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 

ACUT~ DERMAL TOXICITY STUDY 1N RATS 

OECD402 

AUTHOR: 

Janice O. Kuhn, PhD, DABT 

STUDY INITIATION DATE: 11 September 2009 

STUDY CONfPLETION DATE: 27 October 2009 

CONDUCTED BY: 

STILLMEADOW, Inc. 

12852 Park One Drive 

Sugar Land, TX 77478 

LABORATORY STUDY NUMBER: 

13293-09 

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 
13293-09 

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GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

This study was designed and performed at STILLMEADOW, Inc. and was conducted in compliance 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,Ll (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. 

o Kuhn, PhD, DABT 

D rector, STILLMEADOW, Inc. 

Signature of Agent of Sponsor 

Agent Name 

Sponsor: Sasol Germany GmbH 

Signature of Agent of Submitter 

Agent Name 

Submitter: Sasol NA 

Date 

Date 

Date 

STILLMEADOW, Inc. 
QUALITY ASSURANCE STATEMENT 

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

Study Title: Acute Dermal Toxicity Study in Rats 

13293-09. 

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

follows: 

Critical Phase Inspected Date Inspected Reported to Study Reported to 

Director Management 

Protocol Review 08 Sep 09 08 Sep 09 08 Sep 09 

Dosing 24 Sep 09 24 Sep 09 24 Sep 09 

Report/Data Audit 20 Qct 09 20 Qct 09 20 Qct 09 

Scott Feazell /0 Date 

Quality Assurance, STILLMEADOW, Inc. 

STILLMEADOW, Inc. 
TABLE OF CONTENTS 

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GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT ............................................................. 2 

QUALITY ASSURANCE STATEMENT .......................................................................................................... 3 

Su-MMARY ........................................................................................................................................................ 5 

INTRODUCTION ............................................................................................................................................... 5 

TEST SUBSTANCE ........................................................................................................................................... 5 

TEST SySTEM ................................................................................................................................................... 6 

Experimental Animals ..................................................................................................................................... 6 

Animal Husbandry .......................................................................................................................................... 6 

PROCEDURES ................................................................................................................................................... 6 

Test Substan~e Preparation and Administration .............................................................................................. 6 

Removal of Test Substance ............................................................................................................................. 7 

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

Dermal Irritation Observations ........................................................................................................................ 7 

Postmortem Observations ................................................................................................................................ 7 

RESULTS AND DISCUSSION ......................................................................................................................... 7 

MortalitylEstimated LDso Values ....... _ .................................... : ........................................................................ 7 

Body Weights .................................................................................................................................................. 7 

Clinical SignslDermal Irritation .............................................................. -......................... " ............................. 7 

Necropsy Findings ........................................................................................................................................... 7 

CONCLUSION ..................................................................................................................... : ............................. 8 

SIGNATURE ...................................................................................................................................................... 8 

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

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

TABLE 2 - Pharmacologic and/or 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.l160164-88-4), was evaluated for its dermal 

toxicity potential and relative skin irritancy when a single dose moistened with 1.0 mL of deionized water/g 

test substance, at a level of 2020 mg/kg, was applied to the intact skin of albino rats. No mortality occurred 

during the study. There were no clinical signs of toxicity or dermal irritation at any time throughout the 

study. There was no effect on body weight gain with the exception of two animals that lost weight during the 

1 sI week. The gross necropsy conducted at termination of the study revealed no observable abnormalities. 

The estimated LD5Q, as indicated by the data, was determined to be greater than 2020 mg/kg. 

INTRODUCTION 

The objective of this study was to assess the systemic toxicity potential and relative skin irritancy of the test 

substance when administered to rats in accordance with US OECD 402, OPPTS 870.1200, 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 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 23 Sep 09, and the animals were 

treated as follows: 

Dose Level Male Treatment Female Treatment In-life Termination Date 

mglkg Date I Time Date I Time Males I Females 

2020 24 Sep 09 I 0958 24 Sep 09 I 1002 08 Qct 09 i 08 Qct 09 I 

Label Identification: 

Date & Quantity Received: 

Physical Description: 

Storage: 

Purity: 

Stability: 

TEST SUBSTANCE 

Alcohols, C 18-22, distn. Residues CAS N 0.1160164-88-4; 

Lot No. 035851MA; Spec: 59BIRN2 

11 Sep 09; 246.3 g (GW) 

Tan solid 

Room temperature 

See Certificate of Analysis 

Exp: Aug 2013 per provided information 

Data generated for characterization and stability and the level· of GLP compliance for that data is the 

responsibility of the sponsor. Records pertaining to identity, synthesis methods and location of documentation 

are the responsibility of the sponsor. A copy ofthe Certificate of Analysis is included as report Appendix A. 

