STILLMEADOW 

I NCO R P 0 RAT E D 

VOLUME OF OF SUBMISSION 

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

FINAL REPORT 

ACUTE DERMAL IRRITATION STUDY IN RABBITS 

OECDNO.404 

AUTHOR: 

Janice O. Kuhn, PhD, DABT 

STUDY INITIATION DATE: 11 September 2009 

STUDY COMPLETION DATE: 12 October 2009 

CONDUCTED BY: 

STILLMEADOW, Inc. 

12852 Park One Drive 

Sugar Land, TX 77478 

LABORATORY STUDY NUMBER: 

13295-09 

VOLUME ..l. OF ..l. OF STUDY 

PAGE..l.OFJQ 

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 
13295-09 

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GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

This study was designed and perfonned at STllLMEADOW, 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 perfonned 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 perfonned 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: 

11 Nousan 6283 Article 3.1 (18), 12.5 and 12.7 The provided Certificate of Analysis was not accompanied 

by a GLP compliance statement. 

uhn, PhD, DABT 

ctor, STILLMEAbOW, Inc. 

Signature of Agent of Sponsor 

Agent Name 

Sponsor: Sasol Gennany GmbH 

Signature of Agent of Submitter 

Agent Name 

Submitter: Sasol NA 

I Date 

12- fJ-e::ro f 

Date 

Date 

STILLMEADOW, Inc. 
QUALITY ASSURANCE STATEMENT 

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

Study Title: Acute Dennal Irritation Study in Rabbits 

13295-09 

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The study report and data have been audited in accordance with Good Laboratory Practice Standards· and 

STILLMEADOW, mc. Standard Operating Procedures (SOPs). The fma1 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 perfonned 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 Reported to 

Critical Phase Inspected Date Inspected Study Director Management 

Protocol Review 8 Sep 09 8 Sep 09 8 Sep 09 

Body Weights 25 Sep 09 25 Sep 09 25 Sep 09 

ReportiData Audit 08 Oct 09 08 Oct 09 08 Oct 09 

Richard L. Martin, MS, CPhT Date 

Quality Assurance, STILLMEADOW, mc. 

STILLMEADOW, Inc. 
TABLE OF CONTENTS 

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GOOD LABORATORY PRACTICE COMPLIANCE STATENfENT .......................................................... : .. 2 

QUALITY ASSURANCE STATENfENT ................................................................. .-; ....................................... 3 

SUMMARY ............................................................ : ........................................................................................... 5 

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

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

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

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

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

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

Test Substance Administration ........................................................................................................................ 6 

Removal of Test Substance ............................................................................................................................. 6 

Observations .................................................................................................................................................... 7 

Irritation Scoring Method ................................................................................................................................ 7 

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

Evaluation ......................................................................................... .-.............................................................. 7 

CONCLUSION ................................................................................. '" ............................................................... 7 

SIGNATURE ...................................................................................................................................................... 7 

STUDY PERSONNEL ....................................................................................................................................... 7 

LEGEND TO TABLE 1 ............... ; ...................................................................................................................... 8 

TABLE 1 - Signs of Dennal Irritation ................................................................................................................ 9 

APPENDIX A - Certificate of Analysis ............................................................................................................ 10 

STILLMEADOW, Inc. 
SUMMARY 

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A primary dennal irritation study was conducted on three albino rabbits using test substance Alcohols, C18-

22, distn. residues (CAS No: 1160164-88-4). There was one intact test site per animal. Each test site was 

treated with 500 mg of test substance moistened with 0.1 mL of deionized water and covered with a semipenneable dressing. The test substance was maintained in contact with the skin for 4 hours. Observations for 

dermal irritation and defects were made at 1, 24, 48 and 72 hours after removal of the dressings. 

Irritation scores derived from the respective erythema and edema scores through the 72-hour observations for 

each animal are presented below. 

Erythema Edema 

Hours after Unwrap Hours after Unwrap Irritation 

1 24 48 72 1 24 48 72 Scores 

4230-M 0 0 0 0 0 0 0 0 0.00 

4232-M 0 0 0 0 0 0 0 0 0.00 

4233-F 0 0 0 0 0 0 0 0 0.00 

Primary Irritation Index (PIT) = 0.0 

Based on the PIT of 0.0, the test substance is rated non-irritating. 

