08 March 2016, Brussels, Belgium: AGM and Annual Technical Meeting

The Annual General Meeting (open to Member Company Delegates only) will start the day and be followed by the ATM which will bring together ECETOC scientists, regulatory experts and business

development managers within member companies to explore if and how a science-based organisation such as ECETOC can help bring best scientific practices into the International Harmonisation of Chemical Regulation. It will also explore implications of ECETOC activities and how science understanding can add value to business activities in emerging markets.

The morning will provide an understanding of ECETOC Activities to meet current and anticipated (3 to 5-year time scale) scientific challenges in chemical risk assessment, and review how regulatory and business development Managers see the scientific challenges particularly as we move to international harmonisation of chemical regulation. The afternoon will focus on identifying where ECETOC science can help address challenges in the international harmonisation of chemical regulation. This will be achieved through breakout sessions where ECETOC scientists and regulatory experts will address a series of questions.

Answers to these questions will be consolidated and presented to the participants before the close of the meeting and shared with the ECETOC Board of Directors to aid their strategic planning with the focus on ensuring ECETOC continues to add value for the industry and the regulatory community in the area of chemical risk assessment. http://bit.ly/ecetoc-2016-agm-atm

Winter 2015e-Newsletter Issue 29

E U R O P E A N C E N T R E F O R E C O T O X I C O L O G Y A N D T O X I C O L O G Y O F C H E M I C A L S

www.ecetoc.org

Front page• 2016 Human Health & Exposure and

Environmental Review meetings

• 2016 AGM and Annual Technical Meeting

Page 2• Scientific Committee News• Recent Events

Page 3• Recent Events (continued)• Upcoming events

Page 4• Latest publications

IssueIn This

ECETOC Members: have your say and contribute to the ECETOC Science Programme at the 2016 Human Health & Exposure,

Environmental Review and Annual Technical Meetings

01-02 February 2016, Brussels, Belgium: Human Health and Exposure Science Review

From 2014, ECETOC now holds biennial Human Health Science Scoping Meetings to consult

with its membership and stakeholders on topical science issues to be included in the ECETOC Human Health Science Programme.

In February 2014 the first Human Health Science Scoping Meeting identified 12 priority themes for ECETOC and Cefic LRI consideration. During this 2016 Review Meeting, participants will hear about progress and achievements since 2014. They will also develop new recommendations for future work through brainstorm sessions. The regulatory community and key chemical sectors will give their views during the meeting to ensure that recommendations are both relevant and impactful.

Recommendations from this meeting will be taken into account by the ECETOC Scientific Committee and Cefic LRI when deciding their respective future scientific work programmes. http://bit.ly/ecetoc-2016-hhr

24-25 February 2016, Brussels, Belgium: Environment Progress Review

This 2 day annual meeting has 2 objectives:

• Day 1 sets out to inform ECETOC member company scientists about the progress in current and recently completed ECETOC Task Forces, Workshops and Cefic Long-range Research Initiative (LRI) projects in the environmental sciences.

• The second day will be a brainstorming session to generate new ideas for next year’s ECETOC Environment Programme and new ideas for RfPs (Requests for Proposals) within the LRI programme.

Like the Human Health Science Scoping Meetings, recommendations from this meeting are taken into account by the ECETOC Scientific Committee and Cefic LRI when deciding their respective future scientific work programmes.http://bit.ly/ecetoc-2016-er

For more information on these meetings, please contact the ECETOC Secretariat by email: info@ecetoc.org or tel. +32 2 675 3600.

SETAC Europe 25th Annual Meeting: Young Scientist Awards (YSA)03-07 May 2015 Barcelona, Spain

The ECETOC Best Platform Award honours the early career scientist with the best platform presentation at the SETAC Europe 25th Annual Meeting. The award winner receives a monetary prize and free registration to the next SETAC Europe Annual Meeting.

