Glycerides, C16-18 (even numbered) and their amidation products with diethylenetriamine

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

15 November 2012 - 25 April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

An OECD 301 F GLP study for a similar substance is available and is used within a read-across approach. The composition of source and target substance is described and discussed in detail in the attached supporting information as well as the read-across justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test item without emulsifier was investigated.

Amidoamine 2 (UVCB, low nitrogen) - based on hydrogenated tallow instead of hydrogenated palm oil:
Name of test material (as cited in study report): FCM (DETA)M C16-18 TLW hydrogenated (Amidoamine 2 (UVCB) based on hydrogenated tallow instead of hydrogenated palm oil)
Former chemical name: Amides, from diethylenetriamine and hydrogenated tallow
CAS No.: 68920-82-1
New chemical name: Glycerides, C16-18 (even-numbered) mono-, di- and tri- and amides, from diethylenetriamine and fatty acids C16-18 (even-numbered)
Physical state: pale yellowish solid at 20 °C
Batch No.: PU22340011
Expiry date of batch: 21 August 2014
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

Not adapted activated sludge from the aeration tank of the ARA Werdhölzli (8048 Zürich, Switzerland), a municipal biological waste water treatment plant was used.

Duration of test (contact time):

28 d

Initial conc.:

47.5 mg/L

Based on:

DOC

Parameter followed for biodegradation estimation:

O2 consumption

Reference substance:

benzoic acid, sodium salt

Test performance:

At the applied initial test concentration of 47.5 mg/l the test substance showed no significant toxic effect on the microbial population, since the biodegradation of the mixture (test substance + reference compound sodium benzoate) was within the expected theoretical value during the whole test period. The test was considered valid, since more than 25% degradation occurred within 14 days. Test item Amidoamine 2 was not abiotically degraded (by processes using O2) during the whole test period of 28 days in the absence of microorganisms as confirmed by the lack of oxygen consumption.

Key result

Parameter:

% degradation (DOC removal)

Value:

25

Sampling time:

28 d

Details on results:

Based on the data of the individual O2 determinations the mean biodegradability in the Manometric Respirometry Test of amidamine 2 was calculated to be 25% after 28 days. The biodegradation of amidoamine 2 reached 21% at the end of the 10-d window. No lag phase was observed before biodegradation occurred.

Results with reference substance:

The positive control, sodium benzoate (reference substance), reached 84% biodegradation after 14 days, thus confirming suitability of inoculum and test conditions.

Table 1: O2 uptake of the test units, the inoculum blank and the corresponding degradation data.

 

	Inoculum blank*	Test unit no. 1 containing test material		Test unit no. 2 containing test material
Times (d)	BOD (mg O2/l)	BOD (mg O2/l)	Degradation (%)**	BOD (mg O2/l)	Degradation (%)**	Mean degradation of no. 1+2 (%)
0	0.0	0.0	0.0	0.0	0.0	0.0
1	-6.0	2.0	8.5	-2.0	4.3	6.4
2	-4.0	6.0	10.7	0.0	4.3	7.5
3	-1.0	8.0	9.6	4.0	5.3	7.5
4	2.0	10.0	8.5	6.0	4.3	6.4
5	3.0	12.0	9.6	8.0	5.3	7.5
6	4.0	16.0	12.8	10.0	6.4	9.6
7	8.0	18.0	10.7	12.0	4.3	7.5
8	7.0	18.0	11.7	14.0	7.5	9.6
9	9.0	22.0	13.9	14.0	5.3	9.6
10	10.0	22.0	12.8	16.0	6.4	9.6
11	11.0	26.0	16.0	16.0	5.3	10.7
12	12.0	28.0	17.1	18.0	6.4	11.7
13	12.0	30.0	19.2	18.0	6.4	12.8
14	11.0	32.0	22.4	16.0	5.3	13.9
15	12.0	32.0	21.3	18.0	6.4	13.9
16	12.0	36.0	25.6	18.0	6.4	16.0
17	13.0	38.0	26.7	18.0	5.3	16.0
18	13.0	40.0	28.8	20.0	7.5	18.1
19	15.0	40.0	26.7	20.0	5.3	16.0
20	12.0	44.0	34.1	20.0	8.5	21.3
21	14.0	44.0	32.0	22.0	8.5	20.3
22	13.0	46.0	35.2	22.0	9.6	22.4
23	15.0	46.0	33.1	24.0	9.6	21.3
24	15.0	48.0	35.2	24.0	9.6	22.4
25	15.0	48.0	35.2	24.0	9.6	22.4
26	16.0	50.0	36.3	24.0	8.5	22.4
27	16.0	50.0	36.3	26.0	10.7	23.5
28	16.0	52.0	38.4	26.0	10.7	24.5

