(a) What substances will be tested under this section? Table 2 in paragraph (j) of this section identifies the chemical substances that must be tested under this section. For the chemical substances identified as ``Class 1'' chemical substances in Table 2 in paragraph (j) of this section, the purity of each chemical substance must be 99% or greater, unless otherwise specified in this section. For the chemical substances identified as ``Class 2'' chemical substances in Table 2 in paragraph (j), a representative form of each chemical substance must be tested. The representative form selected for a given Class 2 chemical substance should meet industry or consensus standards where they exist.
(b) Am I subject to this section? (1) If you manufacture (including import) or intend to manufacture, or process or intend to process, any chemical substance listed in Table 2 in paragraph (j) of this section at any time from February 7, 2011 to the end of the test data reimbursement period as defined in 40 CFR 791.3(h), you are subject to this section with respect to that chemical substance.
(2) If you do not know or cannot reasonably ascertain that you manufacture or process a chemical substance listed in Table 2 in paragraph (j) of this section during the time period described in paragraph (b)(1) of this section (based on all information in your possession or control, as well as all information that a reasonable person similarly situated might be expected to possess, control, or know, or could obtain without unreasonable burden), you are not subject to this section with respect to that chemical substance.
(c) If I am subject to this section, when must I comply with it? (1)(i) Persons subject to this section are divided into two groups, as set forth in Table 1 of this paragraph: Tier 1 (persons initially required to comply), and Tier 2 (persons not initially required to comply). If you are subject to this section, you must determine if you fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.
Table 1--Persons Subject to the Rule: Persons in Tier 1 and Tier 2----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------Persons initially required to comply with this Persons not initially required to comply with this section
section (Tier 1). (Tier 2).Persons not otherwise specified in column 2 of Tier 2A. Persons who manufacture (as defined at TSCA section
this table that manufacture (as defined at 3(7)) or intend to manufacture a chemical substance included
TSCA section 3(7)) or intend to manufacture a in this section solely as one or more of the following:
chemical substance included in this section. --As a byproduct (as defined at 40 CFR 791.3(c));
--As an impurity (as defined at 40 CFR 790.3);
--As a naturally occurring substance (as defined at 40 CFR
710.4(b));
As a non-isolated intermediate (as defined at 40 CFR 704.3);
--As a component of a Class 2 substance (as described at 40 CFR
720.45(a)(1)(i));
--In amounts of less than 500 kg (1,100 lbs) annually (as
described at 40 CFR 790.42(a)(4)); or
--For research and development (as described at 40 CFR
790.42(a)(5)).
B. Persons who process (as defined at TSCA section 3(10)) or
intend to process a chemical substance included in this
section (see 40 CFR 790.42(a)(2)).----------------------------------------------------------------------------------------------------------------Note: kg--kilogram, TSCA--Toxic Substances Control Act.
(ii) Table 1 of paragraph (c)(1)(i) of this section expands the list of persons in Tier 2, that is, those persons specified in 40 CFR 790.42(a)(2), (a)(4), and (a)(5), who, while legally subject to this section, must comply with the requirements of this section only if directed to do so by EPA under the circumstances set forth in paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of this section.
(2) If you are in Tier 1 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, you must, for each test required under this section for that chemical substance, either submit to EPA a letter of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the exemption application must be received by EPA no later than March 9, 2011.
(3) If you are in Tier 2 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, you are considered to have an automatic conditional exemption and you will be required to comply with this section with regard to that chemical substance only if directed to do so by EPA under paragraphs (c)(5), (c)(7), or (c)(10) of this section.
(4) If no person in Tier 1 has notified EPA of its intent to conduct one or more of the tests required by this section on any chemical substance listed in Table 2 in paragraph (j) of this section on or before March 9, 2011, EPA will publish a Federal Register document that would specify the test(s) and the chemical substance(s) for which no letter of intent has been submitted and notify manufacturers in Tier 2A of their obligation to submit a letter of intent to test or to apply for an exemption from testing.
