Annex XV report PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 Substance Name(s): 1,6,7,8,9,14,15,16,17,17,18,18- Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”TM) [covering any of its individual anti- and syn-isomers or any combination thereof] EC Number(s): 236-948-9; -; - CAS Number(s): 13560-89-9; 135821-74-8; 135821-03-3 Submitted by: United Kingdom Date: 29 August 2017 ANNEX XV – IDENTIFICATION OF DECHLORANE PLUS AS SVHC CONTENTS PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57..........................................................................................IV PART I ...............................................................................................................................................1 JUSTIFICATION ..................................................................................................................................1 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES ...................................2 1.1 Name and other identifiers of the substance................................................................................2 1.2 Composition of the substance ........................................................................................................2 1.3 Identity and composition of degradation products/metabolites relevant for the SVHC assessment ....................................................................................................................................3 1.4 Identity and composition of structurally related substances (used in a benchmarking or read- across approach) ...........................................................................................................................7 1.5 Physicochemical properties ..........................................................................................................12 2. HARMONISED CLASSIFICATION AND LABELLING..........................................................................16 3. ENVIRONMENTAL FATE PROPERTIES ...........................................................................................17 3.1 Degradation ..................................................................................................................................17 3.1.1 Abiotic degradation ...............................................................................................................17 3.1.2 Biodegradation ......................................................................................................................18 3.1.3 Other data..............................................................................................................................23 3.1.4 Summary and discussion of degradation...............................................................................23 3.2 Environmental distribution ...........................................................................................................24 3.2.1 Adsorption/desorption...........................................................................................................24 3.2.2 Volatilisation..........................................................................................................................24 3.2.3 Distribution modelling ...........................................................................................................25 3.3 Data indicating potential for long-range transport.......................................................................26 3.4 Bioaccumulation ...........................................................................................................................30 3.4.1 Bioaccumulation in aquatic organisms (pelagic & sediment organisms) ..............................30 3.4.2 Bioaccumulation in terrestrial organisms (soil dwelling organisms, vertebrates) .................44 3.4.4 Summary and discussion of bioaccumulation........................................................................52 4. HUMAN HEALTH HAZARD ASSESSMENT ......................................................................................55 4.1 Toxicokinetics (absorption, metabolism, distribution and elimination) .......................................55 5. ENVIRONMENTAL HAZARD ASSESSMENT ....................................................................................57 6. CONCLUSIONS ON THE SVHC PROPERTIES ...................................................................................58 6.1 CMR assessment ...........................................................................................................................58 6.2 PBT and vPvB assessment.............................................................................................................58 6.2.1 Assessment of PBT/vPvB properties.......................................................................................58 6.2.1.3.1 Fulfilment of the T criterion based on human health classification .................................63 6.2.1.3.2 Fulfilment of the T criterion based on ecotoxicity data ................................................63 6.2.2 Summary and overall conclusions on the PBT and vPvB properties.......................................65 PART II ............................................................................................................................................67 7. REGISTRATION AND C&L NOTIFICATION STATUS .........................................................................67 7.1 Registration status.......................................................................................................................67 7.2 CLP notification status ..................................................................................................................67 8. TOTAL TONNAGE OF THE SUBSTANCE..........................................................................................67 i ANNEX XV – IDENTIFICATION OF DECHLORANE PLUS AS SVHC 9. INFORMATION ON USES OF THE SUBSTANCE...............................................................................68 Quantities ...........................................................................................................................................71 10. INFORMATION ON STRUCTURE OF THE SUPPLY CHAIN..............................................................73 11. ADDITIONAL INFORMATION......................................................................................................73 11.1 Substances with similar hazard and use profiles on the Candidate List .....................................73 11.2 Alternatives.................................................................................................................................73 11.3 Existing EU legislation .................................................................................................................73 11.4 Previous assessments by other authorities ................................................................................73 REFERENCES FOR MAIN REPORT AND APPENDICES .........................................................................75 LIST OF APPENDICES........................................................................................................................90 ii ANNEX XV – IDENTIFICATION OF DECHLORANE PLUS AS SVHC TABLES Table 1: Substance identity of 1,6,7,8,9,14,15,16,17,17,18,18- dodecachloropentacyclo-[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene, Dechlorane Plus [1]. ....................................................................................................2 Table 2: Substance identity of (1S,2S,5S,6S,9R,10R,13R,14R)- 1,6,7,8,9,14,15,16,17,17,18,18- dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene, anti- (or exo ) Dechlorane Plus [2, see structural formula below].........................................3 Table 3: Substance identity of (1S,2S,5R,6R,9S,10S,13R,14R)- 1,6,7,8,9,14,15,16,17,17,18,18- dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene, syn- (or endo ) Dechlorane Plus [3, , see structural formula below] .......................................4 Table 4: Constituents other than impurities/additives ......................................2 Table 5: Identity of 1,3-DPMA ......................................................................4 Table 6: Identity of 1,5-DPMA ......................................................................5 Table 7: Identity of DP-1Cl...........................................................................6 Table 8: Identity of DP-2Cl...........................................................................6 Table 9: Identity of selected analogues..........................................................8 Table 10: Overview of physicochemical properties .........................................12 Table 11: Summary of predicted and measured degradation data for Dechlorane Plus analogues..........................................................................................21 Table 12: Input properties used in assessing long range transport potential....28 Table 13: Depuration half-lives and BCF values for chemicals meeting the vB criteria ....................................................................................................39 Table 14: Registration status ......................................................................67 Table 15: CLP notifications .........................................................................67