Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

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:

16th April 2018 to 29th June 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)

Deviations:

yes

Remarks:

Nitrite reference item storage condition were not respected. The maximum storage temperature has been exceeded during a lenght of time upper than authorized limit.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: NF EN ISO 10304-1 F (dated July 10th, 2009)

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

other: NFT 90-101 adapted (dated Feb, 2001)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

EC Number:

944-892-8

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

Test material form:

liquid: viscous

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge (adaptation not specified)

Details on inoculum:

Activated sludge were sampled in the wastewater treatment plant of Rouen conurbation. Activated sludge were maintained in the laboratory under aeration condition before use. The concentration of suspended matter of the activated sludge used for the study was 3.47 g/L (dry weight).

Duration of test (contact time):

ca. 28 d

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

A knoww quantity of test item was mixed with mineral test media and activated sludge. The preparation was agitaed for 28 days in closed vessels containing CO2 trap. O2 uptake was calculated from measurment of pressure in the cloased vessels. Biodegradation rate was calculated from O2 uptake reported to the Chemical Oxygen Demand (COD).

Test media was ventilated until a value close to saturation in air and pH stabilization were obtained. No pH adjustment was needed.

Seven bottles (610 mL) were simultaneously prepared as described below in order to have a final volume of solution (252 mL +/- 1 mL) :
- 2 with test media and inoculum (blank solutions = control),
- 2 with test media, inoculum and test item (test item solution),
- 1 with test media, inoculum and reference item (reference control),
- 1 with test media, inoculum, test item and reference item (toxicity control),
- 1 with test media, test item and sterilizing agent (abiotic control).

Each bottle contained a CO2 trap by addition of NaOH pellets. The oxygen consumption was determined by manometr, determining the reduction of pressure in the tests flasks.
The bottles were closed off with a system to measure head pressure and were stirred throughout the ready biodegradability test using a magnetic stirrer.
The test was carried out in a laboratory controlled room at 21)C +/- 1°C in the dark (temperature results were recorded on the sheet IM-0033).
The BOD (Biological Oxygen Demand) values were given by OXITOP OC 110 Controller and depending from the initial parameters (volume of bottle: 610 mL, filling volume: 252 mL +/- 1 mL).

Reference substance

Reference substance:

benzoic acid, sodium salt

Remarks:

reference item for biodegradability test

Results and discussion

% Degradation

Key result

Parameter:

% degradation (O2 consumption)

Value:

>= 75 - <= 77

Sampling time:

28 d

Details on results:

Lag phase was pass after 2.5 to 3.3 days
Percentage of biodegradability at 28 days was 75-77%.
60% biodegradation was achieved within 17-18 days after the lag phase

Validity:
- Reference control achieved the threshold level (60% of biodegradation) in 3 days (less than 14 days),
- Absolute deviation between two replicates of the test item was 2.0% after 28 days (less than 20%),
- Oxygen uptake of the control was maximum at 32.4 mg/L in 28 days (less than 60 mg/L),
- pH values were in the range 7.4-8.0 for all the conditions,
- Toxicity control showed a biodegradation rate greater than 25% occurred within 14 days, thus the test substance can be assumed to be not inhibitory,
- The abiotic control showed no significant oxygen consumtion after 28 days,
Due to the complex composition of the test item the 10 days windows is not applicable.

see section: "Any other information on results incl. tables"

BOD5 / COD results

BOD5 / COD

Key result

Parameter:

COD

Value:

ca. 2 729 mg O2/g test mat.

Results with reference substance:

reference control achieved the threshold evel (60% of biodegradation) in 3 days (less than 14 days.

For the test item solutions abiotic control, BODs after 28 days were lower than in the controls. no abiotic degradation was observed.

Any other information on results incl. tables

COD Results:

	Weight (mg)	Result in mg O2/g of the test item
Test 1	2.7	2 785
Test 2	2.7	2 672
Average	-	2 729

	Result in mg O2/g	Reference value	Conformity
Quality control	113	100 +/- 18 mg/L	C

Biodegradability testing results:

	Control		Test item solution		Ref. control	Toxicity control	Abiotic control
COD experimental concentration in mg O2/L	0	0	277.0	274.8	169.3	460.8	293.5
Measured Biological Oxygen Demand (BOD) after 28 days (mg/L)	3.8	0.0	210.0	214.0	160.0	368.0	0.0

Percentage of biodegradation:                                                                                                

	Biodegradation rate (%)
Time (days)	Test item solution 1	Test item solution 2	Absolute difference	Reference control	Toxicity control
0	0.0	0.0	-	0.0	0.0
1	0.0	0.0	0.0	0.0	2.5
2	7.9	2.4	5.5	47.9	13.9
3	13.8	7.6	6.2	59.7	23.2
4	19.7	12.9	6.8	66.9	26.7
5	22.4	17.0	5.4	69.2	29.1
7	31.0	25.7	5.3	78.8	34.8
10	38.1	34.4	3.7	83.0	41.6
14	45.9	43.4	2.5	85.2	49.5
21	60.5	62.4	1.9	87.7	63.3
28	75.1	77.2	2.0	93.4	79.5

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

Ready biodegradability test of "BUTYL AVOCADATE DISTILLATED" by measurement of manometric respirometry over a 28-day period fulfils requirements of OECD guideline No. 301 F. The 60% threshold level was reached within the 17-18 days after the lag phase. Due to the complex composition of the test item the 10 days windows is not applicable.

Tests item is readly biodegradable according to the OECD criteria.

Executive summary:

Objective

The scope of this study was, in compliance with the principles of Good Laboratory Practice (GLP), to determine the ready biodegradability of "BUTYL AVOCADATE DISTILLATED" by measurement of manometric respirometryy over 28 -day period.

Method Summary

A known quantity of test item was mixed with mineral test media and activated sludge. The preparation was agitated for 28 days in closed vessels containing CO2 trap. O2 uptake was calculated from measurement of pressure in the closed vessels. biodegradation rate was calculated frol O2 uptake reported to the Chemical Oxygen Demand (COD).

Results

	BUTYL AVOCADATE DISTILLATED
Percentage of Biodegradation at 28 days	75 - 77%
Conclusion	Readily biodegradable

Conclusion

Ready biodegradability test of "BUTYL AVOCADATE DISTILLATED" by measurement of manometric repirometry over a 28 -day period fulfils the requirements of OECD guideline No. 301 F. the 60% threshold level was reached within 17 -18 days after the lag phase. Due to the complex composition of the test item the 10 days windows is not applicable.

Tests item is readily biodegradable according to the OECD criteria.