ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON NITROBENZENE Committee for Risk Assessment RAC Annex 1 Background document to the Opinion proposing harmonised classification and labelling at Community level of Nitrobenzene ECHA/RAC/CLH-O-0000002350-87-01/A1 EC number: 202-716-0 CAS number: 98-95-3 Adopted 3 February 2012 1 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON NITROBENZENE CONTENTS JUSTIFICATION .........................................................................................................................................................8 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES .................................8 1.1 Name and other identifiers of the substance ...................................................................................................8 1.2 Composition of the substance.........................................................................................................................8 1.3 Physico-chemical properties...........................................................................................................................9 2 MANUFACTURE AND USES..............................................................................................................................10 2.1 Manufacture....................................................................................................................................................10 2.2 Identified uses.................................................................................................................................................10 3 CLASSIFICATION AND LABELLING ...............................................................................................................11 3.1 Classification in Annex I of Directive 67/548/EEC........................................................................................11 4 ENVIRONMENTAL FATE PROPERTIES...........................................................................................................12 4.1 Degradation ....................................................................................................................................................12 4.1.1 Stability ...............................................................................................................................................12 4.1.2 Biodegradation ....................................................................................................................................12 4.1.2.1 Biodegradation estimation.....................................................................................................12 4.1.2.2 Screening tests.......................................................................................................................12 4.1.2.3 Simulation tests .....................................................................................................................13 4.1.3 Summary and discussion of persistence ..............................................................................................13 4.2 Environmental distribution .............................................................................................................................13 4.3 Bioaccumulation.............................................................................................................................................13 4.3.1 Aquatic bioaccumulation.....................................................................................................................13 4.3.1.1 Bioaccumulation estimation ..................................................................................................13 4.3.1.2 Measured bioaccumulation data............................................................................................13 4.3.2 Terrestrial bioaccumulation.................................................................................................................14 4.3.3 Summary and discussion of bioaccumulation .....................................................................................15 4.4 Secondary poisoning.......................................................................................................................................15 5 HUMAN HEALTH HAZARD ASSESSMENT.....................................................................................................15 5.1 Toxicokinetics (absorption, metabolism, distribution and elimination) .........................................................15 5.2 Acute toxicity .................................................................................................................................................15 5.2.1 Acute toxicity: oral..............................................................................................................................16 5.2.1.1 Human data ...........................................................................................................................16 5.2.1.2 Animal data ...........................................................................................................................18 5.2.2 Acute toxicity: inhalation ....................................................................................................................20 5.2.2.1 Human data ...........................................................................................................................20 5.2.2.2 Animal data ...........................................................................................................................20 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON NITROBENZENE 5.2.3 Acute toxicity: dermal.........................................................................................................................24 5.2.3.1 Human data ...........................................................................................................................24 5.2.3.2 Animal data ...........................................................................................................................25 5.2.4 Acute toxicity: other routes .................................................................................................................26 5.2.4.1 Comparison With criteria ......................................................................................................26 5.3 Irritation..........................................................................................................................................................29 5.3.1 Skin .....................................................................................................................................................29 5.3.2 Eye.......................................................................................................................................................29 5.3.3 Respiratory tract ..................................................................................................................................30 5.3.4 Summary and discussion of irritation..................................................................................................30 5.3.5 Comparison with classification criteria ...............................................................................................31 5.3.6 Conclusions on classification and labelling.........................................................................................31 5.4 Corrosivity......................................................................................................................................................31 5.5 Sensitisation....................................................................................................................................................32 5.5.1 Skin .....................................................................................................................................................32 5.5.2 Respiratory system ..............................................................................................................................32 5.5.3 Summary and discussion of sensitisation ............................................................................................33 5.5.4 Comparison with classification criteria : .............................................................................................33 5.5.5 Conclusions on classification and labelling.........................................................................................33 5.6 Repeated dose toxicity....................................................................................................................................33 5.6.1 Repeated dose toxicity: oral ................................................................................................................33 5.6.2 Repeated dose toxicity: inhalation.......................................................................................................44 5.6.3 Repeated dose toxicity: dermal ...........................................................................................................58 5.6.4 Other relevant information ..................................................................................................................63 5.6.5 Summary and comparison with classification criteria.........................................................................64 5.6.5.1 Comparison with classification criteria .................................................................................65 5.6.6 Conclusions on classification