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Evaluation of New Scientific Evidence Concerning DINP and DIDP

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Evaluation of New Scientific Evidence Concerning DINP and DIDP Evaluation of new scientific evidence concerning DINP and DIDP In relation to entry 52 of Annex XVII to REACH Regulation (EC) No 1907/2006 Final review report annankatu 18, p.o. box 400, fi-00121 helsinki, finland | echa.europa.eu 2 Evaluation of new scientific evidence concerning DINP and DIDP LEGAL NOTICE The views or positions expressed in this report do not necessarily represent in legal terms the official position of the European Chemicals Agency. The European Chemicals Agency assumes no responsibility or liability for any errors or inaccuracies that may appear. Title: Evaluation of new scientific evidence concerning DINP and DIDP in relation to entry 52 of Annex XVII to REACH Regulation (EC) No 1907/2006 Reference: ECHA-13-R-07-EN ISBN: 978-92-9244-001-5 Publ.date: August 2013 Language: EN © European Chemicals Agency, 2013 Cover page © European Chemicals Agency Reproduction is authorised provided the source is fully acknowledged in the form “Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written notification is given to the ECHA Communication Unit ([email protected]). If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: http://echa.europa.eu/about/contact_en.asp European Chemicals Agency Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland Evaluation of new scientific evidence concerning DINP and DIDP 3 IUPAC NAME EC NUMBER CAS NUMBER DINP 1,2- 271-090-9 68515-48-0 benzenedicarboxylic acid, di-C8-10- branched alkyl esters, C9-rich di-“isononyl” phthalate 249-079-5 28553-12-0 DIDP 1,2- 271-091-4 68515-49-1 benzenedicarboxylic acid, di-C9-11- branched alkyl esters, C10-rich di-“isodecyl” phthalate 247-977-1 26761-40-0 4 Evaluation of new scientific evidence concerning DINP and DIDP Table of Contents 1. CONCLUSIONS .................................................................................................. 7 2. BACKGROUND ................................................................................................... 9 2.1 History of the entry 52 ....................................................................................... 10 2.2 First phase of the review: 6 phthalates ................................................................. 12 2.3 Second phase of the review: DINP and DIDP ......................................................... 13 3. SCOPE OF THE REVIEW ..................................................................................... 14 3.1 New information on human health hazard and exposure ......................................... 15 3.2 Targeting and format of the report ....................................................................... 16 4. INFORMATION ON HAZARD AND RISK .............................................................. 17 4.1 Identity of the substances and physical and chemical properties .............................. 17 4.1.1 Name and other identifiers of the substances ................................................................. 17 4.1.1.1 DINP ...................................................................................................................................... 17 4.1.1.2 DIDP ...................................................................................................................................... 18 4.1.2 Composition of the substances ..................................................................................... 19 4.1.2.1 DINP ...................................................................................................................................... 19 4.1.2.2 DIDP ...................................................................................................................................... 19 4.1.3 Physicochemical properties .......................................................................................... 20 4.2 Manufacture and uses ........................................................................................ 21 4.2.1 Manufacture, import and export ................................................................................... 21 4.2.2 DINP and DIDP in imported articles ............................................................................... 22 4.2.3 Consumption of DINP and DIDP by use category ............................................................. 24 4.2.4 Concentration of DINP and DIDP in articles .................................................................... 28 4.2.5 Uses advised against by the registrants ......................................................................... 28 4.3 Classification and labelling .................................................................................. 29 4.3.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) ... 29 4.3.2 Classification and labelling in classification and labelling inventory/Industry’s self classification(s) and labelling ......................................................................................................... 29 4.4 Human health hazard assessment ........................................................................ 32 4.4.1 Toxicokinetics (absorption, metabolism, distribution and elimination) ................................. 33 4.4.1.1 DINP ...................................................................................................................................... 33 4.4.1.1.1 EU Risk Assessment conclusion ............................................................................................ 33 4.4.1.1.2 Risk assessments from other international organizations and bodies ........................................ 34 4.4.1.1.3 New studies/description key studies ..................................................................................... 34 4.4.1.2 DIDP ...................................................................................................................................... 37 4.4.1.2.1 EU Risk Assessment conclusion ............................................................................................ 37 4.4.1.2.2 Risk assessments from other international organizations and bodies ........................................ 38 4.4.1.2.3 New studies/description key studies ..................................................................................... 38 4.4.1.3 Toxicokinetic information from an analogue substance, DEHP ........................................................ 40 4.4.1.4 Discussion .............................................................................................................................. 41 4.4.1.5 Conclusions ............................................................................................................................ 43 4.4.2 Acute toxicity ............................................................................................................. 43 4.4.2.1 DINP ...................................................................................................................................... 43 4.4.2.2 DIDP ...................................................................................................................................... 43 4.4.3 Irritation ................................................................................................................... 43 4.4.3.1 DINP ...................................................................................................................................... 43 4.4.3.2 DIDP ...................................................................................................................................... 44 4.4.4 Corrosivity ................................................................................................................ 44 4.4.5 Sensitisation .............................................................................................................. 44 4.4.5.1 EU risk assessment conclusion -DINP ......................................................................................... 44 4.4.5.2 EU risk assessment conclusion -DIDP ......................................................................................... 44 Evaluation of new scientific evidence concerning DINP and DIDP 5 4.4.5.3 Risk assessments from other international organizations and bodies .............................................. 46 4.4.5.4 New studies ............................................................................................................................ 47 4.4.5.5 Conclusion .............................................................................................................................. 56 4.4.6 Repeated dosed toxicity .............................................................................................. 56 4.4.6.1 DINP ...................................................................................................................................... 56 4.4.6.1.1 EU Risk Assessment conclusion ............................................................................................ 56 4.4.6.1.2 Risk assessments from other international organizations and bodies ........................................ 61 4.4.6.1.3 New studies/description key studies ..................................................................................... 65 4.4.6.1.4 Discussion .......................................................................................................................
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