEDTA is a thoroughly investigated substance. It shows no hints of endocrine activity, the reproductive organs are not target organs and no compromised fecundity has been found. Consequently, the EU Risk Assessment concluded that EDTA has not to be classified as reproductive toxicant.

Industry commentsExplanationsPersistence Assessment

EDTA does not reach the pass level for ready biodegradability under the standard OECD criterion, however, biodegradation does occur, depending on retention time, pH, EDTA concentration as well as content and type of chelatable metal present. Moreover, the bacterial metabolism degradation pathway could be shown in enriched bacterial strains. These results have been further confirmed by studies monitoring sewage treatment plants where, depending on the conditions, significant degradation up to approximately 90% could be determined (EU RAR 2004, Table 3.1).

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Biodegradation under such conditions warrant “enhanced biodegradability” and does not qualify for “persistency” under REACH according to the Guidance on information requirements and chemical safety assessment, Part C and Chapter R.11: PBT Assessment, as well as Chapter R.7b: Endpoint specific guidance.

Photodegradation of EDTA metal complexes has been described and determined in several laboratory studies (EU RAR 2004). More recently, Metsärinne (2001) determined ca. 70% photodegradation of Na2H2EDTA within 30 days in river water and natural sunlight without deliberate addition of iron. Virtapohja (2000) determined almost complete degradation of EDTA from paper mill waste water in a Finnish river, most probably due to sunlight. Complexes of EDTA with Co(III) and Mn(II) were found to be unstable against sunlight too, however, with lower degradation constants (EU RAR 2004).

As worst-case assumption solely Fe(III)EDTA has been considered to photodegrade in the EU Risk Assessment (EU RAR 2004).

Moreover, there is a marked discrepancy between the calculated and the measured concentrations in ambient surface waters which could be explained by slow biotic or abiotic degradation in sewage treatment plants and surface waters.

Consequently, EDTA should be considered as ultimately degradable and not as persistent.

Bioaccumulation Assessment

The bioaccumulation of EDTA has been studied and a BCF between ca. 1 and 2 has been determined (EU RAR 2004)

Toxicity Assessment

Acute and long-term tests on all three trophic levels were performed to examine the aquatic toxicity of EDTA. Neither acute nor long-term effects of EDTA on aquatic organisms were observed and EDTA is not classified as carcinogenic, mutagenic, or toxic for reproduction. (EU RAR 2004)

Summary and overall Conclusions on PBT or vPvB Properties

EDTA is neither a PBT nor a vPvB substance.

Endocrine DisruptionEDTA is a thoroughly investigated substance. Dozens of animal studies have been performed in the last 50 years. Additionally, EDTA is used in humans in chelation therapy since the 1950’s. It shows no hints of endocrine activity, the reproductive organs are not target organs and no compromised fecundity has been found. Consequently, the EU Risk Assessment concluded that EDTA has not to be classified as reproductive toxicant.Furthermore, EDTA is not listed in any of the following documents:The Communication (2001) 262 from the Commission to the Council and the European Parliament on the implementation of the Community Strategy for Endocrine Disrupters — a range of substances suspected of interfering with the hormone systems of humans and wildlife, Annex 1, Tables 2-4.The Commission Staff Working Document SEC (2004) 1372 on the implementation of the Community Strategy for Endocrine Disrupters — a range of substances suspected of interfering with the hormone systems of humans and wildlife, Annex 3, Tables 1-4.The Commission Staff Working Document SEC (2007) 1635 on the implementation of the Community Strategy for Endocrine Disrupters — a range of substances suspected of interfering with the hormone systems of humans and wildlife, Annex 2, Tables 1-4.The bkh-Report towards the establishment of a priority list of substances for further evaluation of their role in endocrine disruption, final report 06-21-2000, Annex 15, “List of 66 substances with classification high, medium or low exposure concern”.

Rapporteur comment:

EDTA is an Annex III substance (Directive 2008/105/CE).

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EDTA has been included in the prioritization process as a result of the EU Risk Assessment with the conclusion that there is a need for specific measures to limit the risks, because of concerns for environmental effects as a consequence of exposure arising from the use of EDTA in industrial detergents, by paper mills, circuit board producers and releases during recovery of EDTA containing wastes (Commission Communication 2006/C 90/04). It is recommended:— to facilitate permitting and monitoring under Council Directive 96/61/EC (Integrated Pollution Prevention and Control), EDTA should be included in the ongoing work to develop guidance on ‘Best Available Techniques’ (BAT).— to take persistent complexing agents into account in the European eco-labelling of paper products and to extend the existing European eco-labelling for cleaners to industrial cleaners under Regulation 1980/2000/EC.

