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RISK ASSESSMENT Trisodium Nitrilotriacetate

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RISK ASSESSMENT Trisodium Nitrilotriacetate R307_hh_env_0808 Draft of 20.08.2008 RISK ASSESSMENT Trisodium Nitrilotriacetate CAS-No.: 5064-31-3 EINECS-No.: 225-768-6 Draft of 20.08.2008 1 R307_0808_hh_env.doc Draft of 11.03.2008 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: [email protected] 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. R307_0808_hh_env.doc Draft of 11.03.2008 Contents 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 2 CAS No 5064-31-3 R307_0808_hh_env.doc Draft of 11.03.2008 3.3 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 3 CAS No 5064-31-3 R307_0808_hh_env.doc Draft of 11.03.2008 0 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 4 CAS No 5064-31-3 R307_0808_hh_env.doc Draft of 11.03.2008 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 Na3NTA are examined. For all life-cycle steps, the PEC/PNEC ratios are below 1. Therefore, 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 Na3NTA in formulation process) and 3 (high pressure cleaning), and inhalation exposure (with a critical exposure level of 2 mg/m3) has to be reduced for scenario 1 (production of NTA) and 2b (use of Na3NTA 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 5 CAS No 5064-31-3 R307_0808_hh_env.doc Draft of 11.03.2008 Man 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 6 CAS No 5064-31-3 R307_0808_hh_env.doc Draft of 11.03.2008 1 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: NaOOC N COONa NaOOC 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 7 CAS No 5064-31-3 R307_0808_hh_env.doc Draft of 11.03.2008 Physico-chemical properties Trisodium nitrilotriacetate (Na3NTA) 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 Na3NTA Melting point 410 °C with decomposition BASF, 1996 above 200 °C 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 Chemsafe, 1997 decomposition (200 °C) 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 8 CAS No 5064-31-3 R307_0808_hh_env.doc Draft of 11.03.2008 and 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 relevant 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 Na3NTA is not recommended with respect to the environment. Human Health • (Classification according to Annex I) Xn Harmful R 22 Harmful if swallowed Xi Irritant R 36 Irritating to eyes • (Proposal of the rapporteur) Classification and Labelling of Na3NTA has been concluded by the EU C&L Committee in March 2006 (See ANNEX 1 Draft list 31st ATP New entries 16/10/2006 (31B). Xn Harmful R 22 Harmful if swallowed Xi Irritant R 36 Irritating to eyes 9 CAS No 5064-31-3 R307_0808_hh_env.doc Draft of 11.03.2008 Carcinogenic, cat. 3 R 40 Limited evidence of a carcinogenic effect Oral LD50 values of approximately 750 mg/kg bw were determined for monkeys, of 1300- 1470 mg/kg bw for female rats and of 1600-2220 mg/kg bw for male rats. Based on these data the substance has to be classified as "Xn, harmful" and labelled with "R 22 - harmful if swallowed". There is no valid information on eye irritation testing according to current international test guidelines. On animal welfare reasons, we propose to assess the eye irritating properties of Na3NTA on the basis of the test carried out for Monsanto (1968) and BASF (1982) and taking also into account the strongly basic nature of a 1% aqueous solution.
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