§795.250. Developmental neurotoxicity screen. — Inbound Citations
40 C.F.R. § 795.250
Statutory Authority
Cited by 4 regulations in release Current.
Citations to 40 U.S.C. § 795.250 as a whole
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(i) A developmental neurotoxicity test of DGBE shall be conducted after a public program review of the Tier I data from the functional observational battery, motor activity, and neuropathology tests in paragraph (c)(2) of this section, and the reproductive tests in paragraph (c)(1) of this section, and if EPA issues a Federal Register notice or sends a certified letter to the test sponsor specifying that the testing shall be initiated. The test shall be performed in rats in accordance with § 795.250 of this chapter.
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(D) The developmental neurotoxicity test shall be conducted with isopropanol in accordance with § 795.250 of this chapter, except for paragraph (c)(1)(iv).(1) For purposes of this section, the following provisions also apply:(i) Numbers 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 shall be used at each dose level.(ii) [Reserved](2) [Reserved]
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(1) 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.
Citations to §795.250(c)(3)(iii)
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(1) 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.