* mean of two replicates

** The calculation is based on the nominal concentration of the test substance of 43.0
mg/l and a theoretical O2 demand (ThOD) in mg O2/mg test substance of 2.180
The applied ThOD in the test vessels in mg O2/l was 93.7

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

The test item attained 25% degradation after 28 days and is therefore considered to be not readily biodegradable according to the OECD Section 3 revised introduction (2006).
The chemical composition of the source substance is almost identical with minor deviations in the C-chain distribution of the starting material (minor differences in the ratio of linear, saturated C16 and C18 fatty acids bound in triglycerides (see table below). No influence on the predicted biodegradation of the target substance is expected.

Executive summary:

The biodegradation of amidoamine test item was determined in a Klimisch 1 GLP study according to Part C.4 -D of the Commission Regulation (EC) No 440/2008 and OECD 301 F ( Manometric Respirometry). The test item attained 25% degradation after 28 days and is therefore considered to be not readily biodegradable according to the OECD Section 3 revised introduction (2006). This study is considered relevant for the risk assessment.

The chemical composition of the source substance is almost identical with minor deviations in the C-chain distribution of the starting material (minor differences in the ratio of linear, saturated C16 and C18 fatty acids bound in triglycerides (see table below). No influence on the predicted biodegradation of the target substance is expected.

Reference 2

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 November 2012 - 25 April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

A read-across hypothesis is provided (attachment) as justifcation based on structural similarities of source and target substance.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test item without emulsifier was investigated.

Source substance:

Amidoamine 2 (UVCB, low nitrogen) - based on hydrogenated tallow instead of hydrogenated palm oil:
Name of test material (as cited in study report): FCM (DETA)M C16-18 TLW hydrogenated (Amidoamine 2 (UVCB) based on hydrogenated tallow instead of hydrogenated palm oil)
Former chemical name: Amides, from diethylenetriamine and hydrogenated tallow
CAS No.: 68920-82-1
New chemical name: Glycerides, C16-18 (even-numbered) mono-, di- and tri- and amides, from diethylenetriamine and fatty acids C16-18 (even-numbered)
Physical state: pale yellowish solid at 20 °C
Batch No.: PU22340011
Expiry date of batch: 21 August 2014
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions

Target substance:

Amidoamine 2 (UVCB, low nitrogen):
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
CAS No.: 1618093-67-6
New chemical name: Glycerides, C16-18 (even-numbered) mono-, di- and tri- and amides, from diethylenetriamine and fatty acids C16-18 (even-numbered)
Physical state: pale yellowish solid at 20 °C
Batch No.: PU50070067
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

Not adapted activated sludge from the aeration tank of the ARA Werdhölzli (8048 Zürich, Switzerland), a municipal biological waste water treatment plant was used.

