Survey and health assessment of preservatives in toys Survey of chemical substances in consumer products no. 124, 2014 Title: Editing: Survey and health assessment of preservatives in Pia Brunn Poulsen, FORCE Technology toysSurvey and health assessment of preservatives Rasmus Nielsen, FORCE Technology in toys Published by: The Danish Environmental Protection Agency Strandgade 29 1401 Copenhagen K Denmark www.mst.dk/english Year: ISBN no. 2014 978-87-93178-07-6 Disclaimer: When the occasion arises, the Danish Environmental Protection Agency will publish reports and papers concerning research and development projects within the environmental sector, financed by study grants provided by the Danish Environmental Protection Agency. It should be noted that such publications do not necessarily reflect the position or opinion of the Danish Environmental Protection Agency. However, publication does indicate that, in the opinion of the Danish Environmental Protection Agency, the content represents an important contribution to the debate surrounding Danish environmental policy. Sources must be acknowledged. 2 Survey and health assessment of preservatives in toys Contents Foreword .................................................................................................................. 6 Conclusion and Summary .......................................................................................... 7 1. Introduction ....................................................................................................... 9 1.1 Background ............................................................................................................................ 9 1.2 Purpose ................................................................................................................................... 9 1.3 Definition of toys being examined in this project ................................................................. 9 2. Legislation and labelling schemes ..................................................................... 10 2.1 Legislation ............................................................................................................................. 10 2.1.1 Classification and labelling .................................................................................... 10 2.1.2 The Cosmetic Products Directive .......................................................................... 10 2.1.3 Toys – standards .................................................................................................... 11 2.2 Labelling schemes ................................................................................................................. 13 2.2.1 The A label from the Joint Council of Creative & Hobby Materials (FFFH) .................................................................................................................... 13 2.2.2 The Swan Label ...................................................................................................... 17 2.2.3 The Flower .............................................................................................................. 18 3. Survey of the market ........................................................................................ 19 3.1 Approach for the survey ....................................................................................................... 19 3.2 Results from the survey: General information from contact to various organisations etc. ................................................................................................................. 20 3.3 Product-specific results from the survey ............................................................................ 20 3.3.1 Modelling clay ........................................................................................................ 21 3.3.2 Hobby paint ........................................................................................................... 23 3.3.3 Finger paint ........................................................................................................... 26 3.3.4 Window paint/glass paint..................................................................................... 28 3.3.5 Face paint and make-up ....................................................................................... 30 3.3.6 Glue ........................................................................................................................ 33 3.3.7 Slime ...................................................................................................................... 35 3.3.8 Soap bubbles ..........................................................................................................37 3.3.9 Summery: Which preservatives are used in toys? ............................................... 38 4. Hazard assessment (screening) of the preservatives ......................................... 40 4.1 Parabens ................................................................................................................................ 41 4.1.1 Methylparaben (CAS 99-76-3) .............................................................................. 41 4.1.2 Ethylparaben (CAS 120-47-8) .............................................................................. 42 4.1.3 Propylparaben (CAS 94-13-3) .............................................................................. 42 4.1.4 Butylparaben (CAS 94-26-8) ................................................................................ 42 4.1.5 Isobutylparaben (CAS 4247-02-3) ....................................................................... 43 4.2 2-phenoxyethanol (CAS 122-99-6)...................................................................................... 43 4.3 Sodium benzoate (CAS 532-32-1) ....................................................................................... 44 4.4 DMDM Hydantoin (CAS 6440-58-0) ................................................................................. 44 4.5 Potassium sorbate (CAS 24634-61-5/590-00-1) ................................................................ 45 4.6 Iodopropynyl butylcarbamat (IPBC) (CAS 55406-53-6) ................................................... 45 Survey and health assessment of preservatives in toys 3 4.7 Bronopol (CAS 52-51-7) ....................................................................................................... 46 4.8 1,2-benzisothiazol-3(2H)-on (BIT) (CAS 2634-33-5) ........................................................ 47 4.9 Kathon (CAS 55965-84-9) ................................................................................................... 47 4.9.1 2-methyl-2H-isothiazol-3-one (MI) (CAS 2682-20-4) ....................................... 48 4.9.2 5-chloro-2-methyl-2H-isothizol-3-one (MCI) (CAS 26172-55-4) ....................... 49 4.10 Dichlorobenzyl alcohol (CAS 1777-82-8) ............................................................................ 49 4.11 Benzyl alcohol (CAS 100-51-6) ............................................................................................ 50 4.12 Formaldehyde (CAS 50-00-0)............................................................................................. 50 4.13 2-phenylethanol (CAS 60-12-8) ........................................................................................... 51 4.14 Benzyl benzoate (CAS 120-51-4) ......................................................................................... 52 4.15 2-amino-2-methylpropanol (CAS 124-68-5) ...................................................................... 52 4.16 Denatonium benzoate (CAS 3734-33-6) ............................................................................. 52 4.17 Diazolidinylureum (CAS 78491-02-8) ................................................................................ 53 4.18 Polyaminopropyl biguanide (CAS 32289-58-0 / 70170-61-5 / 133029-32-0 / 28757-47-3) .......................................................................................................................... 53 4.19 Sodium hydroxymethyl glycinate (CAS 70161-44-3) ......................................................... 54 4.20 Selection of preservatives .................................................................................................... 54 5. Exposure scenarios .......................................................................................... 57 5.1 Formulas of calculation ........................................................................................................ 57 5.1.1 Dermal exposure for a substance with skin application ...................................... 58 5.1.2 Dermal exposure for a substance migrating from a product .............................. 58 5.1.3 Oral exposure if the substance is swallowed ........................................................ 59 5.2 Clarification of relevant exposure parameters ................................................................... 59 5.2.1 Amount of product used (Qprod) ........................................................................... 59 5.2.2 Weight fraction of substance in the product (Fcprod) ............................................ 61 5.2.3 Migration rate of substance in the product (Fcmigr) .............................................. 61 5.2.4 Contact duration (Tcontact) and frequency (n) of exposure .................................... 61 5.2.5 Body weight (BW) .................................................................................................