Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Biodegradation in water: screening tests

Administrative data

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 13, 2021 to March 20th 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Molecular formula:

not applicable - UVCB substance

IUPAC Name:

Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Specific details on test material used for the study:

Test item name: Finestar 2009
CAS Number: 2225876-48-0
Water solubility: soluble in water
Molecular formula: C12 H22 O8
Molecular weight: 294.30
Batch/Lot number: 3253082031
analyzed purity: 100% active
Saponification value: 45.87
Date of manufacture: August 27, 2020
Date of expiry: August 26, 2021
Appearance: Pale yellow viscous liquid
Storage temperature: Room temperature (15 to 30°C)
Storage condition: Keep away from light, moisture, and oxidizing - reducing chemicals
Storage container: Keep in original container

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

sewage, predominantly domestic, adapted

Details on inoculum:

Preparation, Pre-conditioning and Analysis of inoculum
Secondary effluent from the JRF Sewage Treatment Plant treating predominantly domestic sewage was used as the inoculum. The Secondary effluent was filtered through a Whatman No. 1 filter paper.

The inoculum was pre-conditioned by aerating at 22 ± 2 °C for 7 days. The inoculum was analysed
for microorganism concentration and confirmed as 1.2×104 CFU/mL.

Test Conditions
Temperature Range : 22 ± 2 °C
Incubation was performed under dark conditions.

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

3.01 mg/L

Based on:

ThOD

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

Preparation of Test Solutions

Stock Solution of Test Item (TI)
A weight of 20.04 mg test item (purity 100% purity) was transferred into a 10 mL capacity volumetric flask, dissolved in 5 mL water and the volume was made up to the mark with water [stock solution 2004.00 mg/L, TI].

Bulk Solution of Test Item
The test suspension was prepared by adding 6.0 mL of test item stock solution (TI) and 4.0 mL of
inoculum to 3990 mL of mineral medium in a 5 L conical flask. The solution was mixed thoroughly. The final concentration of test item in mineral medium was 3.01 mg/L.

Stock Solution of Reference Substance (RS)
A weight of 20.24 mg Sodium benzoate (purity 99.20%) was transferred into a 10 mL capacity
volumetric flask and dissolved in 5 mL water and the volume was made up to the mark with water [stock solution 2007.81 mg/L, PC].

Bulk Solution of Procedure Control
The procedure control was prepared by mixing 6.0 mL stock solution of Sodium benzoate and
4.0 mL of inoculum to 3990 mL of mineral medium in a conical flask of 5 L capacity. The solution was mixed thoroughly. The final concentration of reference substance in mineral medium was
3.01 mg/L.

Bulk Solution of Inoculum Blank
The inoculum blank was prepared by mixing 4.0 mL inoculum with 3996 mL of mineral medium in a conical flask of 5 L capacity. The solution was mixed thoroughly.

Bulk Solution of Toxicity Control
The toxicity control was prepared by mixing 3.0 mL stock solution of Sodium benzoate, 3.0 mL stock solution of test item and 2.0 mL of inoculum to 1992mL of mineral medium in a conical flask of 2 L capacity. The solution was mixed thoroughly. The final concentration was 3.01mg/L of reference substance and 3.01 mg/L of test item in mineral medium.

Preparation of Bottles
The inoculum blank, test blank, test solution and procedure control were dispensed into their respective pre-labeled BOD bottles (capacity: 300 mL) in duplicate for analysis of DO on days 0, 7, 14, 21, and 28. The toxicity control was also dispensed into its respective pre-labeled bottles in duplicate for days 0, 7, and 14. The day zero samples were analysed for DO immediately after dispensing.

Reference substance

Reference substance:

benzoic acid, sodium salt

Results and discussion

% Degradation

Key result

Parameter:

% degradation (O2 consumption)

Value:

30.59

Sampling time:

28 d

Details on results:

Mean Value of DO
The mean DO value in the inoculum blank on days 0, 7, 14, 21, and 28 was 8.59, 8.01, 8.18, 8.05 and 7.99 mg/L, respectively. The mean DO value in test solution on days 0, 7, 14, 21, and 28 was 8.49, 7.48, 7.31, 6.86 and 6.54 mg/L, respectively. The mean DO value in procedure controls on days 0, 7, 14, 21, and 28 was 8.52, 4.90, 4.41, 3.89, and 3.53 mg/L, respectively. The mean DO value for the toxicity controls on days 0, 7, and 14 was 8.58, 4.76, and 3.70 mg/L, respectively.

Mean Oxygen Depletion
The mean oxygen depletion (mg O2/L) for the inoculum blank on days 7, 14, 21, and 28 was 0.58,
0.41, 0.54, and 0.60 mg/L, respectively. The mean oxygen depletion for test solution on days 7, 14,
21, and 28 was 1.01, 1.18, 1.63 and 1.95 mg/L, respectively. The oxygen depletion for the reference substance in the procedure control on days 7, 14, 21, and 28 was 3.62, 4.11, 4.63, and 4.99 mg/L, respectively. The oxygen depletion for the reference substance in the toxicity control on days 7, and 14 was 3.82 and 4.88 mg/L, respectively.

DO Consumption
The oxygen consumption for the test item on days 7, 14, 21, and 28 was 0.43, 0.77, 1.09 and
1.35 mg/L, respectively. The oxygen consumption for the reference substance in the procedure control on days 7, 14, 21, and 28 was 3.04, 3.70, 4.09 and 4.39 mg/L, respectively. The oxygen consumption for the reference substance and test item in the toxicity control on days 7, and 14 was 3.24 and 4.47 mg/L, respectively.

Theoretical Oxygen Demand
The theoretical oxygen demand (ThOD) for test item and for the reference substance were 1.468 and 1.666 mg O2/mg, respectively.

