2-({3-(octadecanoyloxy)-2,2-bis[[](octadecanoyloxy)methyl]propoxy}methyl)-2-[[](octadecanoyloxy)methyl]propane-1,3-diyl dioctadecanoate

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Refer to analogue justification document provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Parameter:

% degradation (CO2 evolution)

Value:

7.6

Sampling time:

28 d

Remarks on result:

other:

Remarks:

source, RA-A, CAS 68604-38-6, REAGENS, 2013, CO2 Evolution test, RL1

Interpretation of results:

under test conditions no biodegradation observed

Description of key information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

Key value for chemical safety assessment

Biodegradation in water:

under test conditions no biodegradation observed

Additional information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

 

No study investigating the biodegradation of Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2). Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) is applied.

Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substance, the source substance is considered to be a suitable representative for the evaluation of the biodegradation of the target substance. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.

The biodegradability of Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) was tested in a GLP guideline study following the specifications given by OECD guideline 301 B. The study was conducted under aerobic conditions using domestic activated sludge as inoculum. During the incubation time of 28 days the degradation was followed by determining the CO2 production. A degradation rate of 7.6% was determined at test termination. Thus, a significant biodegradation of the substance was not determined under the test conditions. However, inhibitory effects of the test substance on activated sludge organisms were not observed in the toxicity control of the study. The substance is therefore considered as not readily biodegradable and in accordance with Regulation (EC) No. 1907/2006, it is regarded as very persistent (v P).

Based on the available results from a structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar environmental fate profile and comparable structure, it can be concluded that Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] will not be readiliy biodegradable.