The U.S. Environmental Protection Agency (EPA) has published preliminary materials for the upcoming Integrated Risk Information System (IRIS) toxicological review of diisononyl phthalate (DINP), a member of the phthalate family of chemicals used in food-contact materials and a host of other industrial applications.
The agency scheduled a discussion of the upcoming review at the IRIS Bimonthly Public Science Meeting to be held October 29-30, 2014, in Arlington, Virginia, the preliminary materials include (i) “a planning and scoping summary,” (ii) “information on the approaches used to identify pertinent literature,” (iii) “results of the literature search,” (iv) “approaches for selection of studies for hazard identification,” (v) “presentation of critical studies in evidence tables and exposure-response arrays,” and (vi) “mechanistic information for DINP.”
In addition to feedback on these general topics, EPA has specifically requested public comment and discussion on “DINP-induced liver effects, including spongiosis hepatis”; “the evidence for DINP-induced male reproductive toxicity; “the relevance of the xenograft and ex-vivo tissue studies”; the human relevance of animal studies associating mononuclear cell leukemia with DINP exposure; and the “transparency and utility of mechanistic data.” The agency is also seeking “any additional studies published or nearing publication that may provide data for the evaluation of human health hazard or dose-response relationships.”
The IRIS review of DINP is especially significant with respect to its status as a Proposition 65 carcinogen because the American Chemistry Council filed a declaratory relief action against the California Office of Environmental Health Hazard Assessment (OEHHA) in June to overturn the December 2013 listing by the state’s Carcinogen Identification Committee. If the lawsuit is successful it would prevent the listing from taking effect.
DINP is the predominant replacement chemical for companies seeking to find an alternative for Di(2-ethylhexyl)phthalate (DEHP). In July, an expert panel for the U.S. Consumer Product Safety Commission reccomended that the agency permanantly ban the use of DINP in children’s products.