Development of a toxicity evaluation program for dental materials and products. II. Screening for systemic toxicity

Abstract

A series of systemic toxicity tests for various types of compounds are presented with illustrative data and discussed in regard to their relevance as potential screening tests for dental compounds and products. In developing and marketing a new dental material, it is important not only to ensure safety for the patient but also for the dentist, dental assistant, and laboratory worker who routinely handles and uses the product. Data are presented on a number of commercially available dental products as well as various chemical entities, which were tested by one or more of the methods described.

Rat subcutaneous tissue response to modified Portland Cement, a new mineral trioxide aggregate

“…Materials must not have deleterious effect when in contact with tissues before they are marketed and used routinely in the clinic (14). Following ISO/6876 and 10993-5 regulations (15), in vitro cytotoxicity tests, such as tissue and cell culture assays, are important to provide initial evidence in the study of dental materials, and are critical in order to identify those components exercising cytotoxic effects.…”

Methylmethacrylat [MAK Value Documentation in German language, 1984]

“…Die beobachtete kurze ZNSDepression nach MMA-Kontakt der fast gesamten Hautfläche eines Kaninchens [2] könnte u. U. der Einatmung des Dampfes zugeschrieben werden. Da bei okklusiven Patch-Tests mit bis zu 8 ml/kg KG [3] keine Mortalität beim Kaninchen festzustellen war, wird geschlossen, daß flüssiges MMA in letalen Mengen nicht durch die intakte Haut dringt. MMA-Sensibilisierungstests beim Meerschweinchen zeigen kein eindeutiges Bild: Positive Ergebnisse [35,90] wie auch negative [3] werden beschrieben, ferner werden MMAKreuzsensibilisierungen gegenüber Ethyl-und n-Butylmethacrylat beobachtet [90].…”

Joint FAO/WHO Expert Committee on Food Additives (JECFA)

“…In dogs and guinea-pigs, the oral LD50 values were 4680 and 5897 mg/kg bw, respectively (Spealman et al, 1945). In mice, oral LD50 values ranged from >4550 to 5251 mg/kg bw (Lawrence et al, 1974;Ward, 1976;Moreno, 1982). In rats, oral LD50 values ranged from >2000 to >10 000 mg/kg bw (Deichmann, 1941;Deichmann & LeBlanc, 1943;Spealman et al, 1945;Shelanski, 1972;Moreno, 1976Moreno, , 1977aMoreno, , 1977bMoreno, , 1978Moreno, , 1980Kajiura, 1977a;BASF, 1978;Moore, 2000;Klein, 2003).…”