392072 

RECEIVED 

OPPT CBIC i SOCMA 

Society of Chemical Manufacturers & Affiliates 

February 11, 2013 

Document Control Office (7405M) 

Office of Pollution Prevention and Toxics (OPPT) 

Environmental Protection Agency 

Environmental Protection Agency East Building, Room E6428 (202-564-8930) 

1201 Constitution Avenue, NW 

Washington, DC 20460 

Attention: Toxic Substances Control Act Section 4 

40 CFR 799.5087 J"1

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B,Bli"a1

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Docket ID Number EPA-HQ-OPPT-2007-0531 

Re: Second Revised Test Plan; Testing of Certain High Production Volume Chemicals; Second 

Group of Chemicals, Federal Register 76 (5), 1067-1093, January 7, 2011; Castor Oil, sulfated, 

sodium salt, CAS No. 68187-76-8 

To Whom It May Concern: 

The U.S. Environmental Protection Agency (EPA) promulgated a final TSCA test rule on January 

7, 2011 (76 FR 1067-1093) that requires manufacturers (including importers) and processors of 

Sulfated Castor Oil to conduct testing to obtain screening level data for health and 

environmental effects and chemical fate. 

The Sulfated Castor Oil (SCO) Consortium, a cost-sharing consortium affiliated with the Society 

of Chemical Manufacturers & Affiliates (SOCMA), consists of three member companies: Afton 

Chemical Corporation, Manufacturers Chemical, LLC, and Emerald Carolina Chemical LLC. SCO 

submitted a test plan on October 18, 2011 and a revised test plan on April 6, 2012 to conduct 

the required studies as a first step in fulfilling the requirements of the test rule. 

Based on comments and recommendations provided in reviews of two previous test plan 

submissions, the SCO offers the following in this second revised test plan: 

Test Substance 

In previous test plan reviews EPA approved testing on commercially marketed Castor Oil, 

sulfated, sodium Salt, CAS No. 68187-76-8 with a nominal concentration of 75%. In order to 

comply with EPA's stated requirement to provide additional characterization of the test 

substance prior to initiation of testing, SCO has conducted additional testing of the proposed 

test substance. As you will note in the test results (Attachment A), additional data on the 

composition of the test substance is provided including data on the percentage of sulfated 

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ISO ON SNIV1NOO 
glycerides and fatty acids, inorganic sodium sulfate and other constituents. It is important to 

note that the products tested here and proposed for additional HPV testing are stable 

dispersions containing no surfactants, solvents or stabilizers. 

The test substance designated by the rule is Castor Oil, sulfated, sodium salt, CAS No. 68187-76-

8. The following properties should be noted about the test substance as it exists commercially: 

• Sulfated castor oil is commercially available only as an aqueous mixture and is 

commercialiy available in various concentrations, from 25 - 75% in water; 

• The material has a variable composition that consists of a mixture of naturally occurring 

glycerides and fatty acids, which have been sulfated. Characterization of the test material 

{Attachment A) indicates no triglycerides but does include monoglycerides and 

diglycerides; and 

• Sulfated castor oil is produced using naturally occurring materials resulting in a substance 

whose characteristics can vary within a narrow range for each constituent. 

In accordance with the recommendations provided in EPA's review of the initial and revised 

test plans, the following additional provisions are incorporated into this second revised test 

plan: 

• The composition of the solution (percentage of sulfated glycerides and fatty acids, 

inorganic sodium sulfate, as well as any other impurities) will be defined in the study 

report and each endpoint value will be expressed in terms of the concentration of active 

ingredient by adjusting for the amount of water present in the aqueous solution. EPA 

originally requested information be provided on sulfated triglycerides but given the 

results of preliminary testing showing no triglycerides, SCO proposes providing total 

sulfated glycerides instead; and 

• For all toxicity tests, the final study report will include the measured composition of the 

test substance, including identities and concentrations of major ingredients and 

impurities. 

Physical/Chemical Properties 

Conducting melting and boiling point studies on the commercial aqueous product makes little 

practical sense, because the values will reflect the presence of substantial amounts of water. 

