(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'' substances in Table 2 in paragraph (j) of this section, the purity of each chemical substance must be 99% or greater, except for 1,3-propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester) (CAS No. 78-11-5), also known as pentaerythritol tetranitrate (PETN). PETN cannot be tested at 99% purity because of its explosive properties. It must be diluted in water or tested as a stabilized mixture with an appropriate stabilizer (e.g., D-lactose monohydrate is the stabilizer in PETN, NF which is a mixture of 20% by weight PETN and 80% by weight D-lactose monohydrate). The stabilizer used must be tested as a control. For the chemical substances identified as ``Class 2'' 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 April 17, 2006 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 an 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 not initially required
Persons initially required to comply to comply with this section
with this section (Tier 1) (Tier 2)------------------------------------------------------------------------Persons not otherwise specified in A. Persons who manufacture (as
column 2 of this table that defined at TSCA section 3(7))
manufacture (as defined at TSCA or intend to manufacture a
section 3(7)) or intend to manufacture chemical substance included in
a chemical substance included in this this section solely as one or
section. more of the 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 lbs.) annually (as
described at 40 CFR
790.42(a)(4)); or
--For R & D (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)).------------------------------------------------------------------------
(ii) Table 1 of paragraph (c)(1)(i) of this section expands the list of persons specified in Sec. 790.42(a)(2), (a)(4), and (a)(5) of this chapter, 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)(5) and (c)(8) 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 May 15, 2006.
(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) or (c)(8) 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 by May 15, 2006, EPA will publish a Federal Register document that will specify the test(s) and the chemical substance(s) for which no letter of intent has been submitted, and notify manufacturers and processors in Tier 2 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 2 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, and if you manufacture or process this chemical substance as of April 17, 2006, 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 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)(4) 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.
(7) 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)(6) 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.
(8) 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 Sec. Sec. 790.93 and 790.97 of this chapter, 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.
(9) If you are required to comply with this section, but your manufacturing or processing of 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)(8) 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 manufacturing 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 part 790 of this chapter, as modified by this section, including the submission of letters of intent to test or exemption applications, the conduct of testing, and the submission of data; Part 792--Good Laboratory Practice Standards of this chapter; 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. Sec. 790.80; 790.82(e)(1); 790.85; and 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 part 707, subpart D, of this chapter.
(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 11 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.
(ii) Standard Test Method for Partition Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography, ASTM E 1147-92. (Reapproved 1997)
(iii) Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians, ASTM E 729-96. (Reapproved 2002)
(iv) Standard Test Method for Measurements of Aqueous Solubility, ASTM E 1148-02.
(v) Standard Test Method for Estimating Acute Oral Toxicity in Rats, ASTM E 1163-98. (Reapproved 2002)
(vi) Standard Guide for Conducting Daphnia Magna Life-Cycle Toxicity Tests, ASTM E 1193-97. (Reapproved 2004)
(vii) Standard Guide for Conducting Static Toxicity Tests with Microalgae, ASTM E 1218-04.
(viii) Standard Test Method for Determining Biodegradability of Organic Chemicals in Semi-Continuous Activated Sludge (SCAS), ASTM E 1625-94. (Reapproved 2001)
(ix) Standard Test Method for Vapor Pressure of Liquids by Ebulliometry, ASTM E 1719-97.
(x) Standard Test Method for Determining Vapor Pressure by Thermal Analysis, ASTM E 1782-03.
(xi) Water Quality--Evaluation of Ultimate Aerobic Biodegradability of Organic Compounds in Aqueous Medium--Static Test (Zahn-Wellens Method), Second Edition, June 1, 1999, ISO 9888-99.
(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 guidelines from the American Society for Testing and Materials, 100 Bar Harbor Dr., West Conshohocken, PA 19428-2959, and a copy of the ISO guideline from the International Organization for Standardization, Case Postale, 56 CH-1211 Geneve 20 Switzerland. You may inspect each test method at the EPA Docket Center, EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC 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/code--of--federal--regulations/ibr--locations.html.
(i) Reporting requirements. A final report for each specific test for each subject chemical substance must be received by EPA by May 17, 2007, 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 at: http://www.epa.gov/chemrtk/robsumgd.htm.
(j) Designation of specific chemical substances and testing requirements. The chemical substances identified by chemical name, Chemical Abstract Service Number (CAS No.), 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 (see table 3 of this
CAS No. Chemical name Class section)----------------------------------------------------------------------------------------------------------------74-95-3..................... Methane, dibromo-...... 1 A, C1, E2, F2.78-11-5..................... 1,3-Propanediol, 2,2- 1 A4, A5, B, C6, F2.
bis[(nitrooxy)methyl]-
, dinitrate (ester).84-65-1..................... 9,10-Anthracenedione... 1 A4, A5, F2.110-44-1.................... 2,4-Hexadienoic acid, 1 A, C4.
