A 1-year toxicity study in dogs is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides

Kobel, Werner; Fegert, Ivana; Billington, Richard; Lewis, Richard; Bentley, Karin S.; Bomann, Werner; Botham, Phil; Stahl, Bernhard; Ravenzwaay, Bennard van; Spielmann, Horst

doi:10.3109/10408440903300098

Cited by 28 publications

(13 citation statements)

References 8 publications

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“…There is no disputing the need for repeat-dose studies in dogs of three months' duration. The weight of evidence, however, of all these reviews together-and in particular the studies conducted in dogs (Gerbracht and Spielmann 1998;Spielmann and Gerbracht 2001;Box and Spielmann 2005;Doe et al 2006;Baetcke et al 2005;Kobel et al 2010;US 2006)-shows conclusively that there is little value in conducting a one-year dog study in addition to a three-month study, which strongly suggests that such studies can be safely eliminated from the list of studies that are mandatory for the safety assessment of pesticides. Of all the chemicals in the databases analyzed in the four main publications critically reviewed here, only 3-4% had reference doses the setting of which was influenced by the results of a one-year dog study.…”

Section: Discussionmentioning

confidence: 99%

Progress in Eliminating One-Year Dog Studies for the Safety Assessment of Pesticides

Spielmann

2018

Alternatives to Animal Testing

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We reviewed six key peer-reviewed publications that assessed the need for one-year studies of pesticide toxicity in dogs. Each of the six papers took a different approach to comparing the value of one-year studies relative to three-month studies, and despite the adoption of different databases and approaches, each study reached the same conclusion: the recommended limit to the testing of pesticide toxicity in dogs should be three months. Therefore, the present review supports the conclusion that the routine inclusion of a one-year dog study should not be a mandatory requirement for the safety assessment of pesticides, since it is scientifically no longer justifiable. We recommend that the OECD should adapt a harmonized approach that is in line with the legislation in Europe and the USA.

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Section: Discussionmentioning

confidence: 99%

Progress in Eliminating One-Year Dog Studies for the Safety Assessment of Pesticides

Spielmann

2018

Alternatives to Animal Testing

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“…This was achieved on the basis of existing data or evidence that the tests proposed were unnecessary or unjustified (eceae, 2014). Another recent example is the welcome decision that the year-long chronic-toxicity test for pesticides is no longer required in dogs, on the basis that it is not scientifically justified (Kobel et al, 2010). The test has been dropped in the EU, the United States, and Canada.…”

Section: Abandonment Of Redundant and Duplicative Animal Testsmentioning

confidence: 99%

Extrapolation of Animal Research Data to Humans: An Analysis of the Evidence

Ram¹

2019

Animal Experimentation: Working Towards a Paradigm Change

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“…Briefly, Dellarco et al 4) reported that the toxicological profiles of subacute and long-term toxicity studies in dogs were almost consistent among 70 of 110, and that in comparison of these NOAEL and LOAEL between subacute and long-term studies, the differences of values were within 1.5 times. They reported that 2% of the total pesticides examined were judged to require long-term toxicity study in USEPA [4][5][6] . Kobel.…”

Section: Analysis On Toxicological Necessity Of Dog Long-term Toxicitmentioning

confidence: 99%

Evaluation of Necessity of 1-year Toxicity Study in Dogs - development of the New Tiered Approach for Toxicity Studies of Pesticide Considering Species Difference in “toxicity profile” and “toxicity dose-response”

2018

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Recently, a long-term (1-year) dog toxicity study has not been a mandatory toxicity study for application of agricultural chemical in the United States (US) and the European Union (EU). This study was conducted to propose a guide for making science-based judgement on the necessity of long-term dog toxicity study, which is one of required toxicity studies at toxicological evaluation in Japanese pesticide regulation system. In order to carry out the proposal we analyzed the results of toxicity studies including subacute (3-month) toxicity study in dogs or toxicity studies in other species in the pesticide evaluation reports published by the Food Safety Commission of Japan (FSCJ), the responsible regulatory body for toxicological evaluation of pesticides in food. In the analysis of evaluation reports of 286 pesticides ADI (acceptable daily intake) of 93 pesticides (32.5%) were established based on dog studies. The ADIs of 74 pesticides among them, however were not considered to have a big influence if the long-term dog toxicity study was omitted. With regard to the other four agents the possibility that the long-term dog study becomes unnecessary was considered by adding detailed examination. With respect to the remaining 15 agents, we could not judge that long-term dog study were unnecessary. The analysis indicated that the dog long term test could be omitted in most cases. On the other hand, it should be considered carefully necessity of the long-term dog study when the toxicological profiles observed in dogs and rats were different, when the toxicity susceptibility in dogs was considered high, when no no-observed-adverse-effect level (NOAEL) is specified in subacute toxicity study in dogs or when bioaccumulation in dogs is concerned. We also noted that the studies already conducted for pesticide registered previously should be used for their hazard evaluation.

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A 1-year toxicity study in dogs is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides

Cited by 28 publications

References 8 publications

Progress in Eliminating One-Year Dog Studies for the Safety Assessment of Pesticides

Progress in Eliminating One-Year Dog Studies for the Safety Assessment of Pesticides

Extrapolation of Animal Research Data to Humans: An Analysis of the Evidence

Evaluation of Necessity of 1-year Toxicity Study in Dogs - development of the New Tiered Approach for Toxicity Studies of Pesticide Considering Species Difference in “toxicity profile” and “toxicity dose-response”

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