NTP-CERHR Expert Panel report on the reproductive and developmental toxicity of propylene glycol

Abstract

The National Toxicology Program (NTP) and the National Institute of Environmental Health Sciences (NIEHS) established the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) in June 1998. The purpose of the Center is to provide timely, unbiased, scientifically sound evaluations of human and experimental evidence for adverse effects on reproduction, including development, caused by agents to which humans may be exposed. Propylene glycol was selected for evaluation by the CERHR based on its high production and widespread public exposure due to its use as an antifreeze and de-icing agent, as well as its use in paints, coatings, foods, drugs, and cosmetics. This evaluation results from the efforts of a nine-member panel of government and non-government scientists that culminated in a public expert panel meeting held February 11–13, 2003. This report has been reviewed by CERHR staff scientists and by members of the Ethylene Glycol/Propylene Glycol Expert Panel. Copies have been provided to the CERHR Core Committee, which is made up of representatives of NTP-participating agencies. This report is a product of the expert panel and is intended to (1) interpret the strength of scientific evidence that propylene glycol 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 exposures of the general public, occupational groups, and other sub-populations, (3) provide objective and scientifically thorough assessments of the scientific evidence that adverse reproductive/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 assessments of risk. The Expert Panel Report on Propylene Glycol will be a central part of the subsequent NTP CERHR Monograph. The monograph will include the NTP CERHR Brief, the expert panel report, and all public comments on the expert panel report. The NTP CERHR Monograph will be made publicly available and transmitted to appropriate health and regulatory agencies. The NTP-CERHR is headquartered at NIEHS, Research Triangle Park, NC and is staffed and administered by scientists and support personnel at NIEHS and at Sciences International, Inc., Alexandria, Virginia. Reports can be obtained from the website ( http://cerhr.niehs.nih.gov) or from: Michael D. Shelby, Ph.D., NIEHS EC-32, P.O. Box 12233, Research Triangle Park, NC 27709, USA. Tel.: +1-919-541-3455; e-mail: shelby@niehs.nih.gov