Debunking Human Health Risk, APPENDIX D - LBAMspray.com

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LIGHT BROWN APPLE MOTH ERADICATION PROJECT APPENDIX D DRAFT PEIR HUMAN HEALTH RISK ASSESSMENT D3.2.8.1 Environmental Fate and Chemistry D3.2.8.1.1 Physical and Chemical Properties of Active Ingredients The NoMate formulation is an off-white to light brown, viscous liquid with a mild, sweet odor. The liquid suspension disperses in water and has a pH between 7.5 and 8.5 (SBI 2008) (See Table D3-38). The molecular formulas and weights of the pheromones (E)-11-Tetradecen-1-yl Acetate and (E,E)-9,11-Tetradecadien-1-yl Acetate are C 16 H 30 O 2 (254.41g) and C 16 H 28 O 2 (252.4g), respectively. The corresponding CAS numbers are 33189-72-9 and 30562-09-5 (ISCA 2008). Table D3-38 Physico-Chemical Properties of NoMate ® LBAM MEC Parameter Value(s) and conditions Source: SBI 2008 Vapor pressure Not available Boiling point 212ºF Solubility in water Octanol/water partition coefficient Appearance Liquid suspension disperses in water Not available (aqueous mixture) Off-white to light brown viscous liquid pH 7.5-8.5 Dissociation characteristics Not available D3.2.8.1.2 Environmental Transformation and Degradation Product information developed by SBI indicates that NoMate will last no more that 40 days in the environment. Weather conditions can reportedly affect the persistence of this material (e.g., UV radiation, rainfall), but details are not available (SBI, undated). The NoMate pheromones are SCLPs, a category that, as previously noted, includes most of the known pheromones produced by insects in the order Lepidoptera (OECD 2002; USEPA 1995). The straight chain hydrocarbon structure (Figure D3-11), combined with an absence of environmentally persistent chemical substituents indicate that the SCLPs would not be expected to persist, accumulate, or concentrate in biota or in the environment. D3.2.8.1.3 Mammalian Toxicity METABOLISM As noted in previous sections on pheromone-containing products, the USEPA (1995) predicted that SCLPs would be metabolized either by -oxidation to yield a series of two-carbon compounds, or by glucuronide conjugation and subsequent urinary elimination. STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES The toxicity of SCLPs was initially reviewed in the discussion of HERCON. Additional information from symptom reports following the aerial application of two CheckMate formulations was provided in the discussion of CheckMate toxicity. D3-82 App D_HHRA_508.doc JULY 2009
SECTION 3 TOXICITY ASSESSMENT D3.2.9 Toxocity of NoMate ® LBAM MEC Analogous to the other LBAM pheromone-containing products discussed earlier, a series of acute toxicity studies were completed by independent toxicology laboratories in 2008, with results submitted to the USDA. The study results for NoMate are summarized in Table D3-39. A review of these data by the DPR (2008d) determined that the studies of acute oral, dermal, and inhalation toxicity, as well as those that evaluated primary eye and dermal irritation are acceptable to support use of the product, and indicate Toxicity Category IV hazards (the lowest toxicity rating). Results of the LLNA dermal sensitization study was also deemed acceptable; data from that study indicate that NoMate is a potential skin sensitizer. Results from the Buehler guinea pig dermal sensitization study–also considered to be acceptable by DPR - yielded no evidence to indicate that NoMate is a dermal sensitizer. Table D3-39 summarizes the findings of mammalian toxicity studies completed on NoMate. Table D3-39 Summary of Toxicity Data for NoMate ® LBAM MEC Author/ Study Material Toxicity EPA Hazard Rating Kuhn 2008. Stillmeadow 11766-08 Kuhn 2008. Stillmeadow 11767-08 Kuhn 2008 Stillmeadow 11922-08 Crutchfield 2008. Stillmeadow 11768- 08 Kuhn 2008 Stillmeadow 11771-08 Kuhn 2008 Stillmeadow 11769-08 Kuhn 2008. Stillmeadow 11770-08 NoMate ® LBAM MEC Acute Oral Toxicity Study (UDP) in Rats. NoMate ® LBAM MEC Acute Dermal Toxicity Study in Rats. NoMate ® LBAM MEC Skin Sensitization Study in Guinea Pigs NoMate ® LBAM MEC Acute Inhalation Toxicity Study in Rats. NoMate ® LBAM MEC Skin Sensitization: Local Lymph Node Assay in Mice NoMate ® LBAM MEC Acute Eye Irritation Study in Rabbits NoMate ® LBAM MEC Acute Dermal Irritation Study in Rabbits. Acute oral LD50 >5,000mg/kg. LD50 >5050mg/kg Did not elicit a sensitizing reaction in Guinea Pigs LC50 >2.12 mg/L Decreased activity & piloerection caused by exposure, but effects reversible and no longer evident by Day 6. No observable abnormalities from 4 hr exposure. Sensitizer Produced a stimulation index of > 3 in 2 test groups. No positive effects in eyes. Rated minimally irritating 72 hour observation period. Nonirritating; Very low toxicity; USEPA Category IV Very low toxicity; USEPA Category IV Negative. Not a skin sensitizer in this assay Very low toxicity; USEPA Category IV Positive. Evidence of potential for skin sensitization Very low toxicity; USEPA Category IV Very low toxicity; USEPA Category IV D3.2.9.1 Physical and Chemical Properties of Inert Ingredients As noted above, 80% of NoMate consists of inert ingredients (SBI 2008). Although the specific identity of these ingredients have not been made publicly available by the manufacturer, the inert ingredients in the formulation meet National Organic Program standards, and are on USEPA list 4A and 4B, indicating they are biodegradable (SBI 2008). BIO-TAC ® is an adhesive used to hold NoMate products on plant foliage. The principal functional agent of BIO-TAC ® is polybutene, which has been registered in the United States since 1960 for use as an insect control agent, since 1963 as a bird repellent, and since 1967 as a tree squirrel repellent. The mode of action of BIO-TAC ® is more to trap than repel (USEPA JULY 2009 App D_HHRA_508.doc D3-83
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A P P E N D I X D Human Health Risk
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Table of Contents Executive Summary
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TABLE OF CONTENTS D5.1.1 Toxicity V
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TABLE OF CONTENTS Table D3-33 Table
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TABLE OF CONTENTS Table D4-40 Table
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TABLE OF CONTENTS F I G U R E S Fig
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TABLE OF CONTENTS IARC Internationa
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Executive Summary This human health
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EXECUTIVE SUMMARY The HQs for both
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EXECUTIVE SUMMARY estimates of heal
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S E C T I O N D 1 Introduction The
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SECTION D1 INTRODUCTION In screenin
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S E C T I O N D 2 Problem Formulati
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SECTION D2 PROBLEM FORMULATION Spi
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SECTION D2 PROBLEM FORMULATION D2.3
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S E C T I O N D 3 Toxicity Assessme
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LIGHT BROWN APPLE MOTH ERADICATION
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