799.4440 Triethylene glycol monomethyl ether.§ 799.4440 Triethylene glycol monomethyl ether.
(a) Identification of test substance. (1) Triethylene glycol monomethyl ether (TGME, CAS No. 112-35-6) shall be tested in accordance with this section.
(2) TGME of at least 90 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 or process TGME, other than as an impurity, after May 17, 1989, 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.
(c) Developmental neurotoxicity - (1) Required testing. Developmental neurotoxicity testing shall be performed in the Sprague-Dawley rat by gavage in accordance with § 795.250 of this chapter except for the provision in paragraph (c)(3)(iii) of § 795.250.
(2) For the purpose of this section, the following provisions also apply:
(i) Number of animals. The objective is for a sufficient number of pregnant rats to be exposed to ensure that an adequate number of offspring are produced for neurotoxicity evaluation. At least 24 litters are recommended at each dose level.
(ii) Dose levels and dose selection. In the absence of developmental toxicity or maternal toxicity the maximum dose shall be 5 grams/kilogram.
(3) Reporting requirements - (i) The developmental neurotoxicity test shall be completed and the final report submitted to EPA within 21 months of the initiation of the test.
(ii) Progress reports shall be submitted to EPA at 6- month intervals, beginning six months after the initiation of the test.
(d) Effective date. (1) The effective date of this final rule is May 17, 1989, except for paragraph (c)(2)(i) and (c)(3)(i) of this section. The effective date for paragraph (c)(2)(ii) and (c)(3)(i) of this section is May 21, 1991.
(2) The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.[54 FR 13477, Apr. 3, 1989; 56 FR 23232, May 21, 1991, as amended at 58 FR 34205, June 23, 1993]