INTRODUCTION 

The objective of this study was to assess the relative primary skin irritation level of the test substance on 

rabbits in accordance with OECD 404; OPPTS 870.2500; and Canadian notification. This study was 

conducted for Sasol Gennany 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 21 Sep 09, and the animals were treated with the test substance 

between 0915 and 0917 on 22 Sep 09. The in-life portion of the study was tenninated on 25 Sep 09. 

Label Identification: 

Date & Quantity Received: 

Physical Description: 

Storage: 

Purity: 

Stability: 

TEST SUBSTANCE 

Alcohols, CI8-22, distn. residues CAS No: 1160164-88-4 

Lot: 035851MA Spec: 59BIRN2 

11 Sep 09; 246.3 g (GW) 

Tan solid 

Room temperature 

Refer to Certificate of Analysis 

Exp: Aug 2013 per provided infonnation 

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. 

STn,LMEADOW, Inc. 
Experimental Animals 

Species & Strain: 

TEST SYSTEM 

Albino rabbit; New Zealand White 

13295-09 

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Justification of Species: The rabbit is preferred by the various regulatory agencies for use in primary 

dermal irritation testing. 

Source: Nichols Rabbitry Inc.; Lumberton, TX 

Date BornlDate Received: 21 Jun 09 / 9 Sep 09 . 

Quarantine Period: 5 days 

Quantity & Sex: 2 male & 1 female (nulliparous & non-pregnant) 

Animal/Group Identification: Ear tag / Cage cards 

Initial Body Weights: Male: 2.850-3.200 kg; Female: 2.700 kg 

Final Body Weights: Male: 2.950-3.200 kg; Female: 2.775 kg 

Animal Husbandry 

Cage Type: 

Housing: 

Suspended, wire bottom, stainless steel 

1 per cage 

Environmental Controls 

Set to Maintain: . Temperature 200± 3° C 

. 12-hour light/dark cycle 

Actual TemplRel. Humidity: 19-22° C / 60-98% 

. Relative Humidity 30-70% 

. 10-12 air changes/hour 

Food: 

Water: 

Protocol deviation: humidity outside protocol range but did not affect study 

outcome. 

PM! Feeds, InC.TM Lab Rabbit Diet #5321, ~8 oz. daily 

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 Pub1.). 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 Administration 

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to 

expose an area at least 8 x 8 cm. Only those animals with exposure areas free of pre-existing skin irritation or 

defects were selected for testing. A single intact exposure site was selected as the test site while the 

contralateral intact site served as a control site. 

On Day 0, 500 mg oftest substance moistened with 0.1 mL of deionized water was applied to each test site 

and covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch. Each patch was secured in place with a strip of 

non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable 

dressing (orthopedic stockinette) which was secured on both edges with strips of tape to retard evaporation of 

volatile substances and to prevent possible ingestion of the test substance. 

Removal of Test Substance 

After four hours, the patches and 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. 

STILLMEADOW, Inc. 
Observations 

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The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 

1,2,4,48 and 72 hours after unwrap. 

Irritation Scoring Method 

The scoring scale used to rate dermal irritation is presented in the Legend to Table 1. For each animal, all of 

the erythema and edema scores through 72 hours were added, and the sum was divided by 4 to obtain an 

individual irritation score. The primary irritation index was determined by calculating the mean of the 

irritation scores for all the animals and was used to obtain a rating for the test substance. 

RESULTS AND DISCUSSION 

Evaluation 

Signs of dermal irritation or defects are presented in Table 1. Erythema and edema were not observed at any 

time throughout the study. No other signs of irritation were observed during the study. 

CONCLUSION 

The primary irritation index of 0.0 out of a possible 8.0 was obtained from the observations at 1, 24, 48 and 

72 hours, and was used to give Alcohols, C18-22, distn. residues (CAS No: 1160164-88-4) a descriptive 

rating of non-irritating. 

Study Director: 

ce . Kuhn, PhD, DABT . 

Toxicologist, STILLMEADOW, Inc. 

