SRC TR

- 10

- 023

HPV4 CHEMICAL DATA ADEQUA CY REVIEW

Butanedioic acid, (tetrapropenyl)

- , CAS No. 27859

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Prepared by:

Justine Von Runnen

, William L. Richards, Carlye A. Austin

, 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 .002

Submitted to:

OPPT/RAD/HP VCB (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

February 9

, 2010HPV4 Chemical Data Adequacy Review

Butanedioic acid, (tetrapropenyl)

- , CAS No. 27859

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February 2010

DRAFT

Submitted to: High Production Volume Chemicals Branch

Risk Assessment Division

Office of Pollution Prevention and Toxics Environmental Protection Agency

WAM: Meena Sona wane 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 HPV4 Chemical Data Adequacy Review CAS No. 27859

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1 A. PREPARATION OF THE DATA ADEQUACY ASSESSMENTS

A

- 1. Source material used for assessment

For this unsponsored chemical, a comprehensive literatu re search was performed to identify available toxicity data for the following SIDS endpoints:

Acute toxicity to fish Acute toxicity to Daphnia Toxicity to aquatic plants

Acute (oral, inhalation, dermal ) toxicity Repeated

- dose toxicity Reproductive toxicit y Developmental toxicity

Gene mutation

Chromosomal aberrations

Studies relevant to non

- SIDS endpoints (e.g., eye and skin irritation; neurotoxicity) conducted via oral, inhalation, or dermal routes were also identified through literature searching.

The f ollowing sources were searched for toxicity data:

PubMed

- B ibliographic database that contains references to journal articles in the life

sciences with a concentration on biomedicine

T OXNET

- N ational L ibrary of M edicine databases on toxicology, hazardo us chemicals, environmental health, and toxic releases; includes:

**•** TOXLINE with BIOSIS and NTIS ;

**•** Development and Reproductive Toxicology File (DART) ;

**•** Chemical Carcinogenesis Research Information System (CCRIS)

- Carcinogenicity and mutagenicity test resu lts for over 8000

**•** chemicals) ;

**•** Hazardous Substances Data Bank (HSDB)

- Comprehensive, peer

reviewed toxicology data for about 5000 chemicals ;

**•** Genetic Toxicology Data Bank (GENE

- TOX)

- Peer

- reviewed genetic toxicology test data for over 3000 chemicals.

T SCATS

- U npublished technical reports submitted by industry to the EPA under the

Toxic Substances Control Act

Registry of toxic effects of chemical substances (RTECs)

Environmental Fate Database (EFDB)

ECOTOX

- EPA’s peer

- reviewed ecotoxicology databaseDraft HPV4 Chemical Data Adequacy Review CAS No. 27859

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2 EPA’s Integrated Risk Information System (IRIS) website

Agency for Toxic Substances and Disease Registry (ATSDR) website

National Toxicology Program (NTP) website

International Program on Chemical Safety Concise International Chemical Assessment

Docum ents (IPCS INC HE M or CICADs)

European Chemical Substances Information System (ESIS)

- source of IUCLID Datasets

Any available IUCLID Datasets found through the ESIS website and robust summaries submitted to EPA by former sponsors on the assigned chemica ls were retrieved. Original sources were obtained for any relevant toxicity data found for the assigned chemicals.

While IUCLID D ataset s sometimes contained studies of interest, certain study descriptions contained insufficient detail to assess adequac y. In these cases, the primary source of the study, if available and accessible, was obtain ed and review ed.

A

- 2. Evaluating data adequacy

Using standard OECD testing guidelines and professional judgment as guides, available toxicity studies for the unsponsored chemical were reviewed for adequacy. Summaries were prepared for all relevant data found, even if little or no study detail was available. Each study was summarized according to a standard format and assigned a Klimisch reliability code; all

s tudy summaries for the chemical were combined into a single summary document. For studies already assigned Klimisch codes (e.g., studies summarized in IUCLID datasets), an explanation was provided if the reviewer’s assessment of data adequacy differed fro m the pre

- assigned Klimisch code. A table summarizing data availability/adequacy for each SIDS endpoint is

included at the end of the summary document.

B. SPECIFIC INFORMATION ON THE AVAILABLE TOXICITY DATA

The available data for each of the SIDS t oxicity endpoints are evaluated on the following

pages. Studies for a common endpoint are grouped together in the document and an endpoint adequacy assessment is provided near the top of the first page of the summaries for that endpoint. If the data avai lable for the endpoint is determined to be inadequate, a basis for that conclusion is supplied. NOTE: If no relevant studies were identified for the chemical , only the data availability/adequacy summary table was completed for the report

.Draft HPV4 Chemical Data Adequacy Review CAS No. 27859

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3 B

- 1. TOXICI TY TO AQUATIC PLANTS

Summary of endpoint: Inadequate

Study 1: Acute toxicity in Pseudokirchneriella subcapitata

Title: Acute Toxicity to Aquatic Plants

This study is: Adequate Not Adequate

Test substance purity no t provided; lack of analytical confirmation of test material concentration

in test solutions (WAFs); a ll test concentrations and the EC 50 are expressed as nominal loading

levels

.