(E,E)-.112-52-7.................... 1-Chlorododecane....... 1 A2, A3, A4, A5, B, C3, D, E1, E2, F1.118-82-1.................... Phenol, 4,4'- 1 A1, A2, A3, B, E2.
methylenebis[2,6bis(1,
1-dimethylethyl)]-.149-44-0.................... Methanesulfinic acid, 1 A1, A5, E2, F1.
hydroxy-, monosodium
salt.
409-02-9.................... Heptenone, methyl-..... 2 A, B, C1, D, E1, E2, F1.594-42-3.................... Methanesulfenyl 1 A, B, C1, E1, E2, F2.
chloride, trichloro-.1324-76-1................... Benzenesulfonic acid, 2 A4, C2, F1.
[[4-[[4-
(phenylamino)phenyl][4-
(phenylimino)-2,5-
cyclohexadien-1-
ylidene]methyl]phenyl]
amino]-2941-64-2................... Carbonochloridothioic 1 A, B, C1, E2, F1.
acid, S-ethyl ester.8005-02-5................... C.I. Solvent Black 7... 2 A, F2.----------------------------------------------------------------------------------------------------------------
Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph----------------------------------------------------------------------------------------------------------------
Test requirements and
Testing category Test symbol references Special conditions----------------------------------------------------------------------------------------------------------------Physical/chemical properties A 1. Melting Point: ASTM n-Octanol/water
E 324 (capillary tube) Partition Coefficient
2. Boiling Point: ASTM or log Kow:
E 1719 (ebulliometry). Which method is
3. Vapor Pressure: ASTM required, if any, is
E 1782 (thermal determined by the test
analysis). substance's estimated
4. n-Octanol/Water \1\ log Kow as
Partition Coefficient follows:
(log 10 basis) or log log Kow <0: no testing
Kow: (See special required.
conditions for the log log Kow range 0-1:
Kow test requirement Method A or B.
and select the log Kow range >1-4:
appropriate method to Method A or B or C.
use, if any, from log Kow range >4-6:
those listed in this Method B or C.
column.). log Kow >6: Method C.
Method A: 40 CFR Test sponsors are
799.6755 (shake flask). required to provide in
Method B: ASTM E 1147 the final study report
(liquid the underlying
chromatography). rationale for the
Method C: 40 CFR method selected. In
799.6756 (generator order to ensure
column). environmental
5. Water Solubility: relevance, EPA highly
(See special recommends that the
conditions for the selected study be
water solubility test conducted at pH 7.
requirement and select Water Solubility:
the appropriate method Which method is
to use, if any, from required, if any, is
those listed in this determined by the test
column.). substance's estimated
Method A: ASTM E 1148 \2\ water solubility.
(shake flask). Test sponsors are
Method B: 40 CFR required to provide in
799.6784 (shake flask). the final study report
Method C: 40 CFR the underlying
799.6784 (column rationale for the
elution). method selected. In
Method D: 40 CFR order to ensure
799.6786 (generator environmental
column). relevance, EPA highly
recommends that the
selected study be
conducted at pH 7.
5,000 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, choose either of None
Inherent biodegradation the methods listed in
this column:
1. ASTM 1625
(semicontinuous
activated sludge test)
OR.
2. ISO 9888 (Zahn-
Wellens method).----------------------------------------------------------------------------------------------------------------Aquatic toxicity C1 For C1, Test Group 1 or The following are the
Test Group 2 listed in special conditions for
this column must be C1, C2, C3, C4, C5,
used to fulfill the and C7 testing; there
testing requirements-- are no special
See special conditions for C6.
conditions. If log Kow <4.2: Test
Test Group 1 for C1:... Group 1 is required
1. Acute Toxicity to If log Kow >=4.2: Test
Fish: ASTM E 729. Group 2 is required
2. Acute Toxicity to Which test group is
Daphnia: ASTM E 729. required is determined
3. Toxicity to Plants by the test
(Algae): ASTM E 1218. substance's measured
Test Group 2 for C1:... log Kow as obtained
1. Chronic Toxicity to under A\3\.
Daphnia: ASTM E 1193.
2. Toxicity to Plants
(Algae): ASTM E 1218.
--------------------------------------------------
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.
2. Toxicity to Plants
(Algae): ASTM E 1218.
Test Group 2 for C2:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
2. Toxicity to Plants
(Algae): ASTM E 1218.
--------------------------------------------------
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.
2. Toxicity to Plants
(Algae): ASTM E 1218.
Test Group 2 for C3:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
2. Toxicity to Plants
(Algae): ASTM E 1218.
--------------------------------------------------------------------------
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.
