Thresholds of Toxicological Concern for Cosmetics-Related Substances: New Database, Thresholds, and Enrichment of Chemical Space

A new dataset of cosmetics-related chemicals for the Threshold of Toxicological Concern (TTC) approach has been compiled, comprising 552 chemicals with 219, 40, and 293 chemicals in Cramer Classes I, II, and III, respectively. Data were integrated and curated to create a database of No-/Lowest-Observed-Adverse-Effect Level (NOAEL/LOAEL) values, from which the final COSMOS TTC dataset was developed. Criteria for study inclusion and NOAEL decisions were defined, and rigorous quality control was performed for study details and assignment of Cramer classes. From the final COSMOS TTC dataset, human exposure thresholds of 42 and 7.9 μg/kg-bw/day were derived for Cramer Classes I and III, respectively. The size of Cramer Class II was insufficient for derivation of a TTC value. The COSMOS TTC dataset was then federated with the dataset of Munro and colleagues, previously published in 1996, after updating the latter using the quality control processes for this project. This federated dataset expands the chemical space and provides more robust thresholds. The 966 substances in the federated database comprise 245, 49 and 672 chemicals in Cramer Classes I, II and III, respectively. The corresponding TTC values of 46, 6.2 and 2.3 μg/kg-bw/day are broadly similar to those of the original Munro dataset

Nanotechnology and Risk Governance in the European Union: the Constitution of Safety in Highly Promoted and Contested Innovation Areas

[EN]The European Union (EU) is strategically committed to the development of nanotechnology and its industrial exploitation. However, nanotechnology also has the potential to disrupt human health and the environment. The EU claims to be committed to the safe and responsible development of nanotechnology. In this sense, the EU has become the first governing body in the world to develop nanospecific regulations, largely due to legislative action taken by the European Parliament, which has compensated for the European Commission’s reluctance to develop special regulations for nanomaterials. Nevertheless, divergences aside, political bodies in the EU assume that nanotechnology development is controllable and take for granted that both the massive industrial use of nanomaterials and a high level of environmental and health protection are compatible. However, experiences such as the European controversy over agri-food biotechnology, which somewhat delegitimized the regulatory authority of the EU over technological safety and acceptability, arguably show that controllability assumptions are contestable on the grounds of alternative socio-economic and cultural preferences and values. Recently developed inclusive governance models on safety and innovation, such as"Responsible Research and Innovation" (RRI), widelyclaim that a diversity of considerations and issues areintegrated into R&D processes. Even so, the possibility of more radically alternative constitutions of sociotechnical safety seems to be seriously limited by the current ideology of innovation and economic imperatives of the global, knowledge-based, capitalist economy.This work is based mainly upon research supported by the Basque Government’s Department of Education, Universities and Research under a Postdoctoral Fellowship for the Improvement of Research Personnel in a Foreign Country (grant BFI08.183). It has also been supported by the Basque Government’s Department of Education, Language Policy and Culture (grant IT644-13), the Spanish Ministry of Economy and Competitiveness and the European Regional Development Fund (grant FFI2015-69792-R), and the University of the Basque Country UPV/EHU (grant EHUA15/13). The author also wishes to thank Heather A. Okvat for her assistance in revising the initial, original version of the article, and to two anonymous reviewers for their constructive and thorough comments on the present version. Any shortcomings in the work remain the responsibility of the author