Section 3 of Commission Recommendation 2006/283/EC advises risk reduction measures for the environment, including

- for relevant Member State to establish Environmental Quality Standards (EQS) and to include the national pollution reduction measures to achieve those EQS by 2015 in the river basin management plans;

- to set emission limit values or equivalent parameters or technical measures in order for the installations concerned to operate according to the BAT by the end of October 2007,

- and to ensure that no risk for the environment is expected by controlling local emissions to the environment, by national rules where necessary.

There are no indications that the substance should be considered as a PBT, vPvB, or POP substance or as an endocrine disrupting substance.

Concerns have been expressed however on the persistency of complexing agents (by Commission Communication 2006/C 90/04 (E.C., 2006) and by the Scientific Committee on Toxicity, Ecotoxicity and the Environement (CSTEE, 2003), and EDTA has been considered as basically not biodegradable (EU risk assessment, E.C., 2004a, CSTEE, 2003). The additional information provided by Industry above is conform to the conclusions of the EU-RAR, indicating that EDTA can degrade under certain conditions, but also forms chelates with metals and other compounds recalcitrant to degradation.CSTEE states in its opinion (CSTEE, 2003) that “EDTA is not easily degraded. It is biodegraded in particular conditions that may occur in industrial treatment plants but that seem unlikely to occur in natural waters as well as in municipal treatment plants”.

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3 PROPOSED QUALITY STANDARDS (QS)

3.1 ENVIRONMENTAL QUALITY STANDARD (EQS)QS for -- is the “critical QS” for derivation of an Environmental Quality Standard

Add any comment on possible residual uncertainty.

Value Comments

Proposed AA-EQS for [matrix] [unit]Corresponding AA-EQS in [water] [µg.l-1]

Critical QS is QS--.

See section 6

Proposed MAC-EQS for [freshwater] [µg.l-1]Proposed MAC-EQS for [marine waters] [µg.l-1]

See section

3.2 SPECIFIC QUALITY STANDARD (QS)

Protection objective* Unit Value Comments

Pelagic community (freshwater) [µg.l-1]See section

Pelagic community (marine waters) [µg.l-1]

Benthic community (freshwater) [µg.kg-1 dw] e.g. EqP,see section Benthic community (marine) [µg.kg-1 dw]

Predators (secondary poisoning)

[µg.kg-1biota ww]

See section 6.2[µg.l-1]

(freshwaters) (marine waters)

Human health via consumption of fishery products

[µg.kg-1biota ww]

See section 6.3[µg.l-1] (freshwaters)

(marine waters)

Human health via consumption of water [µg.l-1]

* Please note that as recommended in the Technical Guidance for deriving EQS (drat version), “EQSs […] are not reported for ‘transitional and marine waters’, but either for freshwater or marine waters”. If justified by substance properties or data available, QS for the different protection objectives are given independently for transitional waters or coastal and territorial waters.

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James, 16/03/10,

TO BE DETERMINED LATER ON – ON HOLD


4 MAJOR USES AND ENVIRONMENTAL EMISSIONS

4.1 USES AND QUANTITIESEDTA is used as a complexing agent in many industries but also in household detergent and agriculture (van Herwijnen and Fleuren, 2009) or as a cosmetic.

Information below is directly extracted from EDTA EU-RAR (E.C., 2004a)

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7


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4.2 ESTIMATED ENVIRONMENTAL EMISSIONS

Industry commentsIn Section 3.1.3.3. it was concluded that significant remobilization process can only occur in extreme cases e.g. at local point emission sites with high releases of EDTA.

As a result of a risk management procedure under Existing Chemicals Regulation 793/93 the risk management of EDTA for the aqueous environment has already been placed under the authority of the Member States by the Commission Recommendation 2006/238/EC and the Commission Communication 2006/C 90/04. The risk management experts of the Member States saw no need for additional measures at European level.

