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Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

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Administrative data

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)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
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
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Parameter:
% degradation (O2 consumption)
Value:
84.1
Sampling time:
28 d
Remarks on result:
other:
Remarks:
source, CAS 71010-76-9, Exxon, 2006, O2 consumption, RL2
Parameter:
% degradation (CO2 evolution)
Value:
96
Sampling time:
28 d
Remarks on result:
other:
Remarks:
source, CAS 68424-31-7, BASF, 2006, CO2 evolution, RL2
Parameter:
% degradation (O2 consumption)
Value:
75
Sampling time:
28 d
Remarks on result:
other:
Remarks:
source, CAS 25151-96-6, BASF, 2000, O2 consumption, RL1
Parameter:
% degradation (O2 consumption)
Value:
62
Sampling time:
14 d
Remarks on result:
other:
Remarks:
source, CAS 25151-96-6, BASF, 2000, O2 consumption, RL1
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable

Description of key information

Readily biodegradable: ≥ 60% in 28 days


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:
readily biodegradable

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 Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids is available. Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9), Tetra-esterification products of C5, C7, C8, C10 fatty acids with pentraerythritol (CAS 68424-31-7) and 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) is applied.


Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substances, the source substances are 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 ready biodegradability of source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) was conducted according to OECD 301F (GLP) under aerobic conditions using fresh activated, non-adapted sludge from a municipal sewage treatment plant (STP) as inoculum. A test concentration of 50.2 mg/L (test material) was applied. A mean biodegradation of 84% based on O2 consumption was observed after 28 d. Since the substance reached the pass level for OECD 301F (biodegradation is > 60% after 28 d) the substance is stated to be readily biodegradable according to the OECD criteria. The study with source substance Tetra-esterification products of C5, C7, C8, C10 fatty acids with pentraerythritol (CAS 68424-31-7) was conducted according to OECD 301B (CO2 Evolution Test). Domestic activated sludge (non adapted) was used as inoculum. A mean degradation of 96% was observed at test termination after 28 days, the 10-day-window was reached. Therewith the test substance can be classified as readily biodegradable according to OECD criteria. The third study with the source substance 2,2 bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) was conducted under aerobic conditions according to ISO guideline 10708 (BODIS-Test) using sewage effluents, obtained from a domestic STP, as inoculum. A test concentration of 100 mg/L (ThOD) was applied. Based on O2 consumption a mean biodegradation of 75% was observed after a test period of 28 days and the 14-day window was passed.


Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar environmental fate profile and comparable structure, it can be concluded that Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids can be expected to be readily biodegradable according to the OECD guideline criteria.