PMID- 24859074 OWN - NLM STAT- MEDLINE DCOM- 20150309 LR - 20140714 IS - 1096-0295 (Electronic) IS - 0273-2300 (Linking) VI - 69 IP - 3 DP - 2014 Aug TI - Risk Assessment of residual monomer migrating from acrylic polymers and causing Allergic Contact Dermatitis during normal handling and use. PG - 467-75 LID - S0273-2300(14)00095-6 [pii] LID - 10.1016/j.yrtph.2014.05.013 [doi] AB - Acrylic, Poly Methyl Methacrylate (PMMA) based polymers are found in many industrial, professional and consumer products and are of low toxicity, but do contain very low levels of residual monomers and process chemicals that can leach out during handling and use. Methyl Methacrylate, the principle monomer is of low toxicity, but is a recognized weak skin sensitizer. The risk of induction of contact allergy in consumers was determined using a method based upon the Exposure-based Quantitative Risk Assessment approach developed for fragrance ingredients. The No Expected Sensitization Induction Level (NESIL) was based on the threshold to induction of sensitization (EC3) in the Local Lymph Node Assay (LLNA) since no Human Repeat Insult Patch Test (HRIPT) data were available. Categorical estimation of Consumer Exposure Level was substituted with a worst case assumption based upon the quantitative determination of MMA monomer migration into simulants. Application of default and Chemical-Specific Adjustment Factors results in a Risk Characterization Ratio (RCR) of 10,000 and a high Margin of Safety for induction of Allergic Contact Dermatitis (ACD) in consumers handling polymers under conservative exposure conditions. Although there are no data available to derive a RCR for elicitation of ACD it is likely to be lower than that for induction. CI - Crown Copyright (c) 2014. Published by Elsevier Inc. All rights reserved. FAU - Pemberton, Mark A AU - Pemberton MA AD - Systox Ltd, Wilmslow, Cheshire, UK. Electronic address: markpemberton@systox.com. FAU - Lohmann, Barbara S AU - Lohmann BS AD - CFCS-Consult GmbH, Essen, Germany. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20140520 PL - Netherlands TA - Regul Toxicol Pharmacol JT - Regulatory toxicology and pharmacology : RTP JID - 8214983 RN - 0 (Allergens) RN - 0 (Methylmethacrylates) RN - 0 (Polymers) SB - IM MH - Allergens/adverse effects/chemistry MH - Dermatitis, Allergic Contact/*etiology MH - Environmental Exposure/*analysis MH - Humans MH - Local Lymph Node Assay MH - Methylmethacrylates/*adverse effects/*chemistry MH - Patch Tests/methods MH - Polymers/*adverse effects/*chemistry MH - Risk Assessment MH - Skin/drug effects MH - Skin Tests/methods OTO - NOTNLM OT - Acrylic polymer OT - Allergic Contact Dermatitis OT - Consumer exposure OT - Methyl Methacrylate OT - Migration OT - PMMA OT - Residual monomer OT - Risk Assessment OT - Skin sensitization EDAT- 2014/05/27 06:00 MHDA- 2015/03/10 06:00 CRDT- 2014/05/27 06:00 PHST- 2014/04/02 00:00 [received] PHST- 2014/05/07 00:00 [revised] PHST- 2014/05/08 00:00 [accepted] PHST- 2014/05/27 06:00 [entrez] PHST- 2014/05/27 06:00 [pubmed] PHST- 2015/03/10 06:00 [medline] AID - S0273-2300(14)00095-6 [pii] AID - 10.1016/j.yrtph.2014.05.013 [doi] PST - ppublish SO - Regul Toxicol Pharmacol. 2014 Aug;69(3):467-75. doi: 10.1016/j.yrtph.2014.05.013. Epub 2014 May 20.