~ J~~SED STqp~SS'Z UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 

### I ~ I I ~~lq~ PROSEG~` 11111111 11 

## JAN 06 2010

MEMORANDUM SUBJECT: Request for review of s HPV-1 test rule 

### FROM : Jim

Willis, Di OFFICE OF PREVENTION, PESTICIDES AND TOXICSUBSTANCES

ies conducted in response to TSCA section 4

Chemical Control TO : Oscar Hernandez, DhIector

Risk Assessment Division (7403M) Bob Lee, Director Economics, Exposure, and Technology Division (7406M) I

c~ This is a request that RAD review the 67 studies listed in the table below that have be~p conducted in response to the first HPV (HPV-1) test rule (51 FR 13708, March 16, 2006) . The - studies do not address all the tests for all the chemicals listed in the final rule because a consrdirable' . number of adequate existing studies were submitted after the final rule was published. All o:9#1ese studies have been evaluated. The 67 studies include 29 health and eco effects studies to be reviewed by RAD, 34 physical/chemical properties studies to be reviewed by EETD/ICB, and 4 biodegradation studies to be reviewed by EETD/EAB. The table at the end of this memo lists the studies by the CAS No. and name of the tested chemical, the name of the required test, and the applicable 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 fromEPAto use a different guideline. Each study is listed as the last 4 digits of its Document No. in EPA's electronic docket for the HPV-1 test rule, EPA-HQOPPT-2005-0033. The last column lists the last four digits of the Document No. of the robust summary. Most of the studies and robust summaries are in the electronic docket and can be accessed at www .regulations.gov by entering the Document No. of the study or summary. There is not a robust summary for every study because robust summaries were not required, only requested, by the HPV-1 test rule. Five studies have been copyrighted, and therefore are not in the electronic docket and cannot be reproduced. The EPAemployee or contractor that has been assigned to review one or 

## CONTAINS NOCBI Internet Address (URL) 9 http :/Iwww .epa .gov Recycled/Recyclable e Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Papermore or the copyrighted studies should contact the project manager, Catherine Roman (202-564-

8172) to receive an electronic copy with the provision that it cannot be reproduced or published. Four studies have been claimed to be CBI and can only be read by someone cleared for CBI . These studies are in the CBI Center (EPA East, Room6428, 8:30 am to 4:00 pm) . There are, however, robust summaries in the electronic Docket for the four CBI studies. Please have the assigned reviewers determine the adequacy of the 67 studies by determining compliance with the applicable guideline and/or whether it fulfills the Agency's data needs for that particular endpoint . For each study please have the reviewer complete a "Review of TSCA Section 4 Final Study Report ." Ablank copy ofthat formis attached. Have the reviewer enter the reasons why the study was found adequate or inadequate. These reviews will be added to the docket . If the reviewer would like an electronic copy of a blank review form, please have himcontact the project manager, Catherine Roman (564-8172) . I'd appreciate if this request can be completed by Mar 31, 2010, or earlier if possible. If you have any questions, or require additional clarification, please contact Catherine Roman . cc: Mark Townsend David Brooks Cathy Fehrenbacher Tracy Williamson Gerry Brown/ Docket No. EPA-HQ-OPPT-2005-0033 C . Roman

### 3 STUDIES CONDUCTED FOR HPV-1 TEST RULE p. 3

CAS Chemical name Required test Applicable Document Document No. test number of number of robust guideline' study summary

(EPA-HQ- (EPA-HQ-OPPT

### OPPT-2005- 2005-0033- 0033-XXXX) XXXX) ("X" ("X" digits are digits are listed listed below) below) 

### 74-95- Methane, dibromo melting p oint OECD 102 0254.2 None 3 -boiling p oint OECD 103 0254.2 None vapor pressure OECD 104 0254.1 0254 n-octanol/ OECD 107 0254.2 None water partition coefficient water OECD 105 0254.2 None solubility Acute tox to ASTM E 0259.1 0259 

### Fish 729 Acute tox to ASTM E 0259.2 0259 

### Daphnia 729 toxicity to ASTME 0254.3 None 

### algae 1218 chromosomal 799.9537 0254.5 0254.4 aberration 

### repro/devel tox 799.9355 0259.3 and .4 0259 screening 

### 78-11- 1,3-Propanediol, 2,2- n-octanol/ 0294.2 None 5 bis[(nitrooxy)methyl]- water partition 799.6755 Copyrighted

, dinitrate (ester) coefficient



### water 799.6784 0294.2 None Aka PETN solubility Copy i g hted biodegradation ASTM E 0294.2 None 1625 or Copyrighted 

### ISO 9888 toxicity to ASTM E 0294.3 and .4 None al gae 1218 repro/devel tox 799

.9355 0294.1 None screening 

### 84-65- 9,10-Anthracenedione n-octanol/ ASTM E 0222.1 0222.3 1 water partition 1147 coefficient water solubility 799.6784 0222.1 0222 .3 

