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Annex XV Report

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Annex XV Report Substance Name: 2-(2H-benzotriazol-2- yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) EC Number: 253-037-1 CAS Number: 36437-37-3 SUPPORT DOCUMENT FOR IDENTIFICATION OF 2-(2H-BENZOTRIAZOL-2-YL)-4-(TERT- BUTYL)-6-(SEC-BUTYL)PHENOL (UV-350) AS A SUBSTANCE OF VERY HIGH CONCERN BECAUSE OF ITS VPVB (ARTICLE 57 E) PROPERTIES SVHC SUPPORT DOCUMENT - UV-350 CONTENTS PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 ..........................................................10 PART I ................................................................................................................ ERROR! BOOKMARK NOT DEFINED. JUSTIFICATION ................................................................................................................................................12 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES ............12 1.1. Name and other identifiers of the substance ..................................................................................... 12 1.2. Composition of the substance .................................................................................................................. 13 1.3. Identity and composition of structurally related substances (used in a grouping or read-across approach) ................................................................................................................. 14 1.4. Physicochemical properties ....................................................................................................................... 18 2. HARMONISED CLASSIFICATION AND LABELLING .....................................................................19 3. ENVIRONMENTAL FATE PROPERTIES ...............................................................................................19 3.1. Degradation .................................................................................................................................................... 19 3.1.1. Abiotic degradation .............................................................................................................................. 19 3.1.2. Biodegradation ....................................................................................................................................... 20 3.1.3. Field data ................................................................................................................................................. 40 3.1.4. Summary and discussion of degradation..................................................................................... 46 3.2. Environmental distribution ........................................................................................................................ 49 3.2.1. Adsorption/desorption......................................................................................................................... 49 3.2.2. Volatilisation ........................................................................................................................................... 49 3.2.3. Distribution modelling ......................................................................................................................... 50 3.2.4. Field data ................................................................................................................................................. 51 3.2.5. Summary and discussion of environmental distribution ........................................................ 51 3.3. Data indicating potential for long-range transport .......................................................................... 51 3.4. Bioaccumulation ............................................................................................................................................ 51 3.4.1. Bioaccumulation in aquatic organisms (pelagic and sediment organisms) .................... 51 3.4.2. Field data ................................................................................................................................................. 53 3.4.3. Summary and discussion of bioaccumulation ............................................................................ 54 4. HUMAN HEALTH HAZARD ASSESSMENT ..........................................................................................54 5. ENVIRONMENTAL HAZARD ASSESSMENT .......................................................................................54 6. CONCLUSIONS ON THE SVHC PROPERTIES ...................................................................................54 6.1. CMR assessment ........................................................................................................................................... 54 6.2. PBT and vPvB assessment ......................................................................................................................... 54 6.2.1. Assessment of PBT/vPvB properties .............................................................................................. 54 6.2.2. Summary and overall conclusions on the PBT and vPvB properties ................................. 56 REFERENCES FOR PART I .............................................................................................................................57 ANNEX I - ADDITIONAL INFORMATION ON UV-350 ......................................................................61 ANNEX I.A – ANALYSIS OF QSAR APPLICATION: PREDICTION OF POTENTIAL PERSISTENT PROPERTIES IN THE ENVIRONMENT FOR UV-350 ..............................................61 ANNEX I.B – DEGRADATION KINETIC MODELLING OF TWO W/S-SIMULATION STUDIES ...............................................................................................................................................................71 ANNEX I.C – ANALYSIS OF QSAR APPLICATION: PREDICTION OF LOG KOW FOR UV- 2 (156) SVHC SUPPORT DOCUMENT - UV-350 327 AND UV-350 ............................................................................................................................................ 110 ANNEX I.D – ANALYSIS OF QSAR APPLICATION: PREDICTION OF LOG KOC FOR UV- 327 AND UV-350 ............................................................................................................................................ 117 ANNEX I.E – MONITORING STUDY RESULTS FOR PHENOLIC BENZOTRIAZOLES .......... 126 3 (156) SVHC SUPPORT DOCUMENT - UV-350 TABLES Table 1: Substance identity .......................................................................................... 12 Table 2: Constituents ................................................................................................... 13 Table 3: Structurally related substance identity of UV-320 ................................................ 14 Table 4: Structurally related substance identity of UV-327 ................................................ 15 Table 5: Structurally related substance identity of UV-328 ................................................ 17 Table 6: Overview of physicochemical properties ............................................................. 18 Table 7: Results of BIOWIN 2, 3, and 6 predictions of biodegradability for UV-350 .............. 20 Table 8: Results of the Degradation Screening Tests on UV-320, UV-327 and UV-328 .......... 20 Table 9: Overview of available physico-chemical data for UV-320, UV-327, UV-328, UV-350, EC 407-000-3, and metabolite M1 ................................................................................. 24 Table 10: Fragments to be considered for qualitative assessment of degradation times; substances are ordered by decreasing degradability (cf. above) ........................................ 27 Table 11: Detailed conditions for the water/sediment simulation test (aerobic) ................... 28 Table 12: Detailed information on the field trial sites and treatments according to Lai et al. (2014) ....................................................................................................................... 37 Table 13: Overview of reported DT50-values (dissipation in the field) by Lai et al. (2014) ..... 38 Table 14: Summary of dissipation half-lives of M1 for water and sediment under different test conditions (DT50 values for 20 °C) ................................................................................. 40 Table 15: Concentrations of phenolic benzotriazoles in sediment cores (in µg/g) according to Lopez-Avila and Hites (1980). ....................................................................................... 41 Table 16: Concentration profile of UV-327 based on a graphical evaluation from Reddy et al. (2000) and expected concentration based on a DegT50 of 180 d at the different depths ........ 43 Table 17: Concentrations of phenolic benzotriazoles in sediment cores from Narragansett Bay (concentrations taken from a graph) .............................................................................. 44 Table 18: Comparison of concentrations from literature after and during the respective production periods ....................................................................................................... 45 Table 19: Results adsorption behaviour predictions of UV-350........................................... 49 Table 20: Distribution of UV-350 according to Mackay Level III Fugacity Model (estimation with standard parameters as provided by EPI Suite v4.10) ...................................................... 50 Table 21: Distribution of UV-350 in sewage treatment
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