California Proposition 65 Exposure Assessment for Deflecto LLC Execumat Chair Mats UL Environment Report Number 100033735-1162663EA Prepared for: Deflecto LLC Joseph Regula 7035 E 86th St Indianapolis, IN 46250-0057 Prepared by: Eric Rosenblum Senior Toxicologist (916) 201-9475 Eric.Rosenblum@ul.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC EXECUTIVE SUMMARY This report conservatively estimates the lifetime average daily consumer exposure to the Proposition 65 listed volatile organic compounds (VOCs) 1,4 dioxane, acetaldehyde and 1methylethylbenzene (cumene) that could occur during anticipated use of the Deflecto Execumat Chair Mats within a private office, school classroom, and home residence.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC OVERVIEW AND INTRODUCTION California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) is intended to protect California citizens and the State's drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC ROUTES OF EXPOSURE TO VOCS RELEASED FROM THE EXECUMAT CHAIR MATS 1,4 dioxane, acetaldehyde, and cumene are classified as volatile organic chemicals (VOCs) and are present in air mostly in the gas phase. Therefore, the release of these VOCs from consumer products to indoor air results predominantly in exposure through inhalation of the gasphase.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC Equation 1 estimates the 1,4 dioxane, acetaldehyde and cumene concentrations in specific indoor environments based on measured emission rates (EFA), the emitting surface area (A) that is within the indoor environment, and the clean, outdoor, ventilation airflow rate (Q).
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC herein to represent the single-point discrete emission factors for use in Equation 1 for the Execumat Chair Mats over the product life. Flow Rates of Outdoor Ventilation Air Ventilation, as defined here, is the flow rate of clean outdoor air into an occupied indoor space or a building. Ventilation is the primary means of reducing the concentrations of air contaminants that are generated indoors.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC office may not be fully representative due to its omission of common area, it nevertheless is selected to represent the private office scenario in the model (Table 1) because of its more conservative lower airflow rate. School classroom scenario The standard school classroom scenario defined in CDPH Standard Method V1.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC 0.23 h-1 outdoor air change rate (CDPH 2017). For modeling the impacts of VOC emissions from indoor building products, perfect mixing of indoor air throughout the home is assumed. Emitting Surface Area of the Execumat Chair Mats The emitting surface area for the Execumat Chair Mats is based on client-provided information. The surface area of the Execumat Chair Mats is reported as 4.7 m2. Table 1.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC Following OEHHA guidance, the office and school classroom scenarios estimate that an exposed consumer inhales indoor air during a typical eight-hour work day and that the volume of inhaled air is 10 m3 (OEHHA, 2009, Table 2). Within the residential scenario, it is assumed that indoor air is mixed throughout the house and exposure is not limited to an 8-hour work day.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC Table 3. Lifetime Average Daily Doses (LADDs) Exposure 1,4 Dioxane LADD Acetaldehyde LADD Scenario (µg/day) (µg/day) Cumene LADD (µg/day) Private Office 0.4 2.0 1.0 School Classroom 0.04 0.2 0.1 Home Residence 0.2 1.1 0.5 NSRL 301 901 3.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC requirements. Higher ventilation rates are likely within each of these environments and would result in lower indoor air formaldehyde concentrations.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC REFERENCES ASHRAE, 2016a. ANSI/ASHRAE Standard 62.1-2016 - Ventilation for Acceptable Indoor Air Quality. Atlanta, GA. ASHRAE, 2016b. ANSI/ASHRAE Standard 62.2-2016 –Ventilation and Acceptable Indoor Air Quality in Residential Buildings. Atlanta, GA. ATSDR, 2010. Toxicological Profile for Styrene http://www.atsdr.cdc.gov/toxprofiles/tp53.pdf. Carter R.D., Zhang J.S., 2007.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC OEHHA, 2012. Technical Support Document for Exposure Assessment and Stochastic Analysis, FINAL, August 2012. 11 Residential and Worker Exposure Duration, Individual vs. Population Cancer Risk, and Evaluation of Short Term Projects Technical Support Document for Exposure Assessment and Stochastic Analysis, FINAL, August 2012. Available at .
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC 02/11/2019 Eric Rosenblum Ph.D.
Released by UL Environment Date Prepared: February 11, 2019 Report #: 1000339735-1162663EA ©2019 UL LLC APPENDIX A NSRL Report for Cumene CA Prop 65 Exposure Assessment Page 15 | 15
Proposition 65 Proposed No Significant Risk Level (NSRL) for Cumene (CAS# 9882-8) Prepared for: Deflecto LLC Joseph Regula 7035 E 86th St Indianapolis, IN 46250-0057 Prepared by: Eric Rosenblum Senior Toxicologist (916) 201-9475 Eric.Rosenblum@ul.
