SRC TR

- 10

- 117

HPV4 CHEMICAL DATA ADEQUA CY REVIEW

2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl]

derivs. , CAS No. 68442

- 77

- 3

Prepared by:

Justine Von Runnen

, Chris Janson , and Joan D. Garey

Chemical, Biological and Environmental 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

Wash ington, D.C. 20460

Elizabeth Margosches

, Alternate Project Officer Meena Sonawane, Work Assignment Manager David Brooks, Alternate Work Assignment Manager

July 2 , 2010HPV4 Chemical Data Adequacy Review

2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydr o

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl] derivs., CAS No. 68442

- 77

- 3

July 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. Chemical, Biological and Environmental Center 2451 Crystal Drive, Suite 804 Arlington, VA 22202Draft HPV4 Chemical Data Adequacy Review CAS No. 68442

- 77

- 3

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 t o Daphnia Toxicity to aquatic plants

Acute (oral, dermal, inhalation) 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

- 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 Toxicolo gy 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 ch emicals ;

**•** Genetic Toxicology Data Bank (GENE

- TOX)

- Peer

- reviewed genetic toxicology test data for over 3000 chemicals.

TSCATS

- U npublished technical reports submitted by industry to the EPA under the Toxic Substances Control Act]

Registry of toxic effec ts of chemical substances (RTECs)

Environmental Fate Database (EFDB)

ECOTOX

- EPA’s peer

- reviewed ecotoxicology databaseDraft HPV4 Chemical Data Adequacy Review CAS No. 68442

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- 3

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

Agency for Toxic Substances and Disease Registry (ATSDR) website

National T oxicology 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 at aset 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 a dequacy

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 detai l 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., studi es 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 endp oint 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 ide ntified for the chemical , only the data availability/adequacy summary table was completed for the report

.Draft HPV4 Chemical Data Adequacy Review CAS No. 68442

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3 CAS No. 6844 2

- 77

- 3: Summary of Endpoints

Endpoint Study Information

Available Acceptable Data Gap

Aquatic Effects Acute Toxicity to Fish No No Y es Acute Toxicity to Daphnia No No Yes Toxicity to Aquatic Plants No No Yes

Health Effects Acute Toxicity No No Yes Repeated

- Dose Toxicity No No Yes

Gene Mutation No No Yes

Chromosomal Aberrations No No Yes

Reproductive Toxicity No No Yes Develop mental Toxicity No No Yes