(5) If you are in Tier 2A (as specified in Table 1 in paragraph (c) of this section) with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, and if you manufacture, or intend to manufacture, this chemical substance as of February 7, 2011, or within 30 days after publication of the Federal Register document described in paragraph (c)(4) of this section, you must, for each test specified for that chemical substance in the document described in paragraph (c)(4) of this section, either submit to EPA a letter of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the exemption application must be received by EPA no later than 30 days after publication of the document described in paragraph (c)(4) of this section.
(6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its intent to conduct one or more of the tests required by this section on any chemical substance listed in Table 2 in paragraph (j) of this section within 30 days after the publication of the Federal Register document described in paragraph (c)(4) of this section, EPA will publish another Federal Register document that would specify the test(s) and the chemical substance(s) for which no letter of intent has been submitted, and notify processors in Tier 2B of their obligation to submit a letter of intent to test or to apply for an exemption from testing.
(7) If you are in Tier 2B (as specified in Table 1 in paragraph (c) of this section) with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, and if you process, or intend to process, this chemical substance as of February 7, 2011, or within 30 days after publication of the Federal Register document described in paragraph (c)(6) of this section, you must, for each test specified for that chemical substance in the document described in paragraph (c)(6) of this section, either submit to EPA a letter of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the exemption application must be received by EPA no later than 30 days after publication of the document described in paragraph (c)(6) of this section.
(8) If no manufacturer or processor has notified EPA of its intent to conduct one or more of the tests required by this section for any of the chemical substances listed in Table 2 in paragraph (j) of this section within 30 days after the publication of the Federal Register document described in paragraph (c)(6) of this section, EPA will notify all manufacturers and processors of those chemical substances of this fact by certified letter or by publishing a Federal Register document specifying the test(s) for which no letter of intent has been submitted. This letter or Federal Register document will additionally notify all manufacturers and processors that all exemption applications concerning the test(s) have been denied, and will give the manufacturers and processors of the chemical substance(s) an opportunity to take corrective action.
(9) If no manufacturer or processor has notified EPA of its intent to conduct one or more of the tests required by this section for any of the chemical substances listed in Table 2 in paragraph (j) of this section within 30 days after receipt of the certified letter or publication of the Federal Register document described in paragraph (c)(8) of this section, all manufacturers and processors subject to this section with respect to that chemical substance who are not already in violation of this section will be in violation of this section.
(10) If a problem occurs with the initiation, conduct, or completion of the required testing or the submission of the required data with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, under the procedures in 40 CFR 790.93 and 790.97, EPA may initiate termination proceedings for all testing exemptions with respect to that chemical substance and may notify persons in Tier 1 and Tier 2 that they are required to submit letters of intent to test or exemption applications within a specified period of time.
(11) If you are required to comply with this section, but your manufacture or processing of, or intent to manufacture or process, a chemical substance listed in Table 2 in paragraph (j) of this section begins after the applicable compliance date referred to in paragraphs (c)(2), (c)(5), or (c)(6) of this section, you must either submit a letter of intent to test or apply to EPA for an exemption. The letter of intent to test or the exemption application must be received by EPA no later than the day you begin manufacture or processing.
(d) What must I do to comply with this section? (1) To comply with this section you must either submit to EPA a letter of intent to test, or apply to and obtain from EPA an exemption from testing.
(2) For each test with respect to which you submit to EPA a letter of intent to test, you must conduct the testing specified in paragraph (h) of this section and submit the test data to EPA.
(3) You must also comply with the procedures governing test rule requirements in 40 CFR part 790 (except for those requirements listed in this paragraph as not applicable to this section), including the submission of letters of intent to test or exemption applications, the conduct of testing, and the submission of data; 40 CFR Part 792--Good Laboratory Practice Standards; and this section. The following provisions of 40 CFR part 790 do not apply to this section: Paragraphs (a), (d), (e), and (f) of Sec. 790.45; paragraph (a)(2) and paragraph (b) of Sec. 790.80; Sec. 790.82(e)(1); Sec. 790.85; and Sec. 790.48.
