[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: 40CFR799.1645]



[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 effects--(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 

oncogenicity testing of 2-ethylhexanol is September 16, 1987.



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