SRC TR-10-023

HPV4 CHEMICAL DATA ADEQUACY REVIEW

Butanedioic acid, (tetrapropenyl)-, CAS No. 27859-58-1

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/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

February 9, 2010
HPV4 Chemical Data Adequacy Review

Butanedioic acid, (tetrapropenyl)-, CAS No. 27859-58-1

February 2010

DRAFT

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 22202
Draft HPV4 Chemical Data Adequacy Review CAS No. 27859-58-1

1

A. PREPARATION OF THE DATA ADEQUACY ASSESSMENTS

A-1. Source material used for assessment

For this unsponsored chemical, a comprehensive literature 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 toxicity

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 following sources were searched for toxicity data:

PubMed - Bibliographic database that contains references to journal articles in the life 

sciences with a concentration on biomedicine

TOXNET - National Library of Medicine databases on toxicology, hazardous 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 results for over 8000 

• chemicals);

• Hazardous Substances Data Bank (HSDB) - Comprehensive, peerreviewed toxicology data for about 5000 chemicals;

• Genetic Toxicology Data Bank (GENE-TOX) - Peer-reviewed genetic 

toxicology test data for over 3000 chemicals.

TSCATS - Unpublished 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 database
Draft HPV4 Chemical Data Adequacy Review CAS No. 27859-58-1

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 

Documents (IPCS INCHEM 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 chemicals were retrieved. Original 

sources were obtained for any relevant toxicity data found for the assigned chemicals. 

While IUCLID Datasets sometimes contained studies of interest, certain study 

descriptions contained insufficient detail to assess adequacy. In these cases, the primary source 

of the study, if available and accessible, was obtained and reviewed.

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 

study 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 from 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 toxicity 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 available 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. 27859-58-1

3

B-1. TOXICITY 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 not provided; lack of analytical confirmation of test material concentration 

in test solutions (WAFs); all test concentrations and the EC50 are expressed as nominal loading 

levels. 

TEST SUBSTANCE 

Identity: Butanedioic acid, (tetrapropenyl)-, CAS No. 27859-58-1

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; concentrations were all based on nominal loading 

levels.

Exposure duration: 96 hours

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

Test 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. 27859-58-1

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 solution was allowed to stand for 4 hour before the water phase was removed. The 

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 per 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 examination 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 footcandles. 

Test temperature: 24.0 C. 

Dilution Water: Sterile enriched alga growth media (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 values (calculated from nominal WAF loading rates) for

Pseudokirchneriella subcapitata were 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 96 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 throughout 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; 3300 mg/L pH: 3.9-4.0. No biological effects were noted during the study on cell 

size, shape, 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 of 
Draft HPV4 Chemical Data Adequacy Review CAS No. 27859-58-1

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); all concentrations are expressed as nominal. 

REFERENCE

Alkenyl Succinic Anhydrides Category Robust Summaries submitted by Petroleum Additives 

Panel Health & Environmental Research Task Group. Updated: 11/22/2002. OPPT Receipt 

Date: 12/10/ 2002. 
Draft HPV4 Chemical Data Adequacy Review CAS No. 27859-58-1

6

B-2. CAS No. 27859-58-1: Summary of Endpoints

Endpoint Study Information 

Available

Acceptable Data Gap

Aquatic Effects

Acute Toxicity to Fish No - Yes

Acute Toxicity to Daphnia No - Yes

Toxicity 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