Registration Dossier

Environmental fate & pathways

Biodegradation in water: screening tests

Administrative data

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
other: Weight of evidence
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Weight of evidence assessment based on structural analogue and hydrolysis products
Justification for type of information:
No data on the ready biodegradability is available for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol". The readily biodegradability of this substance is therefore assessed in a weight of evidence analysis based on existing data on similar compounds. See the attached report.

The following type of substances were included in the assessments: other glycerol esters (both data and QSAR), glycerols, fatty acids and alcohol ethoxylates. The main data sources were: NICNAS, Danish EPA QSAR, the HERA reports for alcohol ethoxylates and fatty acids.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The conclusion is based on a collection of data performed equivalent or similar to relevant guidelines. Please refer to attached weight of evidence document.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Paste
Details on test material:
Same ID as the registered substance

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, adapted
Duration of test (contact time):
28 d

Results and discussion

% Degradation
Key result
Parameter:
other: The substance is found to be readily biodegradable based on WoE
Sampling time:
28 d
Remarks on result:
other: Readily based on WoE

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Interpretation of results:
readily biodegradable
Conclusions:
Based on a weight of evidence approach, the substance is concluded to be readily biodegradable.
Executive summary:

“Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is an UVCB substance. Several test data on ready biodegradability is found on the main constituents, expected primary degradation products and substances with similar properties..

QSAR predictions on ready biodegradability using the Danish QSAR database for both the main constituents and expected degradation products from the primary biodegradation have been used to support and complement the test data.

Both the test data and the QSAR predictions support that “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” should be considered as readily biodegradable.

Based on the studies available for the group of polyglyceryl fatty acid monoesters and diesters, the relevant hydrolysis products and the components of the UVCB substance, it is concluded that “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is readily biodegradable.