SRC TR

- 10

- 115

HPV4 CHEMICAL DATA ADEQUA CY REVIEW

Naphthenic acids, reaction products with diethylenetriamine , CAS No. 68131

- 13

- 5

Prepared by:

Christopher Janson

, Justine Von Runnen , and Joan D. Garey

Chemical, Biological and Environmen tal 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 Margo sches

, Alternate Project Officer

Meena Sonawane, Work Assignment Manager

David Brooks, Alternate Work Assignment Manager

July 2 , 2010HPV4 Chemical Data Adequacy Review

Naphthenic acids, reaction products with diethylenetriamine , CAS No. 68131

- 13

- 5

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. 68131

- 13

- 5

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, dermal, inhalation) toxici ty

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 i dentified 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 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

tox icology 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 effects of chemical substances (RTECs)

Environmental Fate Database (EFDB)

ECOTO X

- EPA’s peer

- reviewed ecotoxicology databaseDraft HPV4 Chemical Data Adequacy Review CAS No. 68131

- 13

- 5

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 Co ncise 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 E PA 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 co ntained 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 a s 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 an d 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 review er’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 DAT A

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 s ummaries 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. 68131

- 13

- 5

3 CAS No. 68131

- 13

- 5: Summary of Endpoints

Endpoint Study Information

Available Acceptable Data Gap

Aquatic Effects

Acute Toxicity to Fish No No Yes

Acute Toxicity to Daphnia No No Yes

Toxicity to Aquatic Plants No No Y es

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

Developmental Toxicity No No Yes