International round robin test to consolidate OECD 301 tests for ready biodegradability
German Environmental Agency, FKZ 372 465 709 0, project duration 8/2024 – 9/2027
Screening tests from the OECD 301 series and OECD 310, which are used to determine the ready biodegradability, are considered to possess an equal level of reliability in their outcome, although they have significant methodological and historical differences. With the further development of these tests, less frequently used test systems could be dispensed, and the basic conditions of the remaining test procedures could be better standardized. This would also improve the comparability of the test results between substances. The aim of the project is to examine the possibility of merging and improving the existing OECD test guidelines for testing the ready biodegradability of chemicals. To this end, a proposal for a consolidated test design for testing ready biodegradability will be developed. In a second step, an international round robin test with at least 10 qualified GLP laboratories will be organised, realised and evaluated.
In work package (WP) 1, the literature study from the previous project (Gartiser et al., 2017, 2023) will be updated and supplemented and the basic conditions of the various screening tests according to OECD 301 and OECD 310 will be systematically compared.
In WP 2, a proposal for a consolidated test design for testing ready biodegradability, based on OECD 301 or 310, will be developed. The existing measurement devices for determining the endpoints DOC, O2 consumption and CO2-evolution are considered. In addition, recommendations on the origin, characterization and pretreatment of the inoculum, the use of additional control approaches, the minimum number of parallel approaches in degradation tests, the number of measurements and the validity criteria are to be developed. The intended volumes of the test vessels are also to be checked and standardized.
In WP 3, the study plan for the round robin test (WP 4) will be developed. In coordination with the German Environment Agency, three test substances and one reference substance will be selected for being parallel tested in the newly developed consolidated test and the previous standard test. Suitable GLP laboratories from the OECD member states (Europe, USA, Japan, etc.) are being proposed and binding templates for documenting the study process will be developed.
AP 4 includes the organization, realisation and evaluation of an international round robin test with at least 10 GLP laboratories from different OECD countries. The participating laboratories will receive compensation for their expenses. Approximately 60 individual tests with three replicates each will be carried out. The evaluation is carried out using descriptive static methods and in accordance with DIN ISO 5725-2 and ISO/TS 5594 (ring test statistics). In addition, an international workshop on the project results and the draft OECD test guideline of the consolidated test will be organized and carried out in the first quarter of 2027.
Sponsor
German Environmental Agency (FKZ 372 465 709 0)
Realisation
Hydrotox GmbH, Freiburg, Andrea Brunswik-Titze, Dr. Stefan Gartiser
ToxRat Solutions GmbH & Co. KG, Dr. Monika Ratte
Dr Brill Regulatory Services GmbH, Hamburg, Heike Schimmelpfennig
Project duration
August 2024– September 2027
Project description
Screening tests from the OECD 301 series and OECD 310, which are used to determine the ready biodegradability, are considered to possess an equal level of reliability in their outcome, although they have significant methodological and historical differences. With the further development of these tests, less frequently used test systems could be dispensed, and the basic conditions of the remaining test procedures could be better standardized. This would also improve the comparability of the test results between substances. The aim of the project is to examine the possibility of merging and improving the existing OECD test guidelines for testing the ready biodegradability of chemicals. To this end, a proposal for a consolidated test design for testing ready biodegradability will be developed. In a second step, an international round robin test with at least 10 qualified GLP laboratories will be organised, realised and evaluated.
In work package (WP) 1, the literature study from the previous project (Gartiser et al., 2017, 2023) will be updated and supplemented and the basic conditions of the various screening tests according to OECD 301 and OECD 310 will be systematically compared.
In WP 2, a proposal for a consolidated test design for testing ready biodegradability, based on OECD 301 or 310, will be developed. The existing measurement devices for determining the endpoints DOC, O2 consumption and CO2-evolution are considered. In addition, recommendations on the origin, characterization and pretreatment of the inoculum, the use of additional control approaches, the minimum number of parallel approaches in degradation tests, the number of measurements and the validity criteria are to be developed. The intended volumes of the test vessels are also to be checked and standardized.
In WP 3, the study plan for the round robin test (WP 4) will be developed. In coordination with the German Environment Agency, three test substances and one reference substance will be selected for being parallel tested in the newly developed consolidated test and the previous standard test. Suitable GLP laboratories from the OECD member states (Europe, USA, Japan, etc.) are being proposed and binding templates for documenting the study process will be developed.
AP 4 includes the organization, realisation and evaluation of an international round robin test with at least 10 GLP laboratories from different OECD countries. The participating laboratories will receive compensation for their expenses. Approximately 60 individual tests with three replicates each will be carried out. The evaluation is carried out using descriptive static methods and in accordance with DIN ISO 5725-2 and ISO/TS 5594 (ring test statistics). In addition, an international workshop on the project results and the draft OECD test guideline of the consolidated test will be organized and carried out in the first quarter of 2027.
Contact person at Hydrotox
Andrea Brunswik-Titze
Hydrotox GmbH
Bötzinger Str. 29
D-79111 Freiburg
Tel.: +49-761- 4 55 12-0
E-Mail: brunswik(at)hydrotox.de