Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Biodegradation:

- QSAR prediction, The Estimation Programs Interface (EPI) SuiteTM v4.1, BIOWIN estimation model (v4.10), not readily biodegradable

- Supporting data from 2,4 -Bismaleimidotoluene, study according to OECD TG 301B, GLP, not readily biodegradable

Additional information

In the present report biodegradability was estimated by QSAR prediction using EPISuite and the Biowin models. m-Xylylenebismaleimide is considered to be not readily biodegradable based on the QSAR prediction. BIOWIN estimates the probability of rapid aerobic and anaerobic biodegradation of an organic compound in the presence of mixed populations of environmental microorganisms.  BIOWIN contains seven separate models. These models predict the biodegradability based on structural features and molecular weight. The molecular weight as well as the fragments which can be derived from the chemical structure are used in the models training data set, thus the substance lies in the applicability domain of the prediction models and the prediction is considered reliable.

 In a supporting study conducted according to OECD TG 301B, GLP, the biodegradability of the structurally similar compound 2,4 -Bismaleimidotoluene was determined.

The test medium was inoculated with activated sludge from a sewage treatment plant mainly fed with municipal wastewater. The rate of degradation was monitored by measuring the carbon dioxide produced over the 28-d period.

The test item was tested with a concentration of 19 mg/L in duplicates. The biodegradation of the test item was followed by titrimetric analyses of the quantity of CO2 produced by the respiration of bacteria. The degradation was finished on day 28 by acidification, the last titration was made on day 29. The percentage CO2 production was calculated in relation to the theoretical CO2 (ThCO2) of the test item. The biodegradation was calculated for each titration time.

The 10 % level (beginning of biodegradation of the test item) was not reached 14 days of the test. The pass level of 60 % was not reached at the end of the study period. The mean biodegradation came to a maximum of 17 % after 28 days.

To check the activity of the test system sodium acetate was used as functional control. The percentage of degradation of the functional control reached the pass level of 60 % after 10 days.

In the toxicity control containing both test and reference item a biodegradation rate of 39 % occurred within 28 days .

The test item m-Xylylenebismaleimide is not readily biodegradable in this CO2 evolution test and failed the 10 d window criterion.