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Draft Risk Assessment Report, Which Is Then Presented at a Meeting of Member State Technical Experts for Endorsement

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Draft Risk Assessment Report, Which Is Then Presented at a Meeting of Member State Technical Experts for Endorsement RISK ASSESSMENT REPORT ZINC DISTEARATE CAS-No.: 557-05-1 91051-01-3 EINECS-No.: 209-151-9 293-049-4 GENERAL NOTE This document contains: - part I Environment (pages 63) - part II Human Health (pages 124) R074_0805_env RISK ASSESSMENT ZINC DISTEARATE CAS-No.: 557-05-1 & 91051-01-3 EINECS-No.: 209-151-9 & 293-049-4 Final report, May 2008 PART 1 Environment Rapporteur for the risk evaluation of zinc distearate is the Ministry of Housing, Spatial Planning and the Environment (VROM) in consultation with the Ministry of Social Affairs and Employment (SZW) and the Ministry of Public Health, Welfare and Sport (VWS). Responsible for the risk evaluation and subsequently for the contents of this report is the rapporteur. The scientific work on this report has been prepared by the Netherlands Organization for Applied Scientific Research (TNO) and the National Institute of Public Health and Environment (RIVM), by order of the rapporteur. Contact point: Bureau Reach P.O. Box 1 3720 BA Bilthoven The Netherlands R074_0805_env PREFACE For zinc metal (CAS No. 7440-66-6), zinc distearate (CAS No. 557-05-1 / 91051-01-3), zinc oxide (CAS No.1314-13-2), zinc chloride (CAS No.7646-85-7), zinc sulphate (CAS No.7733- 02-0) and trizinc bis(orthophosphate) (CAS No.7779-90-0) risk assessments were carried out within the framework of EU Existing Chemicals Regulation 793/93. For each compound a separate report has been prepared. It should be noted, however, that the risk assessment on zinc metal contains specific sections (as well in the exposure part as in the effect part) that are relevant for the other zinc compounds as well. For these aspects, the reader is referred to the risk assessment report on zinc. 2 CAS No. 557-05-1 & 91051-01-3 R074_0805_env CONTENTS 0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT 5 1 IDENTIFICATION OF THE SUBSTANCE 7 1.1 Environmental classification and labelling of zinc distearate 8 1.1.1 Introduction 8 1.1.2 Test results water solubility and aquatic toxicity 9 2 GENERAL INFORMATION ON EXPOSURE 11 2.1 Production 11 2.2 Use pattern 12 2.2.1 General 12 3 ENVIRONMENT 15 3.1 General introduction 15 3.2 Exposure assessment 16 3.2.1 Exposure scenarios 17 3.2.1.1 General 17 3.2.1.2 Local exposure assessment 19 3.2.1.2.1 General 19 3.2.1.2.2 Production of zinc distearate 19 3.2.1.2.3 General information on the use categories of zinc distearate in the EU 29 3.2.1.2.4 Formulating and processing in the rubber (and polymer) industry 30 3.2.1.2.5 Formulating and processing of zinc distearate in the building industry 31 3.2.1.2.6 Formulation and application of zinc distearate in the coating industry 33 3.2.1.2.7 Processing of zinc distearate in the chemical industry 34 3.2.1.2.8 Formulation and processing of zinc distearate in textile industry 36 3.2.1.2.9 Formulation and processing of zinc distearate in the pulp, paper and board industry 37 3.2.1.2.10 Formulation and private use of zinc distearate in the personal/domestic category 38 3.2.1.2.11 Formulation and processing of zinc distearate in the metal extraction, refining and processing industry. 39 3.2.1.2.12 Formulation and processing of zinc distearate in other industries 40 3.2.1.2.13 Measured local data in the environment 41 3.2.1.2.14 Summary of results for the local exposure assessment 42 3.3 Effects Assessment 43 3.3.1 Aquatic and terrestrial compartment 43 3.3.1.1 Zinc disterate 43 3.3.1.1.1 Aquatic compartment 43 3.3.1.2 Zinc 44 3.3.2 Atmosphere 46 3.3.3 Secondary poisoning 46 3.4 Risk characterisation 47 3.4.1 General 47 3.4.2 Local risk characterisation 53 3 CAS No. 557-05-1 & 91051-01-3 R074_0805_env 3.4.2.1 Aquatic compartment 53 3.4.2.1.1 STP effluent 53 3.4.2.1.2 Surface water (incl. sediment) 54 3.4.2.2 Terrestrial compartment 55 3.4.2.3 Atmospheric compartment 55 3.4.2.4 Secondary poisoning 55 3.4.3 Regional risk characterisation 58 APPENDIX 3.4 BIOAVAILABILITY CORRECTIONS 60 4 REFERENCES 62 4 CAS No. 557-05-1 & 91051-01-3 R074_0805_env 0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT CAS No. 557-05-1 and 91051-01-3 EINECS No. 209-151-9 and 293-049-4 IUPAC Name Zinc Distearate ( ) 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 (X) iii*) A conclusion applied to local scenarios in which the local scenario merits conclusion (ii) but where (possibly) due to high regional background concentrations a local risk cannot be excluded. LOCAL Conclusion (ii) is drawn for