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CIR EXPERT PANEL MEETING JUNE 8-9, 2020 Distributed for Comment Only -- Do Not Cite Or Quote Data Supplement MI CIR EXPERT PANEL MEETING JUNE 8-9, 2020 Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: Expert Panel for Cosmetic Ingredient Safety Members and Liaisons From: Jinqiu Zhu, PhD, DABT, ERT, Toxicologist, CIR Christina L. Burnett, Senior Scientific Writer/Analyst, CIR Date: May 29, 2020 Subject: Draft Amended Safety Assessment on Methylisothiazolinone – Wave 3 Since the Draft Amended Safety Assessment on Methylisothiazolinone (MI) was prepared by CIR staff, the US Environmental Protection Agency (EPA) has released a draft risk assessment for Methylchloroisothiazolinone (MCI) and MI,1 and a hazard characterization of isothiazolinones2 (MI062020wave3_epa1 and MI062020wave3_epa2, respectively). The documents have been reviewed by CIR staff and the following notes have been prepared for the Panel’s review. 1. The Panel reopened MI based, in-part, upon the adverse effects on the inhalation of humidifier disinfectants containing MCI/MI. The following summaries of inhalation data from the EPA reports are relatively new:1 • Residential and occupational handler risks were assessed using the MI maximum application rate of 400 ppm by weight. The inhalation margins of exposure (MOEs) for residential aerosol exposures range from 15 to 14,000 and are not of concern because they are greater than the level of concern (LOC) of 10. The inhalation MOE of 1.0 for the residential handler applying paint, however, is of toxicological concern (Table 20 in MI062020wave3_epa1). The MOE for post application exposure to the MI vapors is 1.9 on the day after painting and is of concern; the exposures to the paint vapors decline over time, and, by day 12 after painting, the MOE is 11 which is not of concern (Table 21 in MI062020wave3_epa1). • The inhalation MOEs for occupational aerosol exposures range from 4.4 to 5,800. The MOE of 4.4 for the airless spray application of paint is of concern because it is less than the LOC of 10 (Table 28 in MI062020wave3_epa1). The occupational inhalation MOE for MI vapors emitted from MI preserved paints is 0.5 and is of concern (Table 30 in MI062020wave3_epa1). • The inhalation route of exposure, to be aggregated for the residential use of MI-treated cleaners, includes the co- occurrence of a handler applying cleaners using a trigger spray & wipe, plus mopping floors. Table 26 presents the aggregate inhalation MOE of 170 for the daily application of the cleaners, which is not of toxicological concern (above the LOC of 10). The EPA also assessed incidental oral and dermal post-application exposures for MI in textiles and floor cleaners. Though these assessments are not relevant to cosmetic exposures, the following results from the cumulative risk characterization are interesting: • Because the toxic effects seen with the dermal exposure pathway differ from the effects seen with the oral pathway, the dermal exposures are not additive to the effects resulting from dietary exposure; therefore, these would not be aggregated in a cumulative risk assessment.2 In other words, each of the three routes of exposure (oral, dermal, and inhalation) are based on different toxicological endpoints; thus, exposures across routes are not aggregated.1 • The EPA has determined that although the isothiazolinones share some chemical and/or toxicological characteristics (e.g., chemical structure or apical endpoint), the toxicological database does not support a testable hypothesis for a common mechanism of action. No further cumulative evaluation is necessary for the isothiazolinones.1 __________________________________________________________________________________________ 1620 L St NW, Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote 2. The novelty of the case study in the documents is that the EPA has used the Artificial Neural Network (ANN) model that combines multiple non-animal methods to predict local lymph node assay (LLNA) EC3 values to extrapolate dermal risk for the currently registered isothiazolinones, as part of registration review. The data generated from in vitro and in chemico assays have been used to derive concentrations of the isothiazolinones that can induce skin sensitization (concentrations that can cause sensitization in persons not previously exposed). In addition, the EPA has determined that the in vitro and in chemico studies provide information that is more reliable and relevant to humans than the information obtained with the LLNA.2 This use of the in vitro and in chemico assays, along with the ANN-based defined approach, are the first use of such information in regulatory risk assessment. 