Daniela Batista of the University of Minho, Braga, Portugal (Centre of Molecular and Environmental Biology) won the 2015 award for her presentation ‘Pollution induced community tolerance of microbial decomposers to silver nanoparticles’ - Daniela Batista, Ahmed Tlili, Mark O. Gessner, Cláudia Pascoal, and Fernanda Cássio.

For more information: http://barcelona.setac.eu/awards_programme/young_scientist_award

Emerging Issues: the use and safety assessment of small RNA molecules 24 August 2015, Prague, Czech Republic

Chaired by Achim Aigner (University of Leipzig) and Bennard van Ravenzwaay (BASF), this ECETOC sponsored workshop at European Environmental Mutagenesis and Genomics Society (EEMGS) 44th Annual Meeting looked at the significance of small RNAs (the Dlk1-Dio3 imprinted gene cluster noncoding RNAs

are novel candidate biomarkers for liver tumour promotion), employing RNA-mediated gene regulation in crop technology, the risk assessment of RNAi-based GM plants, investigating the role of miRNAs as biomarkers of effect, and small RNAs as biomarkers of effect.

Further information can be found on the EEMGS website: http://eemgsmeeting2015.eu/

Eurotox 2015: ECETOC Christa Hennes Young Scientist Award 13-16 September 2015, Porto, Portugal

In 2014, this Best Poster Award for toxicological research into mechanisms and risk assessment was renamed in memory of the late Dr Christa Hennes, ECETOC Human Health Sciences Manager, who was instrumental in its organisation. This is a Best Poster Award for toxicological research into mechanisms and risk assessment, selected by a panel in which ECETOC participates. The winner receives a monetary prize and a free invitation to the following year’s EUROTOX meeting.

The 2015 winner was Eiki Kimura of the University of Tokyo, Tokyo, Japan (Department of Medicine) for the poster on ‘AhR activation and TCDD exposure impair dendritic morphology in the developing olfactory bulb’.

Eurotox 2015 website: http://www.eurotox2015.com/

ECETOC e-Newsletter issue 29, Page 2

Scientific Committee News

Immediate Action

Addressing immediate regulatory scientific needs, these are in general topics that need to be completed within 12-18 months.

Newly-Established Task Forces

Assessing aquatic toxicity and bioaccumulation of sparingly soluble substances and manufactured nanomaterials

The objectives of this Task Force are:

- To build upon and update the guidance provided in ECETOC Monograph No. 26 (1996) by critically re-examining the relevance of undissolved particulate substance, from the nano to the macro scale, in aquatic toxicity tests with emphasis on uptake and bioaccumulation.

- To identify circumstances where current aquatic hazard testing approaches are acceptable and make recommendations where a different approach may be warranted for sparingly soluble particulate substances including nanomaterials.

- To develop guidance which assists distinguishing intrinsic toxicity from physical effects, characterising physical effects, and identifying circumstances where physical effects may contribute to population relevant risk.

Transformational Programmes

Addressing topics of longer term scientific relevance, aimed at producing transformational change in chemicals management. These are in general horizontal themes to be completed over 3-5 years. There are currently 3 programmes:

• Ecological Relevance of Risk Assessment

This activity will address the complexity and variability in Risk Assessment by improving ecological relevance to enable better risk mitigation and risk management.

• Using ‘Omics Data Wisely in Decision Making

This activity will establish robust frameworks and guidance for attaining, analysing and applying ‘omic data in regulatory decision making.

• Globalisation of ECETOC TRA Tool

This activity seeks to expand the use and applicability of the ECETOC Targeted Risk Assessment (TRA) Tool beyond Europe and REACH.

The ECETOC Science Programme is focussed on enhancing the effectiveness and efficiency of chemicals risk assessment. For convenience, ECETOC can be viewed as addressing immediate needs (required in a 12-18 month timeframe) and longer term (3-5 years) activities through the Transformational Programmes.

Recent Events

ECETOC e-Newsletter issue 29, Page 3

Identifying limitations of the OECD water-sediment test (OECD 308) and developing suitable alternatives to assess persistence 06 October 2015, Dübendorf, Switzerland

Over the years, several shortcomings of the OECD guideline 308 have been identified and its usefulness for persistence and exposure assessment has been questioned.