all local scenarios, including secondary poisoning, except those listed below. Conclusion iii) or iii*) is drawn for specified scenarios, because: STP • the PECSTP exceeds the PNECadd for microorganisms in a number of processing scenarios listed in Table 3.4.18 (conclusion iii). Surface water • the Clocaladd in water exceeds the PNECadd for surface water in a number of processing scenarios listed in Table 3.4.18 (conclusion iii). The Clocaladd/PNECadd ratio is between 0.5 and 1 for three processing scenarios listed in Table 3.4.18, indicating that a potential risk at local scale cannot be excluded due to the possible existence of high regional background concentrations (conclusion iii*). Sediment • for two production sites and a number of processing scenarios listed in Table 3.4.18 the Clocaladd in sediment exceeds the PNECadd (conclusion iii). For all remaining sites and scenarios listed in Table 3.4.18 the Clocaladd/PNECadd is < 1. However, a potential risk at local scale cannot be excluded due to possible high regional background concentrations (conclusion iii*). 5 CAS No. 557-05-1 & 91051-01-3 R074_0805_env Soil • for two processing scenarios listed in Table 3.4.18 the PECadd/PNECadd is above 1 (conclusion iii). REGIONAL The regional risk characterisation is discussed in the RAR on Zinc Metal. 6 CAS No. 557-05-1 & 91051-01-3 R074_0805_env 1 IDENTIFICATION OF THE SUBSTANCE CAS-No. 557-05-1 and 91051-01-31 EINECS No. 209-151-9 and 293-049-4 IUPAC name: zinc-distearate Synonyms: dibasic zinc stearate; octadecanoic acid, zinc salt; stearic acid, zinc salt; zinc octodecanoate; zinc stearate Molecular formula: Zn(C18H35O2)2 Structural formula: H C O O C H 35 17 Zn 17 35 O O Molecular weight: 632.3 Purity/impurities, additives Purity: > 97% w/w Impurity: stearic acid (CAS-No. 57-11-4) < 2% w/w palmitic acid (CAS-No. 57-10-3) < 2% w/w Additives: none Physico-chemical properties In table 1A the physico-chemical properties are summarized. Table 1A Physico-chemical properties of zinc stearate Property Result Comment Physical state solid Melting point 130ºC * Boiling point not applicable **** Relative density no data Vapour pressure not applicable **** Surface tension not applicable **** Water solubility 0.79 mg/l at 15°C *** ˜0.9 mg/l at 20°C 0.97 mg/l at 25°C Solubility in other solvents insoluble in alcohol and ether; * soluble in benzene Partition coefficient 1.2 ** 1 Commercially produced stearic acid is always a mixture of what chemically was called stearic acid (C18) and palmitic acid (C16). In practice, the description “Fatty acids, C16-18, zinc salts” registered under CAS no 91051- 01-3 is a more exact fit with commercial zinc stearate, but it is only listed on EINECS and Chemical Abstracts have never indexed a single entry to this number. Based on these considerations, the CAS no 91051-01-3 was added. 7 CAS No. 557-05-1 & 91051-01-3 R074_0805_env Property Result Comment n-octanol/water (log value) Flash point 277 ºC *** Flammability not flammable ***,**** Autoflammability temperature 421 ºC *** Explosive properties not explosive **** Oxidizing properties not oxidizing **** Granolometry mean diameter 19.79 µm ** * More than one apparently independent source. No methods are specified. ** One source. *** More than one apparently independent source. No methods are specified. Flash point must have been determined on melted material as it is irrelevant for solids. **** Conclusion based on theoretical and/or structural considerations. These data are mainly derived from The Merck Index (1989), CRC Handbook of Chemistry and Physics (1995), Sax’s Dangerous Properties of Industrial Materials (1984), Patty’s Industrial Hygiene and Toxicology (1981), Römpp Chemie Lexikon (1995), Gilliard (1999), and company information. For an extended description see HEDSET. Conclusion: Data on boiling point, vapour pressure, and surface tension were not provided. In view of the nature of the substance determination of these parameters is considered to be irrelevant. Information on flammability, explosive properties and oxidizing properties is not available. However, on theoretical considerations the compound is concluded to be not flammable, not explosive and not oxidizing. All other required physico-chemical data were submitted. None of these data is based on test results, substantiated with reports. However, the data are considered as sufficiently reliable to fulfil the Annex VIIA requirements. 1.1 ENVIRONMENTAL CLASSIFICATION AND LABELLING OF ZINC DISTEARATE 1.1.1 Introduction For a general introduction on the classification and labelling of metals, the reader is referred to sections 1.2.1 and 1.2.2 of the risk assessment report on zinc metal.
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