Triglycerides, C16-18 (even numbered), reaction products with diethylenetriamine

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:

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.

Amidoamine (UVCB)
Pulcra ID: DE07_2014_012_BEL66 (amidoamine without emulsifier)
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

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.

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 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).

Key value for chemical safety assessment

Biodegradation in water:

inherently biodegradable

Type of water:

freshwater