Registration Dossier

Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The substance is considered as not readily biodegradable as shown by QSAR calculation.

Key value for chemical safety assessment

Biodegradation in water:
under test conditions no biodegradation observed

Additional information

The substance is an UVCB, therefore all three main components only differing in structure were assessd with QSAR calculation. Three different models were applied: Catalogic 301C, IRFMN implemented in Vega and SRC BioWin 1 - 7 as implemented in EpiSuite. Concluding, all three structures were considered as not readily biodegradable. For detailed results please refer to table 1.

Table 1 QSAR calculation of biodegradability of all three structures. AD = Applicability Domain.

 

Structure 1

Within AD

Structure 2

Within AD

Structure 3

Within AD

IRFMN (Vega)

Possible Readily biodegradable

no

Possible Readily biodegradable

no

Possible Readily biodegradable

no

Catalogic

Not ready biodegradable

yes

Not ready biodegradable

yes

Not ready biodegradable

yes

EpiSuite

 

BioWin 1-2

Biodegrades fast

yes

Does not biodegrade fast

yes

Does not biodegrade fast

yes

BioWin 3-4

Weeks - days

yes

Months-weeks

yes

Months - weeks

yes

BioWin 5-6

Does not biodegrade fast

yes

Does not biodegrade fast

yes

Does not biodegrade fast

yes

BioWin 7

Does not biodegrade fast

no

Does not biodegrade fast

no

Does not biodegrade fast

no

Ready biodegradability prediction

No

 

No

 

No

 

Overall conclusion

Not ready biodegradable

Not ready biodegradable

Not ready biodegradable

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 of biodegradation (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 of the test item on aerobic biodegradability in water are not provided.