TEST SUBSTANCE

Identity: Butanedioic acid, (tetrapropenyl)

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Remarks: Test material purity not provided

METHOD

Method/guideline followed: US EPA Toxic Substances Control Act Test Guideline #797.1050 (1993), OECD Guideline for Testing of Chemicals #201 Alga, Growth Inhibition Test (1984).

Test type : Static acute toxicity test

GLP compliant?: Yes

Year study was performed: 1996

Test species: Pseudokirchneriella subcapitata . Cells taken from an in

- house culture of Pseudokirchneriella subcapitata that was originally purchased from the University of Texas at Austin alga collection.

Analytical monitoring: Not performed ; concentrat ions were all based on nominal loading

levels

.

Exposure duration: 96 hours

Concentrations tested: 0 (c ontrol and 0.3, 3.0, 33, 330 and 3300 mg/L WAF loading rates.

Tes t method/conditions remarks:

Insoluble material was observed at 24, 48 and 96 hours in test vessels containing 330 and 3300 mg/L. No other insoluble material was observed during the study.Draft HPV4 Chemical Data Adequacy Review CAS No. 27859

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4 Statistical Methods: Average specific growth rate was calculated as the natural log of the number of cells/ml at 72 and 96 hours minus the natural log of the number of cells/ml at 0 hour, divided by the hour of exposure. Results were interpreted by standard statistical techniques. All calculations were performed using nominal concentrations of the test material with the number of cells/mL, then with the average specific growth rates.

Test System: Each WAF was prepared only at the beginning of the test. A measured weight of

test material was added to a measured volume of dilution water in a glass vessel and stirred for 20 hours. Stirring accomplished using a magnetic stirrer. Mixing speed was adjusted such that a vortex formed approximately 25% of the distance to the bottom. Following the mixing period,

the test solutio n was allowed to stand for 4 hour before the water phase was removed. T he siphoned water phase (i.e., WAF) was used for the aquatic toxicity test.

Test Conditions: A static test was conducted; i.e., there was no daily renewal of test solution.

Two 100

- mL replicates per treatment, inoculum ~10,000 cells/mL. The 250

- mL Erlenmeyer flasks were covered to reduce entry of dust, etc. During the test all treatment and control flasks were randomly placed on an orbital shaker adjusted to approximately 100 cycles pe r minute under constant light (24 hours/day). The occurrence of relative size differences, unusual cell shapes, colors, flocculations, adherence of cells to test containers or aggregation of cells was determined visually by means of direct microscopic exam ination with a hemocytometer. Cell

counts were made at 72 and 96 hours.

Light: Cool

- white fluorescent lights provided a light intensity of approximately 400

- 430 foot

candles.

Test temperature: 24.0 C.

Dilution Water: Sterile enriched alga growth medi a (US EPA, 1978) adjusted to pH 7.5. Measured total suspended solids in fresh untreated alga media were <10 mg/L, respectively. Test media pH was 7.4 at 0

- hour and 10.2 after 96 hours.

RESULTS

Endpoint value(s): The 96

- hour EC50 value s (calculated from nominal WAF loading rates) for Pseudokirchneriella subcapitata w ere 93 and 100 mg/L for number of cells/mL and growth rate, respectively. The NOEC (nominal WAF loading rate) was 33 mg/L.

Results remarks: Insoluble material was observed at 24, 48 and 9 6 hours in test vessels containing 330 and 3300 mg/L. No other insoluble material was observed during the study. The algal population grew well resulting in an average of 1,508,000 cells/mL in the control after 96 hours. Water quality was acceptable throug hout the study. The two highest concentrations of test material significantly decreased the pH of the test media at the beginning of the test (330 mg/L pH: 4.3

- 4.4; 3 3 00 mg/L pH: 3.9

- 4.0. No biological effects were noted during the study on cell size, shap e, color, flocculation, adherence to test containers or aggregation.

The toxic effects were determined to be algistatic based on the rapid re

- growth of an aliquot ofDraft HPV4 Chemical Data Adequacy Review CAS No. 27859

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5 cells taken from the 330mg/L test vessel and cultured in fresh control media.

Control response was satisfactory.

CONCLUSIONS

The test material was considered algistatic to freshwater alga.at loading rates of 330 and 3000 mg/L.

STUDY RELIABILITY

[ 3 ]: Not reliable

- test substance purity not provided; lack of any analytical confirmation of test

material concentration in test solutions (WAFs); a ll concentrations are expressed as nominal.

REFERENCE

Alkenyl Succinic Anhydri d es Category Robust Summaries submitted by Petroleum Additives Panel Health & Environmental Research Task Group . U pd ated : 11/22/2 002 . OPPT Receipt

Date: 12/10/ 2002.Draft HPV4 Chemical Data Adequacy Review CAS No. 27859

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6 B

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. CAS No. 27859

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- 1 : Summary of Endpoints

Endpoint Study Information

Available Acceptable Data Gap

Aquatic Effects Acute Toxicity to Fish No

- Yes Acute Toxicity to Daphnia No

- Yes

Tox icity to Aquatic Plants Yes No Yes

Health Effects Acute Toxicity No

- Yes Repeated

- Dose Toxicity No

- Yes

Gene Mutation No

- Yes

Chromosomal Aberrations No

- Yes

Reproductive Toxicity No

- Yes Developmental Toxicity No

- Yes