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5 ENVIRONMENTAL BEHAVIOUR

5.1 ENVIRONMENTAL DISTRIBUTION

Master reference

Water solubility (mg.l-1)[EDTA] : 400 at 20°C[Na4EDTA] : 500 000 at 20°C

E.C., 2004aE.C., 2004b

Volatilisation The vapour pressure is estimated to be very low for partially ionic substances. Therefore a determination was not conducted

Vapour pressure (Pa) See aboveE.C., 2004aE.C., 2004bHenry's Law constant

(Pa.m3.mol-1) See above

Adsorption Due to the ionic structure under environmental pH conditions, no adsorption onto the organic fraction of soil or sediments is expected.

Organic carbon – water partition coefficient (KOC) See above -

Sediment – water partition coefficient(Ksusp-water) See above -

BioaccumulationAccording to the very low value of BCF, the substance is not likely to bioaccumulate. BCF value of 1.8 can be used to derive quality standard.

Octanol-water partition coefficient (Log Kow) - 5.01 (estimated) E.C., 2004a

BCF (measured) 1.1 – 1.8 E.C., 2004a

Master reference

Hydrolysis EDTA is resistant to hydrolysis process E.C., 2004a

Photolysis

Free EDTA is not submitted to photolysis under environmental conditions.DT50 = 20 d for Fe(III)EDTA complex.Other EDTA complexes are considered as persistent.Industry commentsFe(III), Co(III) and Mn(II) Complexes of EDTA have been proven to photodegrade. Photodegradation in river water and ambient sun without deliberate addition of Fe has been shown.DT50 = 20 d for Fe(III)EDTA complex has been taken as worst case.Other EDTA complexes are considered as persistent as worst case.

E.C., 2004aMetsärinne 2001Virtapohja 2000

Biodegradation EDTA is considered non biodegradable in surface waters and in municipal waste water treatment plants (WWTP). A partial degradation is expected in industrial WWTP.However, biodegradation is favoured in WWTP when some environmental conditions are joint :

- High hydraulic retention time and high sludge

E.C., 2004aNörtemann 2003

Satroutdinov 2003van Ginkel 2003

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retention time,- Alcaline pH,- High EDTA concentration,

Free EDTA (not complexed with metals).Industry commentsEDTA is not readily biodegradable under OECD conditions.Biodegradation of EDTA as well as Mg-, Ca-, Zn- and Mn-EDTA could be shown with adapted bacteria.Degradation could be proven in industrial WWTP when some environmental conditions are joint:

- High hydraulic retention time and high sludge retention time,

- Slightly alcaline pH,- High EDTA concentration to favor adaption

According to the REACH criteria EDTA is considered enhanced biodegradable.

After 19 days, 10% EDTA is degraded when concentration are 7 – 50 mg.l-1.EDTA is not readily biodegradable.

Gerike and Fischer, 1979in E.C., 2004a

For the purpose of the risk assessment (E.C., 2004a), the following degradation rates have been selected:

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Industry commentsExplanationsWater solubilityThe solubility of H4EDTA is ca. 400 mg/L at 20°C. In contrast the solubility of Na4EDTA is 500,000 mg/L (= 500 g/L) (Ullmann 2000).

Photolysis

Under environmental conditions EDTA is present as complex, the type of central metal depends on the conditions in the ambient water, especially the presence of metals, natural chelating agents and pH. Speciation calculations show a preference for Ni, Zn and Cu in the slightly alkaline regime and Fe in the slightly acidic regime (EU RAR 2004, Kari 1996).

Photodegradation of EDTA metal complexes has been described and determined in several laboratory studies (EU RAR 2004). More recently, Metsärinne (2001) determined ca. 70% photodegradation of EDTA within 30 days in river water and natural sunlight without deliberate addition of iron. Virtapohja (2000) determined almost complete degradation of EDTA in a Finnish river, most probably due to sunlight. Complexes of EDTA with Co(III) and Mn(II) were found to be unstable against sunlight, too, however, with lower degradation constants (EU RAR 2004).

Due to the good water solubility and low adsorption tendency of EDTA metal complexes it is accepted that EDTA complexes reside almost exclusively in the water body of which at least the surface part is subjected to sunlight.

The marked discrepancy between the calculated and the measured concentrations in ambient surface waters could be explained by slow degradation.

Biodegradation

EDTA does not reach the pass level for ready biodegradability under the standard OECD criteria. Additionally, it is found in many surface waters in the ppb range.

