Phenylenediamines (PDAs) Test Results
ITC Recommendation/Designation - Sixth Report
45 FR 35897; May 28, 1980
Advance Notice of Proposed Rulemaking (ANPR)
47 FR 973; January 8, 1982
Decision Not To Test (DNT)/34 PDAs
50 FR 4267; January 30, 1985
Proposed Test Rule (PRM)/o-, m-, p-PDA and sulfate salts of and p-PDA
51 FR 472; January 6, 1986
Final Test Rule (FRM)/o-, m-, p-PDA and sulfate salts of and p-PDA
54 FR 49285; November 30, 1989
53 FR 913; January 14, 1988/Modification - Neurotoxicity testing
55 FR 12639; April 5, 1990/Modification to Test Standard
56 FR 23228; May 21, 1991/Technical Amendment
57 FR 24958; June 12, 1992/Technical Amendment
58 FR 30989; May 28, 1993/Time Extension
62 FR 20176; April 25, 1997/Request for Comment: Deletion of Early-Life-Stage Study (p-PDA) (last outstanding test).
Project Manager: J. Helm
Section Chief: R. Northrop
Status: Closed. All required tests for the 5 phenylenediamines required by the FRM have been completed. Test results have been forwarded to the Risk Assessment Division for review and disposition. DNT affecting 34 phenylenediamines is based on insignificant exposure to or low or no production of the chemicals in question. The eight toluenediamines that were considered for testing in the ANPR, have been referred to the Risk Assessment Division for a data needs determination. They are being considered for a separate test rule.
Identification of Chemicals
The PDAs are defined as: all nitrogen-unsubstituted phenylenediamines with zero to two substituents on the ring selected from the same or different members of the groups of halo, nitro, hydroxy, hydroxy-lower alkoxy, lower-alkyl and lower-alkoxy substituents (lower refers to a group containing between one and four carbons). Forty-seven PDAs are in this category. In developing a testing decision, EPA sub sequently divided the PDAs into three categories: unsubstituted PDAs, toluene diamines, and no-test PDAs. The five unsubstituted PDAs covered by the FRM and the eight toluenediamines considered for testing in the ANPR are listed in Attachment A; the thirty-four PDAs covered by the DNT are listed in Attachment B.
Announced Receipt of Test Data
Du Pont submitted the following test results: Acute aquatic toxicity to o-, m-, and p-PDA to fathead minnow (Pimephales promelas) and Daphnia magna; Chronic toxicity of m-PDA to Daphnia magna; oxidative half-life of o-, m-, and p-PDA in well water; oxidative half-life of p-PDA in river water; and results of algal testing of o-, m-, and p-PDA (51 FR 6468; February 24, 1986). The submitted tests are the result of a voluntary testing program.
E.I. Du Pont de Nemours and Co. submitted oral neurotoxicity studies in rats, indirect photolysis screening tests, and acute toxicity to rainbow trout for o-, m, p-PDA (55 FR 5005; December 4, 1990).
Indirect photolysis studies on o-, m-, p-PDA were resubmitted (55 FR 53348; December 28, 1990).
Du Pont submitted mouse bone marrow micronucleus assays for m-PDA, an acute aquatic toxicity study for o-, m-, and p-PDA (56 FR 5688; February 12, 1991), and a sex-linked recessive lethal assay with Drosophila melanogaster (56 FR 22715; 5/16/91).
Subchronic neurotoxicity tests (FOB, motor activity, and neuropathology) was submitted by Du Pont (57 FR 33348; July 28, 1992).
E. I. Du Pont de Nemours and Company submitted test data for p-PDA that were received by EPA on December 29, 1992. The submissions describe the static-renewal acute 48-hr EC50 of p-PDA fed to water fleas (Daphnia magna) and the 21-day toxicity of p-PDA to water fleas (58 FR 7784; February 9, 1993).
E. I. Du Pont de Nemours and Company submitted test data for o-PDA that were received by EPA on January 19, 1993. The submissions describe (1) the static-renewal acute 48-hr EC50 of o-PDA fed to water fleas (Daphnia magna), (2) Flow-through 21-day toxicity of o-PDA to Daphnia magna, and the static renewal 21-day toxicity of o- PDA to Daphnia magna (58 FR 9174; February 19, 1993).Results of Testing Table