STILLMEADOW, Inc. 
Experimental Anima:ls 

Species & Strain: 

Justification of Species: 

Source: 

Date BornlDate Received: 

Quarantine Period: 

Quantity & Sex: 

Animal/Group Identification: 

Weights on Dosing Day: 

Animal Husbandry 

Cage Type: 

Housing: 

Environmental Controls 

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 dermal study. 

Texas Animal Specialties, Humble, TX 

21 Ju1 09110 Sep 09 

5 days 

5 male and 5 female (nulliparous and non-pregnant) 

Ear punch / Cage cards 

Male: 273-312 g; Female: 187-202 g 

Suspended, wire bottom, stainless steel 

1 per cage 

Set to Maintain: . Temperature 22°± 3° C . Relative Humidity 30-70% 

. 12-hour light/dark cycle . 10-12 air changeslhour 

Actual TemplRel. Humidity: 21-22° C / 50-94% 

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

affect study outcome. 

Food: PMI Feeds InC.TM Formulab #5008; available ad libitum 

Water: Municipal water supply analyzed by TCEQ Water Utilities Division; tap water, 

available ad libitum (automatic 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 

Healthy albino rats were released from quarantine. Each animal was prepared on the day prior to treatment by 

clipping the dorsal surface of the trunk free of hair to expose not less than 10% of the total body surface area. 

Care was taken to avoid abrading the skin. Only those animals with exposure areas free of pre-existing skin 

irritation or defects were used for this study. All animals were treated with 2020 mg/kg of the test substance. 

Each dose was moistened with a sufficient amount of deionized water (1.0 mL/g of test substance). An 

individual dose was calculated for each animal based on its Day 0 body weight just before exposure. The test 

substance was applied evenly to each exposure area in a thin, uniform layer. The area of application was 

covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each 

animal was then wrapped with vet wrap that was secured in place with non-irritating adhesive tape to prevent 

possible ingestion of the test substance. 

STILLMEADOW, Inc. 
Removal of Test Substance 

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After 24 hours, the wrappings were removed. The test sites were gently washed with room temperature tap 

water and a clean cloth to remove as much residual test substance as possible. 

In-life Observations 

Observations for mortality and clinicallbehavioral,signs 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. 

Dermal Irritation Observations 

Observations for evidence of dermal irritation were made at approximately 60 minutes after removal of 

wrappings, and on Days 4, 7, 11 and 14. 

Postmortem Observations 

On Day 14 after dosing, animals were euthanized by an overdose of CO2. All study animals were subjected to 

gross necropsy and all abnormalities were recorded. 

RESULTS AND DISCUSSION 

MortalitylEstimated LD50 Values 

There was no mortality during the study. The estimated acute dermal LD5o, as indicated by the data, was 

determined to be greater than 2020 mg/kg body weight. 

Body Weights 

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

the test substance, with the exception of two females that lost weight slightly during Week 1, but gained 

weight during Week 2. 

Clinical SignslDermal Irritation 

Clinical signs of toxicity are presented in Table 2. All animals appeared normal for the duration 6fthe study. 

There were no signs of dermal irritation at any observation period. 

Necropsy Findings 

Individu~l necropsy fmdings are presented in Table 1. The gross necropsy conducted at termination of the 

study revealed no observable abnormalities. 

STILLMEADOW, Inc. 
CONCLUSION 

13293-09 

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The test substance, A1cohols, C18-22, distn. Residues (CAS No.l160164-88-4), was evaluated for its acute 

dennal toxicity potential and relative skin irritancy when administered to albino rats. The acute dennal LDso; 

as indicated by the data, is greater than 2020 mglkg in males and females. 

