SRC TR-12-077

HPV3 TOXICITY STUDY PLAN REVIEW (FINAL)

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1), 

CASRN 52556-42-0

Prepared by:

William L. Richards, Teresa Manyin, and Laura Morlacci

Defense and Environmental Solutions Division

SRC, Inc.

7502 Round Pond Road

North Syracuse, NY 13212

Contract No. EP-W-09-027

Task FG007.3.009.006

Submitted to:

OCSPP/OPPT/RAD (7403M)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue

Washington, D.C. 20460

Bryan Lobar, Project Officer

Meena Sonawane, Work Assignment Manager

David Brooks, Alternate Work Assignment Manager

October 24, 2012
HPV3 Study Plan Review (Final) CASRN 52556-42-0

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HPV3 Toxicity Study Plan Review: 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-

yloxy)-, sodium salt (1:1), CASRN 52556-42-0

In response to the test rule, “Testing of Certain High Production Volume Chemicals; Third 

Group of Chemicals”, 76 FR 65385, October 21, 2011, the COPS-1 Consortium, a cost-sharing 

consortium formed and managed under the Society of Chemical Manufacturers and Affiliates 

(SOCMA), submitted a study plan on August 29, 2012 for several toxicity tests to be conducted 

by WIL Research Europe with 1-propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium 

salt (1:1), CASRN 52556-42-0, also known as COPS-1.

1. General Comments:

The test rule classifies 1-propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt 

(1:1), CASRN 52556-42-0 as a Class 1 Chemical Substance for which testing must be conducted 

with material having a purity of 99% or greater. For toxicity testing, the COPS-1 Consortium 

proposes the testing of a “typical commercial product as supplied by a member of the 

Consortium with details of purity and known properties.” However, information on the expected 

or known purity of this “typical commercial product” was not provided in the August 29, 2012 

letter. If the COPS-1 Consortium believes that a 99% level of purity of 1-propanesulfonic acid, 

2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) is unattainable for the “typical commercial 

product” that is proposed for testing, the Consortium may request a modification (see 76 FR 

65395). 

For all toxicity tests, the final study report should include the analyzed composition of the test 

substance, including identities and concentrations of major ingredients and of impurities. 

2. Aquatic Toxicity

Under the testing requirement C1 of the test rule, a determination of whether to perform aquatic 

toxicity testing under Test Group 1 or Test Group 2 is based on a consideration of the log Kow for 

the test substance. If log Kow is < 4.2, Test Group 1 testing is required; if log Kow is ≥ 4.2, Test 

Group 2 testing is required. The August 29, 2012 letter from the COPS-1 Consortium presented 

a printout from KOWWIN that provides an estimated log Kow value of -5.00 for 1-

propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1). Based on criteria of 

Table 3 (p. 65407) of the test rule, the finding of an estimated log Kow of -5.00 indicates that 

testing to determine an experimental log Kow for 1-propanesulfonic acid, 2-hydroxy-3-(2-propen1-yloxy)-, sodium salt (1:1) is not required. Therefore, on the basis of the estimated log Kow of -

5.00, EPA approves the COPS-1 Consortium plan to fulfill the C1 testing requirement for 1-

propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) as a Test Group 1 

substance. 

Pending the COPS-1 Consortium’s resolution with EPA of the test substance purity/composition 

issue described under General Comments, above, EPA approves the Consortium’s plan to 

conduct the following three aquatic toxicity studies to fulfill the C1 testing requirement for 1-

propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1): 
HPV3 Study Plan Review (Final) CASRN 52556-42-0

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1. Acute Toxicity to Fish, ASTM E 729-96 (reapproved 2007)/OPPTS 850.1075

2. Acute Toxicity to Daphnia, ASTM E729-96 (reapproved 2007)/OPPTS 850.1010 

3. Toxicity to Plants (Algae), ASTM E1218-04 ε1/OPPTS 850.5400

Each tested concentration and endpoint value should be expressed in terms of the concentration 

of the active ingredient 1-propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt 

(1:1).

3. Mammalian Toxicity

Pending the COPS-1 Consortium’s resolution with EPA of the test substance purity/composition 

issue described under General Comments, above, EPA approves the Consortium’s plan to 

conduct the following studies of 1-propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, 

sodium salt (1:1) to fulfill the Mammalian Toxicity testing requirements of the test rule:

1. An Acute Oral Toxicity – Up-and-Down Procedure test using 40 CFR 799.9110(d)(1)(i)(A) to 

fulfill testing requirement D.

2. A Bacterial Reverse Mutation Test using 40 CFR 799.9510/OECD 471 to fulfill testing 

requirement E1.

3. An In vitro Mammalian Chromosome Aberration Test using 40 CFR 799.9537/OECD 473 to 

fulfill testing requirement E2.

4. A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screening Test using 40 CFR 799.9365/OPPTS 870.3650/OECD 422 to fulfill testing 

requirement F1.

Each concentration tested for the genotoxicity studies required under E1 and E2 should be 

expressed in terms of the concentration of the active ingredient 1-propanesulfonic acid, 2-

hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1). Each dose tested and endpoint value for the 

studies required under D and F1 will be expressed in terms of the dose of the active ingredient.

Conclusion: The study plan submitted to fulfill testing requirements C1 (Test Group 1 

endpoints), D, E1, E2, and F1 for 1-propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, 

sodium salt (1:1), CASRN 52556-42-0, also known as COPS-1, is considered adequate with the 

stipulations listed above.