(e) If I do not comply with this section, when will I be considered in violation of it? You will be considered in violation of this section as of 1 day after the date by which you are required to comply with this section.
(f) How are EPA's data reimbursement procedures affected for purposes of this section? If persons subject to this section are unable to agree on the amount or method of reimbursement for test data development for one or more chemical substances included in this section, any person may request a hearing as described in 40 CFR part 791. In the determination of fair reimbursement shares under this section, if the hearing officer chooses to use a formula based on production volume, the total production volume amount will include amounts of a chemical substance produced as an impurity.
(g) Who must comply with the export notification requirements? Any person who exports, or intends to export, a chemical substance listed in Table 2 in paragraph (j) of this section is subject to 40 CFR part 707, subpart D.
(h) How must I conduct my testing? (1) The tests that are required for each chemical substance are indicated in Table 2 in paragraph (j) of this section. The test methods that must be followed are provided in Table 3 in paragraph (j) of this section. You must proceed in accordance with these test methods as required according to Table 3 in paragraph (j) of this section, or as appropriate if more than one alternative is allowed according to Table 3 in paragraph (j) of this section. Included in Table 3 in paragraph (j) of this section are the following 18 test methods which are incorporated by reference:
(i) Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals, ASTM E 324-99, approved September 10, 1999.
(ii) Standard Test Method for Partition Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography, ASTM E 1147-92 (Reapproved 2005), approved August 1, 2005.
(iii) Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians, ASTM E 729-96 (Reapproved 2007), approved October 1, 2007.
(iv) Standard Test Method for Measurements of Aqueous Solubility, ASTM E 1148-02 (Reapproved 2008), approved February 1, 2008.
(v) Standard Test Method for Estimating Acute Oral Toxicity in Rats, ASTM E 1163-98 (Reapproved 2002), approved October 10, 2002.
(vi) Standard Guide for Conducting Daphnia Magna Life-Cycle Toxicity Tests, ASTM E 1193-97 (Reapproved 2004), approved April 1, 2004.
(vii) Standard Guide for Conducting Static Toxicity Tests with Microalgae, ASTM E 1218-04\e1\, approved April 1, 2004.
(viii) Standard Test Method for Vapor Pressure of Liquids by Ebulliometry, ASTM E 1719-05, approved March 1, 2005.
(ix) Standard Test Method for Determining Ready, Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel CO2 Production Test. ASTM E 1720-01 (Reapproved 2008), approved February 1, 2008.
(x) Standard Test Method for Determining Vapor Pressure by Thermal Analysis, ASTM E 1782-08, approved March 1, 2008.
(xi) Water Quality--Evaluation of Ultimate Aerobic Biodegradability of Organic Compounds in Aqueous Medium--Method by Analysis of Inorganic Carbon in Sealed Vessels (CO2 Headspace Test). First Edition, March 15, 1999. ISO 14593:1999(E).
(xii) Water Quality--Evaluation in an Aqueous Medium of the ``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method by Analysis of Dissolved Organic Carbon (DOC). Second Edition, September 15, 1994. ISO 7827:1994(E).
(xiii) Water Quality--Evaluation of Ultimate Aerobic Biodegradability of Organic Compounds in Aqueous Medium by Determination of Oxygen Demand in a Closed Respirometer. Second Edition, August 1, 1999. ISO 9408:1999(E).
(xiv) Water Quality--Evaluation of Ultimate Aerobic Biodegradability of Organic Compounds in Aqueous Medium--Carbon Dioxide Evolution Test. Second Edition, March 1, 1999. ISO 9439:1999(E).
(xv) Water Quality--Evaluation in an Aqueous Medium of The ``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method by Analysis of Biochemical Oxygen Demand (Closed Bottle Test). First Edition, October 15, 1994. ISO 10707:1994(E).
(xvi) Water Quality--Evaluation in an Aqueous Medium of the Ultimate Aerobic Biodegradability of Organic Compounds--Determination of Biochemical Oxygen Demand in a Two-Phase Closed Bottle Test. First Edition, February 1, 1997. ISO 10708:1997(E).
