### DISCLAIMER This report is the property ofClariant. Its content is confidential and not for general release. It is not allowed to cite and reveal the report orits content to a third party without prior written approval of Clariant. 

## EXPERT STATEMENT Leuco SulfurBlack 1 3tj515F5 

# harianTh 

# ....

Calculation ofthe Partition Coefficient (n-Octanol I 

## Water) Study Director: Test Facility:
Sponsor: Dr Martin Kiihne Harlan Laboratories Ltd. Zelgliweg 1 4452 Itingen I 

### Switzerland
Clariant Products (Switzerland) Ltd. Rothausstrasse 61 4132 Muttenz 1 I 

### Switzerland Study Identification: Harlan Laboratories Study C88384 Version: Final Study Completion Date: April14, 2010 Page 1of8



## CONTAINS NO CPHarlan Laboratories Study C88384 Leuco Sulfur Black 1 

## CONTENTS Expert Statement Page2

CONTENTS ....................................................................................................................................2 SIGNATURE .................................................................................................................................. 3 PREFACE .......................................................................................................................................4 General Information...............................................................................................................4 Responsibilities......................................................................................................................4 Schedule.................................................................................................................................4 Archiving ...............................................................................................................................4 1 PURPOSE.............................................................................................................................. 5 2 TEST ITEM ...........................................................................................................................6 3 RESULTS AND DISCUSSION............................................................................................7 4 CONCLUSION...................................................................................................................... 8Harlan Laboratories Study C88384 Leuco SulfurBlack 1 

## SIGNATURE

Study

### Director: Expert Statement Page 3



### Dr Martin KUhneHarlan Laboratories Study C88384 Leuco Sulfur Black I 

## PREFACE General Information Test Item: Study Title: Sponsor: Study Monitor: Test Facility: 

### Responsibilities Study Director/Scientific Author: 

### Schedule Date ofIssue: 

### Archiving Expert Statement Page4

Leuco Sulfur Black 1 Calculation ofthe Partition Coefficient (n-Octanol I Water) Clariant Products (Switzerland) Ltd. Rothausstrasse 61 4132 Muttenz 1 I Switzerland DrBruno Kunz Harlan Laboratories Ltd. Zelgliweg 1 4452 ltingen I Switzerland

DrMartin Kiihne
April14, 2010
Harlan Laboratories Ltd., 4452 Itingen/Switzerland will retain the expert statement ofthe present study for at least ten years. No data will be discarded without the Sponsor's written consent.Harlan Laboratories Study C88384 Leuco Sulfur Black 1 

## 1 PURPOSE Expert Statement PageS



### In this study the partition coefficient (n-octanol!water) of Leuco Sulfur Black 1 should be estimated. The partition coefficient provides a rational basis for an assessment of the potential bioaccumulation ofthe test item.Harlan Laboratories Study C88384 Leuco Sulfur Black 1 

## 2 TESTITEM Expert Statement

Data oftest item as supplied by the Sponsor. Identification: CAS Nr.: Description: Batch Number: Composition:

Stability ofthe test item: Stability ofthe test item dilution: Expiry date: Storage Conditions: Leuco Sulfur Black 1 66241-11-0 Thixotrophic, black, wet presscake ESA0007595 Leuco Sulfur Black 1: 52.75% (calculated by amount ofby-compounds) 2,4-Dinitrochlorobenzene: < 20 ppm 2,4-Dinitrophenole: < 20 ppm Sulfate: 970 ppm Chloride: 750 ppm Sodium: 1.3% (w/w) Water: 45.75% (w/w) by Karl-Fischer titration Stable under storage conditions > 4 h in water July 11, 2011 At room temperature (range 20 

### +!- 5 °C), light protected Page6Harlan Laboratories Study C88384 Leuco Sulfur Black I Expert Statement 

## 3 RESULTS AND DISCUSSION Page?



### The partition coefficient (Pow) is defined as the ratio ofthe solubility ofthe test item in octanol and in water: 

### p = Cn-octanol

ow cwater 

### No chromatographic method is applicable to determine the solubility ofLeuco Sulfur Black 1 in n-octanol. Although it is possible to estimate the water solubility ofLeuco Sulfur Black 1 (62.4 mg/L as determined in Harlan Laboratories Study C75560) by measurement of the Total Carbon (TC) content this analytical method is inapplicable in case ofn-octanol as a solvent. Therefore it is impossible to determine the log Pow of Leuco Sulfur Black 1 according to the guideline.

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# . ·dWv**t~, .:=:~ll·t·** Harlan Laboratories Study C88384 Leuco Sulfur Black 1 

## 4 CONCLUSION Expert Statement Page 8

No chromatographic method is available to estimate the solubility ofLeuco Sulfur Black I in noctanol. Therefore the log Pow cannotbe determined according to the guideline.



## CONTAINS NO CBI 

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