# 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 ACUTEDERMALIRRITATION STUDYINRABBITS 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 ParkOneDrive SugarLand, TX 77478 LABORATORY STUDYNUMBER: 

### 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.com13295-09 Page 2 of 10 GOOD LABORATORYPRACTICE COMPLIANCE STATEMENT This study was designed and perfonned at STllLMEADOW, Inc. and was conducted in compliance with United States Environmental Protection AgencyTSCA 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 ofAnalysis 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 ofAgriculture, Forestry & Fisheries, Notification No. 11 Nousan 6283, Director-General of Agricultural ProductionBureau with exception of: 

### 11 Nousan 6283 Article 3.1 (18), 12.5 and 12.7 The provided Certificate ofAnalysis was not accompanied by a GLP compliance statement.
uhn, PhD, DABT ctor, STILLMEAbOW, Inc.
Signature ofAgent ofSponsor Agent Name Sponsor: Sasol Gennany GmbH
Signature ofAgent ofSubmitter AgentName Submitter: SasolNA I Date 

# 12- 

# fJ-e::rof

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 Page 3 of 10

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 Unithas notbeen involved in the actual conduct ofthis study. The QualityAssurance Unit perfonned a recent facility inspection on 10 Jul 09. All fmdings were reported to Management, and thereport 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 Reportedto 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 QualityAssurance, STILLMEADOW, mc.

STILLMEADOW, Inc.

### TABLE OF CONTENTS 13295-09 Page 4 of10

GOOD LABORATORYPRACTICE COMPLIANCE STATENfENT
..........................................................:.. 

### 2 QUALITYASSURANCE 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 ofTest 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 ofDennal Irritation
................................................................................................................ 9 APPENDIXA - Certificate ofAnalysis
............................................................................................................ 10

STILLMEADOW, Inc.

### SUMMARY 13295-09 Page 5 oflO

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 oftest 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 ofthe 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 of0.0, the test substance is rated non-irritating. INTRODUCTION The objective of this study was to assess the relative primary skin irritation level ofthe 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 ofthe study. All procedures in this study are in compliance with Animal Welfare Act Regulations. The protocol, raw data, this report and a sample oftest 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 ofthe 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 Referto Certificate ofAnalysis Exp: Aug 2013 perprovided infonnation Data generated for characterization and stability is the responsibility of the sponsor. Records pertaining to identity, synthesis methods and location ofdocumentation are the responsibility ofthe sponsor. A copy ofthe Certificate ofAnalysis is included as report AppendixA.

STn,LMEADOW, Inc.Experimental Animals Species & Strain: TEST SYSTEM

Albino rabbit; NewZealand White 13295-09 Page 6 of 10

Justification ofSpecies: The rabbit is preferred bythevarious regulatory agencies for use in primary dermal irritation testing. Source: NicholsRabbitry Inc.; Lumberton, TX Date BornlDate Received: 21 Jun 09 / 9 Sep 09
. QuarantinePeriod: 5 days Quantity & Sex: 2 male & 1 female (nulliparous & non-pregnant) Animal/Group Identification: Eartag/ Cage cards Initial BodyWeights: 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

Setto 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 protocolrange but did not affect study outcome. PM!Feeds, InC.TM Lab RabbitDiet#5321,**~8** oz. daily Municipal water supply analyzedbyTCEQ 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 ofLaboratoryAnimals" (NRC Pub1.). No contaminants were expectedto have been present in the feed or waterthat wouldhave interfered with or affected the results ofthe study. 

### PROCEDURES Test Substance Administration Each animal was prepared on the day priorto treatment by clipping the dorsal area ofthe trunk free ofhair to expose an areaat least 8 x 8 cm. Onlythose animals with exposure areas free ofpre-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 oftape to retard evaporation of volatile substances and to preventpossible ingestion ofthetest substance. Removal ofTest Substance After four hours, the patches and wrappings were removed. The test sites were gently washed with room temperature tap water and a clean clothto remove as much residual test substance as possible.
STILLMEADOW, Inc.Observations 13295-09 Page 7 oflO
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 ScoringMethod 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 usedto obtain a rating for the test substance. RESULTS AND DISCUSSION Evaluation Signs ofdermal irritation or defects are presented in Table 1. Erythema and edema were not observed at any time throughout the study. No other signs ofirritation were observed during the study. CONCLUSION The primary irritation index of0.0 out ofa 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 ofnon-irritating.
StudyDirector: ce . Kuhn, PhD, DABT . Toxicologist, STILLMEADOW, Inc. STUDYPERSONNEL 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 PrimaryDermal Irritation Scoring Scale (DraizeTechnique*) 

### Evaluation ofSkin Reactions ErythemaFormation No erythema Very slight erythema (barely perceptible) Well-defmed erythema Moderate erythema Severe erythema (beetredness) to slight eschar formation (injuries in depth)
EdemaFormation No edema Maximum Possible
Very slight edema (barelyperceptible) Slight edema (edges ofarea well defmed by defmite raising) Moderate edema (raised approximately 1 mm) Severe edema (raised more than 1 mm and extending beyondthe area ofexposure) Maximum Possible Score 

# o 1 

### 2 3 4 4 Score



# o 1 2 3 4 4 13295-09 Page 8 of 10

* - Draize, John H., Woodard, Geoffrey, and Calvery, H.O., Methods for the Study ofIrritation and Toxicity ofSubstances Applied Topicallyto the Skin and Mucous Membranes. J. Pharm & Ther. 82,377 (1944). 

### Classification ofTest Substance DescriptiveRating 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 onlythe observations scheduled through 72 hours.

STILLMEADOW, Inc.

### TABLE 1- Signs ofDermalIrritation 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 

# I 48 

# .1 

# I I I 24 

# I 48 

# I 1 ! 24 72 7 10 14 1 72 i 

### I 

# I I 

# I I I 

# I I 4230-M 0 

# 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 PrimaryIrritation 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 

## ! I 1 ! 24 48 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 ofskin 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.

### APPENDIXA - Certificate ofAnalysis 

# 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: Alcohols r C18-22, distn. Residues 03S8S/ldA 25/0S/20Q9 08/2013

Tests Unit Rellttlt
. (S9B1RN2) 

### 13295-09 Page 10 of 10**-;;:;;;;.=:=;Ie._~-eea._i!i~~e~-=Sl==;~~!:!l:lz=;;:::=;-;:;==-=-:.::t:3I:liil_iii_~-=:;;';=.===liII_iiiiii"-==-~.:.:;..:-=--=~;s;::r;::;=:;;;;:;;.=~!!::aIi-;;;:o;a:.iIiI';;;;-;;':;;;==l** 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 Works inspectol" :M. Sprung

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