(xvii) Water Quality--Guidance for the Preparation and Treatment of Poorly Water-Soluble Organic Compounds for the Subsequent Evaluation of Their Biodegradability in an Aqueous Medium. First Edition, August 15, 1995. ISO 10634:1995(E).
(xviii) Guideline for the Testing of Chemicals: Melting Point/Melting Range. OECD 102. July 27, 1995.
(2) The Director of the Federal Register approved this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of the ASTM test methods from the American Society for Testing and Materials, 100 Bar Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, telephone number: (610) 832-9585, web address: http://www.astm.org; copies of the ISO test methods from the International Organization for Standardization, 1, ch. de la Voie-Creuse, Case postale, 56 CH-1211 Geneve 20 Switzerland, telephone number: +41 22 749 01 11, web address: http://www.iso.org; and a copy of the OECD guideline from the Organization for Economic Cooperation and Development, 2, rue Andr[eacute] Pascal,75775 Paris Cedex 16 France, telephone number: +33 1 45 24 82 00, web address: http://www.oecd.org. You may inspect each test method and guideline at the EPA Docket Center, EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(i) Reporting requirements. A final report for each specific test for each subject chemical substance must be received by EPA by March 7, 2012, unless an extension is granted in writing pursuant to 40 CFR 790.55. A robust summary of the final report for each specific test should be submitted in addition to and at the same time as the final report. The term ``robust summary'' is used to describe the technical information necessary to adequately describe an experiment or study and includes the objectives, methods, results, and conclusions of the full study report which can be either an experiment or in some cases an estimation or prediction method. Guidance for the compilation of robust summaries is described in a document entitled ``Draft Guidance on Developing Robust Summaries'' which is available on-line: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
(j) Designation of specific chemical substances and testing requirements. The chemical substances identified by chemical name, Chemical Abstract Service Registry Number (CASRN), and class in Table 2 of this paragraph must be tested in accordance with the requirements designated in Tables 2 and 3 of this paragraph, and the requirements described in 40 CFR part 792--Good Laboratory Practice Standards:
Table 2--Chemical Substances and Testing Requirements------------------------------------------------------------------------
Required tests/
CASRN Chemical name Class (See table 3 of
this section)------------------------------------------------------------------------75-07-0............... Acetaldehyde..... 1 C2, F2.78-11-5............... 1,3-Propanediol, 1 C4.
2,2-bis
[(nitrooxy)
methyl]-,
dinitrate
(ester).84-65-1............... 9,10- 1 C6.
Anthracenedione.89-32-7............... 1H,3H-Benzo [1,2- 1 A3, A4, A5, B,
c:4,5-c'] C1, D, E1, F1.
difuran-1,3,5,7-
tetrone.110-44-1.............. 2,4-Hexadienoic 1 C6.
acid, (E,E)-.118-82-1.............. Phenol, 4,4'- 1 C1.
methylenebis
[2,6-bis (1,1-
dimethylethyl)-.119-61-9.............. Methanone, 1 B, C2.
diphenyl-.144-62-7.............. Ethanedioic acid. 1 A1, A2, A3, A5,
B, C1, E2.149-44-0.............. Methanesulfinic 1 E1.
acid,.
hydroxy-,
monosodium salt.2524-04-1............. Phosphorochlorido 1 A1, A2, A3, A4,
thioic acid, O,O- A5, B, C1, E1,
diethyl ester. E2, F2.4719-04-4............. 1,3,5-Triazine- 1 C6.
