(a) Identification of test substances. (1) The table in paragraph (c) of this section identifies those chemical substances that shall be tested in accordance with this section.
(2) Substances of at least 98-percent purity shall be used as the test substances.
(b) Persons required to submit study plans, conduct tests, and submit data. All persons who manufacuture (including import or manufacture as a byproduct) or process or intend to manufacture or process one or more of the substances in paragraph (c) of this section, other than as an impurity, after July 29, 1988, 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 for those substances they manufacture or process, or intend to manufacture or process, as specified in this section, subpart A of this part, and parts 790 and 792 of this chapter for single-phase rulemaking.
(c) Designation of testing. The substances identified in the following table by name and CAS number shall be tested in accordance with the designated requirements under paragraphs (d) and (e) of this section. The paragraph numbers listed for a substance refer to the specific testing and reporting requirements specified in paragraphs (d) and (e) of this section.
| Chemical name
| CAS No.
| Required testing under paragraphs (d) and (e) of this section
|
|---|
| Acetamide, 2-fluoro | 640-19-7 | (e)(1)
|
| Bis(2-chloroethoxy)methane | 111-91-1 | (d)(2), (e)(1)
|
| Bis(2-chloroisopropyl)ether | 108-60-1 | (d)(2)
|
| 4-Bromobenzyl cyanide | 16532-79-9 | (d)(1), (2), (e)(1)
|
| Bromoform | 75-25-2 | (d)(2)
|
| 4-Chlorobenzo-trichloride | 5216-25-1 | (e)(1)
|
| 2,4-D | 94-75-7 | (d)(2)
|
| Dibromomethane 74-95-3 (d)(2)
| | |
| 1,2-Dichlorobenzene | 95-50-1 | (d)(2)
|
| 1,1-Dichloroethane | 75-34-3 | (d)(2)
|
| 1,3-Dichloropropanol | 96-23-1 | (d)(1), (e)(1)
|
| Dihydrosafrole | 94-58-6 | (d)(2)
|
| Endrin | 72-20-8 | (d)(2)
|
| Ethyl methacrylate | 97-63-2 | (d)(2)
|
| Maleic hydrazide | 123-33-1 | (d)(1), (2)
|
| Malononitrile | 109-77-3 | (d)(1), (e)(1)
|
| Methanethiol | 74-93-1 | (d)(1)
|
| Methyl chloride | 74-87-3 | (d)(2)
|
| p- Nitrophenol | 100-02-7 | (e)(1)
|
| Pentachlorobenzene | 608-93-5 | (d)(2)
|
| Pentachloroethane | 76-01-7 | (d)(2)
|
| 1,2,4,5-Tetrachlorobenzene | 95-94-3 | (d)(2)
|
| Trichloromethanethiol | 75-70-7 | (d)(1), (2), (e)(1) |
(d) Chemical fate testing—(1) Soil adsorption—(i) Required testing. A soil adsorption isotherm test shall be conducted with the substances designated in paragraph (c) of this section in accordance with § 796.2750 of this chapter except that the provisions of § 796.2750 (b)(1)(vii)(A) shall not apply to 1,3-Dichloropropanol.
(ii) Reporting requirements. The sediment and soil adsorption isotherm tests shall be completed and the final results submitted to EPA within 9 months of the effective date of the final rule except that final results for testing of 1,3-Dichloropropanol and Methanethiol shall be completed and submitted to EPA within 11 months and 15 months, respectively, of the effective date of the final rule.
(2) Hydrolysis—(i) Required testing. A test of hydrolysis as a function of pH at 25 °C shall be conducted with the substances designated in paragraph (c) of this section in accordance with § 796.3500 of this chapter.
(ii) Reporting requirements. The hydrolysis tests with the substances designated in paragraph (c) of this section shall be completed and the final results submitted to EPA within 6 months of the effective date of the final rule except that hydrolysis tests for Dibromomethane, Dihydrosafrole, Ethyl methacrylate, and Methyl chloride shall be completed and the final results submitted to EPA within 12 months of the effective date of the final rule; and hydrolysis tests for 1,2-Dichlorobenzene and 1,2,4,5-Tetrachlorobenzene shall be completed and final results submitted to EPA within 9 months of the effective date of the final rule.
(e) Health effects testing—(1) Subchronic toxicity—(i) Required test. (A) An oral gavage subchronic toxicity test shall be conducted in the rat with the substances designated in paragraph (c) of this section except for bis(2-chloroethoxy) methane (CAS No. 111-91-1) in accordance with § 798.2650 of this chapter.
(B) For Bis(2-chloroethoxy)methane, an oral gavage subchronic toxicity test shall be conducted in the rat in accordance with § 798.2650 of this chapter except for the provisions in paragraphs (e)(9)(i)(A) and (e)(9)(i)(B). For Bis(2-chloroethoxy)methane, the following provisions also apply:
(1) Hematology determinations shall be carried out at least two times during the test period: Just after dosing on day 30 and just prior to terminal sacrifice. Hematology determinations which are appropriate to all studies are: Hematocrit, hemoglobin concentration, erythrocyte count, total and differential leukocyte count, and a measure of clotting potential such as clotting time, prothrombin time, thromboplastin time, or platelet count.
(2) Certain clinical biochemistry determinations on blood shall be carried out at least two times: Just after dosing on day 30 and just prior to terminal sacrifice. Test areas which are considered appropriate to all studies are: Electrolyte balance, carbohydrate metabolism, and liver and kidney function. The selection of specific tests will be influenced by observations on the mode of action of the substance. Suggested determinations are: Calcium, phosphorus, chloride, sodium, potassium, fasting glucose (with the period of fasting appropriate to the species), serum glutamic oxaloacetic transaminase (now known as serum aspartate aminotransferase), ornithine decarboxylase, gamma glutamyl transpeptidase, urea nitrogen, albumen blood creatinine, total bilirubin and total serum protein measurements. Other determinations which may be necessary for an adequate toxicological evaluation include: Analysis of lipids, hormones, acid/base balance, methemoglobin, and cholinesterase activity. Additional clinical biochemistry may be employed, where necessary, to extend the investigation of observed effects.
(ii) Reporting requirements. (A) The oral gavage subchronic tests with the substances designated in paragraph (c) of this section shall be completed and submitted to EPA within 12 months of the effective date of the final rule except that the tests with Bis(2-chloroethoxy)methane, 1,3-Dichloropropanol, and Malononitrile shall be completed and the results submitted to EPA within 15 months of the effective date of the final rule.
(B) Progress reports for each test shall be submitted to the Agency 6 months after the effective date of the final rule.
(2) [Reserved]
(f) Effective date. (1) The effective date of the final rule is July 29, 1988, except for paragraphs (d)(1)(i), (d)(1)(ii), (d)(2)(ii), (e)(1)(i), and (e)(1)(ii)(A) of this section. The effective date of paragraphs (d)(1)(i), (d)(1)(ii), (d)(2)(ii), (e)(1)(i)(B) and (e)(1)(ii)(A) of this section is March 1, 1990. The effective date of paragraph (e)(1)(i)(A), is May 21, 1991.
(2) The guidelines and other test methods cited here are referenced as they exist on the effective date of the final rule.
[53 FR 22324, June 15, 1988; 53 FR 48645, Dec. 2, 1988, as amended at 54 FR 49760, Dec. 1, 1989; 55 FR 7324, Mar. 1, 1990; 56 FR 23232, May 21, 1991; 58 FR 34205, June 23, 1993]