SRC TR

- 10

- 021

HPV4 CHEMICAL DATA ADEQUA CY REVIEW

2,5

- Fura ndione, 3

- (hexadecenyl)dihydro

- , CAS No. 32072

- 96

- 1

Prepared by:

Chris Janson, Carlye A. Austin, William L. Richards, and Joan D. Garey

Environmental Science Center
SRC, Inc.

750 2 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

M eena Sonawane, Work Assignment Manager David Brooks, Alternate Work Assignment Manager

February 5, 2010HPV4 Chemical Data Adequacy Review

2,5

- Furandione, 3

- (hexadecenyl)dihydro

- , CAS No. 32072

- 96

- 1

February 2010

DRAFT

Submitted to: High Pro duction Volume Chemicals Branch

Risk Assessment Division

Office of Po llution Prevention and Toxics Environmental Protection Agency

WAM: Meena Sonawane

Alterna te 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. 32072

- 96

- 1

1 A. PREPARATION OF THE DATA ADEQUACY ASSESSMENTS

A

- 1. Source material used for assessment

For this unsponsored chemical, a comprehensive literature search wa s 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 Developmen tal 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 sou rces 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, 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, peer

reviewed toxicology data for about 5000 chemicals ;

**•** Genetic Toxicology Data Bank (GENE

- TOX)

- Peer

- reviewed genetic toxicology test data for over 3000 chemicals.

TSCATS

- U npu blished 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. 32072

- 96

- 1

2 EPA’s Inte grated 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 I NC 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 chemicals were retr ieved. 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 adequacy. 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 study summari es 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

- as signed 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 endp oints 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 th e 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. 32072

- 96

- 1

3 B

- 1. CAS No. 32072

- 96

- 1: Summary of Endpoints

Endpoint Study Information

Available Acceptable Data Gap

Aquatic Effects Acute Toxicity to Fish Yes N o 1 Yes Acute Toxicity to Daphnia Yes No 1 Yes Toxicity to Aquatic Plants No

- Yes

Health Effects Acute Toxicity Yes No 1 Yes Repeated

- Dose Toxicity No

- Yes

Gene Mutation Yes No 1 Yes

Chromosomal Aberrations No

- Yes

Reproductive Toxicity No

- Yes Developmental Toxicity No

- Yes

1 In the IUCLID dataset for 2,5

- f urandione, 3

- (hexadecenyl)dihydro

- , acute toxicity to aquatic vertebrates and invertebrates were available for a mixture of C16, C18, and C20 succinic anhydrides. Additionally, acute toxicity and gene mutation data were available for a mixture of C16, C18 and C20 alkenylsuccinic anhydrides. These data were not rev iewed because data for mixtures containing 2,5

- f urandione, 3

- (hexadecenyl)dihydro

- are not adequate for characterizing the toxicity of 2,5

- f urandione, 3

- (hexadecenyl)dihydro

-
.