NTP‐CERHR expert panel report on the reproductive and developmental toxicity of bisphenol A

Abstract

The National Toxicology Program (NTP)1 established the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) in June 1998. The purpose of the CERHR is to provide timely, unbiased, scientifically sound evaluations of the potential for adverse effects on reproduction or development resulting from human exposures to substances in the environment. The NTP-CERHR is headquartered at NIEHS, Research Triangle Park, NC, and is staffed and administered by scientists and support personnel at NIEHS. Bisphenol A is a high-production volume chemical used in the production of epoxy resins, polyester resins, polysulfone resins, polyacrylate resins, polycarbonate plastics, and flame retardants. Polycarbonate plastics are used in food and drink packaging; resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants and tooth coatings contain bisphenol A. Exposure to the general population can occur through direct contact with bisphenol A or by exposure to food or drink that has been in contact with a material containing bisphenol A. CERHR selected bisphenol A for evaluation because of (1) high production volume; (2) widespread human exposure; (3) evidence of reproductive toxicity in laboratory animal studies; and (4) public concern for possible health effects from human exposures. Relevant literature on bisphenol A was identified from searches of the PubMed (Medline) and Toxline databases through February 2007 using the term "bisphenol" and the bisphenol A CAS RN (80-05-7). References were also identified from databases such as REPROTOX, HSDB, IRIS, and DART, from the bibliographies of the literature reviewed, by members of the expert panel, and in public comments. CERHR convened a 12-member, independent panel of government and non-government scientists to evaluate the scientific studies on the potential reproductive and developmental hazards of bisphenol A. The expert panel met publicly on March 5–7, 2007 and August 6–8, 2007. The Expert Panel Report on Bisphenol A is intended to (1) interpret the strength of scientific evidence that bisphenol A is a reproductive or developmental toxicant based on data from in vitro, animal, or human studies; (2) assess the extent of human exposures to include the general public, occupational groups, and other sub-populations; (3) provide objective and scientifically thorough assessments of the scientific evidence that adverse reproductive and developmental health effects may be associated with such exposures; and (4) identify knowledge gaps to help establish research and testing priorities to reduce uncertainties and increase confidence in future evaluations. This report has been reviewed by members of the expert panel and by CERHR staff scientists. Copies of this report have been provided to the CERHR Core Committee2 and will be made available to the public for comment. Following the public comment period, CERHR will prepare the NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. This monograph will include the NTP Brief, the Expert Panel Report, and all public comments received on the Expert Panel Report. The NTP-CERHR Monograph will be made publicly available and transmitted to appropriate health and regulatory agencies. Reports can be obtained from the web site (http://cerhr.niehs.nih.gov) or from: Michael D. Shelby, PhD, NIEHS EC-32, PO Box 12233, Research Triangle Park, NC 27709. E-mail: [email protected] Section 1 is based initially on secondary review sources. Primary study reports are addressed by the Expert Panel if they contain information that is highly relevant for determining the effect of exposure on developmental or reproductive toxicity or if the studies were released subsequent to the reviews. The CAS RN for bisphenol A is 80-05-7. Synonyms for bisphenol A listed in Chem IDplus (ChemIDplus, 2006) include: 2-(4,4′-Dihydroxydiphenyl)propane; 2,2-Bis(4-hydroxyphenyl)propane; 2,2-Bis(hydroxyphenyl)propane; 2,2-Bis(p-hydroxyphenyl)propane; 2,2-Bis-4′-hydroxyfenylpropan [Czech]; 2,2-Di(4-hydroxyphenyl)propane; 2,2-Di(4-phenylol)propane; 4,4′-(1-Methylethylidene)bisphenol; 4,4′-Bisphenol A; 4,4′-Dihydroxydiphenyl-2,2-propane; 4,4′-Dihydroxydiphenyldimethylmethane; 4,4′-Dihydroxydiphenylpropane; 4,4′-Isopropylidene diphenol; 4,4′-Isopropylidenebisphenol; 4,4′-Isopropylidene diphenol; Biphenol A; Bis(4-hydroxyphenyl) dimethylmethane; Bis(4-hydroxyphenyl)dimethylmethane; Bis(4-hydroxyphenyl)propane; Bisferol A [Czech]; Bisphenol. Bisphenol A; DIAN; Diano; Dimethyl bis(p-hydroxyphenyl)methane; Dimethylbis(p-hydroxyphenyl)methane; Dimethylmethylene-p,p′-diphenol; Diphenylolpropane; Ipognox 88; Isopropylidenebis(4-hydroxybenzene); Parabis A, Phenol; (1-methylethylidene)bis-, Phenol; 4,4′-(1-methylethylidene)bis-; Phenol, 4,4′-dimethylmethylenedi-; Phenol, 4,4′-isopropylidenedi-; Pluracol 245, Propane; 2,2-bis(p-hydroxyphenyl)-; Rikabanol; Uca