Duration of test (contact time):

28 d

Initial conc.:

47.5 mg/L

Based on:

DOC

Parameter followed for biodegradation estimation:

O2 consumption

Reference substance:

benzoic acid, sodium salt

Test performance:

At the applied initial test concentration of 47.5 mg/l the test substance showed no significant toxic effect on the microbial population, since the biodegradation of the mixture (test substance + reference compound sodium benzoate) was within the expected theoretical value during the whole test period. The test was considered valid, since more than 25% degradation occurred within 14 days. Test item Amidoamine 2 was not abiotically degraded (by processes using O2) during the whole test period of 28 days in the absence of microorganisms as confirmed by the lack of oxygen consumption.

Key result

Parameter:

% degradation (DOC removal)

Value:

25

Sampling time:

28 d

Details on results:

Based on the data of the individual O2 determinations the mean biodegradability in the Manometric Respirometry Test of amidamine 2 was calculated to be 25% after 28 days. The biodegradation of amidoamine 2 reached 21% at the end of the 10-d window. No lag phase was observed before biodegradation occurred.

Results with reference substance:

The positive control, sodium benzoate (reference substance), reached 84% biodegradation after 14 days, thus confirming suitability of inoculum and test conditions.

Table 1: O2 uptake of the test units, the inoculum blank and the corresponding degradation data.

 

	Inoculum blank*	Test unit no. 1 containing test material		Test unit no. 2 containing test material
Times (d)	BOD (mg O2/l)	BOD (mg O2/l)	Degradation (%)**	BOD (mg O2/l)	Degradation (%)**	Mean degradation of no. 1+2 (%)
0	0.0	0.0	0.0	0.0	0.0	0.0
1	-6.0	2.0	8.5	-2.0	4.3	6.4
2	-4.0	6.0	10.7	0.0	4.3	7.5
3	-1.0	8.0	9.6	4.0	5.3	7.5
4	2.0	10.0	8.5	6.0	4.3	6.4
5	3.0	12.0	9.6	8.0	5.3	7.5
6	4.0	16.0	12.8	10.0	6.4	9.6
7	8.0	18.0	10.7	12.0	4.3	7.5
8	7.0	18.0	11.7	14.0	7.5	9.6
9	9.0	22.0	13.9	14.0	5.3	9.6
10	10.0	22.0	12.8	16.0	6.4	9.6
11	11.0	26.0	16.0	16.0	5.3	10.7
12	12.0	28.0	17.1	18.0	6.4	11.7
13	12.0	30.0	19.2	18.0	6.4	12.8
14	11.0	32.0	22.4	16.0	5.3	13.9
15	12.0	32.0	21.3	18.0	6.4	13.9
16	12.0	36.0	25.6	18.0	6.4	16.0
17	13.0	38.0	26.7	18.0	5.3	16.0
18	13.0	40.0	28.8	20.0	7.5	18.1
19	15.0	40.0	26.7	20.0	5.3	16.0
20	12.0	44.0	34.1	20.0	8.5	21.3
21	14.0	44.0	32.0	22.0	8.5	20.3
22	13.0	46.0	35.2	22.0	9.6	22.4
23	15.0	46.0	33.1	24.0	9.6	21.3
24	15.0	48.0	35.2	24.0	9.6	22.4
25	15.0	48.0	35.2	24.0	9.6	22.4
26	16.0	50.0	36.3	24.0	8.5	22.4
27	16.0	50.0	36.3	26.0	10.7	23.5
28	16.0	52.0	38.4	26.0	10.7	24.5

* mean of two replicates

** The calculation is based on the nominal concentration of the test substance of 43.0
mg/l and a theoretical O2 demand (ThOD) in mg O2/mg test substance of 2.180
The applied ThOD in the test vessels in mg O2/l was 93.7

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

The test item attained 25% degradation after 28 days and is therefore considered to be not readily biodegradable according to the OECD Section 3 revised introduction (2006).

Executive summary:

The biodegradation of amidoamine test item was determined in a Klimisch 1 GLP study according to Part C.4 -D of the Commission Regulation (EC) No 440/2008 and OECD 301 F ( Manometric Respirometry). The test item attained 25% degradation after 28 days and is therefore considered to be not readily biodegradable according to the OECD Section 3 revised introduction (2006).

