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RISK ASSESSMENT

Trisodium Nitrilotriacetate

CAS-No.: 5064-31-3

EINECS-No.: 225-768-6

Draft of 20.08.2008

1

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Information on the rapporteur

Contact point:

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA)

Chemikalien, Anmeldung und Zulassung

Federal Institute for Occupational Safety and Health

Division for Chemicals and Biocides Regulation

Friedrich-Henkel-Weg 1-25

44149 Dortmund

fax: +49-(0)231-9071-2679 e-mail: chemg@baua.bund.de The first draft of the Human Health Section of the Comprehensive Risk Assessment Report Trisodium Nitrilotriacetate (NTA), a substance chosen from the EU 3rd Priority List in 1995, which is distributed for the preliminary written procedure was distributed to MS for preliminary comments in October 2006. This document is the revised draft of the Human Health Section of the RAR of NTA which is intended to be discussed in-depth at the TC NES II´07.

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2Contents

0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT 4 1

GENERAL SUBSTANCE INFORMATION 7

2

GENERAL INFORMATION ON EXPOSURE 11

2.1

Production, Import and Export 11

2.2 Processing / Application (Categories of use, Amounts) 11 2.3

Use Pattern 13

3

ENVIRONMENT 14

3.1

Environmental exposure 14

3.1.1 General discussion 14

3.1.2 Aquatic compartment 24

3.1.3 Atmosphere 36

3.1.4 Terrestrial compartment 37

3.1.5 Non compartment specific exposure relevant to the food chain 37

3.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 37

3.2.1 Aquatic compartment 37

3.2.2 Atmosphere 54

3.2.3 Terrestrial compartment 54

3.2.4 Non compartment specific effects relevant to the food chain 55

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33.3 Risk characterisation 55

3.3.1 Aquatic compartment 55

3.3.2 Atmosphere 56

3.3.3 Terrestrial compartment 56

3.3.4 Non compartment specific effects relevant to the food chain 56

4

HUMAN HEALTH 57

4.1

HUMAN HEALTH (TOXICITY) 57

4.1.1 Exposure assessment 57

4.1.2 Effects assessment: Hazard identification and Dose (concentration) - response

(effect) assessment 83

4.1.3 Risk characterisation 167

4.2

HUMAN HEALTH (PHYSICO-CHEMICAL PROPERTIES) 199

4.2.1 Exposure assessment 199

4.2.2 Effects assessment: Hazard identification and Dose (concentration) - response

(effect) assessment 199

4.2.3 Risk characterisation 199

5

CONCLUSIONS / RESULTS 201

6

REFERENCES 203

APPENDIX 1 217

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40 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT

CAS No. 5064-31-3

EINECS No. 225-768-6

IUPAC Name Trisodium nitrilotriacetate

Overall results of the risk assessment:

( ) i) There is need for further information and/or testing ( X ) ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already ( X ) iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account

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Summary of conclusions:

Environment

Conclusion ii) There is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already. In the present risk assessment production and use of Na 3

NTA are examined. For all life-cycle

steps, the PEC/PNEC ratios are below 1. Ther efore, a risk for the environment is not expected.

Human Health

Workers

Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account Concern is derived for repeated dose toxicity and carcinogenicity. Especially dermal exposure (with a critical exposure level of 2.85 mg/kg/day) has to be reduced for scenario 2 (use of Na 3 NTA in formulation process) and 3 (high pressure cleaning), and inhalation exposure (with a critical exposure level of 2 mg/m 3 ) has to be reduced for scenario 1 (production of NTA) and 2b (use of Na 3

NTA in formulation process without LEV).

Conclusion (ii) There is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already. For the other toxicological endpoints the risk orientated conclusions result in no concern with the consequence that risk reduction measures are of low priority.

Consumers

Conclusion (ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already

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6Man exposed indirectly via the environment

Conclusion (ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already

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71 GENERAL SUBSTANCE INFORMATION

Identification of the substance

CAS-No.: 5064-31-3

EINECS-No.: 225-768-6

IUPAC Name: Trisodium nitrilotriacetate

Synonyms: Nitrilotriacetic acid trisodium salt

NTA trisodium salt

CA-Index name: Glycine, N,N-bis(carboxymethyl)-, trisodium salt

Molecular weight: 257.1 g/mol

Empirical formula: C6H6NNa3O6

Structural formula:

NCOONa

NaOOCNaOOC

Purity/impurities, additives

Purity: 92 % w/w

Impurities: < 7 % water

< 3 % sodium glycolate < 2 % disodium iminodi(acetate) < 2 % sodium hydroxide < 1.5 % methanamine < 1 % sodium formate

Additives: none

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Physico-chemical properties

Trisodium nitrilotriacetate (Na

3 NTA) is a colourless crystalline powder at room temperature and normal pressure. Data on the physical and chemical properties are given in table 1.1. Table 1.1: Data on the physical and chemical properties of Na 3 NTA

Melting point 410 °C with decomposition

above 200 °C BASF, 1996

Boiling point not applicable

Relative density 1.77 at 20 °C

1)

BASF, 1997

Vapour pressure not determined

no test conducted because of structural reasons Surface tension not determined no test conducted because of structural reasons Water solubility about 640 g/l at 20 °C Ullmann, 1991

Partition coefficient -2.62 (calculated)

2)

BASF, 1989

Flash point not determined substance is a solid

Flammability not highly flammable

3)

BASF, 1998

Ignition temperature no selfignition up to

decomposition (200 °C) Chemsafe, 1997 Explosive properties not explosive no test conducted because of structural reasons Oxidising properties no oxidising properties no test conducted because of structural reasons 1)

Relative density: pycnometer method

2) Partition coefficient: The logPow was calculated according to the Rekker method with the computer program Pro-logP (version 2.0). 3) Flammability: According to guideline 92/69/EEC test method A.10 (determination of the flammability for solids), the substance did not propagate combustion. The tests according to A.12 (determination of the flammability in contact with water) and A.13 (determination of pyrophoric properties) were not conducted. Due to the properties

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9and the handling of the substance it has not to be assumed that

flammable gases formate in contact with water or the substance has pyrophoric properties.

Classification

Environment

Proposal of the rapporteur (only environmental part) For the classification of biodegradation, the available laboratory tests with uncomplexed NTA should not be used, because biodegradation of this chelator is strongly dependent on the metal speciation. Studies on the degradation in biological treatment plants as well as degradation tests conducted in river water reveal that the degradation properties of NTA (resp. of its metal complexes) are comparable with a readily degradable substance. In addition the substance has no bioaccumulation potential. In tests on the acute toxicity on fish and daphnia effects were only observed when NTA was present in over-stoichiometric concentrations compared to the content of metal ions. The lowest LC50 values were 98 mg/l for both trophic levels. Results of algae growth inhibition tests have to be interpreted carefully, because the observed effects are mainly cause by nutrient deficiency, which is an artefact and not relevan t for the environment. Tests with increased concentrations of nutrient metals (where nutrient deficiency is suppressed) reveal that intrinsic toxicity of NTA is expected only at concen- trations far above 10 mg/l.

Considering all results, a classification of Na

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