Ashes (residues), plant Information on Dossier according to REACH Regulation Ing. Pavel Donát Belchatów October 2011
Substance Name: Ashes (residues), plant (Biomass Ash) EC number: 297-049-5 CAS number: 93333-79-0 Registration number: 01-2119531232-54-XXXX Registration Company ČEZ Energetické produkty, s.r.o. successfully registered substance Ashes (residues), plant in November, the 16 th, 2010 Lead Registrant is ČEZ, a.s. Company ČEZ Energetické produkty, s.r.o. is acting on behalf on the Lead Registrant as Third Party Representative for communication with members of the SIEF
Samples and testing Sample for testing: Mixture of following samples Classical combustion Fly ash from straw combustion Slag from straw combustion Fluidized bed combustion Fly ash from wooden chips combustion Bottom ash from wooden chips combustion Testing started in February 2010 Testing finished in February 2011 - Subchronic oral toxicity test (repeated 90-day toxicity study) update of dossier
Analyzes wooden chips combustion TDK power plant (CEZ Group) Fly ash Parameter Unit October 2007 May 2008 July 2009 SiO 2 % 17,17 34,02 23,12 Al 2 O 3 % 4,09 7,60 13,48 Fe 2 O 3 % 1,53 2,43 3,47 TiO 2 % 0,41 0,62 0,59 CaO % 14,10 8,99 27,39 MgO % 2,07 1,77 2,05 K 2 O % 23,60 13,05 6,91 Na 2 O % 0,49 0,81 7,3 P 2 O 5 % 5,06 4,26 3,49 LOI 950 C % 9,35 5,00 2,28 High variation of parameters wide ranges in SIP
Biomass combustion Fly ash composition Fuel SiO 2 Al 2 O 3 Fe 2 O 3 CaO K 2 O Lignite 43,7 24,7 10,2 6,8 3,2 Straw 56,2 1,2 1,2 6,5 23,7 Miscanthus (African grass) 70,6 1,1 1,0 7,5 12,8 Beech wood 15,2 2,7 3,8 37,3 8,6 Willow tree 50,2 2,0 3,5 23,8 12,0 Wooden chips - TDK 39,8 6,3 1,8 14,9 12,6 Straw - ECJH 49,4 5,2 1,8 7,4 17,5 Wooden chips - EHO 47,7 12,1 3,7 19,9 3,1
Substance Identity Profile (SIP) Chemical composition Mineralogical composition LOI less than 10% Content of compounds of very high concern is limited to be lower than 0,1% in sum
SIP production process Fluidized bed combustion temperatures usually from 800 to appr. 950 C Classical combustion a range of temperatures from 1100 up to 1700 C Biomass fly ash - carried along with the flue gas, leaves the furnace in the upper part of the boiler captured in electrostatic precipitators mechanically by separation in fabric filters Biomass bottom ash - collected at the bottom part of the boiler and represents the coarser part of the ash Biomass slag - collected at the bottom part of the boiler represents the coarser part of the ash
Registration dossier Physico-chemical properties of the substance REACH Directive ES 1907/2006 Test Method Test Result Report No. Study No. 7.2. Melting point 7.4. Relative density 7.7. Water solubility 7.14 Particle size distribution EU A.1 / OECD 102 EU A.3 / OECD 109 EU A.6 / OECD 105 ISO 13320-1 Definite value of melting of the test substance could not be determined in the tested temperature range from 35 C to 640 C Relative density of the test substance is 1,647 Uncertainty of determination was estimated to 0,097 The water solubility of the test substance is 34,0 g/l at the temperature of 20 C Median 19.37 µm Average 45.77 µm cumulative 90% Average 7.80 µm cumulative 10% 10-111 3/10/41 10-121 3/10/43 10-122 3/10/46 10-155 3/10/56