### repro/devel tox 799.9355 0222 .2 0222.3 screeningp. 4 4 CAS' Chemical name Required test Applicable Document Document 

### No. test number of number of robust guidelinel study summary

(EPA-HQ- (EPA-HQ-OPPT

### OPPT-2005- 2005-0033- 0033-XXXX) XXXX) ("X" ("X" digits are digits are listed listed below) below) 

### 110- 2,4-Hexadienoic acid, Melting point ASTM E 0313 0313 44-1 (E,E)- 324 Boiling point ASTM E 0313 0313 Aka Sorbic acid 1719 Vapor pressure ASTM E 0313 0313 

### 1782 Octanol/water ASTM E 0313 0313 partition 1147 coefficient 

### Water ASTM E 0313 0313 solubility 1148 Acute tox to ASTM E 0313 0313 Fish 729 Acute tox to ASTM E 0313 0313 

### Daphnia 729 112- Dodecane, 1-chloro Boiling p oint OECD 103 0314.6 0314.12 52-7 Vapor pressure ASTM E 0314.10 1194 

### Octanol/water 799.6756 0314.8 partition 

### coefficient Water 799.6786 0314.11 solubility 

### Biodegradation ISO 9888 0314.9 Chronic tox to ASTM E 0314.7 

### Daphnia 1193 96-hr tox to ASTM E 0314.5 

### al gae 1218 Acute tox to OECD 425 0314.1 mammals 

### Bacteria 799.9510 0314.2 reverse mutation Chromosomal 799.9537 0314.3 aberration Repeat-dose 799.9365 0314.4 tox with repro/ dev tox screen

### 5 p. 5

CAS Chemical name Required test Applicable Document Document 

### No. test number of number of robust guidelinel study summary

(EPA-HQ- (EPA-HQ-OPPT- ' 

### OPPT-2005- 2005-0033- 0033-XXXX) XXXX) ("X" ("X" digits are digits are listed listed below) below) 118- Phenol, 4,4'- Melting point ASTM E 0274 0274 

### 82-1 methylenebis [2,6-bis 324 (1,1-dimethylethyl)- Boiling point OECD 103 0274 0273

Vapor pressure OECD 104 0274 0274 Aka AN-2 Biodegradation Draft 0275.1 0275 

### OECD Copyrighted 3142 Chromosomal 799.9537 0257 0257, pg. 2 aberration with Copyrighted Copyrighted

Chinese hamster ovary cells 

### 149- Methanesulfinic acid, Melting point ASTM E 0309 0309 44-0 hydroxy-, 324

monosodium

salt Water ASTM E 0309 0309 

### solubility 1148 Aka sodium Chromosomal 799.9539 0309 0309 formaldehyde aberration 

### sulfoxylate (SFS) Repeated dose 799.9365 0309 0309 tox with repro/ dev tox screen 409- Methyl heptenone Melting point ASTM E 0324

.15 0324.16 

### 02-9 324 Boiling p oint OECD 103 0324.15 0324.16 Vapor pressure ASTM E 0324.15 0324.16 1782 octanol/water 799

.6755, 0324 .15 0324 .16 

### partition 799.6756, coefficient or ASTM

E 1147 Water OECD 105 0324 .13 0324.14 solubility 

### Biodegradation OECD 0324.12

301F Acute tox to ASTM E 0324.11 

### fish 729 Acute tox to ASTM E 0324.10 Daphnia 729CAS Chemical name Required test Applicable Document Document

No. test number of number of robust guideline' study summary

(EPA-HQ- (EPA-HQ-OPPT

### OPPT-2005- 2005-0033- 0033-XXXX) XXXX) ("X" ("X" digits are digits are listed 

### listed below) below) Toxicity to ASTM

E 0324.9 algae 1218 

### Acute tox to OECD 425 0324.8 0324.7 mammals 

### Gene mutation 799.9510 0324.6 0324.5 Chromosomal 799.9537 0324.4 0324.3 aberration 

### Repeat dose 799.9365 0324.1 0324.2 tox with repro/ 

### dev tox screen 1324- Benzenesulfonic acid, Octanol/water 799.6755 CBIC DCN 0318 76-1 [[4-[[4-(phenylamino) partition or OECD 40090000007 phenyl] [4- coefficient 117 (phenylimino)-2,5- Acute tox to ASTM E CBIC DCN 0318 cyclohexadien-1- Daphnia 729 40090000007 ylidene]methyl] . Toxicity to ASTM E CBIC DCN 0318 phenyl]amino]- algae 1218 40090000007 Aka Pigment Blue Repeat dose 799.9365 CBIC DCN 0318 

