SRC TR-10-059

HPV1 TEST RULE STUDY – DATA ADEQUACY ASSESSMENT

Methyl Heptanone, CAS No. 409-02-9

Acute Toxicity to Daphnia

Prepared by:

Kendra Moran, Ashlee Aldridge, 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 Wo rk Assignment Manager

March 5, 2010HPV1 Test Rule – Data Adequacy Assessment

Methyl Heptanone, CAS No. 409-02-9

Acute Toxicity to Daphnia

March 2010

Submitted to: High Production Volume Chemicals Branch

Risk Assessment Division

Office of Pollution Prevention and Toxics Environmental Protection Agency

WAM: Meena Sonawane

Alternate WAM: David Brooks 1200 Pennsylvania Avenue, NW

Washington, DC 20460-0001

Prepared By:

SRC, Inc.

Environmental Science Center 2451 Crystal Drive, Suite 804 Arlington, VA 22202Draft HPV1 Test Rule – Data Adequacy – Acute Toxicity to Daphnia CAS No. 409-02-9

PREPARATION OF THE DAT A ADEQUACY ASSESSMENT

This document contains the review of a toxi city 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 guide s, the study was reviewed for adequacy and evaluated for compliance with the test guideline. (T he applicable test guid eline 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 assi gned a Klimisch reliability code. If the study was determined to be inadequate, a basis for th at conclusion is supplie d. For studies already assigned Klimisch codes, an explanation is prov ided if the reviewer’s assessment of data adequacy differed from the pre-assigned Klimisch code.

A detailed evaluation of the test report a nd study conduct is provided at the end of the summary document in a section entitled “Revie w of TSCA Section 4 Final Study Report”. Any deviations from the applicable test guideline are described. The study is also evaluated for compliance with Standard Operating Procedur es, Good Laboratory Prac tice Standards, and Quality Assurance procedures, as well as the use of appropriate controls and test substances. Any deficiencies in the descri ptions of the study method, test system, animals studied, physical conditions, dosage information, indi vidual animal data, calculations, and statistical analyses are described, and internal inconsistencies within the study report are identified. An overall assessment is provided for each of the following: study conduct, data reliability, and data utility.

1Draft HPV1 Test Rule – Data Adequacy – Acute Toxicity to Daphnia CAS No. 409-02-9

ACUTE TOXICITY TO DAPHNIA

Title: Acute Immobilization Test

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: Methyl Heptanone, CAS No. 409-02-9

Remarks: The test substance, Baton Rouge MEK H eavy Ketone Heart Cut C8 Ketone Fraction, was characterized as a complex mixture.

METHOD

Method/guideline followed: OECD TG 202 (1984)

Test type: Static

GLP compliant?: Yes

Year study was performed: 2007

Test species: Daphnia magna Strauss. The daphnids were cultured in-house. Age was <24 hours old from 16-day old parents.

Analytical monitoring: Yes

Exposure duration: 48 hrs

Concentrations tested: 0 (control), 0.75, 2.0, 3.9, 9.1, and 22 mg/L test substance water accomadated fraction (WAF), which corresponded to mean measured concentrations of 0 (control), 0.755, 1.78, 3.34, 7.99, and 16.6 mg/L.

Test method/conditions remarks: Individual Water Accommoda ted Fractions (WAFs) were prepared. The test substance was added to 4 L of reconstituted water in glass aspirator bottles (capacity 4.5 L). The test so lutions and a control were mixe d for 23.5 hours using a 4% vortex (of the static liquid depth). The mixtures were removed through an outlet at the bottom of each mixing vessel into four replicates of approximately 140 mL in 125 mL Erlenmeyer flasks (no headspace). Five daphnids were ad ded to each replicate and the repl icates were closed. The test was performed under static conditions with no aeration.

Dissolved oxygen ranged from 8.2 to 8.4 mg/L a nd pH ranged from 7.6 to 7.8 during the study. Water hardness was 142 mg/L as CaCO3. The TOC of the dilution water was 0.54 ppm. The test water temperatures ranged from 20.7°C to 20.9°C. The environmental condition daily average temperatures ranged from 19.6°C to 20.6°C. Diur nal light was 16 hours light and 8 hours dark

2Draft HPV1 Test Rule – Data Adequacy – Acute Toxicity to Daphnia CAS No. 409-02-9

with light intensity ranging from 444 to 456 Lux during full light hours.

Due to the relatively complex nature and limited water solubility of the test substance, the following exceptions to the guideline apply for th is study: 1) The concentration of the test

substance in solution was not determ ined prior to use.; and 2) It was deemed more appropriate to prepare an individual treatment solution by addi ng the test substance to dilution water and removing the WAF for testing, rather than prepar ing a dilution of the stock solution as outlined in the guideline.

RESULTS

Endpoint value(s): The 48-hour EC 50 value for daphnids was 5.2 mg/L based on mean

measured concentrations and the EL 50 was 6.0 mg/L based on WAF loading rates.

Results remarks: The maximum actual loading rate causing no immobilization was 3.9 mg/L. The maximum measured concentration causing no immobilizati on was 3.3 mg/L. The minimum actual loading rate causing 100% immobilization was 9.1 mg/L. The minimum measured concentration causing 100% immobilization was 8.0 mg/L. Control survival was 100%.

CONCLUSIONS

After Daphnia magna were exposed to a water accommoda ted fraction (WAF) prepared from Baton Rouge MEK Heavy Ketone Heart Cut - C8 Ketone Fraction for 48 hours, the EC 50 was 5.2 mg/L based on mean measured concentrations. The EL 50 was 6.0 mg/L based on WAF loading

rates.

STUDY RELIABILITY [1] Reliable without restrictions.

REFERENCE ExxonMobil Biomedical Sciences, Inc. ( 2007). Daphnia sp., Acute Immobilization Test, Study # 0700842

3Review of TSCA Section 4 Final Study Report

CITB Project Manager: Catherine Roman

Chemical Name: Methyl Heptanone

CAS Registry Number: 409-02-9

Report Title: Daphnid Acute Immobilization Test

Test Sponsor: Exxon Mobil Chemical Company

Testing Lab: Exxon Mobil Biomedical Sciences, Inc.

Test Standard: ASTM E 729

Date Study Received by EPA: 6/23/09 (date posted to http://www.regulations.gov )

Date Study Due to EPA: 5/17/07

Special Instructions (e.g., regarding approved protocol modifications, etc.):

Part I. Test Report and Study Conduct

Enter one of the following codes into each of the checkboxes 1 through 13: Agree [ A ], Disagree [ D ], Not Applicable [ NA ], or Cannot Determine [ C ], and add comment, below, as needed

[D] 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.

[D] 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.

[D] 3. Approved modifications of test 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 of Quality Assurance (QA) inspect ions, their dates, and findings were missing or not signed. There is evidence that QA pr ocedures 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 di fferent from that specified in the section 4 test rule or

Enforceable Consent Agreement (ECA).

[D] 8. Animal identification is inadequate or unclear; use of unhealthy 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 of other discrete observations pertinent to the type of study 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 II. Conclusions

Place a check mark beside the summar y 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. [x] 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. [x] 5. Appropriate methods were used to determine [x] statistical significance. 6. If repeated, the test results would be expected to be the [x]

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). [ ]

Reviewer Comments (continue on separate page, if needed):

Reviewer Name/Title/Branch/Divisio n/Office: Kendra Moran, SRC

Reviewer Signature: David Brooks/HPVB/RAD/OPPTS

Part B. To be filled out by CITB PM

Tiered Testing Decision 1. The tiered testing trigger was me t, 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).