In addition, conducting a boiling point study on the neat material is also irrelevant, because the 

substance is a salt, which by definition will not boil or exert a meaningful vapor pressure, other 

than that caused by residual amounts of water. 

Recommendation: The commercially available nominal 75% concentration material 

should be tested for freezing point and temperature of decomposition (OECD 102 -

Melting Point/Melting Range) to fulfill testing requirements A l and A2, and that the 

requirement for boiling point determination be eliminated. This approach is consistent 

with the intent of the test rule and the nature of the test substance. EPA's reviews of the 

initial test plan and revised test plan did not address this recommendation. 
Aquatic Toxicity 

EPA approved, in its review of the original and revised test plan submissions, SCO's plan to 

conduct the following Test Group 1 tests to fulfill testing requirement CI: Acute Toxicity to Fish 

(ASTM E 729-96 (Reapproved 2007)}, Acute Toxicity to Daphnia (ASTM E 729-96 (Reapproved 

2007)) and Acute Toxicity to Algae (ASTM E 1218-04\el\). In the conduct of these tests, SCO 

will refer to the OECD Series on Testing and Assessment Number 23: Guidance Document on 

Aquatic Toxicity Testing of Difficult Substances and Mixtures for further advice on testing. 

As ECOSAR modeling of these endpoints using the special class of anionic surfactants indicates 

that sulfated castor oil will likely have very low aquatic toxicity, limit tests at nominal 

concentrations of 100 mg/L (active ingredient) of these endpoints have been approved. If any 

evidence of toxicity is observed in the limit tests, the toxicity test will be repeated using a 

minimum of five test concentrations in addition to a control. 

Acute Mammalian Toxicity 

EPA approved, in its review of the original and revised test plan submissions, SCO's plan to 

conduct acute mammalian toxicity testing using Method B (40 CFR 799.9110(d)(l)(i)(A) - Acute 

Oral Toxicity (rat)) to fulfill testing requirement D. 

Mammalian Toxicity - Genotoxicity 

EPA approved, in its review of the original and revised test plan submissions, SCO's plan to 

conduct a Bacterial Reverse Mutation Test (in vitro){40 CFR 799.9510) and an in vitro 

Mammalian Chromosomal Aberration Test (40 CFR 799.9537) to fulfill testing requirements El 

and E2. 

Mammalian Toxicity - Repeated Dose/Reproduction/Developmental 

EPA approved, in its review of the original test plan submission, SCO's plan to conduct a 

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screening Test (40 CFR 799.9365) to fulfill testing requirement F. 

Initiation of the required testing is subject to Environmental Protection Agency's guidance on 

the recommendations offered in this letter. We welcome the opportunity to discuss this 

second revised test plan in a meeting or conference call at the earliest opportunity so we can 

begin testing as quickly as possible. 
Please contact me at (301) 987-0924 or diloretoi@socma.com for questions or additional 

information. 

Sincerely yours, 

— 

John DiLoreto 

Executive Director 

Sulfated Castor Oil Consortium 

Attachments: 

A) Compositional Characterization of Sulfated Castor Oil Products, January 14, 2013 
Attachment A 

Compositional Characterization of Sulfated Castor Oil Products 

January 14, 2013 

Further characterization of the composition of sulfated castor oil products has been requested 

as part of the information required by the U.S. EPA for this high production volume chemical. 

Samples from the three manufacturers forming the Sulfated Castor Oil Consortium were 

analyzed as described below. 

Part 1. A sample of a single lot of Emerald Performance Materials' FREEDOM SCO-75 Sulfated 

Castor Oil was analyzed to determine the relative amounts of fatty acids and glycerides. The 

fatty acids were determined by titration and the glycerides were determined by Saponification. 

