Table 1-Persons Subject to the Rule: Persons in Tier 1 and Tier 2
Persons initially required to comply with this section (Tier 1) | Persons not initially required to comply with this section (Tier 2) |
Persons not otherwise specified in column 2 of this table that manufacture (as defined at TSCA section 3(7)) or intend to manufacture a chemical substance included in this section. | A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a chemical substance included in this section solely as one or 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) ). |
Table 2-Chemical Substances and Testing Requirements
CAS No. | Chemical name | Class | Required tests (see table 3 of this section) |
74-95-3 | Methane, dibromo- | 1 | A, C1, E2, F2. |
78-11-5 | 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester) | 1 | A4, A5, B, C6, F2. |
84-65-1 | 9,10-Anthracenedione | 1 | A4, A5, F2. |
110-44-1 | 2,4-Hexadienoic acid, (E,E)- | 1 | A, C4. |
112-52-7 | 1-Chlorododecane | 1 | A2, A3, A4, A5, B, C3, D, E1, E2, F1. |
118-82-1 | Phenol, 4,4'-methylenebis[2,6bis(1,1-dimethylethyl)]- | 1 | A1, A2, A3, B, E2. |
149-44-0 | Methanesulfinic acid, hydroxy-, monosodium salt | 1 | A1, A5, E2, F1. |
409-02-9 | Heptenone, methyl- | 2 | A, B, C1, D, E1, E2, F1. |
594-42-3 | Methanesulfenyl chloride, trichloro- | 1 | A, B, C1, E1, E2, F2. |
1324-76-1 | Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]- | 2 | A4, C2, F1. |
2941-64-2 | Carbonochloridothioic acid, S-ethyl ester | 1 | A, B, C1, E2, F1. |
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
Testing category | Test symbol | Test requirements and references | Special conditions |
Physical/chemical properties | A | 1. Melting Point: ASTM E 324 (capillary tube) 2. Boiling Point: ASTM E 1719 (ebulliometry) 3. Vapor Pressure: ASTM E 1782 (thermal analysis) 4. n-Octanol/Water Partition Coefficient (log 10 basis) or log Kow: (See special conditions for the log Kow test requirement and select the appropriate method to use, if any, from those listed in this column.) Method A: 40 CFR 799.6755 (shake flask) Method B: ASTM E 1147 (liquid chromatography) Method C: 40 CFR 799.6756 (generator column) 5. Water Solubility: (See special conditions for the water solubility test requirement and select the appropriate method to use, if any, from those listed in this column.) Method A: ASTM E 1148 (shake flask) Method B: 40 CFR 799.6784 (shake flask) Method C: 40 CFR 799.6784 (column elution) Method D: 40 CFR 799.6786 (generator column) | n-Octanol/water Partition Coefficient or log Kow: Which method is required, if any, is determined by the test substance's estimated1 log Kow as follows: log Kow [LESS THAN]0: no testing required. log Kow range 0-1: Method A or B. log Kow range [GREATER THAN]1-4: Method A or B or C. log Kow range [GREATER THAN]4-6: Method B or C. log Kow [GREATER THAN]6: Method C. Test sponsors are required to provide in the final study report the underlying rationale for the method selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7. Water Solubility: Which method is required, if any, is determined by the test substance's estimated2 water solubility. Test sponsors are required to provide in the final study report the underlying rationale for the method selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7. [GREATER THAN]5,000 mg/L: Method A or B. [GREATER THAN]10 mg/L -5,000 mg/L: Method A, B, C, or D. [GREATER THAN]0.001 mg/L-10 mg/L: Method C or D. [LESS THAN EQUAL TO]0.001 mg/L: No testing required. |
Environmental fate and pathways-Inherent biodegradation | B | For B, choose either of the methods listed in this column: 1. ASTM 1625 (semicontinuous activated sludge test) OR 2. ISO 9888 (Zahn-Wellens method) | None |
Aquatic toxicity | C1 | For C1, 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 C1: 1. Acute Toxicity to Fish: ASTM E 729 2. Acute Toxicity to Daphnia: ASTM E 729 3. Toxicity to Plants (Algae): ASTM E 1218 Test Group 2 for C1: 1. Chronic Toxicity to Daphnia: ASTM E 1193 2. Toxicity to Plants (Algae): ASTM E 1218 | The following are the special conditions for C1, C2, C3, C4, C5, and C7 testing; there are no special conditions for C6. If log Kow [LESS THAN]4.2: Test Group 1 is required If log Kow [GREATER THAN EQUAL TO]4.2: Test Group 2 is required Which test group is required is determined by the test substance's measured log Kow as obtained under A3. |
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 for this test requirement and select the method that must be used from those listed in this column. Method A: Acute Inhalation Toxicity (rat): 40 CFR 799.9130 Method B: EITHER: 1. Acute (Up/Down) Oral Toxicity (rat): ASTM E 1163 OR 2. Acute (Up/Down) Oral Toxicity (rat): 40 CFR 799.9110(d)(1)(i)(A) | Which testing method is required is determined by the test substance's physical state at room temperature (25 °C). For those test substances that are gases at room temperature, Method A is required; otherwise, use either of the two methods listed under Method B. In Method B, 40 CFR 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 assay5 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 Test (in vitro): 40 CFR 799.9510 | None |
E2 | Conduct any one of the following three tests for chromosomal damage: In vitro Mammalian Chromosome Aberration Test: 40 CFR 799.9537 OR Mammalian Bone Marrow Chromosomal Aberration Test (in vivo in rodents: mouse (preferred species), rat, or Chinese hamster): 40 CFR 799.9538 OR Mammalian Erythrocyte Micronucleus Test [sampled in bone marrow] (in vivo in rodents: Mouse (preferred species), rat, or Chinese hamster): 40 CFR 799.9539 | Persons required to conduct testing for chromosomal damage are encouraged to use the in vitro Mammalian Chromosome Aberration Test (40 CFR 799.9537 ) to generate the needed data unless known chemical properties (e.g., physical/chemical properties, chemical class characteristics) preclude its use. A subject person who uses one of the in vivo methods instead of the in vitro method to address a chromosomal damage test requirement must submit to EPA a rationale for conducting that alternate test in the final study report. | |
Mammalian toxicity-Repeated dose/ reproduction/ developmental | F1 | Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test: 40 CFR 799.9365 OR Reproduction/Developmental Toxicity Screening Test: 40 CFR 799.9355 AND Repeated Dose 28-Day Oral Toxicity Study in rodents: 40 CFR 799.9305 | Where F1 is required, EPA recommends use of the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (40 CFR 799.9365 ). However, there may be valid reasons to test a particular chemical using both 40 CFR 799.9355 and 40 CFR 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.
40 C.F.R. §799.5085