### 61 tox with repro/ 40090000009

dev tox screen 8005- C.I . Solvent Black 7 Melting point ASTM E 0290.2 290 .1, pg.4 02-5 324 Boiling point ASTM E 0290.2 290 .1, pg. 7 1719 Vapor pressure ASTM E 0290.2 290 .1, pg. 15 

### 1782 Octanol/water 799.6755 0290.2 290 .1, pg. 17 partition 

### coefficient Water 799.6784 0290.2 290 .1, pg. 20 solubility 1 . Applicable guideline = the guideline required by the test rule or a guideline approved for use by EPA in response to a request by test sponsor . 2. Draft OECD Test Guideline 314 entitled "Simulation Tests to Assess the Primary and Ultimate Biodegradability of Chemicals Discharged to Wastewater : Biodegradation in Waste Water,Activated Sludge, Anaerobic Digester Sludge, Mixing Zone for Treated Effluent and Surface

Water, and Mixing Zone for Untreated Wastewater and Surface Water ." 3 . In a 3-20-2008, letter to sponsor, OECD 117 was noted by an EPAscientist as a possible HPLC method that could be used.Reviewof TSCA Section 4 Final Study Report

CITB Project Manager : Chemical Name: CAS Registry Number : Report Title: Test Sponsor : Testing Lab: Test Standard: Date Study Received by EPA : Date Study Due to EPA : Special Instructions (e .g., regarding approved protocol modifications, etc.) : Part 1 . Test Renort and Study Conduct Enter one of the following codes into each of the checkboxes 1 through 13 : Agree [Al, Disagree [Dl, Not Anplicable [NAl or Cannot Determine [Cl and add comment, below, as needed [ [ [ 

### [l [ [[ 

### [l [) [ 1 . The final study report indicates evidence of gross, 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 . 2 . The final study report indicates evidence of deviations fromthe "should" statements in the study protocol that may have a bearing on the study conclusions. List these in comments below . 3 . Approved modifications of test standard or testing protocol (CITB PM describe or attach) were not followed or are inadequately documented . 4 . There is evidence that laboratory Standard Operating Procedures (SOPs) were inadequately followed. 5. The Statement of Quality Assurance (QA) inspections, their dates, and findings were missing or not signed. There is evidence that QA procedures may be inadequate. 6 . There is evidence that Good Laboratory Practice Standards (GLPS) were inadequately followed. 7. The test, control, or reference substances are different fromthat specified in the section 4 test rule or Enforceable Consent Agreement (ECA) . 8 . Animal identification is inadequate or unclear ; use of unhealthy animals or other factors (e .g., deviations from

temperature, lighting, dosing) are apparent . 9 . The final study report inadequately describes the study method. 10. The final study report inadequately desCrlbes the test system . REVIEW

OF TSCA SECTION 4 FINAL STUDY REPORT March 2006 Version[ ] 11 . The final study report inadequately describes the dosage information. [ j 12. The final study report does not accurately reflect the individual animal data (or that of other discrete observations pertinent to the type of study conducted), or individual data were not provided. [ ] 13 . The final study report inadequately describes the calculations, interpolations, data transformations, statistical analyses, or modeling parameters used . Part II . Conclusions Place a check mark beside the summary statement(s) that apply to this reviewand add comments below as appropriate Part A . To be filled out bv Reviewer Study Conduct 1 . The study was well-conducted. [ ] 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 . [ ] statistical significance . 6 . If repeated, the test results would be expected to be the [ ] same. Data Utility 7. The data are useful for risk assessment for the endpoint tested. [ ] 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) . [ ] Reviewer Comments (continue on separate page, if needed) :

Reviewer Name/Title/Branch/Division/Office : Reviewer Signature : Part B . To be filled out bv CITB PM Tiered Testing Decision 1 . The tiered testing trigger was met, additional testing is indicated. (when applicable) 2. The trigger for additional (tiered) testing was not met. Study Acceptability 3 . The study is acceptable . 4. The study may not be acceptable (provide rationale in memo to CITB chief) .



## 180 ON SN1d1N0O REVIEW

OF TSCA SECTION 4 FINAL STUDY REPORT March 2006 Version 

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