SUMMARY OF FINDINGS This report describes the derivation of a cancer potency estimate and NSRL for cumene (CAS# 98-82-8). To estimate the human cancer potency the linearized multistage model was applied to dose response data for increased incidence of lung tumors (alveolar/bronchiolar adenoma or carcinoma) in B6C3F1 mice exposed via inhalation. The potency derivation takes into account differences in respiration rate and body size between humans and experimental animals.
1 INTRODUCTION This report describes the derivation of an NSRL for cumene (CAS# 98-82-8). Cumene was listed on April 6, 2010 as a chemical known to the State of California to cause cancer under Proposition 65 (California Health and Safety Code 25249.5 et seq). Cumene is a high production volume chemical, primarily used as an intermediate in the production of phenol and acetone.
Exposure Level (ppm) Species/Sex Trend test1 Tumor Type 0 250 500 1,000 Lung (alveolar/bronchiolar carcinoma) 9/50 19/50* 32/50** 33/50** p < 0.001 Lung (alveolar/bronchiolar adenoma or carcinoma) 19/50 38/50** 42/50** 43/50** p < 0.001 Spleen (haemangiosarcoma) 0/50 0/50 0/49 4/50* NS All organs (haemangiosarcoma) 0/50 1/50 2/50 4/50 p = 0.002 Thyroid gland (follicular-cell adenoma) 0/50 0/50 0/49 3/50 p = 0.
Studies in rats Groups of 50 male and 50 female F344 rats were exposed to 0, 250, 500 or 1,000 ppm cumene (> 99% pure) for 6 hours plus T90 (12 minutes) per day on 5 days per week for 105 weeks.
3 APPROACH TO DOSE-RESPONSE ANALYSIS The mechanism(s) by which cumene might cause carcinogenic effects are not understood. It is unlikely that for any chemical a single mechanism or mode of action will fully explain the multiple biological alterations and toxicity pathways that can cause normal cells to transform and ultimately form a tumor. However, potential modes of action or molecular alterations have been identified.
Table 3: Animal and Human Cancer Potency Estimates for Cumene. Sex, strain, species Male B6C3F1 Mice Female B6C3F1 Mice Male F344 Rats Type of neoplasm Animal cancer potency (mg/kg-d)-1 Average body weight (kg) Human cancer potency (mg/kg-d)-1 Lung (alveolar/bronchiolar adenoma) 0.009 Lung (alveolar/bronchiolar carcinoma) 0.0122 Lung (alveolar/bronchiolar adenoma or carcinoma) 0.023 0.144 Lung (alveolar/bronchiolar adenoma) 0.0255 0.162 Lung (alveolar/bronchiolar carcinoma) 0.
NSRL= 10-5 x 70kg CSFhuman × 1000 µg/day (Equation 1) Thus, for a 70-kg adult, the intake level posing no significant cancer risk under Proposition 65 is developed using the human cancer potency estimate of 0.191 (mg/kg-d)-1 for cumene, based on mouse lung cancer data. Using Equation 1, and the conservative parameters described herein, the NSRL value of 3.7 μg/day was derived for cumene.
6 REFERENCES IARC 2013. Some Chemicals Present in Industrial and Consumer Products, Food and Drinkingwater. Volume 101 (2013). Available at < https://monographs.iarc.fr/iarc-monographs-onthe-evaluation-of-carcinogenic-risks-to-humans-15/> National Toxicology Program (2009). Toxicology and carcinogenesis studies of cumene (CAS No. 98–82–8) in F344/N rats and B6C3F1 mice (inhalation studies). Natl Toxicol Program Tech Rep Ser, 542: 1–200.
APPENDIX: METHODOLOGY USED TO DERIVE THE NSRL FOR CUMENE Modeling was based on the linearized multistage cancer model for the cumene cancer studies which showed both a significant dose-related trend in the data and had at least two doses with response levels in excess of the control were used for cancer slope factor modeling.
Table A1. Inhalation Lifetime Average Daily Dose Sex, strain, species Male B6C3F1 Mice Female B6C3F1 Mice Male F344/DuCrj (SPF) Rats Female F344/DuCrj (SPF) Rat Administered dose (mg/m3) 0, 1229, 2458, 4916 0, 614.5, 1229, 2458 Body weight (kg) 0.044 0.043 Lifetime Average daily dose (mg/kg-day) 0, 27.8, 55.6, 111.3 0, 22.4, 44.8, 89.7 0, 1229, 2458, 4916 0.410 0.0, 1278.3, 2556.7, 5113.4 0, 1229, 2458, 4916 0.251 0.0, 938.3, 1876.7, 3753.
REFERENCES Anderson EL and the U.S. Environmental Protection Agency Carcinogen Assessment Group (1983). Quantitative approaches in use to assess cancer risk. Risk Analysis 3:277-295. IARC 2013. Some Chemicals Present in Industrial and Consumer Products, Food and Drinkingwater. Volume 101 (2013). Available at < https://monographs.iarc.fr/iarc-monographs-onthe-evaluation-of-carcinogenic-risks-to-humans-15/> 02/11/2019 Eric Rosenblum Ph.D.