The objectives of the 3-year project “LRI ECO18 – Improved strategy to assess chemical persistence at the water-sediment interface” were two-fold: (i) to better understand the value and information content of the existing OECD 308 protocol, and (ii) to develop an improved test strategy for assessing persistence in sediment and surface water in a consistent and robust manner.

This final stakeholder workshop summarised stakeholder perspectives on the status quo of both OECD guidelines 308 and 309, and also disseminated the findings of the Cefic LRI project ECO18. The main focus of the was the question whether and how persistence and half-life information can be obtained from OECD 308 and 309 data.

Defining the role of chemical activity in environ-mental risk assessment within the context of mode of action: Practical guidance and advice 29-30 October 2015, Utah, USA

Society is facing a variety of challenges in environmental risk assessment (ERA): growing concerns about the effects of multiple stressors (both chemical and non-chemical); risks associated with exposure to complex mixtures; and demands to quantify local site-specific risks. At the same time, risk assessors are seeking to provide a more efficient framework on which to address these emerging problems and questions in a manner that reduces cost and the use of animals.

This 2 day meeting was held prior to the SETAC North America meeting in Salt Lake City, at the neighbouring Snowbird Resort in Utah. 36 participants from industry, academia and regulatory

bodies assessed the applicability of using chemical activity in the interpretation of effects data. Recent studies have demonstrated the utility of the concept with respect to acute baseline toxicity, consequently the emphasis of this workgroup was on expanding the concept to chronic baseline toxicity and providing guidance regarding the handling of acute effects for non-narcotic chemicals. The Workshop was a recommendation of ECETOC Technical Report no. 120 and follows the work of Cefic LRI ECO16. The results from this meeting will be published with recommendations for further research and model development.

The Role of Epigenetics in Reproductive Toxicity 12-13 November 2015, Brussels, Belgium

Building on the success of an earlier ECETOC workshop in December 2011: Epigenetics and Chemical Safety, this 2-day follow-on workshop, explored further developments in the understanding of epigenetics in chemical safety and the impact of epigenetics in toxicology now and in the future.

Day 1, attended by 47 participants from industry, academia and regulatory bodies, was a capacity-building activity consisting of a series of talks and case studies with room for questions, focussing on:

(i) Defining epigenetics and understanding its potential value for reproductive toxicology(ii) Understanding the relationship between epigenetic change and adverse end points.

Day 2, open to 34 invited experts only, was a brainstorming activity consisting of break-out groups in which work started on developing a roadmap for the practical use of epigenetic foundational studies to underpin regulatory applications, and a prioritised research agenda to help answer key questions on the role and value of epigenetics in toxicology and chemicals risk assessment.

A Workshop Report will be developed and it is also anticipated to publish the workshop findings in an open access, peer-reviewed journal. Proposals for Cefic LRI-funded research will be developed and the top proposals will be put forward for funding in 2016.

Recent Events (continued)

Upcoming Events (in addition to meetings listed on front page)

Advances in consumer exposure science: Data, Modelling and Aggregate Exposure Assessment26 January 2016, Brussels, Belgium

This Workshop was originally scheduled to take place 01 December 2015 but due to the security alert in Brussels has been moved to 26 January 2016

Although exposure-driven risk assessment has long been included in the toxicological and safety assessment of chemicals, advances in Toxicology in the 21st Century now highlight that exposure assessment is crucial. Describing external and internal human exposure dose through modelling facilitates the targeted use of emerging toxicological tools for safety assessments.

This Workshop will present and review the current state of consumer exposure science by examining data needs, sources (including novel data sources), tools, gaps and the latest innovations.

Noncoding RNAs and Risk Assessment Science 03-04 March 2016, Malaga, Spain

Noncoding RNAs are now known to be involved in post transcriptional gene silencing, epigenetic regulation and mediation of physical and chemical environmental signals. However, although knowledge of how chemical stressors can influence the functionality of ncRNAs is growing, the potential role of ncRNAs in chemicals risk assessment is unclear.

