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(MUSK XYLENE) CAS No: 81-15-2 EINECS No: 201-329-4

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(MUSK XYLENE) CAS No: 81-15-2 EINECS No: 201-329-4 Institute for Health and Consumer Protection European Chemicals Bureau I-21020 Ispra (VA) Italy 5-TERT-BUTYL-2,4,6-TRINITRO-M-XYLENE (MUSK XYLENE) CAS No: 81-15-2 EINECS No: 201-329-4 Summary Risk Assessment Report 2005 Special Publication I.05.15 5-TERT-BUTYL-2,4,6-TRINITRO-M-XYLENE (MUSK XYLENE) CAS No: 81-15-2 EINECS No: 201-329-4 SUMMARY RISK ASSESSMENT REPORT Final report, 2005 The Netherlands Rapporteur for the risk assessment of 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 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 Organisation for Applied Scientific Research (TNO) and the National Institute for Public Health and the Environment (RIVM), by order of the rapporteur. Contact point: Chemical Substances Bureau P.O. Box 1 3720 BA Bilthoven The Netherlands Date of Last Literature Search: 2003 Review of report by MS Technical Experts finalised: 2002 Final report: 2005 © European Communities, 2005 PREFACE This report provides a summary, with conclusions, of the risk assessment report of the substance 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) that has been prepared by The Netherlands in the context of Council Regulation (EEC) No. 793/93 on the evaluation and control of existing substances. For detailed information on the risk assessment principles and procedures followed, the underlying data and the literature references the reader is referred to the comprehensive Final Risk Assessment Report (Final RAR) that can be obtained from the European Chemicals Bureau1. The Final RAR should be used for citation purposes rather than this present Summary Report. 1 European Chemicals Bureau – Existing Chemicals – http://ecb.jrc.it III CONTENTS 1 GENERAL SUBSTANCE INFORMATION ............................................................................................ 3 1.1 IDENTIFICATION OF THE SUBSTANCE.................................................................................... 3 1.2 PURITY/IMPURITIES, ADDITIVES .............................................................................................. 3 1.3 PHYSICO-CHEMICAL PROPERTIES........................................................................................... 3 1.4 CLASSIFICATION AND LABELLING .......................................................................................... 5 2 GENERAL INFORMATION ON EXPOSURE ....................................................................................... 6 3 ENVIRONMENT.......................................................................................................................................... 7 3.1 ENVIRONMENTAL EXPOSURE .................................................................................................... 7 3.1.1 General........................................................................................................................................ 7 3.1.2 PECs at processing and private use............................................................................................ 8 3.2 EFFECTS ASSESSMENT .................................................................................................................. 8 3.2.1 Aquatic compartment (incl. sediment)....................................................................................... 8 3.2.2 Terrestrial compartment ............................................................................................................. 9 3.2.3 Atmosphere................................................................................................................................. 9 3.2.4 Non compartment specific effects relevant to the food chain ................................................... 9 3.3 RISK CHARACTERISATION.......................................................................................................... 9 3.3.1 General........................................................................................................................................ 9 3.3.2 Aquatic compartment (incl. sediment)....................................................................................... 10 3.3.3 Terrestrial compartment ............................................................................................................. 10 3.3.4 Atmosphere................................................................................................................................. 10 3.3.5 Non compartment specific effects relevant to the food chain ................................................... 10 3.3.6 Metabolites of musk xylene ....................................................................................................... 11 3.3.7 PBT assessment .......................................................................................................................... 11 4 HUMAN HEALTH....................................................................................................................................... 12 4.1 HUMAN HEALTH (TOXICITY)...................................................................................................... 12 4.1.1 Exposure assessment .................................................................................................................. 12 4.1.2 Effects assessment ...................................................................................................................... 15 4.1.3 Risk characterisation................................................................................................................... 21 4.1.3.1 Workers ........................................................................................................................ 21 4.1.3.2 Consumers .................................................................................................................... 25 4.1.3.3 Humans exposed via the environment......................................................................... 26 4.1.3.4 Combined exposure...................................................................................................... 27 4.2 HUMAN HEALTH (PHYSICO-CHEMICAL PROPERTIES)..................................................... 29 5 RESULTS ...................................................................................................................................................... 30 5.1 ENVIRONMENT................................................................................................................................. 30 5.2 HUMAN HEALTH.............................................................................................................................. 30 5.2.1 Human health (toxicity).............................................................................................................. 30 5.2.2 Human health (risks from physico-chemical properties)........................................................... 30 1 TABLES Table 1.1 Physico-chemical properties of musk xylene. ................................................................................. 4 Table 3.1 Local PEC/PNEC ratios. .................................................................................................................. 9 Table 4.1 Conclusions of the occupational exposure assessment.................................................................... 14 Table 4.2 Occupational risk assessment for repeated-dose toxicity of musk xylene...................................... 23 Table 4.3 Occupational risk assessment for carcinogenic effects of musk xylene ......................................... 24 Table 4.4 Occupational risk assessment for reproductive effects of musk xylene.......................................... 25 2 1 GENERAL SUBSTANCE INFORMATION 1.1 IDENTIFICATION OF THE SUBSTANCE CAS Number: 81-15-2 EINECS Number: 201-329-4 IUPAC Name: 1-tert-butyl-3,5-dimethyl-2,4,6-trinitrobenzen Synonyms: 5-tert-butyl-2,4,6-trinitro-m-xylene, musk xylene, musk xylol Molecular weight: 297.3 Molecular formula: C12H15N3O6 Structural formula: NO2 NO2 NO2 1.2 PURITY/IMPURITIES, ADDITIVES Purity: >99% Impurities: unidentified impurities, <1% Additives: none 1.3 PHYSICO-CHEMICAL PROPERTIES In Table 1.1 the physico-chemical properties of musk xylene are summarised 3 EU RISK ASSESSMENT – 5-TERT-BUTYL-2,4,6-TRINITRO-M-XYLENE SUMMARY, 2005 Table 1.1 Physico-chemical properties of musk xylene. Property Result Comment Physical state solid, powder Melting point 112-114°C #, * Boiling point not applicable ** Relative density 0.77, 0.85 g/cm3 * Recommended: 0.77 g/cm3 $ Vapour pressure 0.0097 Pa at 40°C, 0.47 Pa at 74.5°C * 0.00003 Pa (calculated) at 20°C Recommended: 0.00003 Pa at 20°C Surface tension not applicable & Water solubility 0.15 mg/l (measured) * 0.49 mg/l (calculated) Recommended: 0.15 mg/l Solubility in other solvents - - Partition coefficient 4.9, 4.4, 3.4 (measured) * n-octanol/water (log value) 3.7, 4.45 (calculated) Recommended: 4.9 $ Flash point 168°C * Flammability flammable * Autoflammability temperature 305-341°C * Explosive properties initiated by shock and heat, * propagation depends on packaging size and characteristics, and is limited in typical transport packaging Oxidising properties not oxidising *** Granulometry 100% v/v < 100 µm * 21.8% v/v < 10 µm 14.4% v/v < 4 µm
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