[Code of Federal Regulations]
[Title 40, Volume 30]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR799.1645]

[Page 238]
 
                   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. 799.1645  2-Ethylhexanol.

    (a) Identification of test substance. (1) 2-Ethylhexanol (CAS No. 
104-76-7) shall be tested in accordance with this section.
    (2) 2-Ethylhexanol of at least 99.0-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, or intend to 
manufacture or process 2-ethylhexanol, other than as an impurity, from 
the effective date of this final rule to the end of the reimbursement 
period shall submit letters of intent to conduct testing, submit study 
plans, conduct tests, and submit data or 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) Health effects--(1) Oncogenic ef fects--(i) Required testing. 
(A) Oncogenicity tests shall be conducted in Fisher 344 rats and B6C3Fl 
mice by the oral route with 2-ethylhexanol in accordance with Sec. 
798.3300 of this chapter, except for the provisions in Sec. 
798.3300(b)(6).
    (B) For the purpose of this section, the following provisions also 
apply to the oncogenicity tests: (1) Administration of the test 
substance. 2-Ethylhexanol shall be administered either by 
microencapsulation before adding it to the diet or by gavage.
    (2) [Reserved]
    (ii) Reporting requirements. (A) The study plan for the oncogenicity 
test shall be submitted at least 45 days before the initiation of 
testing.
    (B) The oncogenicity testing shall be completed and final report 
submitted to the Agency within 53 months of the effective date of this 
final rule if 2-ethylhexanol is administered by gavage or within 56 
months of the effective date of this final rule if administered by 
microencapsulation.
    (C) Interim progress reports shall be submitted to EPA at 6-month 
intervals beginning 6 months after the effective date of the final rule, 
until the final report is submitted to EPA.
    (2) [Reserved]
    (d) Effective date. The effective date of this final rule requiring 
onco gen i city testing of 2-ethylhexanol is September 16, 1987.

[52 FR 28704, Aug. 3, 1987, as amended at 58 FR 34205, June 23, 1993]