STUDY PERSONNEL 

Technical Staff: Carol Morris, BA 

Robert Preston 

Data Services: Connie Pavatte, Report Preparation 

Paul Siemens, BA 

Nancy Casajuana, LAT 

STILLMEADOW, Inc. 
LEGEND TO TABLE 1 

ACUTE DERMAL IRRlTATION STUDY IN RABBITS 

Primary Dermal Irritation Scoring Scale (DraizeTechnique*) 

Evaluation of Skin Reactions 

Erythema Formation 

No erythema 

Very slight erythema (barely perceptible) 

Well-defmed erythema 

Moderate erythema 

Severe erythema (beet redness) to slight eschar formation (injuries in depth) 

Edema Formation 

No edema 

Maximum Possible 

Very slight edema (barely perceptible) 

Slight edema (edges of area well defmed by defmite raising) 

Moderate edema (raised approximately 1 mm) 

Severe edema (raised more than 1 mm and extending beyond the area of exposure) 

Maximum Possible 

Score 

o 

1 

2 

3 

4 

4 

Score 

o 

1 

2 

3 

4 

4 

13295-09 

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* - Draize, John H., Woodard, Geoffrey, and Calvery, H.O., Methods for the Study of Irritation and Toxicity 

of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharm & Ther. 82,377 (1944). 

Classification of Test Substance 

Descriptive Rating 

Non-irritating 

Slightly irritating 

Moderately irritating 

Severely irritating 

Primary Irritation Index 

0.0 

0.1- l.9 

2.0 - 5.0 

5.1 - 8.0 

The primary irritation index is calculated using only the observations scheduled through 72 hours. 

STILLMEADOW, Inc. 
TABLE 1- Signs of Dermal Irritation 

ACUTE DERMAL IRRlTATION STUDY IN RABBITS 

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

Erythema Edema 

Animal 

Number Hours Days Hours i 

1 I 48 .1 I I I 24 I 48 I ! 24 72 7 10 14 1 72 i 

I I I I I I 

I 4230-M 0 I I 0 0 0 0 I 0 0 0 ! ! I I I 

I I I I I I l I 

4232-M 0 0 0 0 I 0 0 0 I 0 ! 

I ! I I I I I I i I 

4233-F 0 0 I 0 I 0 0 0 0 0 I 

I I I 

Primary Irritation Index* = I 0.0 I 

Descriptive Rating = Non-irritating 

* - Only the first four observation times are used for calculations. 

M - Male; F - Female Study Duration: 72 Hrs 

Animal 

Other Observations 

Number Hours I 1 ! 24 ! 48 I 72 7 

4230-M I I I 

- - - I -

4232-M - I - I - I -

4233-F - I - I - I - I 

Note: A dash (-) is used ifthere are no Other signs of skin irritation. 

7 I 

I 

I 

i 

I 

i 

I 

I 

i 

I 

I 

I 

Days 

10 I 14 

I 

I 

i 

Days 

10 ! 

I 

I 

I 

13295~09 

Page 9 of 10 

Primary 

Irritation 

Scores 

0.00 

0.00 

0.00 

14 

STILLMEADOW, Inc. 
APPENDIX A - Certificate of Analysis 

sasoL. 

Brunabuettel r 9/0~/2009 

CER'rIFICATE o F A N A L Y S I S 

Preduct~ 

Lot No.: 

Manufacturing date: 

Expiry date: 

Alcoholsr C18-22, distn. Residues 

03S8S/ldA 

25/0S/20Q9 

08/2013 

Tests Unit Rellttl t . 

(S9B1RN2) 

13295-09 

Page 10 of 10 

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Hydroxyl ~ .Ul.1Dll:le:r bilg Kon/g) 50, 

Estax NO. llhg KOlt/ gJ 41,17 

Acid No. [mg lI:Oit/g) 0,09 

water [wt.%) 0,02 

Iodine NO. lmg X/1OOmy) 5,H 

Basel Germany GmhH 

P.O. Box 1.160 

D-25534 Brunabuettel 

phoner 049 (0)4852/3~2-0 Faxi 049 (0)4852/3285 

:sest regards 

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:M. Sprung 

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STILLMEADOW, Inc.