Fatty acids, tall-oil, reaction products with 2-[(2-aminoethyl)amino]ethanol

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-09-24 to 2012-12-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD guideline 301B and EU method C.4.C in a GLP certified testing facility.

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)

Deviations:

yes

Remarks:

(Temperature range was 17.1 - 21.5°C instead of 20- 24°C. As degradation of the positive control was in the normal range this is considered as uncritical concerning the outcome of the study)

Qualifier:

according to guideline

Guideline:

EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)

Deviations:

yes

Remarks:

(Temperature range was 17.1 - 21.5°C instead of 20- 24°C. As degradation of the positive control was in the normal range this is considered as uncritical concerning the outcome of the study)

GLP compliance:

yes (incl. QA statement)

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Duration of test (contact time):

28 d

Initial conc.:

26.7 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

CO2 evolution

Key result

Parameter:

% degradation (CO2 evolution)

Value:

6

Sampling time:

28 d

Details on results:

The degree of biodegradation reached 6 % after 28 days.
No 10-day window was detected.
The abiotic degradation reached 1.2%.

Emitted Carbon in mg/L

Day	Control 1	Control 2	Positive Control 1	Positive Control 2	Test 1	Test 2	Abiotic Control	Toxicity Control
2	0.23	0.46	0.76	0.59	0.29	0.50	0.11	0.41
4	0.85	1.50	5.19	2.11	1.12	1.34	0.35	3.95
7	1.24	1.90	11.00	7.90	1.81	1.92	0.18	8.68
9	1.94	2.72	15.76	11.00	2.45	3.00	0.17	12.04
11	2.32	2.96	17.68	12.50	2.66	3.41	0.22	13.46
14	2.60	3.61	19.34	15.41	3.06	4.04	0.16	16.63
18	2.94	3.68	20.76	18.00	3.46	4.56	0.18	17.06
23	2.98	3.55	20.02	18.16	3.86	4.71	0.09	16.70
29	3.67	4.20	20.28	19.37	4.48	5.77	0.24	18.20

Degradation Values

In the following table, the percentage biodegradation is presented:

Day	Positive Control 1	Positive Control 2	Positive Control Mean	Test 1	Test 2	Test Mean	Abiotic Control	Toxicity Control
2	2.0	1.2	1.6	-0.3	0.8	0.2	0.5	0.2
4	19.6	4.6	12.1	-0.3	0.8	0.3	1.8	6.9
7	46.0	30.9	38.4	1.2	1.7	1.5	0.9	17.6
9	65.5	42.3	53.9	0.6	3.3	1.9	0.9	24.0
11	73.3	48.1	60.7	0.1	3.8	2.0	1.1	26.7
14	79.2	60.0	69.6	-0.2	4.6	2.2	0.8	33.4
18	85.1	71.7	78.4	0.7	6.1	3.4	0.9	34.0
23	81.7	72.7	77.2	2.9	7.1	5.0	0.5	33.2
29	79.7	75.3	77.5	2.7	9.1	5.9	1.2	35.2

All validity parameters and values are presented in the following table:

Parameter	Criterion	Found	Assessment
IC content of test item solution in medium	≤ 5% of TC	1.72%	valid
CO2emitted by the controls	< 70 mg/L	14.4 mg/L	valid
Difference within replicates	≤20%	6.4%	valid
Degradation of positive control > 60%	≤ 14 days	11 days	valid
Degradation in the toxicity flask on day 14	> 25%	33%	valid

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

The ready biodegradability of 400112 was determined in the CO2 Evolution Test following OECD 301B resp. EU C.4.C.
The degree of biodegradation reached 6 % after 28 days.
No 10-day-window was detected.
The abiotic degradation reached 1.2%.
Therefore the test item 400112 is considered as “not readily biodegradable"

Executive summary:

Ready degradability is defined in the guidelines as degradation surpassing 60% within 10 days after reaching a level of 10%. For the test item 400112 the degree of biodegradation reached 6% after 28 days. A 10-day window was not detected. Therefore, the test item 400112 can not be considered as “readily biodegradable”. Degradation missed 60% within 28 days, too. Therefore, the test item is not considered as “biodegradable within 28 days”, either.

Degradation behaviour of the positive control (Aniline) and the toxicity control was normal. Abiotic degradation was 1.2%. Both replicates of the test item showed good correspondence.

All validity criteria were met. No observations were made which might cause doubts concerning the validity of the study outcome. The result of the test can be considered valid.

Description of key information

The ready biodegradability of 400112 was determined in the CO2 Evolution Test following OECD guideline 301B resp. EU C.4.C. 
The degree of biodegradation reached 6 % after 28 days.
No 10-day window was detected.
The abiotic degradation reached 1.2%. 
Therefore the test item 400112 is considered as “not readily biodegradable"

Key value for chemical safety assessment

Biodegradation in water:

under test conditions no biodegradation observed