(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 November 21, 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 Persons not initially required to
comply with this section (Tier 1) comply with this section (Tier 2)------------------------------------------------------------------------Persons not otherwise specified in A. Persons who manufacture (as
column 2 of this table that defined at TSCA section 3(7)) or
manufacture (as defined at TSCA intend to manufacture a chemical
section 3(7)) or intend to substance included in this section
manufacture a chemical substance solely as one or more of the
included in this section. following:
--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 lb) 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: kgs--kilograms, 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 December 20, 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 December 20, 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 November 21, 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 November 21, 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 submit a study plan and 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, submission of study plans, 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; Sec. 790.48; paragraphs (a)(2) and (b) of Sec. 790.80; paragraph (e)(1) of Sec. 790.82; and Sec. 790.85.
(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 standards from ASTM International, 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 standards from the International Organization for Standardization, 1, ch. de la Voie-Creuse, CP 56, CH-1211 Geneve 20, Switzerland, telephone number: +41-22-749-01-11, Web address: http://www.iso.org; and copies 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 standard and guideline at the EPA Docket Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. The materials are also available for inspection 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 study plan for each specific test for each subject chemical substance must be received by EPA by February 20, 2012 unless an extension is granted in writing pursuant to 40 CFR 790.55. A final report for each specific test for each subject chemical substance must be received by EPA by December 21, 2012 unless an extension is granted in writing pursuant to 40 CFR 790.55. EPA is also requesting that a robust summary of the final report for each specific test 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 online at 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)------------------------------------------------------------------------98-09-9............... Benzenesulfonyl 1 C2, E1, E2, F1
chloride.98-56-6............... Benzene, 1-chloro- 1 B, C6
4-
(trifluoromethyl
)-.111-44-4.............. Ethane, 1,1'- 1 C6, F1
oxybis[2-chloro-.127-68-4.............. Benzenesulfonic 1 A3, F2
acid, 3-nitro-,
sodium salt
(1:1).515-40-2.............. Benzene, (2- 1 A1, A3, A4, A5,
chloro-1,1- B, C1, D, E1,
dimethylethyl)-. E2, F12494-89-5............. Ethanol, 2-[(4- 1 A1, A2, A3, A4,
aminophenyl)sulf A5, B, C1, D,
onyl]-, 1- E1, E2, F1
(hydrogen
sulfate).5026-74-4............. 2- 1 A1, A2, A3, A4,
Oxiranemethanami A5, B, C2, F1
ne, N-[4-(2-
oxiranylmethoxy)
phenyl]-N-(2-
oxiranylmethyl)-22527-63-5............ Propanoic acid, 2- 1 A1, A2, A3, A4,
methyl-, 3- A5, B, C1, D,
(benzoyloxy)- E1, E2, F1
2,2,4-
trimethylpentyl
ester.
25321-41-9............ Benzenesulfonic 1 A2, A3, A4
acid, dimethyl-.52556-42-0............ 1-Propanesulfonic 1 A1, A2, A3, A4,
acid, 2-hydroxy- A5, B, C1, D,
3-(2-propen-1- E1, E2, F1
yloxy)-, sodium
salt (1:1).68082-78-0............ Lard, oil, Me 2 A1, A2, A3, A4,
esters. A5, B, C1, D,
E1, E2, F168442-60-4............ Acetaldehyde, 2 A1, A2, A3, A4,
reaction A5, B, C1, D,
products with E1, E2, F1
formaldehyde, by-
products from68610-90-2............ 2-Butenedioic 2 A1, A2, A3, A4,
acid (2E)-, di- A5, B, C1, D,
C8-18-alkyl E1, E2, F1
esters.70693-50-4............ Phenol, 2,4-bis(1- 1 A1, A2, A3, A4,
methyl-1- A5, B, C1, D,
phenylethyl)-6- E1, E2, F1
[2-(2-
nitrophenyl)diaz
enyl]-.72162-15-3............ 1-Decene, 2 A2, A3, A4, A5,
sulfurized. B, C1, D, E1,
E2, F1------------------------------------------------------------------------
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 Test requirements and
Testing category symbol references Special conditions----------------------------------------------------------------------------------------------------------------Physical/chemical properties.......... A 1. Melting Point: ASTM n-Octanol/water Partition
International (ASTM) E 324-99 Coefficient (log 10 basis)
(capillary tube), if a or--log Kow:
Freezing Point: Organization Which method is required, if
for Economic Cooperation and any, is determined by the
Development (OECD) 102 test substance's estimated
(melting point/melting \i\ log Kow as follows:
range). log Kow <0: no testing
2. Boiling Point: ASTM E 1719- required.
05 (ebulliometry).. log Kow range 0-1: Method A or
3. Vapor Pressure: ASTM E 1782- B.
08 (thermal analysis).. log Kow range >1-4: Method A,
4. n-Octanol/Water Partition B, or C.
Coefficient (log 10 basis) or log Kow range >4-6: Method B
log Kow: (See Special or C.