However, using adapted bacteria many EDTA complexes (MgEDTA, CaEDTA, MnEDTA, ZnEDTA) are degraded into the metabolites ED3A, ED2A to glycine. Other complexes like Fe(III)EDTA, NiEDTA or CuEDTA could not be degraded in the same experiments. (Nörtemann 2003, Satroutdinov 2003).

Additionally, EDTA has been found to be eliminated in monitoring studies by sewage treatment plants fed with EDTA containing waste water from the dairy and beer industries at slightly alkaline conditions (van Ginkel 2003).

Biodegradation under such conditions warrant “enhanced biodegradability” and do not qualify for “persistency” under REACH according to the Guidance on information requirements and chemical safety assessment, Part C and Chapter R.11: PBT Assessment, as well as Chapter R.7b: Endpoint specific guidance.

Consequently, EDTA should be considered as enhanced (ultimately) degradable.

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Rapporteur comment:Concerns have been expressed on the persistency of complexing agents by Commission Communication 2006/C 90/04 (E.C., 2006) and by the Scientific Committee on Toxicity, Ecotoxicity and the Environement (CSTEE, 2003), and EDTA has been considered as basically not biodegradable (EU risk assessment, E.C., 2004a, CSTEE, 2003).

CSTEE states in its opinion (CSTEE, 2003) that “EDTA is not easily degraded. It is biodegraded in particular conditions that may occur in industrial treatment plants but that seem unlikely to occur in natural waters as well as in municipal treatment plants”.

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Aquatic environmental concentrations

5.2 ESTIMATED CONCENTRATIONS

Compartment Predicted environmental concentration (PEC) Master reference

Freshwater (µg.l-1)PEClocal = 95 – 12 000

PECregional = 95

E.C., 2004aE.C., 2004b

Sediment Not relevant

Biota (freshwater)

Not relevantBiota (marine)

Biota (marine predators)

5.3 MEASURED CONCENTRATIONS

Compartment

Measured and quantified environmental concentrations(nb analysis)

Master reference

Freshwater (µg.l-1)cf. table below James et al., 2009(1)

Marine waters (coastal and/or transitional) (µg.l-1)

WWTP effluent (µg.l-1) No data available

Sediment (µg.kg-1 dw)

Sed 2 mm No data (0)

James et al., 2009(1)Sed 20 µm No data (0)

Sed 63µm No data (0)

Biota

Invertebrates (µg.kg-1 ww) No data (0)

James et al., 2009(1)

Fish (µg.kg-1 ww) No data (0)

Marine predators No data available(1) data originated from EU monitoring data collection

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Industry commentsExplanations

Estimated concentrations

It should be pointed out that there is a remarkable difference between the estimated concentrations in the EU Risk Assessment (95 - 12000 ppb) and the monitoring data (INERIS 2009) and the EU Risk Assessment report.

This has also been noted by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE 2003):

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6 EFFECTS AND QUALITY STANDARDS “A result of the exposure assessment was that in the environment always overstoichiometric amounts of metal ions are present, thus there is no uncomplexed EDTA. In Section 3.1.3.3, it is elaborated that always a mixture of different metal complex species occurs in surface waters. As shown below, there is a large influence of the speciation to the ecotoxicity of EDTA. Therefore, tests with EDTA metal complexes have to be considered as well.In the tests, either H4EDTA, the sodium salt or metal complexes were used as test substance. In order to present comparable results, all effect values are calculated as H4EDTA.” (E.C., 2004a)

6.1 ACUTE AND CHRONIC AQUATIC ECOTOXICITYAll studies cited in the tables below are extracted from the European Union Risk Assessment Report for EDTA (E.C., 2004a). Data have been peer reviewed and are considered as valid.

ACUTE EFFECTS Master reference

Algae & aquatic plants(mg.l-1)

Freshwater

Scenedesmus subspicatus / duration?/ Na4EDTAEbC50 = 0.78 (expressed as H4-EDTA)

Batchelder et al., 1980in E.C., 2004a

Industry commentsThe apparent toxicity of complexing agents to algae is related to reduced essential trace metal bioavailability.Experiments with increased nutrient metal concentrations reveal that the direct toxicity on algae is above 310 mg/l.