Study Director: 

Janic 0 Kuhn, PhD, DABT Date 

Se or oxicologist, STILL.MEADOW, Inc. 

Technical Staff: Carol Morris, BA 

Nancy Casajuana, LAT 

Robert Preston 

Data Services: Jeanne Poonnan, BS 

Report 'Preparation 

STUDY PERSONNEL 

Paul Siemens, BA 

Hector Fuentes 

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

Acute Dennal Toxicity Study in Rats 

Test Substance: Alcohols, C18-22, distn. Residues (CAS No.l160164-88-4) 

Dose Level: 2020 mg/kg 

An:imal Dose Body Weights Time of 

Number Amt (g) DayO I Day 7 I Day 14 Death * 

211-M 0.624 309 I 333 i 347 Day 14 I 

212-M 0.630 312 I 330 I 349 Day 14 

213-M 0.551 273 I 285 I 308 Day 14 I 

214-M 0.606 300 I 322 i 350 Day 14 

215-M 0.592 293 I 305 I 333 Day 14 

216-F 0.400 198 ! 195 I 206 Day 14 I 

217-F 0.408 202 I 190 I 201 Day 14 

218~F 0.408 202 I 205 I 217 Day 14 ! 

219-F 0.378 187 I 196 I 211 Day 14 

220-F 0.384 190 I 200 I 205 Day 14 

* -Day of dosing considered Day 0; Day 14 is terminal sacrifice. 

M - Male; F - Female; NOA - No observable abnormalities 

NOA 

NOA 

NOA 

NOA 

NOA 

NOA 

NOA 

NOA 

NOA 

NOA 

13293-09 

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Gross Necropsy Findings 

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

Acute Dermal Toxicity Study in Rats 

Test Substance: A1cohols, C18-22, distn. Residues (CAS No. 1160164-88-4) 

Dose Level: 2020 mg/kg 

Time After Treatment 

Reaction and Severity 

Males 

All normal at each observation 

Females 

All normal at each observation 

Day 0 Day 

13293-09 

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STILLMEADOw", Inc. 
13293-09 

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APPENDIX A - Certificate of Analysis 

saSOL ~ .. ' !!," .' reaching nllW frontiers 

Brunsbuette~1 9/09/2009 

C E R T I FIe ATE o F ANALYSIS 

Product; 

Lot No.; 

Manufacturing date: 

Alcohols, C18-22, distn. Residues 

03585/MA 

(59Bllm2 ) 

25/08/2009 

Expiry dat.e: 08/201.3 

Unit Result 

:::~:==:a.-z==:;;;!.i:t:=====~-====;:;.=====-=;;;-;l •• 1=i=======~=s..=:=-=:==~!;$=.=.;:.e====.===::==:.:;=:;===.u~=;s:r='ZiI;:===; aydroxyl - Number [tng KOH/5r] 50, 

Ester No. (mg xoa/g] 41.:1,7 

Acid No. {mg }(OR/g] 0.09 

Water [wt.%] 0,02 

Iodine No. [l11g I/IOOmg} 5,34 

Sasol Germany GmbH 

p .0. Box 1150 

P-255~4 BIUnabuettel Phone~ 04.9 (0) 4852(392-0 Fax: 049 (O) 4852/3285 

Best. regards 

Works inspeotor 

M. Sprung 

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lnionri31foo Ulld stelll keitlE- Besclulff0l1heils- ul\d Haltbarkalls· 

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dl~ "'~ wlC!iisI'g<;relct>l wir(j. iln Qb:'lj:jsn geJten vnserij Ailg".meinen 

Tills C<lrtilic:ate of 1IIID~'Sie is jor Information only anD does no! gUCl' 

ran1ea any p3rilCular product propertie!!.ll does nllt free IhL'r.,cipi· 

enl or 1ha obligation 10 cwry oul El product l&:eMng inspOl'~I!on, ThI! 

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Cor,a:llcm~ <I .. ~mtmd,,\i ll;-JtQ It\<; HmI: GonCsrr&t!. 

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STILLl\tIEADOW, Inc.