SRC TR-10-047 

HPV1 TEST RULE STUDY – DATA ADEQUACY ASSESSMENT 

1-Chlorododecane, CAS No. 112-52-7 

Acute Toxicity 

Prepared by: 

 Ashlee Aldridge, Justine Von Runnen 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 

March 5, 2010 
HPV1 Test Rule – Data Adequacy Assessment 

1-Chlorododecane, CAS No. 112-52-7 

Acute Toxicity 

March 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. 

Environmental Science Center 

2451 Crystal Drive, Suite 804 

Arlington, VA 22202 
Draft HPV1 Test Rule – Data Adequacy –Acute Toxicity CAS No. 112-52-7

PREPARATION OF THE DATA ADEQUACY ASSESSMENT

This document contains the review of a toxicity study conducted in response to the first 

HPV TSCA Section 4 Test Rule (71 FR 13708, March 16, 2006). Using the applicable test 

guideline and professional judgment as guides, the study was reviewed for adequacy and 

evaluated for compliance with the test guideline. (The applicable test guideline is not always the 

test guideline required by the test rule, because some test sponsors requested and received 

approval from EPA to use a different guideline.) The study was summarized according to a 

standard format, assessed for adequacy, and assigned a Klimisch reliability code. If the study 

was determined to be inadequate, a basis for that conclusion is supplied. For studies already 

assigned Klimisch codes, an explanation is provided if the reviewer’s assessment of data 

adequacy differed from the pre-assigned Klimisch code. 

A detailed evaluation of the test report and study conduct is provided at the end of the 

summary document in a section entitled “Review of TSCA Section 4 Final Study Report”. Any 

deviations from the applicable test guideline are described. The study is also evaluated for 

compliance with Standard Operating Procedures, Good Laboratory Practice Standards, and 

Quality Assurance procedures, as well as the use of appropriate controls and test substances. 

Any deficiencies in the descriptions of the study method, test system, animals studied, physical 

conditions, dosage information, individual animal data, calculations, and statistical analyses are 

described, and internal inconsistencies within the study report are identified. An overall 

assessment is provided for each of the following: study conduct, data reliability, and data utility. 

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Draft HPV1 Test Rule – Data Adequacy –Acute Toxicity CAS No. 112-52-7

ACUTE TOXICITY 

Title: Acute Oral Toxicity with 1-Chlorododecane: Up And Down Procedure In Rats 

The study is: Adequate Not Adequate 

TEST SUBSTANCE 

 

Identity: 1-Chlorododecane, CAS No. 112-52-7 

Remarks: The test substance was a colorless to pale yellow liquid, stored at room temperature 

and was stable for the duration of testing. Batch #N6227945. Purity 97.42%; specific gravity = 

0.883 g/mL. 

METHOD

Method/guideline followed: 40 CFR 799.9110 TSCA Acute Oral Toxicity (1997), OECD 

Guidelines for Testing Chemicals, Test No. 425 (2006) U.S. EPA Health Effects Test 

Guidelines, OPPTS 9870.110 (2002). 

Test type: Acute oral toxicity – limit test 

GLP compliant: Yes

Year study performed: 2008

Test species: Sprague-Dawley derived albino rats (received from Ace Animals Inc., Boyertown 

PA; 9 – 11 weeks; 180-241g) 

Number of animals/sex/dose: 8 female (nulliparous and non-pregnant) 

Route of administration: Gavage 

Vehicle: None 

Doses/concentrations tested: 2000 mg/kg 

Statistical methods used: Not applicable 

Test method/conditions remarks: 

All animals were fasted overnight prior to dosing. A preliminary toxicity test was performed 

with undiluted 1-Chlorododecane administered via gavage to one healthy female rat at a limit 

dose of 2000 mg/kg body weight. Due to the absence of mortality in this animal, four additional 

female rats were administered undiluted 1-Chlorododecane at 2000 mg/kg body weight. Because 

food was not withheld from these animals immediately post-dosing, an additional three female 

rats were administered undiluted 1-Chlorododecane at 2000 mg/kg body weight in order to meet 

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Draft HPV1 Test Rule – Data Adequacy –Acute Toxicity CAS No. 112-52-7

the guideline requirements for a limit test. All animals were observed for clinical signs of 

toxicity and mortality for 14 days following dosing. 

RESULTS

Endpoint value(s): LD50 > 2000 mg/kg-bw 

Results remarks: All animals survived, gained body weight, and appeared active and healthy 

during the study. There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal 

behavior. No gross abnormalities were noted for any of the animals when necropsied at the 

conclusion of the 14-day observation period. 

CONCLUSIONS

Under conditions of this study, the acute oral LD50 of 1-Chlorododecane in the female rat is 

greater than 2000 mg/kg -bw. 

STUDY RELIABILITY

[1] – Reliable without restrictions 

REFERENCE

EPA-HQ-OPPT-2005-0033-0314.1; Durando, J. 2008. Acute Oral Toxicity with 1-

Chlorododecane: Up and Down Procedure in Rats. Eurofins/Product Safety Laboratories for 

Lonza Inc. Study No. 22019 (unpublished report). 

