# STILLMEADOW I NCO R P 0 RAT E D

VOLUME OF OF SUBMISSION Alcohols, C18-22, distn. residues 

### (CAS No: 1160164-88-4) 

### FINALREPORT

- ACUTE ORAL TOXICITY STUDY (UDP) INRATS 

### OECD425 AUTHOR: Janice O. Kuhn, PhD, 

### DABT STUDY INITIATION DATE: 11 September 2009 STUDY COMPLETIONDATE: 2 November 2009 CONDUCTED BY: STaLMEADOW, Inc. 12852 ParkOneDrive 

### SugarLand,TX 77478 

### LABORATORY STUDYNUMBER: 

### 13292-09 VOLUME 

### .lOF ..l.. OF STUDY PAGE..l.. OF 

### ..11 SUBMITTED TO: Sasol Germany GmbH

Anckelmannsplatz 1 Hamburg, Germany 20537



### 12852 Park One Drive. Sugar Land, Texas 77498 .281 240-8828 • Fax 281 240-8448 www.stillmeadow.com13292-09 Page 2 of 11 STATEMENT OF NODATA CONFIDENTIALITY CLAIM No claim of confidentiality is made for any information contained in this study on the basis of its falling within the scope ofFIFRA § 10 Cd) (1) CA), (B) or (C). Company: Sasol Germany GmbH Company Agent:
______________ _ Date:
____________ _ Title
_______________ _ Signature
_______________ _ These data are the property of Sasol Germany GmbH, and as such, are considered to be confidential for all purposes other than compliance withFIFRA 

### § 10. Submission ofthese data in compliance 

### with FIFRA does not constitute a waiver of any right to confidentiality that may exist under any other statute or in any other country.

STILLMEADOW, Inc.

### 13292-09 Page 3 of 11 GOOD LABORATORYPRACTICE COMPLIANCE STATEMENT This study was designed and performed at STILLMEADOW, Inc. and was conducted in compEance with United States Environmental Protection Agency TSCA 40 CFR792 with exception of: Section 792.31(d) and 792.105 (a)(b)(e) The provided Certificate of Analysis was not accompanied by a GLP compliance statement. This study was designed and performed at STILLMEADOW, Inc. and was conducted in compliance with Organization for Economic Cooperation & 

### Development Principles of GLP, Annex 2, C(98)17 with exception of: Section IT, 1.1 (2)(p), 6.1 (1) and 6.2 (2)(4) The provided Certificate ofAnalysis was not accompanied by a GLP compliance statement. This study was designed and performed at STILLMEADOW, Inc. and was conducted in compliance with Japan Ministry ofAgriculture, Forestry & 

### Fisheries, Notification No. 11 Nousan 6283, Director-General of Agricultural Production Bureau with exception of: Article 3.1 (18), 12.5 and 12.7 The provided Certificate of Analysis was not accompanied by a GLP compliance statement.
Janic O. uhn, PhD, DABT Stud D' ector, STILLMEADOW, Inc. Signature ofAgent ofSponsor AgentName Sponsor: Sasol Germany GmbH Signature ofAgent ofSubmitter AgentName Submitter: Sasol NA 

# 02 Date

Date

Date

STILLMEADOW,Inc.QUALITYASSURANCE STATEMENT
Test Substance: Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4) StudyTitle: Acute Oral Toxicity Study (UDP) in Rats 13292-09 Page 4 of 11

The study report and data have been audited in accordance" with Good Laboratory Practice Standards and STILLMEADOW, Inc. Standard Operating Procedures (SOPs). The fmal report accurately reflects the study data. The Quality Assurance Unithas notbeen involved in the actual conduct ofthis study. The QualityAssurance Unit performed a recent facility inspection on 10 Jul 09. All fmdings were reported to Management, and the report and responses are kept in the QualityAssurance files. " The fmdings from any study inspections and audits were reported to the Study Director and Management as follows: Reportedto Study Reported to Critical Phase Inspected Date Inspected Director Management Protocol Review 08 Sep 09 08 Sep 09 08 Sep 09 Necropsy 13 Qct 09 13 Oct 09 13 Oct 09 Report/DataAudit 29 Oct 09 29 Oct 09 29 Oct 09

ScottFeazell ,/ Date QualityAssurance, STILLMEADOW, Inc.

STILLMEADOW, Inc.TABLE OF CONTENTS 13292-09 Page 

### 5 of 

### 11
Page STATEMENT OF NO DATA CONFIDENTIALITY CLAIM ..................................................................;...... 

