Regulatory decision making and the need for and the use of exposure data on pesticides determined to be teratogenic in test animals

Abstract

Major efforts have been made in the development of a system that takes the reviewer step-by-step by the use of the developmental toxicity and exposure assessment data to a recommended risk assessment and risk management position. Thereupon a set of regulatory decisions can be arrived at that are backed up by sound scientific analysis. Examples of pesticides that have been found to be teratogenic in animal testing are provided to demonstrate the process of use of exposure data in making risk assessment and management decisions.

In Vitro Studies of Cellular and Molecular Developmental Toxicity of Adjuvants, Herbicides, and Fungicides Commonly Used in Red River Valley, Minnesota

“…A number of pesticides have been found to induce concentration related developmental toxicity in animals (Murakami & Fukami, 1986;Wang, 1988;Roeleveld et al, 1990). Similarly, a growing body of epidemiological studies suggests that pesticide exposure may be associated with increased risk of birth defects in exposed human populations (Mattison et al, 1990;Czeizel et al, 1993;Garry et al, 1996;Kristensen et al, 1997;Poynor et al, 1997).…”

EMBRYOTOXICITY AND TERATOGENICITY OF FIPRONIL IN RATS (Rattus norvegicus)

“…Such researches can serve in safety evaluation of toxic material to determine the maximum level at which no delectable deleterious effect can be observed, the so-called "maximum no effect level" (FDA, 1970). Evaluation of fetotoxicity/teratogenicity hazards represents an initial determination of approximate safety factor and assessment of a no-observed teratogenic effect dose level (Wang, 1988).…”

Human reproductive hazards. Evaluation and chemical etiology

“…The estimated rate of abortion reported in the literature is variable. One source estimates that 75-78% of all conceptions are resorbed or aborted (73); another estimates the rate as being 30-50% (14). Another study indicates the incidence of spontaneous abortion of recognized pregnancies to be 15-20% (3).…”

“…A few organophosphates are known to be teratogenic-cabaryl in the guinea pig (68) and dog (69), demeton (70) and parathion (71) in the mouse, and dichlorovos in the rabbit (72). Evidence that the fungicides manoseb, dinocap, and nitrofen are potent teratogens has been presented (73). DDE, a metabolite of DDT, is known to have detrimental effects on reproduction in birds by interfering with the hormonal activity of estrogen, which results in decreased deposition of calcium in the egg shell.…”