Biological Oxygen Demand
The BOD value for test item on days 7, 14, 21, and 28 was 0.143, 0.256, 0.362 and 0.449 mg O2/mg, respectively. The BOD value for the reference substance in the procedure control on days 7, 14, 21, and 28 was 1.010, 1.229, 1.359, and 1.458 mg O2/mg, respectively. (Refer to TABLE 3).

Percent Degradation
The percent degradation of the test item on days 7, 14, 21, and 28was 9.74, 17.44, 24.66 and 30.59 %, respectively. The percent degradation for the reference substance (Sodium benzoate) on days 7, 14, 21, and 28 was 60.62, 73.77, 81.57, and 87.52%, respectively. The percent degradation in the toxicity control on days 7 and 14 was 34.35 and 47.39%, respectively.

BOD5 / COD results

Results with reference substance:

Mean Oxygen Depletion
The oxygen depletion for the reference
substance in the procedure control on days 7, 14, 21, and 28 was 3.62, 4.11, 4.63, and 4.99 mg/L,
respectively. The oxygen depletion for the reference substance in the toxicity control on days 7, and 14 was 3.82 and 4.88 mg/L, respectively.

DO Consumption
The oxygen consumption for the reference substance in the procedure control
on days 7, 14, 21, and 28 was 3.04, 3.70, 4.09 and 4.39 mg/L, respectively. The oxygen consumption for the reference substance and test item in the toxicity control on days 7, and 14 was 3.24 and 4.47 mg/L, respectively.

Theoretical Oxygen Demand
The theoretical oxygen demand (ThOD) for test item and for the reference substance were 1.468 and 1.666 mg O2/mg, respectively.

Biological Oxygen Demand
The BOD value for the reference substance in the procedure control on days 7, 14, 21, and
28 was 1.010, 1.229, 1.359, and 1.458 mg O2/mg, respectively.

Percent Degradation
The percent degradation for the reference substance (Sodium benzoate) on days 7, 14, 21,
and 28 was 60.62, 73.77, 81.57, and 87.52%, respectively. The percent degradation in the toxicity control on days 7 and 14 was 34.35 and 47.39%, respectively.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

The percent biodegradation data concluded that Finester 2009 was not readily biodegradable. The test item showed a maximum degradation of 30.59% on day 28 of analysis, whereas the reference substance exhibited a normal pattern of degradation (up to 87.52%) within 28 days. The percent degradation by toxicity control was more than 25% after 14 days. Therefore, the test item was regarded as not readily biodegradable and not toxic to microorganisms in the inoculum

Executive summary:

Study Guidelines
The present study was conducted according to the following guidelines:
OECD, 1992: The Organisation for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, OECD 301 D, Ready Biodegradability (Closed Bottle Test), adopted by the Council on July 17, 1992.

EC, 2008: COUNCIL REGULATION (EC) No 440/2008 of 30 May 2008, laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), C.4. Ready Biodegradability (Closed Bottle, Method C.4-E), Official Journal No L 142, 31/05/2008.

Results-

Mean Value of DO
The mean DO value in the inoculum blank on days 0, 7, 14, 21, and 28 was 8.59, 8.01, 8.18, 8.05 and 7.99 mg/L, respectively. The mean DO value in test solution on days 0, 7, 14, 21, and 28 was 8.49, 7.48, 7.31, 6.86 and 6.54 mg/L, respectively. The mean DO value in procedure controls on days 0, 7, 14, 21, and 28 was 8.52, 4.90, 4.41, 3.89, and 3.53 mg/L, respectively. The mean DO value for the toxicity controls on days 0, 7, and 14 was 8.58, 4.76, and 3.70 mg/L, respectively.

Mean Oxygen Depletion
The mean oxygen depletion (mg O2/L) for the inoculum blank on days 7, 14, 21, and 28 was 0.58,
0.41, 0.54, and 0.60 mg/L, respectively. The mean oxygen depletion for test solution on days 7, 14,
21, and 28 was 1.01, 1.18, 1.63 and 1.95 mg/L, respectively. The oxygen depletion for the reference substance in the procedure control on days 7, 14, 21, and 28 was 3.62, 4.11, 4.63, and 4.99 mg/L, respectively. The oxygen depletion for the reference substance in the toxicity control on days 7, and 14 was 3.82 and 4.88 mg/L, respectively.

DO Consumption
The oxygen consumption for the test item on days 7, 14, 21, and 28 was 0.43, 0.77, 1.09 and
1.35 mg/L, respectively. The oxygen consumption for the reference substance in the procedure control on days 7, 14, 21, and 28 was 3.04, 3.70, 4.09 and 4.39 mg/L, respectively. The oxygen consumption for the reference substance and test item in the toxicity control on days 7, and 14 was 3.24 and 4.47 mg/L, respectively.

Theoretical Oxygen Demand
The theoretical oxygen demand (ThOD) for test item and for the reference substance were 1.468 and 1.666 mg O2/mg, respectively.

Biological Oxygen Demand
The BOD value for test item on days 7, 14, 21, and 28 was 0.143, 0.256, 0.362 and 0.449 mg O2/mg, respectively. The BOD value for the reference substance in the procedure control on days 7, 14, 21, and 28 was 1.010, 1.229, 1.359, and 1.458 mg O2/mg, respectively. (Refer to TABLE 3).

Percent Degradation
The percent degradation of the test item on days 7, 14, 21, and 28was 9.74, 17.44, 24.66 and 30.59 %, respectively. The percent degradation for the reference substance (Sodium benzoate) on days 7, 14, 21, and 28 was 60.62, 73.77, 81.57, and 87.52%, respectively. The percent degradation in the toxicity control on days 7 and 14 was 34.35 and 47.39%, respectively.