Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

Currently viewing:

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)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The hypothesis for this analogue approach is that target and source substances, being different compounds, have similar (eco) toxicological properties based on structural similarity with common functional groups; a quaternized ethanolamine moiety, one to three ester groups with a typical UVCB distribution with long-chain fatty acids of natural origin.
Furthermore identical precursors (triethanolamine, long-chain fatty acids, dimethyl sulphate) are used for manufacturing. Therefore common breakdown products via physical and biological processes, which result in structurally similar chemicals, are evident.
For further information refer to general justification for read-across attached to chapter 13 of this IUCLID file.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See general justification for read-across attached to chapter 13 of this IUCLID file.

3. ANALOGUE APPROACH JUSTIFICATION
See general justification for read-across attached to chapter 13 of this IUCLID file.

4. DATA MATRIX
See general justification for read-across attached to chapter 13 of this IUCLID file.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Key result
Parameter:
% degradation (CO2 evolution)
Value:
116
Sampling time:
28 d

Description of key information

Biodegradability of Fatty acids, C18 unsatd., mono and diester with triethanolamine , di-Me sulfate-quaternizedis evaluated based information from an OECD 301B guideline study with oleic acid-based TEA-Esterquat and supporting information from the partially unsaturated TEA-Esterquat.

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable

Additional information

No experimental data on the biodegradability of the target substance Fatty acids, C18 unsatd., mono and diester with triethanolamine , di-Me sulfate-quaternized are available. However, several biodegradation tests are available for the closely related source substances oleic acid-based TEA-Esterquat and partially unsaturated TEA-Esterquat.

 

Summary

An OECD Guideline 301 B (CO2 Evolution Test) proved the ready biodegradation of the source substance oleic acid-based TEA-Esterquat.

Supporting information is available, form one test according to OECD Guideline 301 D (Closed Bottle Test) and four tests according to OECD Guideline 301 B (CO2 Evolution Test) proved the ready biodegradation of the source substance partially unsaturated TEA-Esterquat under aerobic.

One study according to ECETOC Anaerobic Biodegradation (Technical Report No. 28) proved the biodegradation of the source substance partially unsaturated TEA-Esterquat under anaerobic conditions.

 

Studies in detail

Aerobic biodegradation

The ready biodegradation of oleic acid-based TEA-Esterquat was investigated in a study conducted according to OECD Guideline 301B over a period of 28 days and using predominantly domesticsewage sludge micro-organismsas inoculum. The biodegradation rate was determined by measurement of CO2 evolution. Inoculum blank, procedural/functional control with the reference substance sodium benzoate, and toxicity control using x mg/L test item and x mg/L reference compound were performed.

This study is regarded as reliable without restriction satisfies the guideline requirements for ready biodegradation. The test item proved to be readily biodegradable and fulfilling the 10-d window criterion . The functional control reached the pass level >60% after 14 d. In the toxicity control containing both test and reference item 85% biodegradation ThCO2 occurred within 14 d thus indicating that the test item was not inhibitory at the concentration tested.

Degradation values in excess of 100% were considered to be due to sampling/analytical variation.

 

The ready biodegradation of partially unsaturated TEA-Esterquat was investigated in a study conducted according to OECD Guideline 301 D and EU-Method C.4 -E over a period of 28 days and using domestic sewage as inoculum. The biodegradation rate was determined by measurement of oxygen consumption. Inoculum blank, procedural/functional control with the reference substance sodium benzoate, and toxicity control using 1 mg/L test item and 1 mg/L reference compound were performed. This study is regarded as reliable without restriction and satisfies the guideline requirements for ready biodegradation. The test item proved to be readily biodegradable and fulfilling the 14-d window criterion. The functional control reached the pass level >60% after 14 d. In the toxicity control containing both test and reference item >25% biodegradation based on oxygen consumption occurred within 14 d thus indicating that the test item was not inhibitory at the concentration tested.

 

The ready biodegradation of the partially unsaturated TEA-Esterquat was investigated in a study conducted according to OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test over a period of 28 days and using municipal wastewater treatment plant as inoculum. The biodegradation rate was determined by measurement of CO2. Inoculum blank, procedural/functional control with the reference substance sodium benzoate, and toxicity control using ca. 20 mg/L TOC reference and test substance each were performed. The test item proved to be readily biodegradable (78.8% biodegradation after 7 d; 98.9% biodegradation after 28 d). The reference substance sodium benzoate was biodegraded by 95.5% after 14 d. The degradation in the toxicity control (ca. 20 mg/L TOC reference and test substance each) was 96.8% after 14 d and 98.6% after 28 d. Thus no inhibition of the inoculum was caused by the test substance. The highest mean CO2 evolution of the blank flasks was 28.5 mg/L (according to guideline this value should not exceed 40 mg/L and must be below 70 mg/L). The IC content in the test vessel was <5% of the TOC introduced with the test substance. The difference of extremes of replicate values at the end of the 10-d window and at the end of the test was <20%.

