Tox News: Issue 10, May 2022

Fiona, our Head of Toxicology, has been awarded Fellow Status of the British Toxicology Society (BTS) in recognition of her hard work supporting the Society. Congratulations Fiona!

This will take place on Tuesday 28 June, 1300-1600 BST, and will feature presentations on:

• Overview of previous NC3Rs activities to support the 3Rs in fish acute toxicity testing (Dr Natalie Burden, NC3Rs)
• New OECD Test Guideline 249 Fish Cell Line Acute Toxicity - The RTgill-W1 cell line assay (Dr Stephan Fischer, aQuatox-Solutions and Dr Melanie Fischer, Eawag)
• SWIFT: Strengthening weight of evidence for FET data to replace acute fish toxicity (Dr Adam Lillicrap, NIVA)
• Exploring potential reductions in fish testing in a regulatory context (Dr Michael Lowit, US EPA)

The presentations will be followed by an interactive panel discussion.

We are really pleased to be able to attend in-person conferences again, catch up with people in person and disseminate our work.

Upcoming events

Natalie and Fiona will attend the SETAC Europe 32nd Annual Meeting in Copenhagen, 15-19 May. We have an exhibition stand – number 12 – please come and see us if you are attending. Natalie will be presenting:

• Optimising concentration setting for aquatic vertebrate endocrine tests as a platform presentation in the session Investigating endocrine-disrupting properties of chemicals: developments and challenges towards new approach methodologies (NAMs) at 13.45 on Monday 16 May.
• Laboratory survey on assessing vitellogenin in the Late‑breaking poster session on Thursday 19 May.

Natalie and Fiona will attend the EFSA ONE – Health, Environment, Society – Conference 2022 virtually, 21-24 June. Natalie is presenting a poster on ‘Optimising concentration setting for aquatic vertebrate endocrine tests’.

Recent events

We gave three poster presentations at the Society of Toxicology 61st Annual Meeting in San Diego, CA, USA (27-31 March):

• Natalie presented ‘Optimising concentration setting for aquatic vertebrate endocrine tests’ (P359) in the Endocrine Toxicology session.
• Fiona presented ‘Guidance to support the use of evident toxicity in acute oral toxicity studies’ (P513) in the Regulation/Policy session.
• Helen presented ‘The use of recovery animals across monoclonal antibody development packages: opportunity for further optimization remains’ (P509) in the Regulation/Policy session.

Our collaborative work with the European Partnership for Alternative Approaches (EPAA) was also featured in a presentation by Hsiaotzu Chien (The Netherlands Medicines Evaluation Board): ‘Evaluating optimal toxicity study designs with monoclonal antibodies: results from a MEB/Industry/NC3Rs survey (P510) in the Regulation/Policy session.

Fiona attended and presented at The Cosmetic, Toiletry and Perfumery Association (CTPA)’s workshop on New Approach Methodologies Workshop in London in March. More information on the workshop can be read in this blog post.

Fiona, Helen and our new Programme Manager for Replacement Technologies Ah-Lai attended the BTS Annual Congress 2022 in Newcastle in April, where Fiona chaired ‘Symposium 6: Microsampling in Toxicology: Maximising the scientific, business and 3Rs advantages’, in which Helen gave a presentation entitled ‘Current use, 3Rs benefits and barriers for microsampling: results from survey of academia, pharmaceutical, agrochemical and CRO sectors’.

The NC3Rs regularly delivers webinars hosted by NC3Rs staff members and grant holders on different 3Rs topics. Recordings of past webinars can be found on the NC3Rs website. To receive regular updates on upcoming webinars and other new learning resources, subscribe to the NC3Rs newsletter.

Increasing confidence in New Approach Methodologies for regulatory decision-making

In collaboration with the British Toxicology Society (BTS) and the Health and Safety Executive’s (HSE) Chemicals Regulation Division (CRD), the NC3Rs held a two-day virtual workshop in February to raise awareness of new approach methodologies (NAMs). The workshop explored how regulatory application and acceptance of these tools can be increased by overcoming the most significant barriers to their implementation.

Ten years of CRACK IT webinar series

Recordings of every webinar in the ‘Ten years of CRACK IT’ webinar series held over the past year are now available online. These include presentations on:

• Assessing the genotoxic potential of gene therapy products in vitro
• Putting in vitro platforms at the heart of cardiotoxicity testing
• Chipping away at in vivo nephrotoxicity testing
• The worm that turned the tide on in vivo DART testing

Food restriction in rodent studies – is it necessary and how could it affect your data and animal welfare?

The NC3Rs hosted a webinar on 4 May to address the scientific and welfare implications of using food restriction with rodents. The webinar featured presentations from academic and industry experts in the fields of preclinical diabetes, daily torpor and regulatory toxicology.

A list of all NC3Rs publications in Toxicology and Regulatory Sciences can be found in our bibliography.

• Prior H, Clarke D, Jones D, Salicru E, Schutten M, Sewell F (2022). Exploring the Definition of “Similar Toxicities”: Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species. International Journal of Toxicology, in press. doi: 10.1177/10915818221081439
• Sewell F, Corvaro M, Amanda A, Burke J, Daston G, Delaney B, Domoradzki J, Forlini C, Green M, Hofmann T, Jäckel S, Lee M, Temerowski M, Paul Whalley P, Lewis R (2022). Recommendations on dose level selection for repeat dose toxicity studies. Archives of Toxicology, in press. doi: 10.1007/s00204-022-03293-3
• Tan YM, Barton H, Boobis A, Brunner R, Clewell H, Cope R; Dawson J, Domoradzki J, Egeghy P,; Gulati P, Ingle B, Kleinstreuer N, Lowe K, Lowit A, Mendez E, Miller D, Minucci J; Nguyen J, Paini A, Perron M, Phillips K, Qian H, Ramanarayanan T, Sewell F, Villanueva P, Wambaugh J, Embry M (2021). Opportunities and challenges related to saturation of toxicokinetic processes: implications for risk assessment. Regulatory Toxicology and Pharmacology 127: e105070. doi: 10.1016/j.yrtph.2021.105070
• Prior H, Blunt H, Crossman L, McGuire A, Stow R, Sewell F (2021). Refining procedures within regulatory toxicology studies: improving data and animal welfare. Animals 11(11): 3057. doi: 10.3390/ani11113057