3 
Review of TSCA Section 4 Final Study Report 

CITB Project Manager: Catherine Roman 

Chemical Name: 1-Chlorododecane 

CAS Registry Number: 112-52-7 

Report Title: Acute Oral Toxicity with 1-Chlorododecane: Up and Down Procedure in Rats 

Test Sponsor: Lonza, Inc. 

Testing Lab: Eurofins Product Safety Laboratories 

Test Standard: OECD 425 

Date Study Received by EPA: September 19, 2008 Date Study Due to EPA: May 17, 2007 

Special Instructions (e.g., regarding approved protocol modifications, etc.): As required for compliance with the 

"Testing of certain High Production Volume Chemicals; Final Rule" (Federal Register; 40 CFR Parts 9 and 799; 

Thursday, March 16, 2006 pp 13708-13730), the guideline reference, 40 CFR 799.91 10 TSCA Acute Oral Toxicity, 

was added to the Test Procedure Guidelines section of the protocol. 

 

Part I. Test Report and Study Conduct

Enter one of the following codes into each of the checkboxes 1 through 13: Agree [A], Disagree [D], Not 

Applicable [NA], or Cannot Determine [C], and add comment, below, as needed

 [D] 1. The final study report indicates evidence of gross, unauthorized or undocumented deviation from 

 the EPA test standard requirements, including “shall,” “must,” or “will” violations. List 

 significant test standard deviations and “shall,” “must,” or “will” violations in comments below. 

 [D] 2. The final study report indicates evidence of deviations from the “should” statements in the study protocol 

that may have a bearing on the study conclusions. List these in comments below. 

 [NA] 3. Approved modifications of test standard or testing protocol (CITB PM describe or attach) were not 

followed or are inadequately documented. 

 [D] 4. There is evidence that laboratory Standard Operating Procedures (SOPs) were inadequately followed. 

 [D] 5. The Statement of Quality Assurance (QA) inspections, their dates, and findings were missing or not 

signed. There is evidence that QA procedures may be inadequate. 

[D] 6. There is evidence that Good Laboratory Practice Standards (GLPS) were inadequately followed. 

 [D] 7. The test, control, or reference substances are different from that specified in the section 4 test rule or 

Enforceable Consent Agreement (ECA). 

 [D] 8. Animal identification is inadequate or unclear; use of unhealthy animals or other factors (e.g., deviations 

from temperature, lighting, dosing) are apparent. 

 [D] 9. The final study report inadequately describes the study method. 
 [D] 10. The final study report inadequately describes the test system. 

[D] 11. The final study report inadequately describes the dosage information. 

[D] 12. The final study report does not accurately reflect the individual animal data (or that of other discrete 

observations pertinent to the type of study conducted), or individual data were not provided. 

[D] 13. The final study report inadequately describes the calculations, interpolations, data transformations, 

statistical analyses, or modeling parameters used. 

Part II. Conclusions

Place a check mark beside the summary statement(s) that apply to this review and add comments below as 

appropriate

Part A. To be filled out by Reviewer

 

Study Conduct 1. The study was well-conducted. [X] 

 2. The study was generally well-conducted, with some minor [ ] 

 deficiencies (list in notes below). 

 3. The study conduct was significantly deficient or questionable, (give [ ] 

 reasons in notes below). 

Data Reliability 4. The study results are precise and accurate. [X] 

 5. Appropriate methods were used to determine [X] 

 statistical significance. 

 6. If repeated, the test results would be expected to be the [X] 

 same. 

Data Utility 7. The data are useful for risk assessment for the endpoint tested. [X] 

 8. The data are useful for some other purpose (e.g., dose-setting). [ ] 

 9. The data are not useful for any purpose (describe in notes below). [ ] 

Reviewer Comments (continue on separate page, if needed): As required for compliance with the "Testing of 

certain High Production Volume Chemicals; Final Rule" (Federal Register; 40 CFR Parts 9 and 799; Thursday, 

March 16, 2006 pp 13708-13730), the guideline reference, 40 CFR 799.91 10 TSCA Acute Oral Toxicity, was 

added to the Test Procedure Guidelines section of the protocol. This had no negative impact on this study as the 40 

CFR 799.91 10 TSCA Acute Oral Toxicity guideline references the OECD Guideline No. 425 also included in the 

protocol. 

Reviewer Name/Title/Branch/Division/Office: Ashlee Aldridge/SRC, Inc. 

Reviewer Signature: David Brooks/HPVCB/RAD/OPPTS 

Part B. To be filled out by CITB PM

Tiered Testing Decision 1. The tiered testing trigger was met, additional testing is indicated. [ ] 

(when applicable) 2. The trigger for additional (tiered) testing was not met. [ ] 

 

Study Acceptability 3. The study is acceptable. [ ] 

 4. The study may not be acceptable [ ] 

 (provide rationale in memo to CITB chief).