Final Report EFSA Lot 2

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Final Report EFSA Lot 2 FINAL REPORT Compared toxicity of chemicals to reptiles and other vertebrates A Report to EFSA CFT/EFSA/PPR/2008/01 Lot 2 Steve Fryday and Helen Thompson1 Environmental Risk Assessment Team, Environmental Risk Programme, The Food and Environment Research Agency York YO41 1LZ UK August 2009 1Tel 44 1904 462515; Fax 44 1094 462111; email [email protected] The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the European Food Safety Authority is subject. It may not be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. CFT/EFSA/PPR/2008/01 COMPARED TOXICITY OF CHEMICALS TO Lot 2 REPTILES AND OTHER VERTEBRATES Contents INTRODUCTION ......................................................................................................... 3 METHODS .................................................................................................................... 3 RESULTS ...................................................................................................................... 4 CONCLUSIONS.......................................................................................................... 18 RECOMMENDATIONS ............................................................................................. 18 APPENDIX 1 Database search terms .......................................................................... 19 APPENDIX 2 Literature found during the course of study ......................................... 21 APPENDIX 3 Oral exposure studies ........................................................................... 68 APPENDIX 4 Studies where exposure was by injection ........................................... 100 APPENDIX 5 Dermal exposure studies .................................................................... 106 APPENDIX 6 Studies involving exposure to dusts and fumigants ........................... 126 APPENDIX 7 Studies with aquatic exposure ............................................................ 129 APPENDIX 8 Studies where exposure was by all routes .......................................... 136 APPENDIX 9 Bird and mammal toxicity data .......................................................... 138 Final report CFT/EFSA/PPR/2008/01 Page 2 of 169 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the European Food Safety Authority is subject. It may not be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. CFT/EFSA/PPR/2008/01 COMPARED TOXICITY OF CHEMICALS TO Lot 2 REPTILES AND OTHER VERTEBRATES INTRODUCTION Data on toxicity to reptiles that may be useful in risk assessment is known to be sparse (e.g. Campbell and Campbell 2000). This review collates the data about toxicity of chemicals to reptiles available in the scientific literature including that published since these recent reviews. It is based on the results of a literature search conducted by Fera’s Information center as well as key publications such as Ecotoxicology of Amphibians and Reptiles (Sparling et al, 2000) and Toxicology of Reptiles: Toxicology and the Environment (Gardner and Oberdörster, 2006). Given the limited amount of data available it was not possible to restrict the results to European species and all studies that described experimental exposure of free-living animals (e.g. not eggs) was collated. The few available toxicity values were collated and compared with data on toxicity to birds and mammals where available. METHODS A literature survey was conducted by the Fera Information Centre using a list of search terms as detailed in Appendix 1. Databases searched were CAB Abstracts, AGRICOLA, AGRIS, Environmental Sciences, MEDLINE(R), Enviroline(R), Pollution Abstracts, Biosis Previews(R), ToxFile and Water Resources Abstracts. Further searches were made of the US EPA Ecotox database, the Reptile and Amphibian Toxicity Literature database (RATL), and key publications and reviews including Campbell and Campbell (2000), Pauli and Money (2000) and Sanchez (2001). The criteria used for assessing reliability of toxicity data will be based on those described in the EU Technical Guidance Document (2003), namely: • A complete test report is available or the test has been described in sufficient detail and the test procedure is in accordance with generally accepted standards (e.g. OECD). • The validity of the data cannot be fully established or the test method differs in some respects from the guidelines and the generally accepted scientific standards. In these cases expert judgement will be used to determine whether the results are suitable or whether they are regarded as not valid. • It is clearly evident that the data are not valid because critical pieces of information are not available and cannot be sourced retrospectively (e.g. if it is not possible to establish the identity of the test substance). These data are likely to be inappropriate for standard setting although they may be used to steer future testing requirements. Given that standard guidelines for reptiles are not available, all of the data collated here fell into the second category. It quickly became apparent that data on toxicity to reptiles was still limited to only a few key studies such as Hall and Clark (1982). More recent studies providing detailed information on acute, sub-acute and subchronic tests on lizards (McFarland et al. Final report CFT/EFSA/PPR/2008/01 Page 3 of 169 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the European Food Safety Authority is subject. It may not be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. CFT/EFSA/PPR/2008/01 COMPARED TOXICITY OF CHEMICALS TO Lot 2 REPTILES AND OTHER VERTEBRATES 2008, Suski et al. 2008) did not study pesticides. We therefore collated all of the information found on the experimental exposure of free-living animals (neonates to adults) and provided separate tables detailing studies with either oral exposure, exposure by injection, dermal exposure, exposure to dusts and fumigants (pest control trials) and aquatic exposure (water snakes and turtles). Where studies were capable of providing information on dose and effects this information was summarized in a staged manner for comparison with bird and mammal toxicity based on the type of data available. Where studies reported a lethal dose (LD50) these were directly compared with bird and mammal toxicity data from the USEPA Ecotox database where available, or alternative sources where necessary. Often this database provided several values for birds or mammals. Where this occurred, the median of the numerical values was reported along with the range to ensure that the presented value encompassed the range of sensitivity. The next summaries included those remaining studies where dose related mortality was reported in either single dose or multiple doses (e.g. subacute, subchronic exposure). These included studies where mortality was the only reported endpoint even where no mortality occurred. Next, studies where dose related symptoms were summarized showing the range of doses and the effects observed at each dose. RESULTS The search terms used in the Fera Information Centre literature search are listed in Appendix 1. The literature from this search was provided to EFSA in an Endnote database along with further literature found during the course of the study. Bibliographic details for these are provided in Appendix 2 along with notes about each reference and reasons for not including them in the collated data where appropriate. In most cases this was because they were residue studies or contaminant studies, or tested the effects of exposing eggs on embryo development. Thus, only studies that were conducted to test the effects of chemicals on free-living animals were included. Due to the limited amount of data available, data on experimental exposure for pest control (e.g. of brown treesnakes) were also included to ensure that the dataset was as complete as possible. As well as data on mortality or symptoms, data on bodyweight and temperature were also included where reported. Summaries of all studies found that met the above criteria are provided in Appendices 3 to 8. These are divided into separate tables
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