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OECD Test Guidelines development for chemicals safety assessment of nanomaterials
- The OECD test guidelines (TGs) for testing chemicals have been widely used for regulatory purposes all over the world since the establishment of the Mutual Acceptance of Data (MAD) principle in 1984. This MAD principle ensures that, if a chemical is tested under the Good Laboratory Practice (GLP) conditions accordingly to an OECD TG, the data should be accepted in all OECD countries. The TGs have been developed, harmonized, internationally validated (round robin tests) and adopted by OECD countries to be used for the physical-chemical characterisation, fate estimation, and hazard identification for risk assessment of various chemicals. In addition to the TGs, OECD Guidance Documents (GDs) usually provide guidance on how to use TGs and how to interpret the results. These GDs do not have to be fully experimentally validated, and hence they are not under MAD, but they are based on relevant published scientific research.
But are the existing TGs and the related GDs applicable and adequateThe OECD test guidelines (TGs) for testing chemicals have been widely used for regulatory purposes all over the world since the establishment of the Mutual Acceptance of Data (MAD) principle in 1984. This MAD principle ensures that, if a chemical is tested under the Good Laboratory Practice (GLP) conditions accordingly to an OECD TG, the data should be accepted in all OECD countries. The TGs have been developed, harmonized, internationally validated (round robin tests) and adopted by OECD countries to be used for the physical-chemical characterisation, fate estimation, and hazard identification for risk assessment of various chemicals. In addition to the TGs, OECD Guidance Documents (GDs) usually provide guidance on how to use TGs and how to interpret the results. These GDs do not have to be fully experimentally validated, and hence they are not under MAD, but they are based on relevant published scientific research.
But are the existing TGs and the related GDs applicable and adequate for the regulatory testing of nanomaterials? In general, for nanomaterials it is accepted that most of the "endpoints" or more precisely measurement variables are applicable. However, for some endpoints new or amended TGs are needed. In addition, several GDs are needed to give more precise advice on the test performance in order to gain regulatory relevant data on nanomaterials.…
Autor*innen: | K. Schwirn, D. Völker, J. Ahtianinen, Alexandra Schmidt, Harald Bresch, K. Kämpf, V. Bachmann, T. Kuhlbusch |
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Persönliche Herausgeber*innen: | H. Bosse, E. Buhr, T. Dziomba, Vasile-Dan HodoroabaORCiD, T. Klein, M. Krumrey |
Dokumenttyp: | Beitrag zu einem Tagungsband |
Veröffentlichungsform: | Graue Literatur |
Sprache: | Englisch |
Titel des übergeordneten Werkes (Englisch): | PTB-Bericht F-61 - NanoWorkshop 2018: Workshop on Reference Nanomaterials |
Jahr der Erstveröffentlichung: | 2019 |
Organisationseinheit der BAM: | 4 Material und Umwelt |
4 Material und Umwelt / 4.2 Material-Mikrobiom Wechselwirkungen | |
Verlag: | Physikalisch-Technische Bundesanstalt |
Verlagsort: | Braunschweig und Berlin |
Jahrgang/Band: | F-61 |
Erste Seite: | 279 |
Letzte Seite: | 279 |
Freie Schlagwörter: | Prüfrichtlinie Guideline; Nano; Nanomaterials; OECD |
Themenfelder/Aktivitätsfelder der BAM: | Umwelt |
Umwelt / Umwelt-Material-Interaktionen | |
Veranstaltung: | NanoWorkshop 2018: Workshop on Reference Nanomaterials |
Veranstaltungsort: | Berlin, Germany |
Beginndatum der Veranstaltung: | 14.05.2018 |
Enddatum der Veranstaltung: | 15.05.2018 |
DOI: | 10.7795/110.20190412 |
ISSN: | 0179-0609 |
ISBN: | 978-3-95606-440-1 |
Verfügbarkeit des Dokuments: | Datei im Netzwerk der BAM verfügbar ("Closed Access") |
Datum der Freischaltung: | 06.11.2019 |
Referierte Publikation: | Nein |