 

The ready biodegradation of partially saturated TEA-Esterquat was investigated in a study conducted according to OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test) over a period of 28 days and using activated sludge from a municipal wastewater treatment plant as inoculum. The biodegradation rate was determined by measurement of CO2 evolution. Inoculum blank, procedural/functional control with the reference substance sodium benzoate, and toxicity control using 20 mg/L test item and 10 mg/L reference compound were performed. This study is regarded as reliable without restriction and satisfies the guideline requirements for ready biodegradation. The test item proved to be readily biodegradable and fulfilling the 10-d window criterion. The functional control reached the pass level >60% after 14 d. In the toxicity control containing both test and reference item 39% biodegradation based on ThCO2 occurred within 14 d thus indicating that the test item was not inhibitory at the concentration tested.

 

The ready biodegradation of partially unsaturated TEA-Esterquat was investigated in a study conducted according to OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test; 1992) over a period of 28 days and using municipal activated sludge as inoculum. The biodegradation rate was determined by measurement of CO2 evolution. Inoculum blank, procedural/functional control with the reference substance sodium benzoate, and toxicity control using 20 mg/L test substance and 35 mg/L reference compound were performed. The test substance proved to be readily biodegradable (75 % biodegradation on average after 28 d; according to the revised OECD Guidelines the 10-d window should not be applied to interpret the results of a test with a mixture of structurally similar chemicals) in a study conducted according to OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test; 1992). The reference substance sodium acetate was biodegraded by 75% after 14 d and thus fulfilling the requirements of the guideline (>60% biodegradation after 14 d). In the toxicity control containg 35 mg/L sodium acetate and 20 mg/L test substance a biodegradation of 64% occurred within 14 d. The results indicate that the test substance was not inhibitory to the microorganisms and the requirements of the guideline (>=25% biodegradation) are fulfilled. The difference of extremes of replicate values of removal of the test substance at the end of the test was <20%. The total CO2 evolution in the control at the end of the test was 44.4 mg/L and is slightly higher than reported in the guideline (should normally <=40 mg/L and not exceed 70 mg/L).

 

The ready biodegradability of partially unsaturated TEA-Esterquat was investigated in a study conducted according to OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test) over a period of 28 days and using activated sludge from a municipal wastewater treatment plant as inoculum. The biodegradation rate was determined by measurement of CO2. The test item proved to be readily biodegradable (71.4% biodegradation after 28 d; according to the revised OECD Guidelines the 10-d window should not be applied to interpret the results of a test with a mixture of structurally similar chemicals). The reference substance was biodegraded by 74% after 14 d. Inoculum blank, procedural/functional control with the reference substance sodium benzoate, and toxicity control using 20 mg/L TOC reference and test substance each were performed. The reference substance was biodegraded by 74% after 14 d. The degradation in the toxicity control (20 mg/L TOC reference and test substance each) was 75.2% after 14 d and 78.3% after 28 d. Thus no inhibition of the inoculum was caused by the test substance. The highest mean CO2 -evolution of the blank flasks was 42.8 mg/L (according to guideline this value should not exceed 40 mg/L and must be below 70 mg/L). The IC content in the test vessel was <5% of the TOC introduced with the test substance. The difference of extremes of replicate values at the end of the 10 -d window and at the end of the test was <20%.

 

Anaerobic biodegradation

The anaerobic biodegradation of partially unsaturated TEA-Esterquat was investigated in a study conducted according to ECETOC Anaerobic Biodegradation (Technical Report No. 28) over a period of 56 days and using anaerobic sludge bacteria from a municipal wastewater treatment plant as inoculum. The biodegradation rate was determined by measurement of dissolved inorganic carbon (DIC). This study is regarded as reliable with restriction and satisfies the guideline requirements for anaerobic biodegradation. The test material attained 76% degradation after 56 days and therefore can be considered as biodegradable under anaerobic conditions.

 

Justification for read-across

The read-across is built on the hypothesis that target and source substances, being different compounds, have similar(eco) toxicologicalproperties based on structural similaritywith common functional groups.

A detailed justification for read-across is attached to chapter 13 of the IUCLID file.