Toxicological Points of Departure/ Levels of Concern Sample Clauses

Toxicological Points of Departure/ Levels of Concern. Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a RfD—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see xxxx://xxx.xxx.xxx/ pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for triflusulfuron-methyl used for human risk assessment is shown in Table 1 of this unit. Table 1—Summary of Toxicological Doses and Endpoints for Triflusulfuron-Methyl for Use in Human Health Risk Assessment Exposure/scenario Point of departure and uncertainty/safety fac- tors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (Females 13–49 years of age and General population, including infants and children). Not required. An appropriate endpoint for this risk assessment was not identified. Chronic dietary (All populations) ...................... NOAEL= 2.44 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.0244 mg/kg/day. cPAD = 0.0244 mg/kg/ day. Chronic oral toxicity/carcinogenicity in the rat LOAEL = 30.6 mg/kg/day based on de- creased body weight/weight gain, hematological changes (primarily males) and increased interstitial cell hyperplasia (males). Cancer (Oral, dermal, inhalation) ..................... Classification: Possible Human Carcinogen (Group C, 1986 Cancer Guidelines), based on in- creased incidence of testicular interstitial cell adenomas in rats. The RfD is considered ade- quately protective of these effects. FQPA SF ...
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Related to Toxicological Points of Departure/ Levels of Concern

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