3. In line with the findings in the Draft Amended Report, the EPA concluded that isothiazolinones do not present a mutagenic or carcinogenic concern, and developmental and reproductive toxicity is not observed. The available isothiazolinone databases indicate that these chemicals are not neurotoxic. However, all the isothiazolinones are positive skin sensitizers. References 1. US Environmental Protection Agency (EPA). Registration Review Draft Risk Assessment for 2-methyl-4-isothiazolin-3- one (MIT) and 5-chloro-2-methyl-4-isothiazolin-3-one (CMIT). Washington, DC April 6, 2020. Pages 94. (Accessed May 27, 2020.) 2. US Environmental Protection Agency (EPA). Hazard Characterization of Isothiazolinones in Support of FIFRA Registration Review. Washington, DC April 6, 2020. Pages 84. (Accessed May 27, 2020.) __________________________________________________________________________________________ 1620 L St NW, Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote MIT and CMIT Human Health and Ecological Risk Assessment DP 455497, 455498, 456952 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEMORANDUM Date: April 6, 2020 SUBJECT: Registration Review Draft Risk Assessment for 2-methyl-4-isothiazolin-3-one (MIT) and 5-chloro-2-methyl-4-isothiasolin-3-one (CMIT) PC Codes: 107103 and 107104 DP Barcode: 455497,455498, 456952 Decision No.: 558140, 455498, 558144 Docket No: EPA-HQ-OPP-2013-0605 Regulatory Action: Registration Review Case No.: 3092 Risk Assessment Type: Draft Risk Assessment (DRA) CAS No.: 2682-20-4, 26172-55-4 TO: Stephen Savage, Chemical Review Manager Rick Fehir, Ph.D., Team Lead Rose Kyprianou, Branch Chief Branch Regulatory Management Branch II Antimicrobial Division (7510P) Office of Pesticide Programs FROM: James Breithaupt, Agronomist Timothy Dole, Industrial Hygienist Kathryn Korthauer, Biologist Timothy McMahon, Ph.D., Senior Toxicologist Danielle McShan, Ph.D., Chemist Siroos Mostaghimi, Ph.D., Senior Scientist Risk Assessment and Science Support Branch Antimicrobial Division (7510P) THROUGH: Melissa Panger, Ph.D., Branch Chief Laura Parsons, Associate Branch Chief Timothy Leighton, Senior Human Health Scientist Diana Hsieh, Ecological Risk Assessment Process Leader Judy Facey, Ph.D., Human Health Risk Assessment Process Leader Risk Assessment and Science Support Branch This document provides the preliminary human health and ecological risk assessment conducted in support of 2-methyl-4-isothiazolin-3-one (MIT) and 5- chloro-2-methyl-4-isothiasolin-3-one (CMIT) for registration review. Page 1 of 94 Distributed for Comment Only -- Do Not Cite or Quote MIT and CMIT Human Health and Ecological Risk Assessment DP 455497, 455498, 456952 Table of Contents EXECUTIVE SUMMARY .................................................................................................... 5 INTRODUCTION .................................................................................................................. 8 2.1 Case Overview ................................................................................................................. 8 2.2 Chemical Ingredient Profile ............................................................................................. 8 2.3 Use Patterns ...................................................................................................................... 9 Active Ingredient Registered Products and Uses ...................................................... 9 Inert Ingredient Registered Products and Uses ....................................................... 11 Usage Information .................................................................................................. 11 2.4 Label Recommendations ................................................................................................ 12 HUMAN HEALTH RISK ASSESSMENT .......................................................................... 12 3.1 Data Deficiencies ........................................................................................................... 12 3.2 Tolerance Considerations ............................................................................................... 12 3.3 Anticipated Exposure Pathways ..................................................................................... 12 3.4 Hazard Characterization and Dose-Response Assessment ............................................ 12 Summary of Toxicological Effects ......................................................................... 12 Evidence of Sensitivity/Susceptibility in the Developing or Young Animal ........
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