1,3,5(2H,4H,6H)-
triethanol.6381-77-7............. D-erythro-hex-2- 1 A4, B, C1.
enonic acid,
gamma.-lactone,
monosodium salt.31138-65-5............ D-gluco-heptonic 1 A1, A2, A4, A5,
acid, monosodium B, C1, D, E1,
salt, (2.xi.)-. E2, F1.66241-11-0............ C.I. Leuco 2 A1, A2, A3, A4,
Sulphur Black 1. A5, B, C1, D,
E1, E2, F1.68187-76-8............ Castor oil, 2 A1, A2, C1, D,
sulfated, sodium E1, E2, F1.
salt.68187-84-8............ Castor oil, 2 A1, A2, B, E1,
oxidized. E2, F1.68479-98-1............ Benzenediamine, 1 A1, A3, A4, A5,
ar,ar-diethyl-ar- C1, E1, E2, F1.
methyl-.68527-02-6............ Alkenes, C12 24, 2 A1, A2, A3, A4,
chloro. A5, B, C1, E2,
F2.68647-60-9............ Hydrocarbons, C 2 A2, A3, A5, B,
4. C1, D, E1, E2,
F1.------------------------------------------------------------------------Note: CASRN = Chemical Abstract Service Registry Number.
Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of this Paragraph
[Note: The ASTM and ISO test methods and the OECD guideline required in this paragraph are incorporated by
reference; see paragraph (h) of this section.]----------------------------------------------------------------------------------------------------------------
Test requirements and
Testing category Test symbol references Special conditions----------------------------------------------------------------------------------------------------------------Physical/chemical properties....... A 1. Melting Point: American n-Octanol/water Partition
Society for Testing and Coefficient (log 10 basis)
Materials (ASTM) E 324-99 or log KOW:
(capillary tube), if a Which method is required,
Freezing Point: if any, is determined by
Organization for Economic the test substance's
Cooperation and estimated \i\ log KOW as
Development (OECD) 102 follows:
(melting point/melting log KOW <0: No testing
range). required.
2. Boiling Point: ASTM E log KOW range 0-1: Method A
1719-05 (ebulliometry). or B.
3. Vapor Pressure: ASTM E log KOW range >1-4: Method
1782-08 (thermal analysis). A, B, or C.
4. n-Octanol/Water log KOW range >4-6: Method
Partition Coefficient (log B or C.
10 basis) or log KOW: (See log KOW >6: Method C.
Special Conditions for the Test sponsors must provide
log KOW test requirement in the final study report
and select the appropriate the underlying rationale
method to use, if any, for the method and pH
from those listed in this selected. In order to
column.). ensure environmental
Method A: 40 CFR 799.6755 relevance, EPA highly
(shake flask). recommends that the
Method B: ASTM E 1147-92 selected study be
(Reapproved 2005) (liquid conducted at pH 7.
chromatography). Water Solubility:
Method C: 40 CFR 799.6756 Which method is required,
(generator column). if any, is determined by
5. Water Solubility: (See the test substance's
Special Conditions for the estimated \ii\ water
water solubility test solubility. Test sponsors
requirement and select the must provide in the final
appropriate method to use, study report the
if any, from those listed underlying rationale for
in this column.). the method and pH
Method A: ASTM E 1148-02 selected. In order to
(Reapproved 2008) (shake ensure environmental
flask). relevance, EPA highly
Method B: 40 CFR 799.6784 recommends that the
(shake flask). selected study be
Method C: 40 CFR 799.6784 conducted starting at pH
(column elution). 7.
Method D: 40 CFR 799.6786 5,000 milligram/
(generator column). Liter (mg/L): Method A or
B.
10 mg/L-5,000 mg/
L: Method A, B, C, or D.
0.001 mg/L-10 mg/
L: Method C or D.
<=0.001 mg/L: No testing
required.Environmental fate and pathways-- B For B, consult Which method is required,
ready biodegradation. International Organization if any, is determined by
for Standardization (ISO) the test substance's
10634:1995(E) for physical and chemical
guidance, and choose one properties, including its
of the methods listed in water solubility. ISO
this column:. 10634:1995(E) provides
1. ASTM E 1720-01 guidance for selection of
(Reapproved 2008) (sealed an appropriate test method
vessel CO2 production for a given test
test) OR. substance. Test sponsors
2. ISO 14593:1999(E) (CO2 must provide in the final
headspace test) OR. study report the
3. ISO 7827:1994(E) underlying rationale for
(analysis of DOC) OR. the method selected.