E.C., 2004a, page 7

Marine No data available

Invertebrates(mg.l-1)

Freshwater

Daphnia magna / 24h / Na4EDTAEC50 = 480 (expressed as H4-EDTA)Daphnia magna / 24h / Na4EDTAEC50 = 790 (expressed as H4-EDTA)Mean value : 640

Bringmann and Kühn, 1977 in E.C., 2004a


Sediment No data available

Fish(mg.l-1)

Freshwater

Lepomis macrochirus / 96h H4EDTA: LC50 : = 41 – 532* Na4EDTA: LC50 : = 121 – 1 592* Zn-EDTA: LC50 : = 422 – 772*

* expressed as H4-EDTA and depending on water quality (see details in the table extracted from EU-RAR, below)As a


Industry proposalLepomis macrochirus / 96hH4EDTA: LC50 : = 374 mg/L




Other taxonomic groups No data available

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Information below is directly extracted from EU-RAR (E.C., 2004a)

Industry commentsExplanation

Acute effects on Algae and Aquatic Plants

In the OECD algae test iron availability is the growth limiting factor and will be blocked by an excess of EDTA, therefore only studies with iron addition should be used to assess the toxicity of EDTA to algae under environmental conditions.

EU RAR 2004, Page 7:


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Nota bene: The citation in the document is not correct. Batchelder 1980 only cites tests on bluegill, not on algae.

Fish, Freshwater, Batchelder 1980

The toxicity of EDTA on fish highly depends on water hardness, pH and metal speciation (EU RAR 2004, page 51).

The effect of pH is firstly seen in the markedly low toxicity of Versene (NH4)2EDTA— LC 50 = 2340 mg/L at pH ca. 5 — in contrast to Versene Acid — LC 50 = 159 mg/L at pH ca. 4 (Batchelder 1980, Table 2).

Secondly, in the study with Versene Acid in very soft water (Batchelder 1980, Table 3 or EU RAR, Table 3.21) the pH has not been determined. However, an LC 50 of 41 mg/L reflects 139 µmol/L H4EDTA together with 100 - 130 µmol/L Ca ( = 10 - 13 mg/L CaCO3), thus almost a 1:1 ratio. This cannot be explained by CaEDTA toxicity, since Na2CaEDTA, Versene Ca, is of markedly low toxicity, LC50 = 2340 mg/L.

Consequently, the results obtained with non-neutralized H4EDTA, Versene Acid, should not be taken into account; the kill is highly driven and/or influenced by the low pH around 4 or even below.

The influence of water hardness on EDTA toxicity on the other side can be derived from Table 3.21 in the EU Risk Assessment, subpart “Na4EDTA”

water hardness LC50 mg/L pH LC50 µmol/L* Ca µmol/LNa4EDTAVery soft (10-13 mg/L CaCO3) 121 7.0 - 7.7 414 100 - 130Medium hard (103 mg/L CaCO3) 792 9.5 - 9.6 2712 1030Very hard (280-320 mg/L CaCO3) 1592 9.5 - 9.6 5452 2800 - 3200

* in accordance with the structure of the EU RAR the molar mass for H4EDTA, 292 g/mol has been used

In soft water 50% kill occurred at ca. 115 µmol/L CaEDTA and ca. 300 µmol/L free EDTA, whilst in medium hard water 50% kill was detected at ca. 1000 µmol/L CaEDTA next to ca. 1700 µmol/L free EDTA and in very hard water Batchelder found 50% kill at ca. 3000 µmol/L CaEDTA and ca. 2500 µmol/L free EDTA.

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Consequently and puzzlingly, the toxicity of free EDTA is further moderated by the presence of CaEDTA, which leads to the assumption that the fish are harmed by generally low water ion content. Here it should be noted that — although bluegill (Lepomis macrochirus) is not especially sensitive to water hardness — 100 µmol Ca is a very low value for surface waters.

Under environmental conditions EDTA is always present as complex (EU RAR 2004, page 45 bottom). The chelating agent will react with a metal ion mainly already in the use phase — it is manufactured and used for that purpose — but latest in the sewage pipes and treatment.

Consequently, best is to use Table 3.23 of the EU Risk Assessment, where Batchelder determined the toxicity of EDTA complexes to bluegill.

The results show that the toxicity of complexes with the toxic metals Cu and Zn is in the same concentration range as the uncomplexed EDTA. Chelates with non-toxic metals (Mn, Ca, Mg) are much less toxic (cited from EU RAR 2004, page 53 above).

