N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide)

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:

08. Jan. 2019 - 19. Mar. 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Temperature range was 19.7 – 20.9 °C instead of 20.0 – 24.0 °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)

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide)

EC Number:

204-613-6

EC Name:

N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide)

Cas Number:

123-26-2

Molecular formula:

C38H76N2O4

IUPAC Name:

12-hydroxy-N-[2-(12-hydroxyoctadecanamido)ethyl]octadecanamide

Test material form:

solid

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

sewage, predominantly domestic, adapted

Details on inoculum:

Activated sludge from a biologic sewage treatment plant was used as inoculum. The chosen plant treats mostly domestic sewage. The sludge was taken from the activation basin of the ESN (Stadtentsorgung Neustadt) sewage treatment plant, Im Altenschemel, 67435 NW-Lachen-Speyerdorf. Date of collection: 11. Jan. 2019, batch no: 20190111. The sludge was filtrated, washed with test medium (2x) and re-suspended in test medium. It was then aerated until use. The dry matter was determined to contain 4800 mg of suspended solids/L.

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

27.4 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

CO2 evolution

Reference substance

Reference substance:

aniline

Results and discussion

% Degradation

Key result

Parameter:

% degradation (CO2 evolution)

Value:

7

Sampling time:

28 d

Details on results:

The degree of biodegradation reached 7 % after 28 days. The 10-day-window was not detected. Degradation missed 60 % within 28 days, too. The abiotic degradation reached 2.5 %.

BOD5 / COD results

Results with reference substance:

The degradation percentage of the reference compound at Day 7 was > 60%.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

The result of the test can be considered valid.

Executive summary:

The test item Bisamid was tested using a concentration of nominally 20 mg organic carbon/L Bisamid in test medium following OECD 301B and EU-Method C.4-C. Aniline was chosen as positive control. Activated sludge was used as inoculum (concentration in the test 25.0 mg dry matter/L). The test was left running for 28 days. All validity criteria were met. Degradation of the positive control surpassed the pass level of 60 % after 7 days. The following data were determined for the test item Bisamid:

10-day-window: not detected

degradation at the end of 10-day-window: none

degradation at the end of the test: 7 %

pass level following guideline: 60 % at the end of 10-day-window for pure substances, respective 60 % at the end of the test for mixtures

Therefore, when applying the 10-day-window, the test item Bisamid is not readily biodegradable following OECD 301B and EU C.4-C respectively. As degradation missed 60% in the course of the test, Bisamid is considered as not ultimately biodegradable, within 28 days, as well.