Re: Fw: Declassified reviews of studies on Pigment Blue (1324-76-1) Notes Link Ryan Wallace to : Jeffrey Santacroce 05/31/2012 03:45 PM

Cc : Catherine Roman, Scott Sherlock

From: Ryan Wallace/DC/USEPA/US To: Jeffrey Santacroce/DC/USEPA/US@EPA Cc: Catherine Roman/DC/USEPA/US@EPA, Scott Sherlock/DC/USEPA/US@EPA
I reviewed the documents with DCNs 40100000011, 40100000012, and 40100000013. Each of these documents is a review of a study or studies provided by the Color Pigment Manufacturers Association, Inc. (CPMA). The confidential business information (CBI) claims in the studies which these reviews reference were declassified by CPMA in a 4/13/2012 letter from J. Lawrence Robinson, President of CPMA, to Scott Sherlock of EPA. Because the studies referenced in the documents with DCNs 40100000011, 40100000012, and 40100000013 are no longer considered as CBI, the reviews are also no longer considered to be CBI. Ryan P. Wallace, Attorney Advisor Environmental Assistance Division Office of Pollution Prevention and Toxics (202) 564
-8824 wallace.ryan@epa.gov

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## - ntUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASH INGTON D

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VIA FACSIMILE: 201-437-4801 April 19,2012 Attention: Glenn Merritt (201-437-4000) OFFICE OF PREVE NTION, PESTICIDES AND TOXIC SUBSTANCES

Subject: Follow-up to fax transmission of4/13/12 (ePMA removal ofCBI claims regarding identified studies) 

### Dear Mr. Merritt: This is sent to you pursuant our conversation ofseveral minutes ago. In Larry Robinson's fax of April 13 th while there is a waiver ofconfidential business information (CBI) claims in the identified studies there is a an assertion ofcopyright protections and some additional text that provides in part
... "Reproduction, reference, summarization, retransmission or other use ofthis copyrighted document.
..including electronic transmission, using the internet oremail
....is strictly prohibited
...." While we understand the basis for the copyright protections, we have a concern that the language in the fax might be interpreted to mean that ePMA is asserting that the studies submitted perthe TSCA activity are not to be made available in an Agency e-docket (electronic docket) or be included in EPA websites among the collection ofTSCA health and safety studies. We are thinking that the identified limitations noted in the fax are not intended to apply to EPA's normal procedures for the handling ofnon-CBI materials submitted by entities subject to TSCA regulations (including the posting ofsuch materials on government websites) and submitted by such entities in order to comply with a TSCA requirement, but are rather intended to limit entities outside the government from the unauthorized use or appropriation ofthe studies. Can you please confirm CPMA's intent? Many thanks.

Scott M. Sherlock, Attorney Advisor Environmental Assistance Division Office ofPollution Prevention and Toxics

### SRC TR-10-074

HPV1 TEST RULE
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### DATA ADEQUACY ASSESSMENT Benzenesulfonic acid, [[4- [[4-(phenylamino)phenyl] [4-(phenylimino)-2,5-cyclohexadien- 1 - ylidene]methyl]phenyl] amino] -, 

### CAS No. 1324-76-1 Acute Toxicity to Daphnia Prepared by: Kendra Moran, Teresa Manyin, and Joan D. Garey Environmental Science Center SRC, Inc. 7502 Round Pond Road North Syracuse, NY 13212
Contract No. EP-W-09-027

Task FG007.0.009.004
Submitted to: OPPT/RAD/HPVCB (7403M) U.S. Environmental Protection Agency 1200 Pennsylvania Avenue Washington, D.C. 20460 Elizabeth Margosches, Project Officer Meena Sonawane, Work Assignment Manager David Brooks, Alternate Work Assignment Manager March 15, 2010 

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### Data Adequacy Assessment

Benzenesulfonic acid,[[4- [[4-(phenylamino)phenyl] [4-(phenylimino)-2,5-cyclohexadien- 1 - ylidene] methyl]phenyl] amino]-, CAS No. 1324-76-1 Acute Toxicity to Daphnia

March 2010

Submitted to: High Production Volume Chemicals Branch Risk Assessment Division Office ofPollution Prevention and Toxics Environmental Protection Agency WAM: Meena Sonawane Alternate WAM: David Brooks 1200 Pennsylvania Avenue, NW

Washington, DC 20460-000 1
Prepared By:

SRC, Inc. Environmental Science Center 2451 Crystal Drive, Suite 804 Arlington, VA 22202

