FINAL REPORT 

Study Title

96-HOUR ACUTE TOXICITY STUDY IN CARP WITH

EXP1313100

(STATIC)

Author

Test Facility

WIL Research Europe B.V.

Hambakenwetering 7

5231 DD ‘s-Hertogenbosch

The Netherlands

 

Laboratory Project Identification

Project 505716

Substance 205622/A

- Page 1 of 24 - 
EXP1313100 Project 505716

- Page 2 - 

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. Aim of the study ................................................................................................................... 6

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

5.4. Storage and retention of records and materials..................................................................... 6

5.5. Definitions ............................................................................................................................ 7

6. MATERIALS AND METHODS ..................................................................................................... 7

6.1. Test Substance .................................................................................................................... 7

6.1.1. Test substance information......................................................................................... 7

6.1.2. Study specific test substance information ................................................................... 7

6.1.3. Reference substance ................................................................................................. 7

6.2. Test System......................................................................................................................... 7

6.3. Holding ................................................................................................................................ 8

6.4. Preparation of test solutions ................................................................................................. 8

6.5. Range-finding test................................................................................................................ 9

6.6. Limit test .............................................................................................................................. 9

6.6.1. Test concentrations .................................................................................................... 9

6.6.2. Test procedure and conditions.................................................................................... 9

6.6.3. Sampling for analysis of test concentrations ............................................................... 9

6.6.4. Measurements and recordings .................................................................................10

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

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

6.8.1. Data handling...........................................................................................................10

6.8.2. Acceptability of the test.............................................................................................10

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

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

6.9.2. List of standard operating procedures deviations ......................................................11

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

7.1. Range-finding test..............................................................................................................11

7.2. Limit test ............................................................................................................................11

7.2.1. Measured concentrations .........................................................................................11

7.2.2. Mortality and other effects ........................................................................................11

7.2.3. Determination of effect concentrations......................................................................12

7.2.4. Experimental conditions ...........................................................................................12

8. CONCLUSION ..........................................................................................................................12

TABLES

Table 1 Incidence of mortality and total mortality during the range-finding test.......................11

Table 2 Incidence of mortality and total mortality during the limit test .....................................11

Table 3 Effect parameters.....................................................................................................12

Table 4 pH-values and dissolved oxygen concentrations (mg/L) during the limit test..............12

Table 5 Temperatures (°C) measured during the limit test .....................................................12

APPENDICES 

APPENDIX 1 REFERENCE TEST ................................................................................................. 13

APPENDIX 2 CERTIFICATE OF ANALYSIS..................................................................................14

APPENDIX 3 ANALYTICAL REPORT............................................................................................15

Final Report


EXP1313100 Project 505716

- Page 5 - 

4. SUMMARY

96-Hour Acute Toxicity Study in Carp with EXP1313100. 

The study procedure described in this report was based on the OECD guideline No. 203, 1992. In 

addition, the procedures were designed to meet the test methods of the Commission Regulation (EC) 

No 440/2008, Part C.1, 2008, the ISO International Standard 7346-1: Static method, 1996 and the 

OECD series on testing and assessment number 23, 2000.

The batch of EXP1313100 tested was a brown solid that was not completely soluble in test medium at 

the loading rates initially prepared. 

A limit test was performed based on the results of a preceding range-finding test. A loading rate of 

100 mg/L was added to the test medium applying two days of magnetic stirring in order to reach 

maximum solubility. The resulting aqueous mixture was filtered through a 0.45 μm membrane filter 

where after the clear and colourless Water Accommodated Fraction (WAF) was used for testing. 

Seven fish per concentration were exposed to the WAF prepared at a loading rate of 100 mg/L and to 

a control. The total test period was 96 hours and samples for analytical confirmation of exposure 

concentrations were taken at the start, after 24 hours of exposure and at the end of the test.

Analysis of the samples taken at the start of the limit test showed a measured concentration of 

0.0045 mg/L in the WAF prepared at a loading rate of 100 mg/L. This concentration slightly decreased 

to 72% of initial at the end of the test. The average exposure concentration was calculated to be 

0.0038 mg/L.

The study met the acceptability criteria prescribed by the protocol and was considered valid.

No mortality was recorded at any of the loading rates of EXP1313100 tested.

The 96h-LL*50 was above a loading rate of 100 mg EXP1313100 per litre. The concentration of 

EXP1313100 in the WAF prepared at a loading rate of 100 mg/L was determined to be 0.0038 mg/L 

based on the average exposure concentration.

*LL = lethal loading rate

Final Report