FINAL REPORT

Study Title

ASSESSMENT OF ACUTE ORAL TOXICITY WITH

EXP1313100

IN THE RAT (ACUTE TOXIC CLASS METHOD)

Author

Test Facility

WIL Research Europe B.V.

Hambakenwetering 7

5231 DD ‘s-Hertogenbosch

The Netherlands

 

Laboratory Project Identification

Project 505697

Substance 205622/A

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EXP1313100 Project 505697 

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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. Study design ............................................................................................................................ 9

6.5. Treatment ................................................................................................................................. 9

6.6. Observations ..........................................................................................................................10

6.7. Electronic data capture ..........................................................................................................10

6.8. Interpretation ..........................................................................................................................10

6.9. List of deviations ....................................................................................................................10

6.9.1. List of protocol deviations .............................................................................................10

6.9.2. 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: CERTIFICATE OF ANALYSIS

Final Report


EXP1313100 Project 505697 

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4. SUMMARY 

Assessment of acute oral toxicity with EXP1313100 in the rat (Acute Toxic Class Method). 

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

OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method" 

Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method" 

EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity" 

FAMIC Guidelines (2011), including the most recent revisions. 

EXP1313100 was administered by oral gavage to two subsequent groups of three female Wistar rats 

at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of 

body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). 

No mortality occurred. 

Lethargy, hunched posture and/or piloerection were noted for all animals on Days 1 and/or 2. 

The body weight gain shown by the animals over the study period was considered to be normal. 

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

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

weight. 

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 

mg/kg body weight. 

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

requirement for acute oral toxicity according to the Globally Harmonized System of Classification and 

Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and Regulation 

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

amendments). 

Final Report