STILLMEADOW 

I NCO R P 0 RAT E D 

VOLUME OF OF SUBMISSION 

Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4) 

FINAL REPORT 

-

ACUTE ORAL TOXICITY STUDY (UDP) IN RATS 

OECD425 

AUTHOR: 

Janice O. Kuhn, PhD, DABT 

STUDY INITIATION DATE: 11 September 2009 

STUDY COMPLETION DATE: 2 November 2009 

CONDUCTED BY: 

STaLMEADOW, Inc. 

12852 Park One Drive 

Sugar Land, TX 77478 

LABORATORY STUDY NUMBER: 

13292-09 

VOLUME .l OF ..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.com 
13292-09 

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STATEMENT OF NO DATA 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 of these 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 

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GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

This study was designed and performed at STILLMEADOW, Inc. and was conducted in compEance with 

United States Environmental Protection Agency TSCA 40 CFR 792 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 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 

Japan Ministry of Agriculture, 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 of Agent of Sponsor 

Agent Name 

Sponsor: Sasol Germany GmbH 

Signature of Agent of Submitter 

Agent Name 

Submitter: Sasol NA 

02 

Date 

Date 

Date 

STILLMEADOW, Inc. 
QUALITY ASSURANCE STATEMENT 

Test Substance: Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4) 

Study Title: Acute Oral Toxicity Study (UDP) in Rats 

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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 Unit has not been involved in the actual conduct of this study. 

The Quality Assurance 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 Quality Assurance files. " 

The fmdings from any study inspections and audits were reported to the Study Director and Management as 

follows: 

Reported to 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/Data Audit 29 Oct 09 29 Oct 09 29 Oct 09 

Scott Feazell ,/ Date 

Quality Assurance, STILLMEADOW, Inc. 

STILLMEADOW, Inc. 
TABLE OF CONTENTS 

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Page 

STATEMENT OF NO DATA CONFIDENTIALITY CLAIM .................................................................. ; ...... 2 

GOOD LABORATORY PRACTICE 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 

Animal Husbandry .......................................................................................................................................... 7 

PROCEDURES ................................................................................................................................................... 7 

Test Substance Preparation and Administration .............................................................................................. 7 

In-life Observations ......................................................................................................................................... 7 

Postmortem Observations ............................................................................................................................... 8 

RESULTS"AND DISCUSSION ......................................................................................................................... 8 

MortalitylEstimated Lethality Values ................................................. ; ........................................................... 8 

Body Weights .................................................................................................................................................. 8 

Clinical Signs .................................................................................................................................................. 8 

Necropsy Findings ........................................................................................................................................... 8 

CONCLUSION ................................................................................................................................................... 8 

SIGNATURE ................................................................... ~ .................................................................................. 8 

STUDY PERSONNEL ....................................................................................................................................... 8 

TABLE 1 - Body Weights, Time of Death, and Gross Necropsy ....................................................................... 9 

TABLE 2 - Pharmacologic andlor Toxicologic Signs ...................................................................................... 10 

APPENDIX A - Certificate of Analysis ............................................................................................................ 11 

STILLMEADOW, Inc. 
SUMMARY 

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The test substance, Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4), was evaluated for its acute 

oral toxicity potential in female albino rats when administered as a gavage dose at a level of 2000 mgikg. The 

study was terminated following the stopping rules of this procedure. No mortality occurred during the study. 

Clinical signs included salivation, crusting on muzzle, and polyuria, which were no longer evident by Day 2. 

There was no effect on body weight gain in animals. The gross necropsy conducted at termination of the 

study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 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 were treated as follows: 

Dose Level 

(mglkg) 

2000 

2000 

2000 

2000 

2000 

Label Identification: 

Date & Quantity Received: 

Physical Description: 

Storage: 

Purity: 

Stability: 

Treatment Animal In-life 

Date Time Number Termination Date 

22 Sep 09 0944 201 06 Oct 09 

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 

Room temperature 

See attached Certificate of Analysis 

Exp: Aug 2013 per provided infonhation 

Data generated for characterization and stability is the responsibility of the sponsor. Records pertaining to 

identity, synthesis methods and location of documentation are the responsibility of the sponsor. A copy of the 

Certificate of Analysis is included as report Appendix A. 

STILLMEADOW, Inc. 
Experimental Animals 

Species & Strain: 

Justification of Species: 

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 

Set to Maintain: 

Actual TemplRel. Humidity: 

Food: 

Water: 

TEST SYSTEM 

Albino rat; Sprague-Dawley , 

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The rat is a representative rodent species preferred by various 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) 

Ear punch / Cage cards 

180-191 g1163-176 g 

Suspended, wire bottom, stainless steel 

1 per cage 

. Temperature 22°± 3° C 

. 12-hour light/dark cycle 

20-22° C / 50-95% 

. Relative Humidity 30-70% 

. 10-12 air changeslhour 

Protocol deviation: Relative humidity was outside protocol range but did not 

affect study outcome. 

PMI Feeds InC.TM Formulab #5008; available ad libitum except for 

approximately 16 hours before dosing 

Municipal water supply analyzed by TCEQ Water Utilities Division; 

available ad libitum from automatic water system 

Animal husbandry and housing at STILLMEADOW, Inc. comply with standards outlined in the "Guide for 

the Care and Use of Laboratory Animals" (NRC Publ.). No contaminants were expected to have been present 

in the feed or water that would have interfered with or affected the· results of the study. 

PROCEDURES 

Test Substance Preparation and Administration 

The test substance was mixed with 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 of 5.00 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel 

ball-tipped intubation needle. The animals were returned to their cages immediately after dosing. 

In-life Observations 

Observations for mortality and clinicallbehavioral sign.s of toxicity were made at least three times on the day 

of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just 

prior to dosing and on Days 7 and 14. 

STILLMEADOW, Inc. 
Postmortem Observations 

13292-09 

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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 Lethality Values 

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. 

Body Weights 

Individual body weights are presented in Table 1. Body weight gain in test animals was unaffected by the 

administration of the 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. 

Necropsy Findings 

Individual necropsy fmdings are presented in Table 1. The gross necropsy conducted at termination of the 

study revealed 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. 

Study Director: 

Technical Staff: Carol Morris, BA 

Paul Siemens, BA 

Nancy Casajuana, LAT 

Data Services: Jeanne Poorman, BS 

Report Preparation 

STUDY PERSONNEL 

Date 

Hector Fuentes 

Robert Preston 

lacinda Chatman, BS 

STILLMEADOW, Inc. 
TABLE 1- Body Weights, Time of Death, 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 of dosing 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 

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Gross Necropsy Findings 

STILLMEADOW, Inc. 
TABLE 2 - Pharmacologic and/or Toxicologic Signs 

ACUTE ORAL TOXICITY STUDY (UDP) IN RATS 

Test Substance: Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4) 

Time After Treatment 

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 not present 

13292-09 

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STILLMEADOW, Inc. 
APPENDIX A - Certificate of Analysis 

C E R T I FIe ATE o F 

13292-09 

Page 11 of 11 

saSOL 

l'eii!chillg new fi'(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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ranlee any particulsJ' pl'CIducl propertfes. It does l\()t.free Ih~ recip!-

ent 0/ the cliliQaticn 10 cal~ out a prod'..!Cl re:::eMng 1l1specliol1. lN~ 

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Coodltians as ameno!l:i u~IQ Ill\; tlrrre concem€'d. 

STILLMEADOW, Inc.