This study is considered relevant for the risk assessment.

Reference 3

Endpoint:

biodegradation in water: screening test, other

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

14 January 2015 - 21 January 2015

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

according to guideline

Guideline:

ISO 9888 Water quality - Evaluation of ultimate aerobic biodegradability of organic compounds in aqueous medium - Static test (Zahn-Wellens method)

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Test item with emulsifier was investigated.

Amidoamine 2 (UVCB, low nitrogen content)
ID: DE07_2015_033_BEL300 (amidoamine with emulsifier)
Chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
CAS No.: 1618093-67-6
New chemical name: Glycerides, C16-18 (even-numbered) mono-, di- and tri- and amides, from diethylenetriamine and fatty acids C16-18 (even-numbered)
Physical state: pale yellowish solid at 20 °C
Batch No.: PU50070067
Expiry date of batch: 16 January 2018
Purity: 100 % (UVCB)
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

Not adapted activated sludge from the aeration tank of municipal wastewater treatment plant Breisgauer Bucht (79108 Freiburg, Germany).

Duration of test (contact time):

7 d

Initial conc.:

551 mg/L

Based on:

COD

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

7d static Zahn-Wellens-Test accoridng to DIN EN ISO 9888 to determine COD elimination from mixture containg 50 - 75% of amidoamine 2 (low nitrogen content).

Reference substance:

acetic acid, sodium salt

Key result

Parameter:

% degradation (O2 consumption)

Value:

99

Sampling time:

7 d

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable, not fulfilling specific criteria

Conclusions:

Results from a Zahn-Wellens test indicate a substantial COD elimination of 71% of the test item after 3 hours by adsorption to the inoculum. The mean COD elimination of the test item after 7 days was 99%.
Remaining test item after use in exhaust processes in textile mills can be removed quantitatively from the waste water stream by absorption to inoculum or addition of flocculation agents.

Executive summary:

In a non-GLP DIN ISO EN 9888 Zahn-Wellens study eliminability of the test item from waste water was determined. Results indicate a substantial COD elimination of 71% of the test item after 3 hours by adsorption to the inoculum. The mean COD elimination of the test item after 7 days was 99%.

Reason for measuring elimination of the test item was the release to wastewater from exhaust processing in textile mills. The main source of release to wastewater from industrial users is expected to be unused active substances in spent baths.

The Zahn-Wellens-Test provides information on the removal of remaining test item after use in exhaust processes from the waste water stream.

Reference 4

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

4 December 2014 - 13 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

prolonged study

Justification for type of information:

An OECD 301B GLP study for a similar substance is available and is used within a read-across approach. The composition of source and target substance is described and discussed in detail in the attached supporting information as well as the read-across justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

prolonged study (56 d)

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

prolonged study (56 d)

Principles of method if other than guideline:

prolonged OECD 301 biodegradation study (56 d)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Target substance:

Amidoamine 2 (UVCB, low nitrogen):
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
CAS No.: 1618093-67-6
New chemical name: Glycerides, C16-18 (even-numbered) mono-, di- and tri- and amides, from diethylenetriamine and fatty acids C16-18 (even-numbered)
Physical state: pale yellowish solid at 20 °C
Batch No.: PU50070067
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

A mixed population of activated sewage sludge micro-organisms was obtained on 16 November 2015 from the aeration stage of the Severn Trent Water Plc sewage treatment plant at Loughborough, Leicestershire, UK which treats predominantly domestic sewage.