### 2 GOOD LABORATORYPRACTICE COMPLIANCE STATEMENT .............................................................. 

### 3 QUALITY ASSURANCE STATEMENT.......................................................................................................... 4 TABLE OF CONTENTS .................................................................................................................................... 5 SUM:M".ARY ........................................................................................................................................................ 6 INTRODUCTION............................................................................................................................................... 6 TEST SUBSTANCE ........................................................................................................................................... 6 TEST SYSTEM................................................................................................................................................... 7 Experimental Animals
.....................................................................................................................................7 AnimalHusbandry
.......................................................................................................................................... 7 PROCEDURES ................................................................................................................................................... 7 Test Substance Preparation and Administration
..............................................................................................7 In-life Observations
.........................................................................................................................................7 Postmortem Observations
............................................................................................................................... 8 RESULTS"AND DISCUSSION ......................................................................................................................... 8 MortalitylEstimatedLethalityValues
.................................................;........................................................... 8 BodyWeights
.................................................................................................................................................. 8 Clinical Signs
.................................................................................................................................................. 8 NecropsyFindings
........................................................................................................................................... 8 CONCLUSION ................................................................................................................................................... 8 SIGNATURE ...................................................................**~**.................................................................................. 8 STUDYPERSONNEL ....................................................................................................................................... 8 TABLE 1 - BodyWeights, Time ofDeath, and Gross Necropsy ....................................................................... 9 TABLE 2 - Pharmacologic andlor Toxicologic Signs
...................................................................................... 10 APPENDIXA - Certificate ofAnalysis
............................................................................................................ 11

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### SUMMARY 13292-09 Page 6 of 11 The test substance, Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4), was evaluated for its acute oral toxicitypotential in female albino rats when administered as a gavage dose at a level of2000 mgikg. The study was terminated following the stopping rules ofthis procedure. No mortality occurred during the study. Clinical signs included salivation, crusting on muzzle, and polyuria, which were no longer evident byDay2. There was no effect on body weight gain in animals. The gross necropsy conducted at termination ofthe study revealed no observable abnormalities. The acute oral LD50 was estimated to be greaterthan 2000 mgikg. INTRODUCTION The objective of this study was to assess the acute oral toxicity potential of the test substance when administered by gavage to nits in accordance with US OECD 425, OPPTS 870.1100, and Canadian notification. This study was conducted for Sasol Germany GmbH, according to the approved protocol and STILLMEADOW, Inc. SOPs. There were no deviations from the protocol that affected the quality or outcome of the study. All procedures used in this study are in compliance with Animal Welfare Act Regulations. The protocol, raw data, this report and a sample of test substance are archived at STILLMEADOW, Inc. The study was initiated on 11 Sep 09, the pre-dose experimental portion began on 21 Sep 09, and the animals weretreated as follows: Dose Level

(mglkg)

2000 2000 2000 2000 2000



### Label Identification: Date & 

### QuantityReceived: Physical Description: Storage: Purity: Stability: Treatment Animal In-life Date Time Number TerminationDate 22 Sep 09 0944 201 06 Oct09 24 Sep 09 0925 202 08 Oct 09 25 Sep 09 0850 203 09 Oct 09 29 Sep 09 0953 204 13 Oct 09 01 Oct 09 1014 205 15 Oct 09 

### TEST SUBSTANCE Alcohols, C18-22, distn. residues (CAS No: 1160164-88
..A); 

### Lot: 035851MA; Spec: 59B1RN2 11 Sep 09; 246.3 g (GW) Tan solid Roomtemperature See attached Certificate ofAnalysis Exp: Aug 2013 perprovided infonhation Data generated for characterization and stability is the responsibility ofthe sponsor. Records pertaining to identity, synthesis methods and location ofdocumentation are the responsibility ofthe sponsor. A copy ofthe Certificate ofAnalysis is included as report Appendix A.

STILLMEADOW, Inc.Experimental Animals Species & Strain: Justification ofSpecies: Source: Date BornlDate Received: Quarantine Period: Quantity & Sex: Animal/Group Identification: Day -1 Wt/Day 0 (fasted) Wt: Animal Husbandry Cage Type: Housing: Environmental Controls

Setto Maintain: Actual TemplRel. Humidity: Food: Water: 

### TEST SYSTEM
Albino rat; Sprague-Dawley , 13292-09 Page 7 of 11

The rat is arepresentative rodent species preferred byvarious regulatory agencies for use in an acute oral study. Texas Animal Specialties, Humble, TX 27 Jul 09 /17 Sep 09 5 days 5 females (nulliparous and non-pregnant) Earpunch/ Cage cards 180-191 g1163-176 

### g Suspended, wire bottom, stainless steel 1 per cage

.Temperature 22°± 3° C

. 12-hourlight/dark cycle 20-22° C / 50-95% .Relative Humidity 30-70%

. 10-12 air changeslhour Protocol deviation: Relative humiditywas outside protocol range but did not affect study outcome. PMIFeeds InC.TM Formulab #5008; available adlibitum exceptfor approximately 16 hours before dosing Municipal water supply analyzed byTCEQ WaterUtilities Division; available adlibitum from automatic water system Animal husbandry and housing at STILLMEADOW, Inc. comply with standards outlined in the "Guide for the Care and Use ofLaboratory Animals" (NRC Publ.). No contaminants were expected to have beenpresent inthe feed or waterthat would have interfered with or affected the·results ofthe study. PROCEDURES Test SubstancePreparation and Administration The test substance was mixedwith corn oil (parade; Exp Apr, 2010) to produce a 40% w/v concentration. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of5.00 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals werereturned totheir cages immediately after dosing. In-life Observations Observations for mortality and clinicallbehavioral sign.s oftoxicity were made at least three times on the day ofdosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recordedjust priorto dosing and on Days 7 and 14.