Finally, one is left with the question, which LC50 should be taken for EDTA. Clearly, the free acid leads to results that are environmentally not relevant. For REACH purposes we propose to use the result with Versene Powder at water of medium hardness (Batchelder 1980, Table 2), LC50 = 486 mg/L Na4EDTA, or, if corrected by molar mass, LC50 = 374 mg/L H4EDTA (EU RAR 2004, Table 3.22), due to the fact that this value represents the lowest LC50 at acceptable pH which has been performed in natural not synthetic water. (Nota bene: This value again is in the same range of the toxicity of complexes with the toxic metals Cu and Zn, EU RAR 2004, Table 3.23)

CHRONIC EFFECTS Master reference

Algae & aquatic plants(mg.l-1)

Freshwater

Scenedesmus subspicatus / duration?/ Na4EDTAEbC10 = 0.37 (expressed as H4-EDTA)


Industry commentsThe apparent toxicity of complexing agents to algae is related to reduced essential trace metal bioavailability.Pseudokirchnerella subcapitata / Fe(III)EDTANOEC = 79.4 (expressed as H4-EDTA)

Geurts and van Wijk, 2001

in E.C., 2004a


Invertebrates(mg.l-1)

FreshwaterDaphnia magna /21 d / Na2H2EDTANOEC = 22 (expressed as H4-EDTA)

BASF, 1996ain E.C., 2004a

MarineArbacia punctulata (Echinoderm)NOEC = 29.2 (expressed as EDTA)

Young and Nelson, 1974in E.C., 2004a


Fish(mg.l-1)

Freshwater Danio rerio / 35d / CaNa2EDTANOEC = > 26.8 (expressed as H4-EDTA)

BASF, 2001in E.C., 2004a



Other taxonomic groups No data available

Apparent EDTA toxicity to algae in standardised tests is an indirect effect of nutrient deficiency (metal complexation of EDTA) which cannot be quantified from the laboratory tests. Therefore, effects on algae cannot be taken into account in the MAC-QS and AA-QS derivation (For more details, see the EU-RAR, E.C., 2004a).

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Rapporteur Comment on the selection of data for MAC determination: In addition to the general restriction on algae expressed above, according to the EU-RAR (E.C., 2004a), none of the data available on fish are useable without some limitations, mainly because of the low relevance of the tests conditions compared to natural environments.For the purpose of MAC determination, it is proposed to use the value used in the EU-RAR to determine the PNEC for intermittent releases: “The assessment of intermittent releases for fresh water is based on the 24-hour EC50 values of 480 and 790 mg/l obtained for daphnids. Both results were obtained under very similar conditions and are within the uncertainty range of effect test results. Therefore, the mean value (640 mg/l) together with an assessment factor of 100 is used. The PNECintermittent is calculated to 6.4 mg/l.”

It should be noted however that CSTEE Opinion on EDTA (2003) states “The rationale of this procedure [PNEC calculation for intermittent releases] is not clear and the figure cannot be accepted by the CSTEE”.

In the Netherlands (van Herwijnen and Fleuren, 2009), it has been proposed to use the acute value of 159 mg.l-1 for Lepomis macrochirus (Medium hardness – 103 mg.l-1 CaCO3, low pH) in the derivation instead of the mean of the two daphnid studies. This would result in a MAC of 1.6 mg.l -1. However, these experimental conditions were considered as not realistic under the EU review (E.C., 2004a)

Tentative QSwaterRelevant study for derivation of QS

Assessment factor Tentative QS

MACfreshwater, eco Daphnia magna / 24h / Na4EDTAEC50 = 480 mg H4-EDTA.l-1

Daphnia magna / 24h / Na4EDTAEC50 = 790 mg H4-EDTA.l-1

Mean value : 640

100 6 400 µg.l-1

MACmarine water, eco 1000 640 µg.l-1

AA-QSfreshwater, eco Daphnia magna /21 dNOEC = 22 mg H4-EDTA.l-1

10 2 200 µg.l-1

AA-QSmarine water, eco 100 220 µg.l-1

AA-QSfreshwater, sed. - EqP - µg.kg-1

ww

- µg.kg-1dw

AA-QSmarine water, sed. - EqP - µg.kg-1

ww

- µg.kg-1dw

Industry proposal

ExplanationTentative QS water

It is puzzling that the MAC is below the AA-QS, as a result of the Assessment Factor of 100, however, this will resolve if the value of 486 mg/L or 374 mg/L is used as LC50. Additionally, it should be considered if — using different values for fish and algae due to the corrections for pH and metal ions — an assessment factor of 10 is appropriate (EQS Guidance 2009 Tables 3.4)