Registration dossier Toxicological information REACH Directive ES 1907/2006 Test Method Test Result Report No. Study No. 8.1.1 Acute toxicity: Dermal irritation / corrosion EU B.4 / OECD 404 No skin irritation was caused by 4-hour exposure to substance 1060 3/10/4 8.1.3 In vitro Skin Corrosion: Human Skin Model Test OECD 431 The test substance was non corrosive in In vitro Skin Corrosion Test on EpiDerm TM tissues 10-108 3/10/4AC 8.1.4 In vitro Skin Irritation OECD draft The test substance was 65,9% of negative control average value (i.e. viability is>50%). Substance was nonirritating in EpiDerm TM model 10-110 3/10/4AI
Registration dossier Toxicological information 8.2. Acute toxicity: Eye irritation / corrosion EU B.5 / OECD 405 Substance was slightly irritating for the eye of rabbit, but all sings of irritation disappeared till 7 th day after exposure. 10-92 3/10/5I 8.2.3 In vitro Eye Irritation OECD draft The test substance was non irritating for EpiOcular TM tissues. 10-130 3/10/5A 8.3. Skin sensitisation Local lymph node assay(nonradioactive endpoint) EU B.42 / OECD 429 Substance elicited negative response in LLNA test 1088 3/10/6 8.4. Mutagenicity Reverse mutation test using bacteria EU B.13/14 / OECD 471 Substance was nonmutagenic for all the Salmonella typhimurium and Ascherichia coli 1085 3/10/12
Registration dossier Toxicological information 8.5. Acute toxicity oral acute toxic class method EU B.1 tris / OECD 423 LD50> 2000 mg/kg Substance is not toxic for harmful (female rat) 1046 3/10/1 8.6.2 Subchronic oral toxicity test (repeated 90- day toxicity study) EU B.26 / OECD 408 On the basis of the results given above the following the dose levels 160, 400 and 1000 mg/kg/day were chosen for this study 11-2 3/10/8 8.5. Acute toxicity (dermal) EU B.3 / OECD 402 EU B.2 LD50> 2000 mg/kg Substance is not toxic nor harmful (rat) 10-293 3/10/2 8.8. Toxicokinetics Assessment of Toxicokinetics behavior 11-15 3/10/8-1
Registration dossier Ecotoxicological information 9.1.2 Algae inhibition test 9.1.3 Acute toxicity for fish EU C.3 / OECD 201 EU C.1 / OECD 203 72 hour E b L 50 >100 mg*l -1 72 hour E r L 50 >100 mg*l -1 72 hour NOELR b =100 mg*l -1 72 hour NOELR r =100 mg*l -1 Test substance is not assigned to any toxicity categories. 10-171 3/10/23 Substance is not assigned to any of quoted toxicity categories. 10-135 3/10/21 9.1.4 Biodegradation: Activated Sludge Respiration Inhibition Test EU C.11 / OECD 209 EC 50 >1000 mg.l -1 10-127 3/10/30 9.1.5 Acute toxicity for Daphnia EU C.2 / OECD 202 Substance is not assigned to any of quoted toxicity categories. 10-134 3/10/22
Identified Uses Use as a fertilizer Use in ash containing construction materials and castings Formulation and repacking Distribution Production of Ash
Chemical Safety Report According to REACH Annex XIII the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT) and very persistent and very bioaccumulative substances (vpvb) do not apply to inorganic substances and are not applicable for the tested substance Biomass ash is neither PBT nor vpvb substance
Exposure and Risk Assessment In the comprehensive chemical safety assessment performed according to Human Health Hazard Assessment, Physico-chemical Hazard Assessment, Environmental Hazard Assessment and PBT and vpvb Assessment no hazard was identified According to Annex I (section 5) an Exposure Assessment is not required Consequently, all identified uses of the substance are assessed as safe for the environment and human health
Data sharing Joint submission registrants 5 Costs for Data sharing granting Letter of Access (LOA) LOA - access to full study reports, robust study summaries and Chemical Safety Report 20 000 Share of administrative cost 2 000 Compensation fee for late access 2 000 000 Total sum 24
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