### PREPARATION OF THE DATA ADEQUACY ASSESSMENT This document contains the review ofa toxicity study conducted in response to the first HPV TSCA Section 4 Test Rule (71 FR 13708, March 16, 2006). Using the applicable test guideline and professional judgment as guides, the study was reviewed for adequacy and evaluated for compliance with the test guideline. (The applicable test guideline is not always the test guideline required by the test rule, because some test sponsors requested and received approval from EPA to use a different guideline.) The study was summarized according to a standard format, assessed for adequacy, and assigned a Klimisch reliability code. Ifthe study was determined to be inadequate, a basis for that conclusion is supplied. For studies already assigned Klimisch codes, an explanation is provided ifthe reviewer's assessment ofdata adequacy differed from the pre-assigned Klimisch code. A detailed evaluation ofthe test report and study conduct is provided at the end ofthe summary document in a section entitled "Review ofTSCA Section 4 Final Study Report". Any deviations from the applicable test guideline are described. The study is also evaluated for compliance with Standard Operating Procedures, Good Laboratory Practice Standards, and Quality Assurance procedures, as well as the use ofappropriate controls and test substances. Any deficiencies in the descriptions ofthe study method, test system, animals studied, physical conditions, dosage information, individual animal data, calculations, and statistical analyses are described, and internal inconsistencies within the study report are identified. An overall assessment is provided for each ofthe following: study conduct, data reliability, and data utility.

### ACUTE TOXICITY TO DAPHNIA Title: Acute toxicity study in Daphnia magnawith C.I. Pigment Blue 61 (static) This study is: Z Adequate R Not Adequate TEST SUBSTANCE Identity: C.J. Pigment Blue 61 (Benzenesulfonic acid,[[4-[[4-(phenylamino)phenyl] [4- (phenylimino)-2,5 -cyclohexadien- 1 -ylidene] methylphenyl] amino] -), 

### CAS No. 1324-76-1 Remarks: 96.83% purity; dark blue powder with granules METHOD Method/guideline followed: OECD TG 202 (2004) Test type: Acute Toxicity to Daphnia
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### Static, Limit Test GLP compliant?: Yes Year study was performed: 2008 Test species: Daphniamagna (Straus 1820) that were <24 hours old. Daphniawere cultured inhouse with a known history and stock cultures did not show signs ofstress. Analytical monitoring: Yes. During the limit test, samples for analysis were taken from both the control and the limit concentration at the start and the end ofthe test. The sample volume was 2 mL and samples were stored in a freezer until analysis. Exposure duration:48 hours Concentrations tested: Loading rates were 0 (control) and 100 mg/L, which corresponded to mean measured concentrations of0 (control) and 0.048 mg/L. Test method/conditions remarks: Test solution preparation involved a 1 0-minute treatment period with ultrasonic waves followed by 3 days ofmagnetic stirring of 100 mg/L C.I. Pigment Blue 61 to reach maximum solubility ofthe test substance in the test medium. Subsequently, the aqueous mixture was filtered through a membrane filter (Schleicher and Schuell, 0.45 rim). The resulting filtrate was observed to be clear and light blue. Adjusted ISO medium (ISO 6341) from tap water purified by Reverse Osmosis (RO-water) was used as dilution water. Four replicates of5 daphnids each were prepared in I00-mL glass exposure vessels with 80 mL test solution for each treatment. Daphnid loading was 62.5 daphnids/L test solution. Immobility was recorded at the 0, 24, and 48-hour observations. Additional positive control (potassium dichromate) groups were included in the testing scheme.

### Water hardness ofdilution water was 180 mg CaCO3

### /L. Dissolved oxygen and pH levels ranged from 8.7 to 8.9 mg/L and 7.8 to 8.1, respectively, at the beginning and the end ofthe exposure period. The pH was not adjusted during the study period. Test temperatures were maintained between 20.9 and 21 .3'C.The photoperiod was 16 hours light: 8hours dark. Statistical methods: The average exposure concentration was calculated as the geometric mean of the concentrations measured at the start and end ofthe test. RESULTS Endpoint value(s): The mean measured 48-hour EC 50 

### value for daphnids was greater than 0.048 mg/L. Results remarks: Positive and negative controls responded adequately. Analysis at test initiation and termination indicated 0.0578 mg/L and 0.0402 mg/L test substance in test solution. Based on these results, the average exposure concentration was calculated to be 0.048 mg/L. No immobility was observed throughout exposure in the negative controls or 0.048 mg/L treated replicates. CONCLUSIONS C.I. Pigment Blue 61 did not induce acute immobilization ofDaphnia magnaat 0.048 mg/L after 48 hours ofexposure (NOEC). The mean measured 48-hour EC50 

