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1,4-Dioxane - with inhalation update

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Peer Reviewed Journal Article

In vivo positive mutagenicity of 1,4-dioxane and quantitative analysis of its mutagenicity and carcinogenicity in rats

Authors: Gi, M; Fujioka, M; Kakehashi, A; Okuno, T; Masumura, K; Nohmi, T; Matsumoto, M; Omori, M; Wanibuchi, H; Fukushima, S (2018) Archives of Toxicology 92:3207-3221. HERO ID: 5029473

[Less] 1,4-Dioxane is a widely used synthetic industrial chemical and its contamination of drinking water and . . . [More] 1,4-Dioxane is a widely used synthetic industrial chemical and its contamination of drinking water and food is a potential health concern. It induces liver tumors when administered in the drinking water to rats and mice. However, the mode of action (MOA) of the hepatocarcinogenicity of 1,4-dioxane remains unclear. Importantly, it is unknown if 1,4-dioxane is genotoxic, a key consideration for risk assessment. To determine the in vivo mutagenicity of 1,4-dioxane, gpt delta transgenic F344 rats were administered 1,4-dioxane at various doses in the drinking water for 16 weeks. The overall mutation frequency (MF) and A:T- to -G:C transitions and A:T- to -T:A transversions in the gpt transgene were significantly increased by administration of 5000 ppm 1,4-dioxane. A:T- to -T:A transversions were also significantly increased by administration of 1000 ppm 1,4-dioxane. Furthermore, the DNA repair enzyme MGMT was significantly induced at 5000 ppm 1,4-dioxane, implying that extensive genetic damage exceeded the repair capacity of the cells in the liver and consequently led to liver carcinogenesis. No evidence supporting other MOAs, including induction of oxidative stress, cytotoxicity, or nuclear receptor activation, that could contribute to the carcinogenic effects of 1,4-dioxane were found. These findings demonstrate that 1,4-dioxane is a genotoxic hepatocarcinogen and induces hepatocarcinogenesis through a mutagenic MOA in rats. Because our data indicate that 1,4-dioxane is a genotoxic carcinogen, we estimated the point of departure of the mutagenicity and carcinogenicity of 1,4-dioxane using the no-observed effect-level approach and the Benchmark dose approach to characterize its dose-response relationship at low doses.

Technical Report
Technical Report

Integrated Risk Information System Program

Author: U.S. EPA (2015) Washington, DC: U.S. Environmental Protection Agency, IRIS. HERO ID: 192196

[Less] The U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) Program provides . . . [More] The U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) Program provides health effects information on chemicals to which the public may be exposed, providing a critical part of the scientific foundation for EPA's decisions to protect public health. EPA has made several changes to this important Program over the past few years, streamlining the assessment development process, improving transparency, and creating efficiencies within the Program. In April 2011, the National Research Council (NRC) made several recommendations to EPA for improving the development of IRIS assessments. The N RC's recommendations were focused on the development of draft assessments, and the NRC was clear that their intent was not to delay assessments. EPA has made progress in implementing these recommendations. Consistent with the advice of the NRC, EPA is implementing these recommendations using a phased approach and is making the most extensive changes to documents that are in the earlier steps of the assessment development process. For assessments that are in the later stages of development, including assessments that have been posted on the IRIS database since the release of the NRC report, EPA is implementing the recommendations as feasible without taking the assessments backwards to earlier steps of the process. Phase 1 of implementing the NRC recommendations has focused on editing and streamlining documents and using more tables, figures, and appendices. EPA is now in Phase 2 of implementing the NRC recommendations and will soon publicly release two draft IRIS assessments that represent a major advancement in implementing the NRC recommendations. EPA is using a new document structure for these draft assessments, including an Executive Summary presenting major conclusions, a Preamble describing methods used to develop the assessment, distinct sections on Hazard Identification and Dose-Response Analysis, and more tables and figures to clearly present data. Additionally as part of Phase 2, EPA is addressing all of the short-term recommendations provided by the NRC. As part of this effort, EPA will make several changes to IRIS assessments. Highlights include: evaluating and describing the strengths and weaknesses of critical studies in a more uniform way; including toxicity values for multiple effects associated with the chemical, if applicable and where the data allow; routinely considering the use of multiple data sets of combined multiple responses in deriving toxicity values, where appropriate; and evaluating existing guidelines to establish clearer criteria for study selection. Phase 3 of implementation will incorporate the longer-term scientific recommendations made by the NRC. The U.S. Congress has directed EPA to issue a progress report to the House and Senate Committees on Appropriations and relevant Congressional authorizing committees to describe EPA's implementation of the NRC recommendations. This report provides Congress, stakeholders, and the public with an update on the IRIS Program and EPA's progress toward implementing the NRC recommendations and improving the Program.

Technical Report
Technical Report

Proposition 65 list of chemicals: Chemicals known to the state to cause cancer or reproductive toxicity

Author: CalEPA (2013) HERO ID: 1882718


Archival Material
Archival Material

Toxic release inventory. 2011 TRI national analysis basic data files

Author: U.S. EPA (2013) HERO ID: 1921062


Data/Software
Data/ Software

WinBUGS model code in support of 1,4-dioxane IRIS assessment

Author: U.S. EPA (2013) [Code]. HERO ID: 1927529


Data/Software
Data/ Software

1,4-Dioxane PBPK model code in support of IRIS assessment

Author: U.S. EPA (2013) [Code]. HERO ID: 1927561


Technical Report
Technical Report

Toxicological review of 1,4-Dioxane (with inhalation update) (CAS No. 123-91-1) in support of summary information on the Integrated Risk Information System (IRIS)

Author: U.S. EPA (2013) (EPA-635/R-11/003-F). Washington, DC: U.S. Environmental Protection Agency. [EPA Report] HERO ID: 1935959


Archival Material
Archival Material

IRIS Process

Author: U.S. EPA (2012) Available online at http://epa.gov/iris/process.htm. (Jun 2, 2012). [Website] HERO ID: 783308

[Less] The IRIS process consists of the development of a draft Toxicological Review for a chemical; internal . . . [More] The IRIS process consists of the development of a draft Toxicological Review for a chemical; internal and external scientific reviews of the draft document; EPA responses to review comments; and development and posting of an IRIS Summary and final Toxicological Review to EPA's web site. EPA announced revisions to the IRIS process in May 2009 and further revisions in 2011.

Technical Report
Technical Report

Fact Sheet: 1,4-dioxane in well water

Author: Connecticut (2012) Hartford, CT: Connecticut Department of Public Health. Environmental & Occupational Health Assessment Program.. [Fact Sheet] HERO ID: 1920785


Archival Material
Archival Material

EWG research shows 22 percent of all cosmetics may be contaminated with cancer-causing impurity

Author: EWG (2012) HERO ID: 1920815