§ 799.3300 Unsubstituted phenylenediamines.
(a) Identification of test substance. (1) The unsubstituted phenylenediamines (pda's), para-phenylenediamine (p-pda, CAS No. 106-50-3), or its sulfate salt (p-pda.H2SO4, CAS No. 1624-57-75), meta-phenylenediamine (m-pda, CAS No. 108-45-2), or its sulfate salt (m-pda.H2SO4, CAS No. 54-17-08), and ortho-phenylenediamine (o-pda, CAS No. 95-54-5) shall be tested in accordance with this section.
(2) p-Pda, m-pda, and o-pda of at least 98 percent purity shall be used as the test substances. Either the hydrochloride or sulfate salt of m-pda shall be used as the test substances. Either the hydrochloride or sulfate salt of m-pda shall be used as a test substance in the oncogenicity test in paragraph (c)(2) of this section if the free base proves to be unstable under the conditions of this study. Either the hydrochloride or sulfate salt of o-pda, p-pda, or m-pda shall be used as a test substance in the 90-day subchronic neurotoxicity studies in paragraph (c)(3)(B) of this section if the free base proves to be unstable under the conditions of these studies. The salt(s) shall be of at least 98 percent purity.
(b) Persons required to submit study plans, conduct tests, and submit data. (1) All persons who manufacture (including import or by-product manufacture) or process m-pda or m-pda.H2SO4, or intend to manufacture or process m-pda or m-pda.H2SO4, after the effective date of this rule to the end of the reimbursement period shall submit letters of intent to test, submit study plans, conduct tests, and submit data, or submit exemption applications as specified in paragraphs (c), (d), and (e) of this section, subpart A of this part, and parts 790 and 792 of this chapter for single-phase rulemaking.
(2) All persons who manufacture (including import or by-product manufacture) or process p-pda, or p-pda.H2SO4, or intend to manufacture or process p-pda, or p-pda H2SO4, after the effective date of this rule to the end of the reimbursement period shall submit letters of intent to test, submit study plans, conduct tests, and submit data, or submit exemption applications as specified in paragraphs (c)(3), (d), and (e) of this section, subpart A of this part and parts 790 and 792 of this chapter for single-phase rulemaking.
(3) All persons who manufacture (including import or by-product manufacture) or process o-pda, or intend to manufacture or process o-pda after the effective date of this rule to the end of the reimbursement period shall submit letters of intent to test, submit study plans, conduct tests, and submit data, or submit exemption applications as specified in paragraphs (c)(3), (d), and (e) of this section, subpart A of this part, and parts 790 and 792 of this chapter for single-phase rulemaking.