MACfreshwater, eco Lepomis macrochirus / 96hLC50 : = 374 mg H4-EDTA.l-1

10 37 400 µg.l-1

MACmarine water, eco 100 3 740 µg.l-1

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James, 17/03/10,

TENTATIVE AF – TO BE DISCUSSED


6.2 SECONDARY POISONING

Secondary poisoning of top predators Master reference

Mammalian oral toxicity

Rat / Oral / 2 years / No effectDisodic calcium saltNOAEL : 250 mg.kg-1

bw.d-1

NOEC : 5 000 mg.kg-1feed ww (CF = 20)

Oser et al., 1963in WHO, 1974

Avian oral toxicity No data available

Tentative QSbiotaRelevant study for derivation of QS

Assessmentfactor

Tentative QS

Biota NOEC : 5 000 mg.kg-1feed ww 30

166 667 µg.kg-1biota ww

corresponding to92 693 µg.l-1 (freshwater)

92 693 µg.l-1 (marine waters)

6.3 HUMAN HEALTH

Human health via consumption of fishery products Master reference

Mammalian oral toxicity

Rat / Oral / 2 years / No effectDisodic calcium saltNOAEL = 250 mg.kg-1

bw.d-1

Oser et al., 1963in WHO, 1974

CMR The substance is not classified for any carcinogenic, mutagenic or reprotoxic properties. E.C., 2008

Tentative QSbiota, hh

Relevant study for derivationof QSbiota, hh

AFThreshold

level(mg.kgbw

-1.d-1)Tentative QSbiota, hh

Human healthNOAEL= 250 mg.kg-1

bw.d-1

(Disodic calcium salt)100(1) ADI(1)= 1,9

(EDTA ion)

115 652 µg EDTA ion.kg-1biota ww

corresponding to64 251 µg.l-1 (freshwaters)

64 251 µg.l-1 (marine waters)(1) This value and the associated assessment factor are considered valid as they were determined by WHO, 2008.

Human health via consumption of drinking water Master reference

Existing drinking water standard(s) No standard Directive 98/83/EC

Any guideline

21

James, 16/03/10,


James, 16/03/10,



7 BIBLIOGRAPHY, SOURCES AND SUPPORTIVE INFORMATION BASF (1996). Determination of the Chronic Toxicity of Trilon BD to the Water Flea Daphnia Magna Straus.Project Number 96/0498/51/1.

BASF (2001). CaNa2EDTA-Early Life-Stage Toxicity Test on the Zebrafish (Danio rerio)

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Bringmann G. and Kühn R. (1977). "The effects of water pollutants on Daphnia magna." Z. Wasser Abwasser Forsch 10(5): 161-166.

CSTEE (2003). Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) Opinion on the results of the Risk Assessment of Ethylenediamine tetraacetate (EDTA) - CAS N°: 60-00-4, EINECS N°: 200-449-4, Envionmental part. CSTEE 39th plenary meeting of 10 September 2003.

E.C. (2004a). European Union Risk Assessment Report for EDTA (CAS n°60-00-4) (final report), Institute for Health and Consumer Protection - European Chemicals Bureau.

E.C. (2004b). European Union Risk Assessment Report for Tetrasodium ethylenediaminetetraacetate (Na4EDTA) (CAS n°64-02-8). Final report., Institute for Health and Consumer Protection - European Chemicals Bureau.

E.C. (2004c). Commission staff working document on implementation of the Community Strategy for Endocrine Disrupters - a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM(1999) 706)). SEC(2004) 1372. Brussels, European Commission.

E.C. (2006). Commission Communication on the results of the risk evaluation and the risk reduction strategies for the substances: Dibutylphthalate; 3,4-Dichloroaniline; Di-'isodecyl' phthalate; 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich; Di-'isononyl' phthalate; 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich; Ethylenediaminetetraacetate; Methyl acetate; Monochloroacetic acid; n-Pentane; Tetrasodium ethylenediaminetetraacetate. E. Commission, Official Journal of the European Union. 2006/C 90/04: 25.

