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Key study, OECD 301F, GLP, 2017, Klimisch 1:

The Ready Biodegradability of GR-86-6599 was determined by the Manometric Respirometry Test.

GR-86-6599 did not inhibit the intrinsic respiration of the inoculum at the test concentration and was therefore considered to be non-toxic to the inoculum at the test concentration.

GR-86-6599 undergoes 62% biodegradation after 28 days in the test conditions.The 10-day window criterion is not fulfilled (11% biodegradation on day 4 and 41% on day 14).The 10-day time window criterion was developed on the assumption that a test substance is degraded according to a “standard” growth curve in ready biodegradability tests. The OECD Guidelines for Testing of Chemicals, Section 3. Part 1: Principles and strategies related to the testing of degradation of organic chemicals (adopted 23 March 2006), states that if a substance consists of “constituents with different chain-lengths, degree and/or site of branching or stereo-isomers, even in their most purified commercial forms” and “it is anticipated that a sequential biodegradation of the individual structures is taking place, then the 10-day window should not be applied to interpret the results of the test.” The 10-day time-window should therefore not be applied as a pass / fail criterion forGR-86-6599, which is a mixture of isomers.

Supporting study, OECD 301F, not GLP, 2015, Klimisch 4:

The Ready Biodegradability of GR-86-6599 was determined by the Manometric Respirometry Test according to the OECD Guidelines for Testing of Chemicals, Method No. 301 F.

 

GR-86-6599 undergoes 70% biodegradation after 28 days (84% after 61 days) in the test conditions. The 10-day window criterion is not fulfilled (14% biodegradation on day 4 and 49% on day 14). However, according to the Revised Introduction to the OECD Guidelines for Testing of Chemicals, Section 3, Part 1, clause 43, 2006 the 10-day window criterion should not be applied to interpret the results of the test in the case a mixture of structurally similar chemicals is tested. Accordingly, as GR-86-6599 is a mixture of E/Z isomer and other structurally similar isomers, the 10-day window criterion should not be applied here.

 

Thus, GR-86-6599 should be regarded as readily biodegradableaccording to this test.

GR-86-6599 did not inhibit the intrinsic respiration of the inoculum at the test concentration.

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