Cefic-lri Programme | European Chemical Industry Council

EMSG35-BASF: Enhanced OECD TG 407 – Development and Validation

Principal Investigator

Dr Elard Jacob
BASF AG
Carl-Bosch-Strasse 38
D-67056 Ludwigshafen
elard.jacob@basf-ag.de
Tel: +49 621 6041611
Fax: +49 621 6058134

Collaborators

Dr Remi Bars, Bayer Crop Science, remi.Bars@bayercropscience.com
Dr Alexius Freyberger, Bayer, alexius.freyberger.af@bayer-ag.de
Dr Jim Freeman, ExxonMobil, jim.freeman@exxonmobil.com
Dr Gian Winkler, Novartis, gian-christian.winkler@syngenta.com
Dr John Ashby, Syngenta CTL UK, john.ashby@syngenta.com

Description

Concerns that toxicological test guidelines may not optimally detect effects on the endocrine system have lead to proposals to enhance the current sub-acute rodent OECD Test Guideline No. 407 (OECD 1995). The efficacy of the modified enhanced (phase 2) protocol (OECD 2000) was investigated in a worldwide effort by 13 laboratories using 10 endocrinologically-active compounds. This test conducted studies with ethinylestradiol. The main objectives of the study were (1) to determine which of the current and/or additional parameters will detect the endocrine effects of ethinylestradiol reliably and sensitively, and (2) to assess intra-laboratory variability by performing two identical studies in parallel. In addition, and outside the scope of the enhanced protocol, effects of ethinylestradiol on metabolizing liver enzymes were investigated.

Related Publications

Publications: 

Andrews P, Freyberger A, Hartmann E, Eiben R, Loof I, Schmidt U, Temerowski M, Becka M. Feasibility and potential gain of enhancing the subacute rat study protocol (OECD test guideline no. 407) by additional parameters selected to determine endocrine modulation. A pre-validation study to determine endocrine-mediated effects of the antiandrogenic drug flutamide. Arch Toxicol. 2001 Apr;75(2):65-73.

Andrews P, Freyberger A, Hartmann E, Eiben R, Loof I, Schmidt U, Temerowski M, Folkerts A, Stahl B, Kayser M. Sensitive detection of the endocrine effects of the estrogen analogue Ethinylestradiol using a modified enhanced subacute rat study protocol (OECD Test Guideline no 407). Arch Toxicol. 2002 May;76(4):194-202.

Presentations:

Hofmann A. The enhanced subacute toxicity test OECD TG 407 for the detection of endocrine active chemicals. Comparison with toxicity tests of longer duration. 6th Annual LRI Workshop, November 2004, Brussels, Belgium.

LRI funding: €1,200,000

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