2. Acute Toxicity to
Daphnia: ASTM E 729.
Test Group 2 for C4:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
--------------------------------------------------------------------------
C5 For C5, Test Group 1 or
Test Group 2 below
must be used to
fulfill the testing
requirements--See
special conditions.
Test Group 1 for C5:...
1. Acute Toxicity to
Daphnia: ASTM E 729.
Test Group 2 for C5:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
--------------------------------------------------------------------------
C6 Toxicity to Plants
(Algae): ASTM E 1218
--------------------------------------------------------------------------
C7 For C7, Test Group 1 or .......................
Test Group 2 of 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.
Test Group 2 for C7:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.----------------------------------------------------------------------------------------------------------------Mammalian toxicity--Acute D See special conditions Which testing method is
for this test required is determined
requirement and select by the test
the method that must substance's physical
be used from those state at room
listed in this column. temperature (25
Method A: Acute [deg]C). For those
Inhalation Toxicity test substances that
(rat): 40 CFR 799.9130. are gases at room
Method B: EITHER:...... temperature, Method A
1. Acute (Up/Down) Oral is required;
Toxicity (rat): ASTM E otherwise, use either
1163 OR. of the two methods
2. Acute (Up/Down) Oral listed under Method B.
Toxicity (rat): 40 CFR In Method B, 40 CFR
799.9110(d)(1)(i)(A). 799.9110(d)(1)(i)(A)
refers to the OECD 425
Up/Down Procedure \4\.
Estimating starting
dose for Method B:
Data from the neutral
red uptake basal
cytotoxicity assay\5\
using normal human
keratinocytes or mouse
BALB/c 3T3 cells may
be used to estimate
the starting dose.----------------------------------------------------------------------------------------------------------------Mammalian toxicity--Genotoxicity E1 Bacterial Reverse None
Mutation Test (in
vitro): 40 CFR
799.9510
--------------------------------------------------------------------------
E2 Conduct any one of the Persons required to
following three tests conduct testing for
for chromosomal chromosomal damage are
damage: encouraged to use the
In vitro Mammalian in vitro Mammalian
Chromosome Aberration Chromosome Aberration
Test: 40 CFR 799.9537 Test (40 CFR 799.9537)
OR. to generate the needed
Mammalian Bone Marrow data unless known
Chromosomal Aberration chemical properties
Test (in vivo in (e.g., physical/
rodents: mouse chemical properties,
(preferred species), chemical class
rat, or Chinese characteristics)
hamster): 40 CFR preclude its use. A
799.9538 OR. subject person who
Mammalian Erythrocyte uses one of the in
Micronucleus Test vivo methods instead
[sampled in bone of the in vitro method
marrow] (in vivo in to address a
rodents: Mouse chromosomal damage
(preferred species), test requirement must
rat, or Chinese submit to EPA a
hamster): 40 CFR rationale for
799.9539. conducting that
alternate test in the
final study report.
--------------------------------------------------------------------------
Mammalian toxicity--Repeated dose/ F1 Combined Repeated Dose Where F1 is required,
reproduction/ developmental Toxicity Study with EPA recommends use of
the Reproduction/ the Combined Repeated
Developmental Toxicity Dose Toxicity Study
Screening Test: 40 CFR with the Reproduction/
799.9365 OR Developmental Toxicity
Reproduction/ Screening Test (40 CFR
Developmental Toxicity 799.9365). However,
Screening Test: 40 CFR there may be valid
799.9355 AND. reasons to test a
Repeated Dose 28-Day particular chemical
Oral Toxicity Study in using both 40 CFR
rodents: 40 CFR 799.9355 and 40 CFR
799.9305. 799.9305 to fill
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----------------------------------------------------------------------------------------------------------------\1\ 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 under
docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket Center, Rm. B102, 1301 Constitution Ave., NW.,
Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.\2\ 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 under docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket Center, Rm. B102,
1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays.\3\ 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. EPA recommends, but does not require, that test sponsors who wish to
conduct Test Group 1 studies on such chemicals to submit to EPA for approval a written request to conduct Test
Group 1 studies 90 days prior to conducting such studies. The written request should include the rationale for
conducting Test Group 1 studies.\4\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA-HQ-
OPPT-2005-0033 at the EPA Docket Center, Rm. B102, 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m.
to 4:30 p.m., Monday through Friday, excluding legal holidays.\5\ The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the
mammalian toxicity-acute endpoint, is available under docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket
Center, Rm. B102, 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
(k) Effective date. This section is effective on April 17, 2006. [71 FR 13730, Mar. 16, 2006, as amended at 71 FR 71062, Dec. 8, 2006; 77 FR 15617, Mar. 16, 2012; 77 FR 28282, May 14, 2012; 78 FR 27863, May 13, 2013]