~ J~~SED STq p~SS 

'Z UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C . 20460 

I ~ I I 

~~lq~ PROSEG~` 11111111 11 

JAN 0 6 2010 

MEMORANDUM 

SUBJECT: Request for review of s 

HPV-1 test rule 

FROM: Jim Willis, Di 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

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 from EPA to 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 EPA employee or contractor that has been assigned to review one or 

CONTAINS NO CBI 

Internet Address (URL) 9 http :/Iwww.epa .gov 

Recycled/Recyclable e Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 
more 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, Room 6428, 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." A blank copy of that form is 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 him contact 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-OPPTOPPT-2005- 2005-0033- 

0033-XXXX) XXXX) ("X" 

("X" digits are digits are listed 

listed below) below) 

74-95- Methane, dibromo melting point OECD 102 0254.2 None 

3 

- 

boiling point 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 ASTM E 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 ighted 

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 

screening 
p. 4 

4 

CAS' Chemical name Required test Applicable Document Document 

No. test number of number of robust 

guidelinel study summary 

(EPA-HQ- (EPA-HQ-OPPTOPPT-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 point 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 point 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 729 
CAS Chemical name Required test Applicable Document Document 

No. test number of number of robust 

guideline' study summary 

(EPA-HQ- (EPA-HQ-OPPTOPPT-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 EPA scientist as a possible HPLC 

method that could be used. 
Review of 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 from the "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 from that 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 review and 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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