SRC TR

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HPV4 CHEMICAL DATA ADEQUA CY REVIEW

2,5

- Furandione, dihydro

- 3

- (tetrapropenyl)

- , CAS No. 26544

- 38

- 7

Prepared by:

Carlye Austin , William L. Richards, and Joan D. Garey

Environmental Science Center

SRC, Inc.

7502 Round Pond R oad

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 8

, 2010HPV4 Chemical Data Adequacy Review

2,5

- Furandione, dihydro

- 3

- (tetrapropenyl)

- , CAS No. 26544

- 38

- 7

February 2010

DRAFT

Submitted to:

High Production V olume Chemicals Branch

Risk Assessment Division

Office of Pollution P revention and Toxics

Environmental Protection Agency

WAM: Meena Sonawane

Alternate WAM: D avid 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. 2 6544

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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 literature search was perform ed to

identify available toxicity data for the following SIDS endpoints:

Acute toxicity to fish

Acute toxicity to Daphnia

Toxicity to aquatic plants

Acute (oral, dermal, inhalation) toxicity

Repeated

- dose toxicity

Reproductive toxicity

Developmental toxic ity

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

- 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,

environ mental 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

**•** c hemicals) ;

**•** 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 npublished t echnical 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. 2 6544

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2 EPA’s Integrated R isk 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 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 chemicals 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 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 summaries for t he 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

K limisch 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 ar e 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 endpoi nt 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. 2 6544

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3 B

- 1. ACUTE TOXICITY

Summary of endpoint: Inadequate

Study 1: Acute oral toxicity study

Title: None specified

The study is: Adequate Not Adequate

Insufficient data were provided to assess study adequacy.

TEST SUBSTANCE

Identity: 2,5

- Furand ione, dihydro

- 3

- (tetrapropenyl)

- , CAS No. 26544

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Remarks: Not specified

METHOD

Method/guideline followed: Not specified

Test type: Acute oral

GLP compliant?: Not specified

Year study performed: Not specified

Test species: Rat

Number of animals/se x/dose: Not specified

Route of administration: Not specified

Vehicle: Not specified

Doses/concentrations tested: Not specified

Statistical methods used: Not stated

Test method/conditions remarks: Not specified

RESULTS

Endpoint value(s): LD50 = 2550 mg/kgDraft HPV4 Chemical Data Adequacy Review CAS No. 2 6544

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4 Results remarks: Not specified

CONCLUSIONS

None

STUDY RELIABILITY

Klimisch code = [4]. Not assignable. Insufficient data were provided to assess study adequacy.

REFERENCE

Deichmann, W.B. and H.W. Gerarde. 1969. Toxicology of Drugs and Che micals. Academic

Press, New York. Page 581.Draft HPV4 Chemical Data Adequacy Review CAS No. 2 6544

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5 Study 2: Acute dermal toxicity study

Title: None specified

The study is: Adequate Not Adequate

Insufficient data were provided to assess study adequacy.

TEST SUBSTANCE

Identity: 2,5

- Furandione, dihydro

- 3

- (tetrapropenyl)

- , CAS No. 26544

- 38

- 7

Remarks: Not specified

METHOD

Method/guideline followed: Not specified

Test type: Acute dermal

GLP compliant?: Not specified

Year study performed: Not specified

Test specie s: Rabbit

Number of animals/sex/dose: Not specified

Route of administration: Not specified

Vehicle: Not specified

Doses/concentrations tested: Not specified

Statistical methods used: Not stated

Test method/conditions remarks: Not specified

RESULTS

Endpoint value(s): LD 50 = 6200 mg/kg

Results remarks: Not specifiedDraft HPV4 Chemical Data Adequacy Review CAS No. 2 6544

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6 CONCLUSIONS

None

STUDY RELIABILITY

Klimisch code = [4]. Not assignable. Insufficient data were provided to assess study adequacy.

REFERENCE

Deichmann, W.B. and H.W. Gerarde. 1 969. Toxicology of Drugs and Chemicals. Academic

Press, New York. Page 581.Draft HPV4 Chemical Data Adequacy Review CAS No. 2 6544

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7 B

- 2. CAS No. 26544

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- 7: Summary of Endpoints

Endpoint Study Information

Available Acceptable Data Gap

Aquatic Effects

Acute Toxicity to Fish No

- Yes

Acute Toxicity to Da phnia No

- Yes

Toxicity to Aquatic Plants No

- Yes

Health Effects

Acute Toxicity Yes

- Yes

Repeated

- Dose Toxicity No

- Yes

Gene Mutation No

- Yes

Chromosomal Aberrations No

- Yes

Reproductive Toxicity No

- Yes

Developmental Toxicity No

- Yes