FINAL REPORT

Study Title

ASSESSMENT OF ACUTE DERMAL TOXICITY WITH

EXP1313100

IN THE RAT

Author

Test Facility

WIL Research Europe B.V.

Hambakenwetering 7

5231 DD ‘s-Hertogenbosch

The Netherlands

 

Laboratory Project Identification

Project 505698

Substance 205622/A

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EXP1313100 Project 505698 

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1. CONTENTS 

1. CONTENTS ...................................................................................................................................... 2

2. STATEMENT OF GLP COMPLIANCE ............................................................................................. 3

3. QUALITY ASSURANCE STATEMENT ............................................................................................ 4

4. SUMMARY ........................................................................................................................................ 5

5. INTRODUCTION .............................................................................................................................. 6

5.1. Preface ..................................................................................................................................... 6

5.2. Aims of the study ...................................................................................................................... 6

5.3. Guidelines ................................................................................................................................ 6

5.4. Storage and retention of records and materials ....................................................................... 7

6. MATERIALS AND METHODS .......................................................................................................... 8

6.1. Test substance ......................................................................................................................... 8

6.1.1. Test substance information ............................................................................................. 8

6.1.2. Study specific test substance information ...................................................................... 8

6.1.3. Test substance preparation ............................................................................................ 8

6.2. Test system .............................................................................................................................. 8

6.3. Animal husbandry .................................................................................................................... 9

6.4. Treatment ................................................................................................................................. 9

6.5. Observations ..........................................................................................................................10

6.6. Electronic data capture ..........................................................................................................10

6.7. Interpretation ..........................................................................................................................10

6.8. List of deviations ....................................................................................................................10

6.8.1. List of protocol deviations .............................................................................................10

6.8.2. List of standard operating procedures deviations .........................................................10

7. RESULTS .......................................................................................................................................11

7.1. Mortality ..................................................................................................................................11

7.2. Clinical signs ..........................................................................................................................11

7.3. Body weights ..........................................................................................................................11

7.4. Macroscopic findings ..............................................................................................................11

8. CONCLUSION ................................................................................................................................11

APPENDICES 

APPENDIX 1: TABLES

APPENDIX 2: TEST SUBSTANCE CERTIFICATE OF ANALYSIS

Final Report


EXP1313100 Project 505698 

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4. SUMMARY 

Assessment of acute dermal toxicity with EXP1313100 in the rat. 

The study was carried out based on the guidelines described in: 

OECD No.402 (1987) "Acute Dermal Toxicity" 

Commission Regulation (EC) No 440/2008, B3: "Acute Toxicity (Dermal)" 

EPA, OPPTS 870.1200 (1998), "Acute Dermal Toxicity" 

JMAFF Guidelines (2000), including the most recent revisions. 

EXP1313100 was administered to five Wistar rats of each sex by a single dermal application at 2000 

mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly 

determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 

15). 

No mortality occurred. 

Erythema (general or maculate), fissuring, scales and/or scabs were seen on the treated skin-area 

and/or left flank of all animals during the observation period. Additionally, all females showed necrosis 

of the treated skin-area and/or left flank between Days 4 and 8. One of these females had a wound on 

the left flank on Days 7 and 8 and scar formation on the left flank on Days 14 and 15. 

The changes noted in body weight gain in males and females were within the range expected for rats 

used in this type of study and were therefore considered not indicative of toxicity. 

No abnormalities were found at macroscopic post mortem examination of the animals. 

The dermal LD50 value of EXP1313100 in Wistar rats was established to exceed 2000 mg/kg body 

weight. 

Based on these results, EXP1313100 does not have to be classified and has no obligatory labelling 

requirement for acute dermal toxicity according to the: 

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United 

Nations (2011) (including all amendments), 

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures 

(including all amendments). 

Final Report