Phthalates: Science, Policy & Perception (and emerging alternatives) Tony Kingsbury ‐ VP Cardno ChemRisk September 17, 2013 Safer Consumer Products Pre ‐ Summit Workshop
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Outline – for the Next 30 minutes Background Perception Policy Science Conclusions
Background - What are Phthalates ? They are actually, phthalate esters , or esters of phthalic acid and are mainly used as plasticizers (substances added to PVC to increase their flexibility, transparency, durability, and longevity of this plastic). Eight common Phthalates dibutyl phthalate (DBP), Diisobutyl phthalate (DIBP), Butyl benzyl phthalate (BBP), phthalic acid Di- n -pently phthalate (DnPP), generic phthalate Di(2-ethylhexyl) phthalate (DEHP), Di- n -octyl phthalate (DnOP), Diisononyl phthalate (DINP), 1,2-diisodecyl ester (DIDP) More than 25 commercially available Phthalates & historically more than 300 plasticizers have been used over the past 80 yrs DEHP
Background - Uses Phthalates are additives used with other materials to impart desired properties. The addition of Phthalates to PVC as a Plasticizer is the most common use. Phthalates, can be found in many products and sectors including: toys, automobiles, packaging, cleaning materials, cosmetics, building materials, flooring, medical devices, clothing, and household furnishings. Largest Use: Wire & Cable Toys make up < 2% Source: www.ecpi.org
Background – Why So Many Phthalates ? With more than 25 commercially available Phthalates… one must ask … Why So Many Phthalates ? Different sizes and configurations of the Alcohols (R units) gives different properties: - Flexibility - Clarity - Low temperature performance - High temperature performance - Weather / Sun resistance - Kink resistance - etc.
Perception
Perception = BAD Why? Perfect Storm Wide spread use in Consumer Products Not chemically bound to structure = Ability to Migrate Widely found in the environment and people Studies show links to health effects… endocrine disruption, etc. Individual products commonly lumped together as “phthalates” Mothers turn against phthalates because of use in mouthing toys
Policy > 1999, European Union (EU) banned the use of six phthalates in the production of children’s toys … DINP, DEHP, DBP, BBP, DIDP & DnOP > 2008, US via Consumer Products Safety Commission followed EU in banning DINP, DEHP, DBP, BBP, DIDP, and DnOP in Children’s articles > Europe Classifies “low” phthalates (3-6 carbons in backbone) as Category 1B Reproductive Agents: Thus they may not be used in toys, childcare items and cosmetics. This same group of phthalates, which includes DBP, BBP, DIBP and DEHP, are recognized as "substances of very high concern" under REACH and are subject to authorization. > ECHA review of DINP and DIDP (toy restriction follow up): Concluded that “existing restriction is justified” but “no further risk reduction measures are needed” > Denmark national phthalate strategy published, 2013 > Denmark considers further bans despite ECHA opinion - Currently Delayed > Australia (NICNAS) DINP review – no additional controls needed (included consideration of cumulative exposures)
Science – Oral Acute Toxicity Oral LD50 (mg/kg) in Rats for Phthalates and Alternatives ‐ Log Scale 53,700 31,400 29,100 29,700 25,000 10,000 10,000 6,300 5,600 5,000 5,000 3,200 3,200 3,000 2,330 1,000 763 The Bigger the Bar, the Less Toxic it Is 300 100 Banned Phthalates Phthalate Alternatives Reference Points Sugar & Salt
Science – Bio-Concentration Bioconcentration Factors for Phthalates and Alternatives 5800 6000 5000 The Smaller the Bar, the Less Bioaccumulative it Is 4000 3000 2000 1700 970 960 1000 810 610 700 430 230 189 76 19 13 0 DINP DEHP DBP BBP DIDP DnOP DINCH DOTP ATBC TXIB TOTM DEHA HBCD Banned Phthalates Alternatives
Science - Developmental Toxicity Developmental Toxicity in Rats: NOAEL mg/kg bw/d 1200 1000 1000 The Bigger the Bar, the Less Toxic it Is 800 600 Banned Phthalates Alternatives 400 350 250 200 200 170 200 158 150 100 50 50 4.8 0 DINP DEHP DBP BBP DIDP DnOP DINCH DOTP ATBC TXIB TOTM DEHA
Science – No. of Carbons Matters Most Problematic Phthalates fall into a Specific Size Range Source: BASF
Conclusions Phthalate Perception … the train has left the station… the Genie is Not Going Back in the Bottle… Phthalates will continue to suffer poor public perception… don’t repeat mistakes with alternatives Phthalates – Perception will drive scrutiny and policy proposals – Science will moderate Phthalates – Not all created Equal – Understand which is being used, why and potential for life cycle exposure … # of carbons in backbone critical Phthalate Alternatives – Not all Created Equal – don’t assume they are an improvement over phthalates - Understand which is being used, why and potential for life cycle exposure… Expect calls for greater Transparency and Information for all plasticizers
Questions? WHILE THE DESCRIPTIONS, DATA AND INFORMATION CONTAINED HEREIN ARE PRESENTED IN GOOD FAITH AND BELIEVED TO BE ACCURATE, THEY ARE PROVIDED FOR GUIDANCE ONLY. BECAUSE MANY FACTORS MAY AFFECT DATA QUALITY, PROCESSING OR APPLICATION/USE, CARDNO CHEMRISK RECOMMENDS THAT THE READER MAKE TESTS TO DETERMINE THE RELIABILITY OF A PRODUCT OR DATA IN QUESTION PRIOR TO USE. NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS, DESCRIPTIONS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. 9/17/13 15
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