E.C. (2007). Commission staff working document on implementation of the "Community Strategy for Endocrine Disrupters" - a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM(1999) 706), COM(2001) 262) and SEC (2004) 1372) SEC(2007) 1635. Brussels, European Commission.

E.C. (2008). Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance). Official Journal of the European Union. L353: 1355.

Gerike P. and Fischer W.K. (1979). "A correlation study of biodegradability determinations with various chemicals in various tests." Ecotoxicol. Environ. 3: 159-173.

James A., Bonnomet V., Morin A. and Fribourg-Blanc B. (2009). Implementation of requirements on Priority substances within the Context of the Water Framework Directive. Contract N° 07010401/2008/508122/ADA/D2. Prioritisation process: Monitoring-based ranking., INERIS / IOW: 58.

Oser B.L., Oser M. and Spencer H.C. (1963). "Safety evaluation studies of calcium EDTA." Toxicology and applied pharmacology 5: 142-162.

van Herwijnen R. and Fleuren R.H.L.J. (2009). Environmental Risk Limits for EDTA. Report 6071822028. Bilthoven (the Netherlands), National Institute for Public Health and the Environment (RIVM): 22.

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WHO (1974). Toxicological evaluation of certain food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers and thickening agents. WHO Food Additives Series No. 5. Geneva, Joint FAO/WHO Expert Committee on Food Additives.

WHO (2008). Guidelines for Drinking-water Quality - Third Edition Incorporating The First And Second Addenda, Volume 1 - Recommendations. Geneva, WHO: 668

Young L. and Nelson L. (1974). "The effects of heavy metal ions on the motility of sea urchin spermatozoa. Biol. Bull." Biol. Bull. 147(236-246).

23


Literature for the Comments/Explanations from CEFIC

EU RAR 2004: EU Risk Assessment Report edetic acid (EDTA) 2004, Vol. 49, final report

Metsärinne 2001: Metsärinne S, Tuhkanen T and Aksela R: Photodegradation of ethylenediaminetetraacetic acid (EDTA) and ethylenediamine disuccinic acid (EDDS) within natural UV radiation range. Chemosphere 45 (2001) 949-955

Virtapohja 2000: Virtapohja JS: Environmental Fate and Effects of Chelating Agents used in the Pulp and Paper Industries, Division of Environmental Chemistry Preprints of Extended Abstracts, Vol 40(1) 2000, 439-441

Ullmann 2000: Ullmann's Encyclopedia of Industrial Chemistry, 2000

Kari 1996: Kari FG and Giger W: Speciation and Fate of Ethylenediaminetetraacetate (EDTA) in Municipal Wastewater Treatment, Wat. Res. Vol 30(1) 1996, 122-134

Nörtemann 2003 Nörtemann B: Biodegradation of Chelating Agents: EDTA, DTPA, PDTA, NTA, and EDDS in Nowack B, Van Briesen JM, Biogeochemistry of Chelating Agents, ACS Symposium Series 910, 2003

Satroutdinov 2003 Satroutdinov AD, Chistyakova TI, Dedyukhina EG, Minkevich IG: Microbial Degradation of EDTA: New EDTA-Degrading Bacterial strains in Nowack B, Van Briesen JM, Biogeochemistry of Chelating Agents, ACS Symposium Series 910, 2003

Van Ginkel 2003 Van Ginkel CG and Geerts R: Full-Scale Biological Treatment of Industrial Effluents Containing EDTA in Nowack B, Van Briesen JM, Biogeochemistry of Chelating Agents, ACS Symposium Series 910, 2003

CSTEE 2003 Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) Opinion on the results of the Risk Assessment of Ethylenediamine Tetraacetate (EDTA), Environmental Part, Brussels 09-10-2003

Batchelder 1980 Batchelder, TL, Alexander, HC and Mc Carty, WM: Acute fish toxicity of the Versene family of chelating agents, Bull. Environm. Contam. Toxicol. 24 (1980) 543-549

EQS Guidance 2009 Technical Guidance for Deriving Environmental Quality Standards, Sept 2009, Version 1

INERIS 2009 INERIS 02-07-2009, Substances factsheet of chemical pollutants “Edetic acid”

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edta · web viewthe apparent toxicity of complexing agents to algae is related to reduced...

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