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Ethylene Glycols Panel Regulatory Update


Panel advocacy efforts focus on collecting information on consumer product exposure and use information and on the impact of ethylene glycol on the most sensitive animal testing species.  Recently, the panel completed a 12-month dietary study in Wistar rats including studies to examine the effect of ethylene glycol and its major metabolites.1   The panel is building upon the results of the chronic study by conducting additional research into the mechanism of kidney toxicity and focusing on increasing the accuracy and reliability of factors used in regulatory risk assessments for ethylene glycol.

The panel has prepared several manuscripts related to ethylene glycol for submission to peer reviewed journals.  These manuscripts focused on the development of a physiologically based pharmacokinetic (PBPK) model for ethylene glycol and its major metabolite, glycolic and oxalic acid, and incorporation of acute and developmental toxicity information into the PBPK model. 

In April 2004, multiple member states of the Organization for Economic Cooperation and Development (OECD) reviewed information submitted in support of the ethylene glycols category at the 18th SIDS Initial Assessment Meeting (SIAM).

Participatory member states of SIAM 18 concluded that the five ethylene glycols addressed in the SIAR were considered of low priority for further environmental work.  Additionally, SIAM 18 concluded that three of the members of the category are of low priority for further work in regards to human health and that two members of the category (ethylene glycol and pentaethylene glycol) are candidates for further human health related work.  In 2007, the panel completed the studies noted by OECD for further work.

The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) convened an expert panel on February 11-13, 2003, in Alexandria, Virginia, to evaluate whether or not exposure to ethylene glycol is a reproductive and/or developmental hazard. The CERHR selected ethylene glycol for evaluation because it is a high production volume chemical and there is the potential for widespread occupational and general population exposures due to its use in heating and cooling systems (e.g., automotive antifreeze).  The CERHR Expert Panel determined the following: 

The overall conclusion is that available data from rat studies suggest that oral doses associated with developmental toxicity are greater than doses associated with renal toxicity.  The Expert Panel judges the likelihood of adverse developmental toxicity from exposure to humans from normal uses is of negligible concern. Refer to the CERHR document for details on developmental toxicity, reproductive toxicity, and a summary of human exposures.  Available at http://cerhr.niehs.nih.gov/chemicals/egpg/ethylene/EG_Monograph.pdf
 
1Wilson DM, Dryzga MD, Bartels MJ and Stebbins KE.  “Ethylene Glycols: 12-Months Dietary Toxicity Study in Wistar Han Rats.”  08 June 2005.



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