Organised by ECETOC in collaboration with Cefic LRI, this workshop intends to reach a common understanding on the current and potential future role of ncRNAs in toxicology and risk assessment – and develop a prioritised research agenda for research over the next 2-3 years in this regard.

A Workshop Report will be developed and it is anticipated to publish the workshop findings in an open access, peer-reviewed journal.

From Bioavailability Science to Regulation of Organic Chemicals

Regulators have recently started to consider bioavailability within retrospective risk assessment frameworks for organic chemicals; by doing so, realistic decision-making with regard to polluted environments can be achieved, rather than relying on the traditional approach of using total-extractable concentrations. However, implementa- tion remains difficult because scientific developments on bioavailability are not always translated into ready-to-use approaches for regulators. Similarly, bioavailability remains largely unexplored within prospective regulatory frameworks that address the approval and regulation of organic chemicals.

This article discusses bioavailability concepts and methods, as well as possible pathways for the implementation of bioavailability into risk assessment and regulation; in addition, this article offers a simple, pragmatic and justifiable approach for use within retrospective and prospective risk assessment

Ortega-Calvo JJ, Harmsen J, Parsons JR, Semple KT, Aitken MD, Ajao C, Eadsforth C, Galay Burgos M, Naidu R, Oliver R, Peijnenburg WJ,, Römbke J, Streck G, Versonnen B. 2015.From Bioavailability Science to Regulation of Organic Chemicals.Environmental Science & Technology 49(17):10255–10264 (Open Access) DOI: 10.1021/acs.est.5b02412

ECETOC Direct Link to the web page of the Article: http://bit.ly/ecetoc-art2015-ortega-calvo-et-al

New ECETOC manuscript addresses the relationship between activity and toxicity for non-polar narcotic chemicals

The relationship between the toxicity of narcotic chemicals and the octanol water partition coefficient (KOW) has been widely explored. An alternative but closely related property can be used to directly frame toxicity within the concept of phase equilibrium thermodynamics. This property, termed chemical activity, is inversely proportional to solubility, proportional to toxicity and should be applicable for the prediction of effects in aquatic species.

This manuscript employs an extensive set of existing data, and provides a proof of concept for the relationship between chemical activity and toxicity for narcotic chemicals. The authors used published methodology and freely available software to classify the data according to Mode of Action 1 (MOA). The analysis of MOA 1 (non-polar narcosis or baseline toxicity) substances shows promise as an alternative to KOW-based predictions of effect.

This Open Access paper has been published in Environmental Science & Technology:Thomas P, Dawick J, Lampi M, Lemaire P, Presow S, van Egmond R, Arnot JA, Mackay D, Mayer P, Galay Burgos M. 2015Application of the Activity Framework for Assessing Aquatic Ecotoxicology Data for Organic ChemicalsEnviron. Sci.Technol 49(20):12289-12296 (Open Access) DOI: 10.1021/acs.est.5b02873ECETOC Direct Link to the web page of the Article: http://bit.ly/ecetoc-art2015-thomas-et-al

Supporting information for this manuscript can be found in the ECETOC Technical Report 120: Activity-Based Relationships for Aquatic Ecotoxicology Data: Use of the Activity Approach to Strengthen MoA Predictions. Published in December 2013 by the same ECETOC Task Force, TR120 can be downloaded from the ECETOC website and via the following direct link: http://bit.ly/ecetoc-tr120-pdf

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ECETOC e-Newsletter issue 29, Page 4

Graphics in this newsletter are based on “The dancers” by anamontreal on Flickr: https://www.flickr.com/photos/30236331@N06/5927216681 They are used under the CC BY-SA 2.0 licence - http://creativecommons.org/licenses/by/2.0/

Latest Publications

For the full list of ECETOC publications, download the catalogue of ECETOC publications at http://bit.ly/ecetoc-catalogue. ECETOC reports are freely available from the ECETOC website:www.ecetoc.org/publications