Duration of test (contact time):

56 d

Initial conc.:

14 mg/L

Based on:

TOC

Parameter followed for biodegradation estimation:

TOC removal

Reference substance:

benzoic acid, sodium salt

Key result

Parameter:

% degradation (CO2 evolution)

Value:

34

Sampling time:

28 d

Key result

Parameter:

% degradation (CO2 evolution)

Value:

73

Sampling time:

56 d

Details on results:

Acidification of the test vessels on Day 56 followed by the final analyses on Day 57 was conducted according to the methods specified in the Test Guidelines. This acidification effectively kills the micro-organisms present and drives off any dissolved CO2 present in the test vessels. Therefore any additional CO2 detected in the Day 57 samples originated from dissolved CO2 that was present in the test vessels on Day 56 and hence the biodegradation value calculated from the Day 57 analyses is taken as being the final biodegradation value for the test item. The results of the inorganic carbon analysis of samples from the firstabsorber vessels on Day 57 showed an increase in all replicate vessels. Inorganic carbon analysis of the samples from the second absorber vessels on Day 57 confirmed that no significant carry-over of CO2 into the second absorber vessels occurred.

Results with reference substance:

Sodium benzoate attained 62% biodegradation after 14 days and 106% biodegradation after 56 days thereby confirming the suitability of the inoculum and test conditions. Biodegradation values in excess of 100% were considered to be due to sampling/analytical variation.

Table: Percentage Biodegradation Values

Day	% Biodegradation
	Procedure Control	Test item	Toxicity control
0	0	0	0
2	39	0	21
6	68	1	30
8	49	0	34
10	59	11	41
14	62	12	34
21	64	21	36
28	72	34	32
35	79	49	40
42	78	42	26
49	104	63	29
56	102	67	25
57*	106	73	28

* Day 57 values corrected to include any carry-over of CO2 detected in Absorber 2 

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

The test item attained 34% degradation after 28 days and 73% degradation after 56 days and therefore can be considered to be inherently biodegradable according to the OECD Section 3 revised introduction (2006). It is considered likely, that the target substance Amidoamine 2 (UVCB, low nitrogen) will show a comparable toxicity to microorganisms as Amidoamine (UVCB) based on the similar chemical composition.

Executive summary:

The biodegradation of amidoamine test item was determined in a Klimisch 1 GLP study according to Part C.4-C of the Commission Regulation (EC) No 440/2008 and OECD 301 B (CO2 Evolution Test). The test item attained 34% degradation after 28 days and 73% degradation after 56 days and therefore can be considered to be inherently biodegradable according to the OECD Section 3 revised introduction (2006). This study is considered relevant for the risk assessment.

It is considered likely, that the target substance Amidoamine 2 (UVCB, low nitrogen) will show a comparable toxicity to microorganisms as Amidoamine (UVCB) based on the similar chemical composition. It is expected that the higher concentration of saturated mono- and diglycerides and the presence of saturated triglycerides in Amidoamine 2 (UVCB, low nitrogen) will have no adverse effect on biodegradation.

Reference 5

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 December 2014 - 13 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

prolonged study

Justification for type of information:

Based on the results of cited OECD 301 F study showing low biodegradation (< 25 %) in 28 d with the amidoamine test item, it was decided by the registrant to conduct a prolonged OECD 301 B biodegradation screening study (56 d), to prove the test item is not persistant under the conditions of the test.

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

prolonged study (56 d)

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

prolonged study (56 d)

Principles of method if other than guideline:

prolonged OECD 301 biodegradation study (56 d)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test item without emulsifier was investigated.

Source substance:

Amidoamine (UVCB)
Pulcra ID: DE07_2014_012_BEL66 (amidoamine without emulsifier)
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
Former CAS No.: 1618093-67-6
New chemical name: Triglycerides, C16-18 (even-numbered), reaction products with diethylenetriamine
Physical state: pale yellowish solid at 20 °C
Batch No.: K8 4309 L481
Expiry date of batch: 09 March 2018
Purity: 100 % (UVCB)
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

Target substance:

Amidoamine 2 (UVCB, low nitrogen):
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
CAS No.: 1618093-67-6
New chemical name: Glycerides, C16-18 (even-numbered) mono-, di- and tri- and amides, from diethylenetriamine and fatty acids C16-18 (even-numbered)
Physical state: pale yellowish solid at 20 °C
Batch No.: PU50070067
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

A mixed population of activated sewage sludge micro-organisms was obtained on 16 November 2015 from the aeration stage of the Severn Trent Water Plc sewage treatment plant at Loughborough, Leicestershire, UK which treats predominantly domestic sewage.