The following results were obtained: 

Organic S03 , as supplied 5.13% CTMC-089A 

Organic S03 ,100% 7.15% 

Composition of FREEDOM SCO-75 (as tested) 

Sulfated Castor Oil 71.78% calculation 

Sodium Sulfate 2.11% N-149B (Cognis) 

Water 26.11% CTMC-053 

100.00% 

Analytical Data - FREEDOM SCO-75 

Acid Value CTM-073B 

Castor Oil 0.95 mg KOH/g 

SCO-75 (as is) 25.77 mg KOH/g 

Saponification Value CTMC-88A 

Castor Oil 165.35 mg KOH/g 

SCO-75 (as is) 89.72 mg KOH/g 

Calculated Data - FREEDOM SCO-75 

Mole ratio - Castor Oil : S03 ~1: 1 

Approximate Composition of Castor Oil, Sulfated, Na Salt as supplied 100% basis 

Glycerides (as SCO) 43.5% 60.6% 

Fatty Acids 23.8% 39.4% 

Saponification Value of Glycerides (calculated) 148.09 

Approximate quantities of species as supplied 100% 

% Diglycerides 33% 75% 

% Monoglycerides 11% 25% 
p. 6 

Part 2. A single sample of product from each of the suppliers was reanalyzed for activity, 

moisture, and salt content, and then each was separated chromatographically. 

The following conditions for the separations were observed: 

Column Length 45 cm 

Column Diameter 1.5 cm 

Column Packing material Silica Gel, 40-140 Mesh 

Sample Size 2g 

Solvents Petroleum ether 

Ethyl ether 

Isopropanol 

Dl Water 

# Aliquots collected for each solvent 5 

Aliquot size 10 cc 

Collection Rate 1 drop per second 

Drop Size 0.025 ml 

This provided the following results: 

Manufacturer 

Project # 

Emerald 

CLR 11402A 

Manufacturers 

CLR 11404 

Afton 

CLR11405 

SCO,% 70.52% 66.55% 66.48% 

so3,% 5.13% 4.84% 4.06% 

Moisture, % by Karl Fisher 26.11% 24.98% 29.96% 

Na2S04 ,% by std. lead titration 2.11% 3.34% 3.20% 

Column Chromatography Results 

as 

supplied 100% 

as 

supplied 100% 

as 

supplied 100% 

Petroleum ether elutables, % 0.1 0.14% 0.3 0.43% 0.09 0.14% 

Ethyl ether elutables, % 20.25 28.09% 27.69 39.25% 25.07 37.71% 

Isopropanol elutables, % 21.65 30.03% 12.72 18.03% 24.03 36.15% 

Water elutables, % 30.09 41.74% 29.84 42.30% 17.29 26.01% 
IR Analysis of the fractions indicated the following: 

Petroleum Ether Fraction: Characteristic - hydrocarbon. No glycerides, fatty acid, 

or organic sulfate observed. 

Ethyl Ether Fraction: Characteristics - a mixture of unsulfated glycerides and fatty 

acids. No sulfate or fatty acid salts observed. 

Isopropanol Fraction: Characteristic-primarily sulfated monoglycerides and 

diglycerides. Traces of fatty acids observed in the Afton and Manufacturers 

samples. No sulfated triglycerides orfatty acid salts (soaps) observed. 

Water Fraction: Characteristic - primarily sulfated fatty acids w/some traces of 

glycerides. No soaps observed. 

The IR spectra of the various fractions are attached as an embedded PDF (Click Image to open). 

Reported By, 

C. Steven Chaffin 

Senior Development Chemist 

Emerald Carolina Chemical, LLC 
1 

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& SOCMA 

1850 M St NW, Suite 700 

Deliver To: Washington, DC 20036-5810 

Contact Person: "Document Control Officer 

Contact Phone Number: 202-564-8930 

Company/Office Name: Document Control Office 

Address: 

Document Control Office (7405M) Office of Pollution Prevention and 

Toxics (OPPT) Environmental Protection Agency Environmental Protection 

Agency East Building, Room E6428 (202-564-8930) 1201 Constitution 

Avenue, NW, Washington, DC 20460 

Description of Package 

Second revised Test Plan for Sulfated Castor Oil Consortium. 

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