GREENWICH CHEMICAL CoNSULTING, INc. 

3300 PGA BouLEVARD • SuiTE 635 

January 15, 2016 

ByCDX 

PALM BEACH GARDENS, FL 33410 

TELEPHONE 561.578.8110 

fACSIMILE 561.578.8120 

CONTAINS NO CONFIDENTIAL 

BUSINESS INFORMATION 

OPPT Document Control Office 

U.S. Environmental Protection Agency 

EPA East Building 

RoomE6428 

1201 Constitution Ave., NW 

Washington, DC 20004 

Attn.: TSCA Section 4 

Re: Submission of Final Test Reports on the Fish and Daphnia Studies by Univar 

USA Inc. under the TSCA Section 4 Test Rule on the Testing of Certain High 

Production Volume Chemicals: Second Group of Chemicals 

D-erythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt 

CAS RN 6381-77-7 

(Sodium erythorbate) 

Docket Identification No. EPA-HQ-OPPT-2007-0531; 40 CFR 799.5087 

Dear Sir/Madam: 

On behalf of its client, Univar USA Inc. (Univar or the Company), Greenwich Chemical 

Consulting, Inc. (Greenwich Chemical Consulting) submits to the U.S. Environmental 

Protection Agency (EPA or the Agency) the fmal test reports on the fish and Daphnia studies 

conducted on the chemical substance, D-erythro-hex-2-enonic acid, .gamma.-lactone, 

monosodium salt [CAS RN 6381-77-7] which is currently subject to a Toxic Substances 
U.S. Environmental Protection Agency 

January 15, 2016 

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Control Act (TSCA) Section 4 test rule. 1 The Company submits these final test reports in 

accordance with this test rule and the regulations set forth at 799.5087. 

I. General Background 

As a matter of background, this test rule addresses 19 high production volume (HPV) 

chemicals that went unsponsored under the Agency's voluntary HPV Chemical Challenge 

Program. One of the 19 chemicals identified in the rule is D-erythro-hex-2-enonic acid, 

.gamma.-lactone, monosodium salt which is identified herein as sodium erythorbate. The rule 

requires manufacturers and importers of these HPV chemicals, including sodium erythorbate, 

to conduct testing to obtain screening level data for human health effects, environmental 

effects, chemical fate, and physical/ chemical properties. 

The Agency has issued this test rule under its TSCA Section 4(a)(1)(B) authority based on its 

determination that HPV compounds, including sodium erythorbate, are "produced in 

substantial quantities; there is or may be substantial human exposure to them; existing data are 

insufficient to determine or predict their health and environmental effects; and testing is 

necessary to develop such data."2 The final rule identifies the following studies on sodium 

erythorbate: 

• n-Octanol/Water Partition Coefficient 

• Ready Biodegradation 

• Aquatic Toxicity Testing: 

Acute toxicity to fish 

Acute toxicity to Daphnia 

Toxicity to plants (algae) 

In the fmal TSCA Section 4 test rule, EPA specified the use of ASTM, ISO, and/ or CFR test 

guidelines for this testing. In its letter dated April 15, 2014, Univar requested that the 

corresponding OECD test guidelines be used in the conduct of these studies. In its May 19, 

2014 response letter, the Agency granted this request. 

Harlan Laboratories Ltd. (Harlan Laboratories) was selected to conduct all of these tests. 3 

Also, Greenwich Chemical Consulting is serving as the study monitor for this testing. 

Because Univar had not yet begun importing sodium erythorbate with the intent to sell it for 

TSCA purposes at the time of the rule's effective date, the specific dates, as set forth in the 

final rule, for the submission of the letter of intent and test reports were not applicable. Univar 

subsequendy submitted its letter of intent to test on January 27, 2014.4 Based on this, EPA 

1 January 7, 2011; 76 Fed. Reg. 1067. 

2 Id. at 1069. 

3 Recently, the laboratory changed its name to Envigo Research Limited. 

4 Upon EPA's receipt of this January 27, 2014 letter of intent to test, Univar planned to begin importing this 

substance for both TSCA purposes and for continuing exempt FDA purposes. 
U.S. Environmental Protection Agency 

January 15, 2016 

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stated in its response letter dated February 11, 2014 that study plans would be due April 15, 

2014 and final reports would be due February 11, 2015.5 

II. Extension Requests 

In its letter dated January 27,2015, Univar requested from EPA an extension to the February 

11, 2015 deadline due to the fact that there has been a significant technical issue encountered 

during the development of the analytical method which is to be used in support of the three 

ecotoxicity studies. The laboratory has also indicated that this same technical issue is being 

encountered during the partition coefficient test, though to a somewhat lesser degree. 

Therefore, Univar requested an extension through October 31,2015 for the submission of the 

final test reports. The Agency granted this extension request in its response letter dated 

February 12, 2015. Subsequendy, in its letter dated October 19, 2015, Univar requested an 

additional set of extensions for the ecotoxicity tests based on continued technical issues 

associated with the stability of the test material in water. In its letter dated October 22, 2015, 

EPA granted the Company's extension request for the fish and Daphnia studies though January 

16, 2016 and the algae study through April16, 2016. 

III. Final Test Report List 

Consistent with the final TSCA Section 4 test rule, the following final test reports are included 

herein: 

• D-erythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77-

7]: Acute Toxicity to Rainbow Trout 

• D-erythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77-

7]: Daphnia sp., 48-Hour Acute Immobilization Test 

IV. Submission of Robust Summaries through HPVIS 

In the fmal test rule, EPA requests, but does not require, that a robust summary also be 

included for each test identified in the rule consistent with the Agency's Drcift Guidance on 

Developing Robust Summaries. The Agency has signaled to other testing consortia that the 

submission of these robust summaries is unnecessary. For example, EPA advised the PCBTF 

Testing Consortium (of which Univar is a member) in early 2013 that robust summaries were 

not necessary under the TSCA Section 4 HPV test rules. If EPA decides that it wishes to 

receive such robust summaries, Univar will certainly provide them. 

5 It is noted that since the time this test rule was issued through today, no other companies have come forward 

indicating their intent to test sodium erythorbate under this rule. 
U.S. Environmental Protection Agency 

January 15, 2016 

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Univar thanks the Agency for its consideration in this matter. For all questions, comments, 

and determinations concerning this matter, please use the contact information given below. 

Mr. John V. Massingale 

Greenwich Chemical Consulting, Inc. 

3300 PGA Boulevard, Suite 635 

Palm Beach Gardens, FL 33410 

Telephone: (561) 578-8110 

Facsimile: (561) 578-8120 

E-mail: john@grcci.com 

Sincerely, 

John V. Massingale 

Principal 

cc: Ms. K. Gilje - Univar 

Ms. S. Lilley - Univar 

Mr. J. Schaeffer- EPA