UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OCT 2 2 2015 

MEMORANDUM 

SUBJECT: Completion of Testing under an Enforceable Consent Agreement for the 

Hazardous Air Pollutant I ,2-Ethylene Dichloride 

FROM: Maria J. Doa, Directol()fn U k-., 

Chemical Control Division, ~·T 

TO: Erika Sasser, Director 

Health and Environmental Impacts Division, OAQPS 

The purpose of this memorandum is to inform the Office of Air Quality Planning and Standards 

(OAQPS) that testing under the Enforceable Consent Agreement for Ethylene Dichloride (EDC) 

(CASRN 107-06-2) is now complete and the results are available in docket EPA-HQ-OPPT2003-0010 for use by the Health and Environmental Impacts Division (HElD). 

At OAQPS' request, the Office of Pollution Prevention and Toxics (OPPTS) published a 

Proposed Test Rule for Hazardous Air Pollutants (HAPs) under section 4 of the Toxic 

Substances Control Act (TSCA) in the Federal Register in June 1996 (61 FR 33 178, June 26, 

1996). The rule proposed testing for 21 chemicals, including EDC, that are listed as HAPs under 

section 1 12 of the Clean Air Act (CAA), and solicited proposals for enforceable consent 

agreements (ECAs). As a result, EPA and the Hazardous Air Pollutant (HAP) Task Force entered 

into an ECA to test EDC for health effects relevant to conducting a residual risk assessment in 

support of the CAA. The testing program was complex in that it included development of 

pharmacokinetics and mechanistic data and a computational dosimetry model for route-to-route 

extrapolations, which would allow the use of data from studies conducted by the oral route of 

exposure to predict the effects of inhalation exposures. The testing is described in the Federal 

Register notice issued on June 3, 2003, announcing the ECA (68 FR 33125). Tier II HAPs 

testing described in the Federal Register notice was later modified to allow an extended onegeneration reproductive effects protocol with a neurotoxicity satellite to substitute for the 

reproductive and neurotoxicity testing protocols originally specified by the ECA. 

Documents that can be accessed in the docket that may be of particular interest to HElD include: 

1) I ,2-Ethylene Dichloride (EDC); Final Enforceable Consent Agreement and Testing 

Consent Order FEDERAL REGISTER NOTICE June 3, 2003 (EPA-HQ-OPPT-2003-

00 10-0001 ); 

2) 1 ,2-Ethylene Dichloride Tier I Program Review Testing; Notice of Availability and 

Solicitation of Comment FEDERAL REGISTER NOTICE September 5, 2006 (EPA-HQOPPT-2003-00 1 0-0089); 

Internet Address (URL) • http:/lwww.epa.gov 

Recycled!Recyclable • Printed with Vegetable 011 Based Inks on 100% Postconsumer. Process Chlorine Free Recycled Paper 
3) L2-Ethylene Dichloride; Completion of EPA Program Review FEDERAL REGISTER 

NOTICE July I 0, 2009 (EPA-HQ-OPPT-2003-001 0-0099); 

4) Final Report; 1.2 Dichloroethane (EDC): Limited Pharmacokinetics and Metabolism 

Study in Fischer 344 Rats February 28, 2006 (February 28, 2006): 

5) Final Report; Physiologically Based Pharmacokinetic Model Development and 

Simulations for Ethylene Dichloride ( 1.2-Dichloroethane) in Rats July 7, 2006 (EPA-HQOPPT-2003-001 0-0086); 

6) Final Report; L2-Ethylene Dichloride (EDC): Acute Inhalation Toxicity with 

Bronchoalveolar Lavage and Histopathology/ Acute Inhalation Neurotoxicity Study in 

F344/DUCRL Rats (part I of 7) (letter and final study repoti -- 7 pmts includes 6 

attachmenls) June 2L 2006 (EPA-HQ-OPPT-2003-001 0-0087); 

7) Final Report: Route-to-Route Extrapolation of 1,2-Dichloroethanc Studies from the Oral 

Route to Inhalation Using Physiologically Based Pharmacokinetic Models: Subchronic 

Toxicity in the Rat July 26, 2010 (EPA-HQ-OPPT-2003-0010-0112); 

8) Final Reproductive Toxicity Report; An Extended One-Generation Drinking Water 

Reproductive Toxicity Study of Ethylene Dichloride in Rats August 24,2015 (EPA-HQOPPT-2003-00 1 0-0134); 

9) Final Report; Final PBPK Modeling of Reproductive Study; Route--to--Route 

Extrapolation of 1.2--Dichloroethane Studies from the Oral Route to Inhalation Using 

Physiologically Based Pharmacokinetic Models: Extended One Generation Toxicity 

Study and Reproductive Toxicity Studies in the Rat July 30,2015 (EPA-HQ-OPPT-2003-

0010-0135). 

If you have any questions or need additional information, please contact John Schaeffer, the 

project manager for the EDC ECA, by telephone at (202) 564-8173 or email at 

schaeffer.john@epa.gov.