Conditions for the log Kow log Kow >6: Method C.
test requirement and select Test sponsors must provide in
the appropriate method to the final study report the
use, if any, from those underlying rationale for the
listed in this column.). method and pH selected. In
Method A: 40 CFR 799.6755 order to ensure environmental
(shake flask).. relevance, EPA highly
Method B: ASTM E 1147-92 recommends that the selected
(Reapproved 2005) (liquid study be conducted at pH 7.
chromatography).. Water Solubility:
Method C: 40 CFR 799.6756 Which method is required, if
(generator column).. any, is determined by the
5. Water Solubility: (See test substance's estimated
Special Conditions for the \ii\ water solubility. Test
water solubility test sponsors must provide in the
requirement and select the final study report the
appropriate method to use, if underlying rationale for the
any, from those listed in method and pH selected. In
this column.). order to ensure environmental
Method A: ASTM E 1148-02 relevance, EPA highly
(Reapproved 2008) (shake recommends that the selected
flask).. study be conducted starting
Method B: 40 CFR 799.6784 at pH 7.
(shake flask).. 5,000 milligram/
Method C: 40 CFR 799.6784 Liter (mg/L): Method A or B.
(column elution).. 10 mg/L-5,000 mg/L:
Method D: 40 CFR 799.6786 Method A, B, C, or D.
(generator column).. 0.001 mg/L-10 mg/L:
Method C or D.
<=0.001 mg/L: No testing
required.Environmental fate and pathways--ready B For B, consult International Which method is required, if
biodegradation. Organization for any, is determined by the
Standardization (ISO) test substance's physical and
10634:1995(E) for guidance, chemical properties,
and choose one of the methods including its water
listed in this column: solubility. ISO 10634:1995(E)
1. ASTM E 1720-01 (Reapproved provides guidance for
2008) (sealed vessel CO2 selection of an appropriate
production test) OR. test method for a given test
2. ISO 14593:1999(E) (CO2 substance. Test sponsors must
headspace test) OR. provide in the final study
3. ISO 7827:1994(E) (analysis report the underlying
of DOC) OR. rationale for the method
4. ISO 9408:1999(E) selected.
(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 Test The following are the special
Group 2 listed in this column conditions for C1, C2, C3,
must be used to fulfill the C4, C5, and C7 testing; there
testing requirements--See are no special conditions for
Special Conditions. C6.
Test Group 1 for C1:.......... Which test group is required
1. Acute Toxicity to Fish: is determined by the test
ASTM E 729-96 (Reapproved substance's measured log Kow
2007).. as obtained under Test
2. Acute Toxicity to Daphnia: Category A, or using an
ASTM E 729-96 (Reapproved existing measured log
2007).. Kow.\iii\
3. Toxicity to Plants (Algae): If log Kow <4.2: Test Group 1
ASTM E 1218-04 e1. is required.
Test Group 2 for C1:.......... If log Kow [gteqt] 4.2: Test
1. Chronic Toxicity to Group 2 is 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..
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: 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: Acute
Toxicity to Daphnia: ASTM E
729-96 (Reapproved 2007)..
Test Group 2 for C5: 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: Acute
Toxicity to Fish: ASTM E 729-
96 (Reapproved 2007)..
Test Group 2 for C7: 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 the
select the method that must test substance's physical
be used from those listed in state at room temperature (25
this column. [deg]C). For those test
Method A: Acute Inhalation substances that are gases at
Toxicity (rat): 40 CFR room temperature, Method A is
799.9130. required; otherwise, use
Method B: EITHER:............. either of the two methods
1. Acute (Up/Down) Oral listed under Method B.
Toxicity (rat): ASTM E 1163- In Method B, 40 CFR
98 (Reapproved 2002). 799.9110(d)(1)(i)(A) refers
OR........................... to the OECD 425 Up/Down
2. Acute (Up/Down) Oral Procedure.\iv\
Toxicity (rat): 40 CFR Estimating starting dose for
799.9110(d)(1)(i)(A).. 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: damage are encouraged to use
In vitro Mammalian Chromosome the in vitro Mammalian
Aberration Test: 40 CFR Chromosome Aberration Test
799.9537.. (40 CFR 799.9537) to generate
OR............................ the needed data unless known
Mammalian Bone Marrow chemical properties (e.g.,
Chromosomal Aberration Test physical/chemical properties,
(in vivo in rodents: mouse chemical class
(preferred species), rat, or characteristics) preclude its
Chinese hamster): 40 CFR use. A subject person who
799.9538. uses one of the in vivo
OR........................... methods instead of the in
Mammalian Erythrocyte vitro method to address a
Micronucleus Test [sampled in chromosomal damage test
bone marrow] (in vivo in requirement must submit to
rodents: Mouse (preferred EPA a rationale for
species), rat, or Chinese conducting that alternate
hamster): 40 CFR 799.9539.. 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: 40 Toxicity Study with the
CFR 799.9365 Reproduction/Developmental
OR........................... Toxicity Screening Test (40
Reproduction/Developmental CFR 799.9365). However, there
Toxicity Screening Test: 40 may be valid reasons to test
CFR 799.9355. a particular chemical using
AND.......................... both 40 CFR 799.9355 and 40
Repeated Dose 28-Day Oral CFR 799.9305 to fill
Toxicity Study in rodents: 40 Mammalian Toxicity--Repeated
CFR 799.9305.. 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. 1995. This reference is available in
docket ID number EPA-HQ-OPPT-2009-0112 at the EPA Docket Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number
for the OPPT Docket is (202) 566-0280.\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-2009-0112 at the EPA Docket Center (EPA/DC),
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-
1744, and the telephone number for the OPPT Docket is (202) 566-0280.\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 chemical
substances 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 chemical
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 (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW.,
Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone
number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280.\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-2009-0112 at the EPA Docket
Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. [76 FR 65404, Oct. 21, 2011]