Description: Das Projekt "Prävalidierung des HET-MN (Hen's Egg Test - Micronucleus Induction) als Ersatzmethode zur in vivo Mikrokernprüfung an Nagern^Teilprojekt 2, Teilprojekt 1" wird/wurde gefördert durch: Bundesministerium für Bildung und Forschung. Es wird/wurde ausgeführt durch: Henkel AG & Co. KGaA, Cosmetics , Toiletries, Biological and Clinical Research.Ziel des Verbundvorhabens ist die Prävalidierung eines Ersatz- und Ergänzungsverfahrens (Alternativmethode) im Bereich der Mutagenitätsprüfung, das das Potential besitzt, in vivo Mutagenitätsprüfungen (OECD TG 474 Mammalian Erythrocyte Micronucleus Test und OECD 475 Mammalian Bone Marrow Chromosome Aberration Test) am Nager zu ersetzen, wobei letztere wesentliche Bestandteile in behördlichen Anmelde- bzw. Zulassungsverfahren darstellen (z.B. bei Industriechemikalien und Arzneimitteln). Mit dem vorliegenden Projekt soll der HET-MN als eine hochempfindliche aber gleichzeitig spezifische Ersatzmethode weiterentwickelt werden, welche klastogene (DNS strangbrechende) und aneugene (Chromosomen-fehlverteilende) Effekte von Prüfsubstanzen zu prognostizieren in der Lage ist. Diese Methode bietet gegenüber den derzeit gängigen behördlich geforderten Tierversuchen weitere Vorteile, was die Vorhersage genotoxischer Eigenschaften verbessert und dadurch den Verbraucherschutz in diesem Bereich stärkt.
Types:
SupportProgram
Origins:
/Bund/UBA/UFORDAT
Tags:
Nagetier
?
Mutation
?
Biopharmazeutikum
?
Arzneimittel
?
Behörde
?
DNA
?
Genotoxizität
?
Mutagenitätstest
?
OECD
?
Prognose
?
Mutagener Stoff
?
Industriechemikalien
?
Knochenmark
?
Testsubstanz
?
Tierversuch
?
Zulassungsverfahren
?
Vermeidung von Tierversuchen
?
Tierschutz
?
Verbraucherschutz
?
Chromosomen
?
In-Vivo
?
Region:
Nordrhein-Westfalen
Bounding boxes:
6.76339° .. 6.76339° x 51.21895° .. 51.21895°
License: cc-by-nc-nd/4.0
Language: Deutsch
Organisations
Time ranges:
2010-09-01 - 2014-05-31
Alternatives
-
Language: Englisch/English
Title: Pre-validierung of the HET-MN (Hen's Egg Test - Mlcronucleus Induction) as an alternative method for the in vivo micronucleus test (OECD guideline 474) - Part 1
Description: In the frame of the new chemical legislation REACh and the 7U' Amendment to the EU Cosmetics Directive the legislator has significantly intensified its efforts to reduce animal testing in the safety assessment of chemicals during recent years. The test methods to be replaced in the near future are mandatory for certain regulatory registration and approval procedures (cosmetics, industry chemicals, pharmaceuticals etc.). For the toxicological endpoint genotoxicity validated in vitro methods are already available. However, they usually suffer from insufficient prediction of the chemical's real, in vivo genotoxic potential. The Hen's Egg Test for Micronucleus Induction (HET-MN) which was developed at the University of Osnabrueck (Wolf et aL, 1997, 2002, 2003, 2008) is a promising tool to supplement existing test batteries to obtain results of higher (more precise) pedictivity. The method combines the established endpoint 'induction of micronuclei' with the well characterized model of the bred hen's egg which enables metabolic activation, elimination, and excretion applied since years in accepted in vitro tests like the HET-CAM. The HET-MN detects clastogens (DNA strand breaking agents) and aneugens (chromosomes missegregation inducing agents) respectively. Therefore, the test method is especially considered as an alternative for the in vivo micronucleus test (OECD guideline 474) and the Mammalian Bone Marrow Chromosome Aberration Test (OECD guideline 475). In a recent project (0315278) the method was successfully transferred from the University of Osnabrueck to the Henkel AG & Co. KGaA as an industrial partner. Subsequently, the protocol has been finalized and further compound testing confirmed the good predictivity of the assay (15 of 16 substances were identified correctly) and also demonstrated a good intra and inter-Iaboratory reproducibility. Following the steps recommended by ECVAM for the acceptance of an in vitro assay the aim of the current project is to achieve the pre-validation of the HET-MN. The three participating laboratories Henkel, the Federal Institute for Risk Assessment (BfR) and the research contract organization Harlan together will verify, and if necessary optimize a prediction model by applying coded chemicals not used before in the HET-MN. The long-term aim is to provide a fully validated and regulatory accepted method for the assessment of the toxicological endpoint genotoxicity. The results of the project will be reported to the public via conventional peer-reviewed scientific publication.
https://ufordat.uba.de/
Resources
Status
Quality score
- Overall: 0.47
-
Findability: 0.56
- Title: 0.36
- Description: 0.13
- Identifier: false
- Keywords: 0.90
- Spatial: RegionIdentified (1.00)
- Temporal: true
-
Accessibility: 0.67
- Landing page: Specific (1.00)
- Direct access: false
- Publicly accessible: true
-
Interoperability: 0.00
- Open file format: false
- Media type: false
- Machine-readable metadata: false
- Machine-readable data: false
-
Reusability: 0.67
- License: ClearlySpecifiedAndFree (1.00)
- Contact info: false
- Publisher info: true
Accessed 1 times.
