SCHER is requested to comment and give an opinion on the health risks to consumers that result from exposure to organostannic compounds from the various nonfood consumer product sources of exposure or from other environmental sources BIOCIDES OTHERS Mostly TBT Wood preservatives Nonallergenic pillows Insoles for shoes Padding of cyclic shorts Spray for treatment of athlete’s foot Polyurethane foam Incorporation in various polymers, e.g. Carpet, flooring, textile coating, feather and downs
INTEGRATED RISK ASSESSMENT Case study - organotin Tuesday December 2011 Herman Autrup HISTORICAL USE - ORGANOTIN COMPOUNDS Moth-proofing agent 1920 Bactericides and fungicides – Dibutyl and tributyl tin Marine antifouling paints 1960 TBT banned from 1/1-2008 imposex mud-snail 1970 SCHER is requested to comment and give an opinion on the health risks to consumers that result from exposure to organostannic compounds from the various non-food consumer product sources of exposure or from other environmental sources AGGEGATE EXPOSURE AND MULTIPLE PATHWAYS ORGANOTIN COMPOUNDS Dibutyltin Tributyltin Dibutyl oxide (DBOT) Dioctyltin Trioctyltin Diphenyltin Triphenyltin MAJOR USES OF ORGANOTIN Tri-substituted Biocide in anti-fouling paints Pesticide Biocide – others Synthesis Mono/di-substituted PVC stabilisers Catalysts Glass coating Total in EU = 19000 t/yr BIOCIDES - OTHERS Mostly TBT Wood preservatives Non-allergenic pillows Insoles for shoes Padding of cyclic shorts Spray for treatment of athlete’s foot Polyurethane foam Incorporation in various polymers, e.g Carpet, flooring, textile coating, feather and downs PVC PROCESSING Flexible PVC – phthalates, adipates Rigid PVC - OT >BT>MT Food-contact material Bottles Tamper-proof packs Credit cards Construction material – window profiles Pipes and mouldings CATALYST - SILICONE DBT – 0.01-01% Automotive – gaskets, lubricants, additives Constrution – sealants Personal care – Diapers Others: greaseproof paper, medical devises ORGANOTIN in HOUSE DUST Kannan et al (2010) Arch Environ Contam Toxicol 58: 901- RISK ASSESSMENT Hazard characterization Exposure characterization Risk characterisation 10 QUANTITY OF ORGANOTIN Many different compounds – different MW potency Amount of organotin compound under consideration – unit of exposure The amount of tin present 22 PADDLING POOL – DBT & TBT Concentration in PVC 583 mg Sn/kg Migration 2.49 ug Sn/dm2 % stabiliser migrated 0.01% Concentation in water 1.33 ug Sn/l 23 PADDLING POOL Worst case exposure - child Oral: Water intake: 0.33 l 20 days/year Exposure: 1.33 ug x 0.33 x 20 /360/8 = 0.003 ug Sn/kg bw/day Dermal uptake less than 0.001 % % TDI 24 CHILDREN – TOYS, PACIFIERS Mouthing of toys – mouthing time and leach rate DBT – dominant stabilizer in flexible PVC “active” leach rate Contact area Mouthing time Intake (10x10/6) Exposure (17/8) = = = = = 10 ng/cm2/hr 10 cm2 10 min/day 17 ng/day ng/kg bw/day 25 FOOD INTAKE - Adult kg bw/day Food contaminants – fish Food contact material high 0.071 ug Sn median 0.007 ug Sn high 0.022 ug Sn median 0.004 ug Sn Baking paper (silicone coated) worst case 0.720 ug Sn 26 UPTAKE VIA ENVIRONMENT Adult Sum ug Sn/kg bw / day Model: EUSES2 (www.ecb.jrc.it) Situations: Production 0.353 Stabiliser in PVC Processing 0.609 Catalyst 0.058 Wood preservation – treatment 