4. ISO 9408:1999(E)
(determination of oxygen
demand in a closed
respirometer) OR.
................. 5. ISO 9439:1999(E) (CO2
evolution test) OR.
................. 6. ISO 10707:1994(E)
(closed bottle test) OR.
................. 7. ISO 10708:1997(E) (two-
phase closed bottle test).
Aquatic toxicity................... C1 For C1, Test Group 1 or The following are the
Test Group 2 listed in special conditions for C1,
this column must be used C2, C3, C4, C5, and C7
to fulfill the testing testing; there are no
requirements--See Special special conditions for C6.
Conditions.. Which test group is
Test Group 1 for C1:....... required is determined by
1. Acute Toxicity to Fish: the test substance's
ASTM E 729-96 (Reapproved measured log KOW as
2007). obtained under Test
2. Acute Toxicity to Category A, or using an
Daphnia: ASTM E 729-96 existing measured log KOW.
(Reapproved 2007). \iii\
3. Toxicity to Plants If log KOW <4.2: Test Group
(Algae): ASTM E 1218-04 1 is required.
\e1\. If log KOW =
Test Group 2 for C1:....... 4.2: Test Group 2 is
1. Chronic Toxicity to required
Daphnia: ASTM E 1193-97
(Reapproved 2004).
2. Toxicity to Plants
(Algae): ASTM E 1218--04
\e1\.
C2 For C2, Test Group 1 or
Test Group 2 listed in
this column must be used
to fulfill the testing
requirements--See Special
Conditions..
................. Test Group 1 for C2:.......
................. 1. Acute Toxicity to
Daphnia: ASTM E 729-96
(Reapproved 2007).
................. 2. Toxicity to Plants
(Algae): ASTM E 1218-04
\e1\.
................. Test Group 2 for C2:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
................. 2. Toxicity to Plants
(Algae): ASTM E 1218-04
\e1\.
C3 For C3, Test Group 1 or
Test Group 2 listed in
this column must be used
to fulfill the testing
requirements--See Special
Conditions..
................. Test Group 1 for C3:.......
................. 1. Acute Toxicity to Fish:
ASTM E 729-96 (Reapproved
2007).
................. 2. Toxicity to Plants
(Algae): ASTM E 1218-04
\e1\.
................. Test Group 2 for C3:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
................. 2. Toxicity to Plants
(Algae): ASTM E 1218-04
\e1\.
C4 For C4, Test Group 1 or
Test Group 2 listed in
this column must be used
to fulfill the testing
requirements--See Special
Conditions..
................. Test Group 1 for C4:.......
................. 1. Acute Toxicity to Fish:
ASTM E 729-96 (Reapproved
2007).
................. 2. Acute Toxicity to
Daphnia: ASTM E 729-96
(Reapproved 2007).
................. Test Group 2 for C4:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
C5 For C5, Test Group 1 or
Test Group 2 listed in
this column must be used
to fulfill the testing
requirements--See Special
Conditions..
................. Test Group 1 for C5:.......
................. 1. Acute Toxicity to
Daphnia: ASTM E 729-96
(Reapproved 2007).
................. Test Group 2 for C5:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).
C6 Toxicity to Plants (Algae):
ASTM E 1218-04 \e1\.
C7 For C7, Test Group 1 or
Test Group 2 listed in
this column must be used
to fulfill the testing
requirements--See Special
Conditions..
................. Test Group 1 for C7:.......
................. 1. Acute Toxicity to Fish:
ASTM E 729-96 (Reapproved
2007).
................. Test Group 2 for C7:.......
................. 1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004).Mammalian toxicity--acute.......... D See special conditions for Which testing method is
this test requirement and required is determined by
select the method that the test substance's
must be used from those physical state at room
listed in this column.. temperature (25 [deg]C).
Method A: Acute Inhalation For those test substances
Toxicity (rat): 40 CFR that are gases at room
799.9130. temperature, Method A is
Method B: EITHER:.......... required; otherwise, use
1. Acute (Up/Down) Oral either of the two methods
Toxicity (rat): ASTM E listed under Method B.
