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Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

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Administrative data

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Description of key information

Readily biodegradable

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable
Type of water:
freshwater

Additional information

The biodegradation of the substance was evaluated by considering four studies.


In the first study, the ready biodegradability of the test item was assessed in a 28-day biodegradation test following the "Manometric Respirometry" method according to t OECD guideline 301F Ready Biodegradability.  The test item showed to be readily biodegradable under the conditions applied in a Manometric Respirometry test, having reached the pass level (60% biodegradation) at the end of the 28 days test, showing a total 78.3% during the test period (mean values between two replicates). Being an UVCB substance, following Regulation 286/2011 (emending the regulation 1272/2008 for the purposes of its adaptation to technical and scientific progress), point 4.1.2.9.5 part c, the 10-day window condition can be waived and the pass level applied at 28 days. Moreover, the test item showed no inhibitory effects on the microorganism activity at the tested concentration, as demonstrated by the 25% of biodegradation exceeded in the toxicity control at the third day of test period.


In the Revised Introduction to the OECD Guidelines for Testing of Chemicals, Section 3 - Part 1: Principles and strategies related to the testing of degradation of organic chemicals, it is reported that "Although these tests are intended for pure chemicals, it is sometimes relevant to examine the ready biodegradability of mixtures of structurally similar chemicals". It further recommends that "a case-by-case evaluation should take place on whether a biodegradability test on such a complex mixture would give valuable information regarding the biodegradability of the mixture as such (i.e. regarding the degradability of all the constituents) or whether instead an investigation of the degradability of carefully selected individual components of the mixture is required.


Registrants have decided to analyse the behaviour of the most conservative components as well. In order to select the most representative and conservative components of the substances, a QSAR screening has been performed on a number of specific structures. In the confidential annex attached below the full justification for the selection of the samples and the performed tests.


Three studies have been performed according to OECD 301F on three selected fractions called



  • CloroparaffinA 14-17


Both test item replicates without Emulsifier reached the 10 % level (beginning of biodegradation) within 6 days. The mean biodegradation on day 28 was ca.60 % as a medium of the test item replicates. Both test item replicates with Emulsifier reached the 10 % level (beginning of biodegradation) within 6 days.



  • FRAZIONE N-EM


The first test item replicate without Emulsifier reached the 10 % level (beginning of biodegradation) within 4 days and the second within 6 days. The first test item replicate reached the 60% threshold within 30 days. The second test item replicate reached the 60% threshold within 26 days. The mean biodegradation on day 28 was ca.60 % as a medium between the two the test item replicates.



  • FRAZIONE EM-Na


Both test item replicates reached the 10 % level (beginning of biodegradation) within 3 days. The 60% threshold was reached within 7 days. The mean biodegradation on day 28 was 84% in the test item replicates without emulsifier and 98% in the test item replicates with emulsifier. After a test period of 28 days, the test item was readily biodegradable within the 10-day window and the 28-day period of the study with and without emulsifier.


As a conclusion the substance and their representative components are all readily biodegradable