Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Not readily biodegradable (according to OECD criteria).

Additional information

The described 'red disazo condensation pigment' is practically insoluble and therefore considered to be essentially not bioavailable. Due to the large molecular size, cellular uptake of the pigment is unlikely. Hence intracellular biodegradation, which is the main degradation route of bacteria, is probably low. It can be concluded that the substance is likely to persist in the environment. The conclusion is supported by two model calculations that showed no biodegradation for the pigment.

Biodegradation tests in water, sediment or soil are not proposed, since no relevant new findings are expected from such investigations.

In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met. Furthermore according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort. 

According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided. 

For the assessment  (Q)SAR results were used for aerobic biodegradability in water.The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment. Therefore, further experimental studies on aerobic biodegradability in water are not provided.