ATLA 46.5, November 2018

//ATLA 46.5, November 2018

Editorial: Electronic cigarettes: Can dependable public health policies be developed and applied without relevant and reliable risk assessments?

Michael Balls and Robert Combes

The use of electronic cigarettes is being encouraged as a way of escaping from the harm resulting from conventional tobacco smoking, while scant attention is being paid to the long-term risks of inhaling electronic cigarette vapour. More information is needed for an acceptable risk assessment, from integrated non-animal testing and sound clinical investigations.
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CAAT News and Views

CAAT staff

New Paper from CAAT’s Thomas Hartung Generates International Press Coverage

2nd Pan-American Conference for Alternative Methods in Brazil Sells Out

Meeting on Internationalisation of Read-across as a Validated New Approach Method for Regulatory Toxicology

Call for Proposals: 2019 Science-based Refinement Awards

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2018-11-30T10:53:42+00:00 Tags: , |

IIVS News and Views

IIVS staff

IIVS Appointed to China’s Alternatives Working Group for Cosmetics

IIVS Collaborates with BASF and Givaudan to Validate a Non-animal Test for Regulatory Submissions

Quanshun Zhang to Deliver Keynote Lecture at CSLAS Annual Meeting

Inhalation Toxicology Webinar Series from PETA International Science Consortium (PISC)

IIVS Practical Methods Workshop 2019

IIVS at ESTIV 2018

IIVS Hosts Quarterly Meeting for Society of Quality Assurance’s Computer Validation and IT Compliance (CVIC) Specialty Section

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2018-11-30T10:51:05+00:00 Tags: , |

A comparison of pyrogen detection tests in the quality control of meningococcal conjugate vaccines: The applicability of the Monocyte Activation Test

Vitor Fernandes Silva, Daniel da Silva Guedes Junior, Ivna Alana da Silveira, Alessandra Santos Almeida, Fernando de Paiva Conte, Isabella Fernandes Delgado, Cristiane Caldeira Silva, Octavio Augusto França Presgrave and Katherine Antunes de Mattos

The meningococcal C conjugate vaccine (MenCC) is an interesting model with which to test the efficacy of the Monocyte Activation Test (MAT) as an alternative method of pyrogen testing in the quality control of vaccines. The MenCC that has been produced by Bio-Manguinhos in Brazil is in the final development stage, and, as recommended in the guidelines for MenCC production, its pyrogen content must be determined by using the Limulus Amoebocyte Lysate (LAL) assay and the Rabbit Pyrogen Test (RPT). This represents an ideal opportunity to compare LAL and RPT data with data obtained by using a MAT system with cryopreserved whole blood and IL-6/IL-1beta as marker readouts. In order to assess the compatibility of the MAT with MenCC, endotoxin and non-endotoxin pyrogen content was quantified by using MenCC samples spiked with lipopolysaccharide (LPS), lipoteichoic acid or zymosan standards. The presence of the aluminium-based adjuvant interfered with the MAT, increasing the readout of IL-1beta in LPS-spiked MenCC batches. This infringed the product-specific validation criteria of the test, and led to IL-6 being chosen as the more suitable marker readout. No pyrogenic contaminants were identified in the MenCC batches tested, demonstrating consistency among the different systems (MAT, RPT and the LAL assay). In conclusion, the introduction of the MAT during MenCC development could contribute to the elimination of animal tests post-licensing, ensuring human protection based on an effective non-animal based method of quality control.

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Severity classification of surgical procedures and application of health monitoring strategies in animal research proposals: A retrospective review

Kathrin Herrmann and Paul Flecknell

Animal experimentation has been one of the most controversial areas of animal use, mainly due to the intentional harms inflicted upon the animals used. In an effort to reduce these harms, research on refinement has increased significantly over the past 20 years. However, the extent to which these efforts have helped to reduce the severity of the research procedures, and thus animal suffering, is uncertain. To provide an indication of the awareness and implementation of refinement methods, we reviewed the experimental techniques for 684 surgical interventions described in 506 animal research applications that had been sent to the German competent authorities for approval in 2010. In this paper, we describe and discuss the severity categorisation of the proposed surgeries and the planned health monitoring strategies. We found that the researchers frequently underestimated the levels of pain, suffering, distress and lasting harm that were to be inflicted on the animals. Furthermore, the planned health monitoring strategies were generally flawed. To ensure responsible treatment of animals and high-quality science, adequate training of research workers in recognising and alleviating animal suffering is essential.

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Does the stress of laboratory life and experimentation on animals adversely affect research data? A critical review

Jarrod Bailey

Recurrent acute and/or chronic stress can affect all vertebrate species, and can have serious consequences. It is increasingly and widely appreciated that laboratory animals experience significant and repeated stress, which is unavoidable and is caused by many aspects of laboratory life, such as captivity, transport, noise, handling, restraint and other procedures, as well as the experimental procedures applied to them. Such stress is difficult to mitigate, and lack of significant desensitisation/habituation can result in considerable psychological and physiological welfare problems, which are mediated by the activation of various neuroendocrine networks that have numerous and pervasive effects. Psychological damage can be reflected in stereotypical behaviours, including repetitive pacing and circling, and even self-harm. Physical consequences include adverse effects on immune function, inflammatory responses, metabolism, and disease susceptibility and progression. Further, some of these effects are epigenetic, and are therefore potentially transgenerational: the biology of animals whose parents/grandparents were wild-caught and/or have experienced chronic stress in laboratories could be altered, as compared to free-living individuals. It is argued that these effects must have consequences for the reliability of experimental data and their extrapolation to humans, and this may not be recognised sufficiently among those who use animals in experiments.

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