STILLMEADOW, Inc.

### Postmortem Observations 13292-09 Page 8 of 11
On Day 14 after dosing, each animal was euthanized by an overdose of CO2• 

### All study animals, were subjected to gross necropsy and all abnormalities were recorded.
RESULTS AND DISCUSSION MortalitylEstimated LethalityValues There was no mortality during the study. The estimated acute oral LD5o, as indicated by the data, was determined to be greater than 2000 mglkg. BodyWeights Individual body weights are presented in Table 1. Body weight gain in test animals was unaffected by the administration ofthe test substance. Clinical Signs Clinical signs are presented in Table 2. The only clinical signs were salivation, crusting around the muzzle, and polyuria in one animal on Days 0 and 1. NecropsyFindings Individual necropsy fmdings are presented in Table 1. The gross necropsy conducted at termination ofthe studyrevealed no observable abnormalities. CONCLUSION The test substance, Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4), was evaluated for its acute oral toxicity potential when administered to albino rats. The acute oral LD50 is estimated to be greater than 2000 mg/kg in females. StudyDirector:

Technical Staff: Carol Morris, BA Paul Siemens, BA Nancy Casajuana, LAT Data Services: Jeanne Poorman, BS ReportPreparation STUDYPERSONNELDate

HectorFuentes RobertPreston lacindaChatman, BS

STILLMEADOW, Inc.TABLE 1- BodyWeights, Time 

### ofDeath, and Gross Necropsy ACUTE ORAL TOXICITY STUDY (UDP) IN RATS Test Substance: Alcohols, C18-22, dstn. residues (CAS No: 1160164-88-4) Dose Level: 2000 mglkg (5.00 mLlkg) Animal Dose Date of Body Weights (g) Number Amt(mL) Dosing Day 0 Day 7

201 0.880 22 Sep 09 176 211 202 0.835 24 Sep 09 167 207 203 0.830 25 Sep 09 166 207 204 0.815 29 Sep 09 163 187 205 0.820 01 Oct 09 164 193 

## * -Day ofdosing is Day 0; Day 14 is terminal sacrifice
.. NOA
- No Observable Abnormalities Day 14 215 215 227 202 204 Time of Death 

### * Day 14 Day 14 Day 14 Day 14 Day 14 NOA NOA NOA NOA NOA 13292-09 Page 9 of 11

Gross Necropsy Findings

STILLMEADOW, Inc.

### TABLE 2 - Pharmacologic and/orToxicologic Signs ACUTE ORALTOXICITY STUDY (UDP) INRATS Test Substance: Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4) Time AfterTreatment Animal**Da~O**

No. Reaction/Severity**~** 

### L 3rd Day Dose Level: 2000 mglkg (5.00 mL/kg)



### 201 Salivation m Crust around muzzle p p Polyuria m 

### 202 Normal at each observation 

### 203 Normal at each observation 

### 204 Normal at each observation 

### 205 Normal at each observation
v 

### = very slight; s 

### = slight; m = moderate; e 

### = extreme; p = present; - 

### = observation notpresent 13292-09 Page 10 of 11

STILLMEADOW, Inc.APPENDIXA - Certificate ofAnalysis



### C E R T I FIe ATE 

### o F 13292-09 Page 11 of 11 

# saSOL l'eii!chillg newfi'(JlltiEfS Erunsbuettel, 9/09/2()09

ANALYSIS
product: Lot 

### No.: Aleohols. C18-22T 

### distn. Residues .03S8S/MA (59B1RN2) Manufacturing date: Expiry date: 2s/o8/20Q9 08/2013

Unit Result

### ~:~::=;s~===~.====~:~===~~======~~~_a~~=======-==:==~=~~~~====~=====~~=====~~~~=--~:=== 

## rmg KeH/g] 50, Estar No. Acid No. [mg Koa/g] 4a,17 [mg Itoa/g] 0,09 Water .Iodine No. [wt.%1 0,02 [rog**~/l00rogl** 5,34



### Sasol Germany GmbH**P.O~** Box 1160**D~25S34** Bxunsbuettel Phone: 049 (0) 4852/392-0 Fax: 049 {O)4852/3285 

### Best regards Works inspector M. sprung

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