Duration of test (contact time):

56 d

Initial conc.:

14 mg/L

Based on:

TOC

Parameter followed for biodegradation estimation:

TOC removal

Reference substance:

benzoic acid, sodium salt

Key result

Parameter:

% degradation (CO2 evolution)

Value:

34

Sampling time:

28 d

Key result

Parameter:

% degradation (CO2 evolution)

Value:

73

Sampling time:

56 d

Details on results:

Acidification of the test vessels on Day 56 followed by the final analyses on Day 57 was conducted according to the methods specified in the Test Guidelines. This acidification effectively kills the micro-organisms present and drives off any dissolved CO2 present in the test vessels. Therefore any additional CO2 detected in the Day 57 samples originated from dissolved CO2 that was present in the test vessels on Day 56 and hence the biodegradation value calculated from the Day 57 analyses is taken as being the final biodegradation value for the test item. The results of the inorganic carbon analysis of samples from the firstabsorber vessels on Day 57 showed an increase in all replicate vessels. Inorganic carbon analysis of the samples from the second absorber vessels on Day 57 confirmed that no significant carry-over of CO2 into the second absorber vessels occurred.

Results with reference substance:

Sodium benzoate attained 62% biodegradation after 14 days and 106% biodegradation after 56 days thereby confirming the suitability of the inoculum and test conditions. Biodegradation values in excess of 100% were considered to be due to sampling/analytical variation.

Table: Percentage Biodegradation Values

Day	% Biodegradation
	Procedure Control	Test item	Toxicity control
0	0	0	0
2	39	0	21
6	68	1	30
8	49	0	34
10	59	11	41
14	62	12	34
21	64	21	36
28	72	34	32
35	79	49	40
42	78	42	26
49	104	63	29
56	102	67	25
57*	106	73	28

* Day 57 values corrected to include any carry-over of CO2 detected in Absorber 2 

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

The test item attained 34% degradation after 28 days and 73% degradation after 56 days and therefore can be considered to be inherently biodegradable according to the OECD Section 3 revised introduction (2006).

Executive summary:

The biodegradation of amidoamine test item was determined in a Klimisch 1 GLP study according to Part C.4 -C of the Commission Regulation (EC) No 440/2008 and OECD 301 B (CO2 Evolution Test). The test item attained 34% degradation after 28 days and 73% degradation after 56 days and therefore can be considered to be inherently biodegradable according to the OECD Section 3 revised introduction (2006). This study is considered relevant for the risk assessment.

Description of key information

The source substance attained 34% biodegradation after 28 days and 73% degradation after 56 days and therefore can be considered to be inherently biodegradable according to the OECD Section 3 revised introduction (2006). The target substance attained 25 % biodegradation after 28 d.

It is considered likely, that the target substance Amidoamine 2 (UVCB, low nitrogen) will show a comparable toxicity to microorganisms as Amidoamine (UVCB) based on the similar chemical composition. It is expected that the higher concentration of saturated mono- and diglycerides and the presence of saturated triglycerides in Amidoamine 2 (UVCB, low nitrogen) will have no adverse effect on biodegradation.

Results from a Zahn-Wellens test indicate a substantial COD elimination of 71% of the test item after 3 hours by adsorption to the inoculum. The mean COD elimination of the test item after 7 days was 99%.

 

Key value for chemical safety assessment

Biodegradation in water:

inherently biodegradable

Type of water:

freshwater