§ 799.2700 Methyl ethyl ketoxime.
(a) Identification of test substance. (1) Methyl ethyl ketoxime (MEKO, CAS No. 96–29–7) shall be tested in accordance with this section.
(2) MEKO of at least 99 percent purity shall be used as the test substance.
(b) Persons required to submit study plans, conduct tests, and submit data. All persons who manufacture (including import) or process or intend to manufacture or process MEKO, including persons who manufacture or process or intend to manufacture or process MEKO as a byproduct, or who import or intend to import products which contain MEKO, after the date specified in paragraph (e) of this section to the end of the reimbursement period, shall submit letters of intent to conduct testing, submit study plans, conduct tests and submit data, or submit exemption applications, as specified in this section, subpart A of this part, and parts 790 and 792 of this chapter for single-phase rulemaking. Persons who manufacture, import, or process MEKO only as an impurity are not subject to these requirements.
(c) Health effects testing—(1) Pharmacokinetics testing—(i) Required testing. Pharmacokinetics testing shall be conducted with MEKO in accordance with paragraph (c)(1)(ii) of this section.
(ii) [Reserved]
(2) Oncogenicity—(i) Required testing. Oncogenicity testing shall be conducted in accordance with § 798.3300 of this chapter.
(ii) Route of administration. MEKO shall be administered either orally or by inhalation.
(iii) Reporting requirements. (A) Oncogenicity testing shall be completed and a final report submitted to EPA within 53 months of the date specified in paragraph (e) of this section.
(B) Interim progress reports shall be submitted to EPA at 6-month intervals, beginning 6 months after the date specified in paragraph (e) of this section, until submission of the final report to EPA.
(3) Developmental toxicity—(i) Required testing. Developmental toxicity testing shall be conducted in a rodent and a nonrodent mammalian species in accordance with § 798.4900 of this chapter.
(ii) Route of administration. MEKO shall be administered orally.
(iii) Reporting requirements. (A) Developmental toxicity testing shall be completed and a final report submitted to EPA within 15 months of the date specified in paragraph (e) of this section.
(B) Interim progress reports shall be submitted to EPA at 6-month intervals, beginning 6 months after the date specified in paragraph (e) of this section.
(4) Reproductive toxicity—(i) Required testing. (A) Reproductive toxicity testing shall be conducted orally in accordance with § 798.4700 of this chapter except for the provisions in paragraphs (c) (8)(iii) and (9)(i) of § 798.4700.
(B) For the purpose of this section, the following provisions also apply:
(1) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination: Vagina, uterus, oviducts, ovaries, testes, epididymides, vas deferens, seminal vesicles, prostate, pituitary gland, and, target organ(s) of all P and F1 animals selected for mating.