### value for daphnids was greater than 0.048 mg/L. STUDY RELIABILITY [2] Reliable with restrictions. The mean measured concentration ofthe limit test solution (0.048 mg/L) exceeded a previously measured water solubility limit (0.0025 mg/L) although no solvent was used; the same method oftest solution preparation was used in an algae toxicity study and resulted in a mean measured concentration of0.422 mg/L. REFERENCE Bouwman, L.M. 2008. Acute toxicity study in Daphnia magna with C.I. Pigment Blue 61 (static). NOTOX B.V. Testing Facility, NOTOX Project # 488233, Study completed 23 October 2008.Review of TSCA Section 4 Final Study Report CITB Project Manager: Catherine Roman Chemical Name: Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien- 1 - ylidene]methyllphenyl] amino]- CAS Registry Number: 1324-76-1 Report Title: Acute toxicity study in Daphniamagnawith C.I. Pigment Blue 61 (static) Test Sponsor: Color Pigments Manufacturers Association, Inc. Testing Lab: NOTOX B.V. Test Standard: ASTM E 729 Date Study Received by EPA: 1/18/08 Date Study Due to EPA: 5/17/07 Special Instructions (e.g., regarding approved protocol modifications, etc.):
Part 1. Test Report and Study Conduct Enter one ofthe following codes into each ofthe checkboxes Ithrough 13: Afree fA]. Disagree [DI. Not Applicable [NA]. or Cannot Determine W1,.and add comment, below, as needed [D] 1.The final study report indicates evidence ofgross, unauthorized or undocumented deviation from the EPA test standard requirements, including "shall," "must," or "will" violations. List significant test standard deviations and "shall," "must," or "will" violations in comments below. [D] 2. The final study report indicates evidence ofdeviations from the "should" statements in the study protocol that may have a bearing on the study conclusions. List these in comments below. [D] 3. Approved modifications oftest standard or testing protocol (CITB PM describe or attach) were not followed or are inadequately documented. [D] 4. There is evidence that laboratory Standard Operating Procedures (SOPs) were inadequately followed. [D] 5.The Statement ofQuality Assurance (QA) inspections, their dates, and findings were missing ornot signed. There is evidence that QA procedures may be inadequate. [D] 6.There is evidence that Good Laboratory Practice Standards (GLPS) were inadequately followed. [D] 7.The test, control, or reference substances are different from that specified in the section 4 test rule or Enforceable Consent Agreement (ECA). [D] 8.Animal identification is inadequate or unclear; use ofunhealthy animals or other factors (e.g., deviations from temperature, lighting, dosing) are apparent. [D] 9. The final study report inadequately describes the study method.[D] 10. The final study report inadequately describes the test system. [D] 11. The final study report inadequately describes the dosage information. [D] 12. The final study report does not accurately reflect the individual animal data (or that ofother discrete observations pertinent to the type ofstudy conducted), or individual data were not provided. [D] 13. The final study report inadequately describes the calculations, interpolations, data transformations, statistical analyses, or modeling parameters used. Part 11. Conclusions Place a check mark beside the summar statement(s) that apply to this review and add comments below as appropriate Part A. To be filled out by Reviewer Study Conduct 1.The study was well-conducted. [xl 2. The study was generally well-conducted, with some minor 

### [ deficiencies (list in notes below). 3. The study conduct was significantly deficient or questionable, (give 

### [

reasons in notes below). Data Reliability 4. The study results are precise and accurate.[ 5. Appropriate methods were used to determine [NA] statistical significance. 6. Ifrepeated, the test results would be expected to be the 

### I same. Data Utility 7. The data are useful for risk assessment for the endpoint tested. [x] 8. The data are useful for some other purpose (e.g., dose-setting). 

### [ 9. The data are not useful for any purpose (describe in notes below). 

### [3
Reviewer Comments (continue on separate page, ifneeded): Data Reliability: The method oftest solution preparation is questionable because (1) the mean measured concentration ofthe test solution (0.048 mgIL) exceeded the referenced solubility limit of0.0025 mg/L (Clamiant, SU-Technology and Innovation Management, Pigment Analytics) and (2) the same method was used in the algae toxicity study and resulted in a mean measured concentration of0.422 mg/L. Therefore, it is unclear ifthe results of the Daphniatoxicity test would be the same ifthe test was repeated. Because no immobility was observed, no EC5 0 was calculated, and therefore, no statistics were necessary. Reviewer Name/Title/BranchlDivision/Office: Kendra Moran and Teresa Manyin, SRC Reviewer Signature~
Y-Ufat BT ft_ AbVOTBHM2% Tiered Testing Decision 1. The tiered testing trigger was met, Additional JestinIg is indicated, 

### ~[ (when applicable) 2. The trigger for additional (tiered~k I'ing wajt4hV 

### [I Study Acceptability 3. The study is acceptable. 4. The study may not be acceptable 

### [ (provide rationale in memo to CITB chief).SRC Document Receipt Documents Logged Out to US EPA's CBIC on March 15, 2010 byJ.Garey

CASE No. Document Description iG031510a HPV1 Data Adequacy Review Document Referencing EPA DCN No. 40090000007 and 40090000009 (algae) J). \:352 JGO31S10b HPV1 Data Adequacy Review Document Referencing EPA DCN No. 40090000007 and 40090000009 (Daphnia) 3X~i\:3c\ JG031510c HPV1 Data Adequacy Review Document Referencing EPA DCN No. 40090000007 and 40090000009 (combined repeated-dose)

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