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TABLE OF CONTENTS

ABOUT THE OECD.................. 6
FOREWORD........................... 7
SUMMARY NOTE ................... 8
PREAMBLE........................... 11
SECTION I - GENERAL INTRODUCTION ................ 12

 

A. Bacillus thuringiensis and Its Uses............. 13
B. Bacillus thuringiensis Toxins ................... 14
C. Susceptible Insects................................ 15

SECTION II - NOMENCLATURE/CLASSIFICATION OF TOXINS AND GENES.... 17
SECTION III - CHARACTERISATION OF THE δ-ENDOTOXINS............. 19

 

A. Protoxins...................................... 19
B. Truncated Active Toxins ................ 19
C. Structure of Toxins ..................... 20
D. Prevalence of the δ-Endotoxins in Microorganisms........ 20

SECTION IV - MECHANISM OF ACTION .................... 21

A. Ingestion and Solubilisation ........................... 21
B. Binding to Receptors ............................. 21
C. Pore Formation and Bacterial Septicemia .......... 24

 

SECTION V - EXPRESSION OF δ-ENDOTOXIN GENES IN PLANTS .... 26

A. Methods of Gene Insertion.......................... 26
B. Promoters.................................... 26
C. Expression Levels in Plants............. 26
D. Variable Expression in Plant Parts ................. 27

 

SECTION VI - RISK ASSESSMENT OF δ-ENDOTOXINS IN PLANTS ....... 29

A. General Issues.................................... 29
B. Human Health Assessment.................... 31

 

1. Acute Toxicity ................................... 31
2. Food Allergenicity................ 32
3. Human Exposure ................ 33
4. Human Risk Assessment ...................... 33
C. Nontarget Species ........................... 33

1. Effects on Non-target Organisms ............. 33

 

a. Effects on Non-target Mammals................ 34
b. Effects on Avian Species.......................... 34
c. Effects on Freshwater Fish.......................... 34

d. Effects on Freshwater Invertebrates ...................... 35
e. Effects on Estuarine and Marine Animals ............... 35
f. Effects on Earthworms ...................................................... 35
g. Effects on Non-target Insects.................................................. 35

 

2. Exposure to Non-target Organisms ..................................... 42
3. Risk to Non-target Organisms ............................................... 45

D. Other Ecological Issues ................................................... 49

 

1. Loss of Effectiveness of Biological Control of Weedy Species.......... 49
2. Potential for Adverse Effects on Endangered or Threatened Species........ 50
3. Potential for Loss of Efficacy.................................... 50

SECTION VII - REFERENCES................................. 52
ADDITIONAL REFERENCES .......................................... 82
ANNEX I ......................................................................... 86
MRID REPORTS REFERENCES FOR TABLES A - H............ 96
QUESTIONNAIRE TO RETURN TO THE OECD..................... 108