1.273 Regional intake 0.005 Major intake is leaf crops 69 % 27 INDOOR AIR AS A SOURCE inhalation Emission from migration/abrasion from room with PVC flooring and wall coverings Assume 1% emissions are airborne Based on continuous occupancy of the room Floor: area 10 m2, PVC (2 mm thick) 28 kg (0.48 mg/day) Wall: area 25 m2, PVC (1 mm) Ventilation : Concentration in air: 35 kg (0.58 mg/day) 300 m3/day 0.48+0.58/300 = 0.035 ug Sn/m3 Adult: 0.008 ug Sn/kg bw/day Child: 0.026 ug Sn/ kg bw/day 28 INTAKE DUST Assumption: 200 mg/day Max conc: (DBT) 3.11 mg Sn/ kg Max intake: 0.62 ug Sn/day Assumption: 100% release of organotin from matrix Adult intake: 0.016 ug Sn/kg bw/day Child intake: 0.117 ug/ Sn/kg bw/day 29 OT IN FOOD CONTACT MATERIAL Function: Migration : Stabiliser in plastics Aqueous ( 3% acetic acid, 10% ethanol) Fatty (iso-octane, 95% ethanol) Food consumption: 200 g fatty food day (adult) Bakery products 23%, dairy 20%, meat 19% Adults intake: 0.104 ug/kg/day, 30 EXPOSURE ESTIMATION FROM TEXTILE Cart Concentration in the product on a weight basis Wart Weight of the product (layer that contains tin) n Contact frequency t avering period Upot = Cart x Wart x n / t 31 Exposure in mg/person/day Product group DBT TBT DOT Sanitary pad Nd Nd 0.046 Nd Nd 0.271 Tampons 0.011 Nd 0.0066 Napkins Nd Nd 0.14 T-shirt 0.00022 0.022 0.029 pantiliners Exposure microgram/kg BW/day Product group DBT TBT DOT Sanitary pad Nd Nd 0.77 pantiliners Nd Nd 4.5 Tampons 0.18 Nd Nd Napkins Nd Nd 28 T-shirt 0.003 0.31 0.41 32 HUMAN – INTERNAL DOSE Liver Denmark Japan Poland 1.1 – 33.0 ng Sn/g 14 – 96 2.4 – 11 Greenpeace – blood Danish Deutch 120 ng Sn/g 320 ng Sn/g 33 RISK CHARACTERISATION Child - group TDI 0.1 ug Sn/kg bw Source Sum % TDI Fish/fishery products 0.284 284 Via environment 5.092 5092 Household dust 0.117 117 T-shirts 0.189 189 Padding pool 0.003 Mouthing toys 0.002 PVC sandels 0.033 33 Baking paper /Cookies 2.325 2325 PVC food packing 0.054 54 34 RISK MANAGEMENT Cease production of biocides in wood treatment and consumer products e.g., foot spray, shoes insoles, non-allergenic pillows Cease use of OT in baking paper Recommendation of fish consumption – amount and type Monte Carlo simulation of exposures for children (8 kg) 30% population % TDI 104 50% population 159 95% population 846 Risk reduction: fish, via environment, indoor air dust, tshirt, cookies 35 CONCLUSION Many different organotin compounds are in use NOAEL determined on Immunotoxicity Not all OT er equally toxic – DOT less Group TDI is used for all organotin compounds based upon weight of tin Several sources of exposure – fish/fishery products being a major source Risk reduction is required – especially for children 36 ... devises ORGANOTIN in HOUSE DUST Kannan et al (2010) Arch Environ Contam Toxicol 58: 901- RISK ASSESSMENT Hazard characterization Exposure characterization Risk characterisation 10 ORGANOTIN. .. AGGEGATE EXPOSURE AND MULTIPLE PATHWAYS ORGANOTIN COMPOUNDS Dibutyltin Tributyltin Dibutyl oxide (DBOT) Dioctyltin Trioctyltin Diphenyltin Triphenyltin MAJOR USES OF ORGANOTIN Tri-substituted Biocide... food) 20 POPULATION EXPOSURE ASSESSMENT CONSUMER PRODUCTS FOOD INTAKE UPTAKE VIA THE LOCAL ENVIRONMENT Route of exposure: dermal, oral and inhalation 21 QUANTITY OF ORGANOTIN Many different compounds