[Code of Federal Regulations]

[Title 40, Volume 31]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR799.4440]



[Page 267]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 799_IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE 

TESTING REQUIREMENTS--Table of Contents

 

                 Subpart B_Specific Chemical Test Rules

 

Sec.  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 Sec.  795.250 of this chapter except for the 

provision in paragraph (c)(3)(iii) of Sec.  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]