1163-98 (Reapproved 2002). In Method B, 40 CFR
OR........................ 799.9110(d)(1)(i)(A)
2. Acute (Up/Down) Oral refers to the OECD 425 Up/
Toxicity (rat): 40 CFR Down Procedure.\iv\
799.9110(d)(1)(i)(A). Estimating starting dose
for Method B: Data from
the neutral red uptake
basal cytotoxicity assay
\v\ using normal human
keratinocytes or mouse
BALB/c 3T3 cells may be
used to estimate the
starting dose.Mammalian toxicity--genotoxicity... E1 Bacterial Reverse Mutation None
Test (in vitro): 40 CFR
799.9510.
E2 Conduct any one of the Persons required to conduct
following three tests for testing for chromosomal
chromosomal damage: In damage are encouraged to
vitro Mammalian Chromosome use the in vitro Mammalian
Aberration Test: 40 CFR Chromosome Aberration Test
799.9537. (40 CFR 799.9537) to
OR........................ generate the needed data
Mammalian Bone Marrow unless known chemical
Chromosomal Aberration properties (e.g., physical/
Test (in vivo in rodents: chemical properties,
mouse (preferred species), chemical class
rat, or Chinese hamster): characteristics) preclude
40 CFR 799.9538. its use. A subject person
OR........................ who uses one of the in
Mammalian Erythrocyte vivo methods instead of
Micronucleus Test [sampled the in vitro method to
in bone marrow] (in vivo address a chromosomal
in rodents: Mouse damage test requirement
(preferred species), rat, must submit to EPA a
or Chinese hamster): 40 rationale for conducting
CFR 799.9539. that alternate test in the
final study report.Mammalian toxicity--repeated dose/ F1 Combined Repeated Dose Where F1 is required, EPA
reproduction/developmental. Toxicity Study with the recommends use of the
Reproduction/Developmental Combined Repeated Dose
Toxicity Screening Test: Toxicity Study with the
40 CFR 799.9365. Reproduction/Developmental
OR........................ Toxicity Screening Test
Reproduction/Developmental (40 CFR 799.9365).
Toxicity Screening Test: However, there may be
40 CFR 799.9355. valid reasons to test a
AND....................... particular chemical using
Repeated Dose 28-Day Oral both 40 CFR 799.9355 and
Toxicity Study in rodents: 40 CFR 799.9305 to fill
40 CFR 799.9305. Mammalian Toxicity--
Repeated Dose/Reproduction/
Developmental data needs.
A subject person who uses
the combination of 40 CFR
799.9355 and 40 CFR
799.9305 in place of 40
CFR 799.9365 must submit
to EPA a rationale for
conducting these alternate
tests in the final study
reports. Where F2 or F3 is
required, no rationale for
conducting the required
test need be provided in
the final study report.
F2 Reproduction/Developmental
Toxicity Screening Test:
40 CFR 799.9355.
F3 Repeated Dose 28-Day Oral
Toxicity Study in rodents:
40 CFR 799.9305.----------------------------------------------------------------------------------------------------------------\i\ EPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this
study. One method, among many similar methods, for estimating log KOW is described in the article entitled
``Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients'' by W.M. Meylan and
P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available
in docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744, from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays.\ii\ EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating
this study. One method, among many similar methods, for estimating water solubility is described in the
article entitled ``Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient''
by W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100-106.
1996. This reference is available in docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm.
3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744,
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.\iii\ Chemical substances that are dispersible in water may have log KOW values greater than 4.2 and may still
be acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such
chemicals may request a modification to the test standard as described in 40 CFR 790.55. Based upon the
supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used
for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.\iv\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available in docket ID number EPA-HQ-
OPPT-2007-0531 at the EPA Docket Center, Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC
20004, telephone number: (202) 566-1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.\v\ The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the
mammalian toxicity-acute endpoint, is available in docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket
Center, Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202)
566-1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. [76 FR 1087, Jan. 7, 2011, as amended at 76 FR 4550, Jan. 26, 2011]