Reproductive Toxicity Evaluation of the Dental Resin Monomer Bisphenol A Glycidyl Methacrylate (CAS 1565-94-2) in Mice

Abstract

The reproductive toxicity potential of the dental resin monomer bisphenol A glycidyl methacrylate (BisGMA; CASRN 1565-94-2) was investigated in male and female Crl: CD1(ICR) mice, 4 dosage groups, and 25 mice/sex/group. Formulations of BisGMA (0, 0.008, 0.08, or 0.8 mg/kg/d) in 0.8% ethanol in deionized water were intubated once daily beginning 28 days before cohabitation and continuing through mating (males) or through gestation day 17. The following parameters were evaluated: viability, clinical signs, body weights, estrous cyclicity, necropsy observations, organ weights, sperm concentration/motility/morphology, cesarean sectioning and litter observations, and histopathological evaluation of select tissues. No deaths or clinical signs related to BisGMA occurred. No significant changes in male and female body weights and body weight gains were recorded at any of the administered dosages of BisGMA. All mating and fertility parameters, and all litter and fetal data, were considered to be unaffected by dosages of BisGMA as high as 0.8 mg/kg/d. Gross or histopathologic tissue changes attributable to the test article were not observed. Reproductive and developmental no observed effect levels (NOAELs) for BisGMA were 0.8 mg/kg/d, the highest dose tested. Comparison of this NOAEL value to published probabilistic estimates of human BisGMA exposure from dental products suggests a margin of safety of at least 280- to nearly 2000-fold. Under the conditions of this study, BisGMA is not a reproductive toxicant.

Farklı Kompozit Dolguların BIS-GMA Salınımlarının İncelenmesi

“…Generally, the highest BIS-GMA release was seen in the first 24 hours, and the amount of residual monomer decreased in the following days. (Moilanen et al (2013), Polydorou et al (2009), Ferracane (1994) In our study, the highest Bis-GMA release was observed in 3 different composite materials within the first 24 hours. Composite contains 1-10% Bis-GMA, flowable composite contains 1-10% Bis-GMA, bulk fill composite contains 2.5-10% Bis-GMA.…”

Elution from direct composites for provisional restorations

“…The availability of data on the recommended intake limits of monomers is limited. Moilanen et al [38,39] conducted studies on acute toxicity after ingestion of BisGMA, TEGDMA, and UDMA in rats and reported LD50 values of 2, 10.837, and 5 mg/kg, respectively. The studies also identified no observed adverse effect level (NOAEL) for reproductive toxicity in mice for BisGMA and TEGDMA, which was 0.8 and 1 mg/kg bw/day, respectively, based on daily exposure for more than a month.…”

Microstructural Features of Current Resin Composite Materials

“…Leachable components from conventional materials include the actual monomers and some of their degradation products, such as triethylene glycol and bishydroxypropoxy-phenyl propane [69,70]. These products have been demonstrated to regulate bacterial adhesion and colonization [71,72], as well as to pose potential toxicity concerns, especially when used in dental adhesives [72][73][74][75]. Several direct restorative materials are in fact conducive of biofilm colonization, and therefore, antimicrobial composites have also been proposed [76,77].…”