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Testing Strategy for MCCPs and LCCPs

EPA anticipates that each company will need to modify the cited test guidelines or propose the 

use of alternate test guidelines when preparing draft study protocols to fulfill the testing strategy

presented herein. Each company must document all proposed modifications from the test 

guidelines in the draft study protocols, provide rationales for the modifications, and submit the 

draft study protocols to EPA for review and approval prior to finalizing the study protocols and 

commencing performance of the studies.

The test substances to be used will be representative congener groups to serve as surrogates for 

the PMN substances and must be synthesized and characterized. The test substances are 

described below. This is necessary to address confounding issues in existing studies and to 

reduce uncertainties in the database for both the range of chlorination and alkyl chain length. 

The testing strategy is presented in three phases. Phase 1 studies will inform environmental 

transport and partitioning. Phase 2 will evaluate the potential environmental transformation with 

identification of major degradants and bioaccumulation of the test substances and/or the 

degradants. Phase 3 will evaluate potential toxicity of the parent substance and/or degradants 

identified under Phases 1 and 2. 

For each study specifying analytical determination of congener groups, EPA expects each 

company to be able to identify, with appropriate mass balance, the alkyl chain length and weightpercent chlorine of the test samples, sorption/desorption fractions, transformation products, etc. 

Synthesis and Characterization of Substances to be Tested

Each company must synthesize and characterize the following representative congener groups 

(hereinafter referred to collectively as the “test substances”):

• Three chlorinated linear C14 paraffin fractions to represent the 30-, 56-, and

> 70-weight-percent chlorine (wt% Cl);

• Three chlorinated linear C16 paraffin fractions to represent the 30-, 56-, and 

> 70-wt% Cl; and

• Three chlorinated linear C18 paraffin fractions to represent the 30-, 56-, and 

> 70-wt% Cl.

The characterization of the test substances must be performed using appropriate analytical 

methods (e.g., GC/MS, HPLC/MS) that provide the carbon chain length and the wt% Cl.1 Each 

 1 See, e.g., Jana Hüttig and Michael Oehme (2006) Congener group patterns of chloroparaffins in marine sediments 

obtained by chloride attachment chemical ionization and electron capture negative ionization, CHEMOSPHERE, Vol. 

64, pp. 1573-1581, at p. 1576 (Figure 1).
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company must provide EPA with a certificate of analysis and all “raw data”2 from the analyses

of the test substances. 

Phase 1 Testing: Environmental Transport and Partitioning

Under Phase 1, each company must perform the testing described in this section on each of the 

test substances. The testing strategy is based on the Agency’s need for information on the 

environmental transport and partitioning of the test substances. The testing is aimed at 

determining where the test substances partition when released to a biological wastewater 

treatment plant (WWTP) and to the environment through discharges to surface water (Phase 1b). 

Phase 1a 

• OPPTS Test Guideline 835.1110: Activated Sludge Sorption Isotherm with 

analytical procedures capable of measuring sorption of congener groups over 

time.

Phase 1b

• OECD Guideline 106: Adsorption – Desorption Using a Batch Equilibrium 

Method with analytical procedures capable of measuring sorption and desorption 

of congener groups over time.

If the results from Phase 1a and 1b testing show that the test substances partition to either of 

these compartments (i.e., sludge and soil), then these results will inform Phase 3 testing. 

Phase 2 Testing: Transformation Studies

Under Phase 2, EPA will evaluate the Phase 1 testing results to determine the appropriate 

compartments for conducting transformation studies. For example, the Phase 1 results will 

inform whether the Phase 2 transformation testing is needed in soil (Phase 2a), sediment (Phase 

2b), and water (Phase 2c) compartments, respectively. For each compartment evaluated, INEOS 

Chlor Americas must ensure that the studies are designed using analytical procedures that are 

capable of identifying and quantifying degradation products.

Phase 2a

• OECD Guideline 307: Aerobic and Anaerobic Transformation in Soil with analytical 

procedures capable of measuring the test substances and their degradation products 

over time.

 2 Note, the terms “raw data” as used herein are the same as defined under 40 CFR Part 792 – Good Laboratory 

Practice Standards, §792.3 Definitions.
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Phase 2b

• OECD Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment 

Systems with analytical procedures capable of measuring the test substances and their

degradation products over time. 

Phase 2c

• OPPTS Test Guideline 835.5270: Indirect Photolysis Screening Test: Sunlight 

Photolysis in Waters Containing Dissolved Humic Substances with analytical 

procedures capable of measuring the test substances and their degradation products 

over time.

Phase 2d testing must be performed on the test substances and degradants identified in Phases 2a, 

b, c. 

Phase 2d

• OECD Guideline 317: Bioaccumulation in Terrestrial Oligochaetes with analytical 

procedures capable of measuring the test substances and their degradation products;

• OECD Guideline 315: Bioaccumulation in Sediment-dwelling Benthic Oligochaetes

with analytical procedures capable of measuring the test substances and their 

degradation products; and 

• OECD Guideline 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure. The 

dietary exposure protocol must be used with analytical procedures capable of 

measuring the test substances and their degradation products.

Phase 3 Testing: Toxicity Testing

Under Phase 3, the degradants identified under the Phase 2 testing will be subject to the 

following toxicity studies in addition to the test substances. Though several test guidelines are 

listed for each of the following environmental compartments, EPA will determine the 

appropriate testing requirements based on the environmental compartment in which the test 

substances or degradants were shown to partition or form, respectively, and the physicochemical 

properties of each.

Phase 3a

• OECD Guideline 222: Earthworm Reproduction Test;

Phase 3b

• OECD Guideline 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked 

Sediment. 

Phase 3c

• OECD Guideline 211(OPPTS 850.1300) Daphnia magna Reproduction Test.

• OECD Guideline 210 (OPPT 850.1400) Early Life-stage Toxicity Test. 
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If, based on the results of testing conducted, EPA determines that the PMN substances or any 

degradation products may present risks to human health or the environment, EPA may require 

additional characterization or restrictions on the manufacture (which includes import), 

processing, distribution, use, and/or disposal of the PMN substances to mitigate exposures to or 

to better characterize the risks presented by the PMN substances or their degradation products.