Registration Dossier

Environmental fate & pathways

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:
22 March 2018 - 19 April 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of 2,3-epoxypropyl phenyl ether and 2,2'-iminodi(ethylamine)
EC Number:
948-518-4
Molecular formula:
(C13H23N3O2 . C31H43N3O6)x
IUPAC Name:
Reaction products of 2,3-epoxypropyl phenyl ether and 2,2'-iminodi(ethylamine)
Test material form:
liquid
Details on test material:
PGE-DETA adduct
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark

FORM AS APPLIED IN THE TEST (if different from that of starting material)
In view of the difficulties associated with the evaluation of the biodegradability of organic compounds with low water solubility, a modification to the standard method of preparation of the test concentration was performed. An approach endorsed by the International Standards Organisation (ISO, 1995) is to dissolve the test item in an auxiliary solvent prior to adsorption onto filter paper. High shear mixing was also applied to break up the filter paper containing the test item.

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
sewage, predominantly domestic (adaptation not specified)
Details on inoculum:
A mixed population of sewage treatment micro-organisms was obtained on 19 March 2018 from the final effluent stage of the Severn Trent Water Plc sewage treatment plant at Loughborough, Leicestershire, UK, which treats predominantly domestic sewage.
Duration of test (contact time):
> 0 - <= 28
Initial test substance concentration
Initial conc.:
100 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
The test item at a concentration of 100 mg/L was exposed to sewage treatment micro-organisms with mineral medium in sealed culture vessels in diffuse light at temperatures of between 20 and 22 ºC for 28 days.
Following the recommendations of the International Standards Organisation (ISO 1995), the test item was dissolved in an auxiliary solvent prior to being adsorbed onto a filter paper and subsequent dispersal in test media. Using this method the test item is evenly distributed throughout the test medium and the surface area of test item exposed to the test organisms is increased thereby increasing the potential for biodegradation.
The biodegradation of the test item was assessed by the measurement of daily oxygen consumption values on Days 0 to 28. Control solutions with inoculum and the reference item, aniline, together with a toxicity control were used for validation purposes.
Reference substance
Reference substance:
aniline

Results and discussion

% Degradation
Key result
Parameter:
% degradation (O2 consumption)
Value:
2
Sampling time:
28 d

Any other information on results incl. tables

The test material PGE-DETA attained 2% biodegradation after 28 days and therefore cannot be considered as readily biodegradable under the strict terms and conditions of OECD Guideline No. 301F.


Biological Oxygen Demand (BOD) Values



























































































































































































































































































Day



BOD (mg O2/L)



Inoculum Control



Procedure Control



Test Item



Toxicity Control



R1



R2



R1



R2



0



0.00



0.00



0.00



0.00



0.00



0.00



1



1.12



0.74



1.42



0.62



1.08



1.12



2



2.42



1.70



2.74



1.42



1.70



1.92



3



3.66



2.66



3.96



2.20



2.34



2.88



4



5.58



5.12



14.08



3.12



3.12



4.78



5



6.12



5.92



57.26



3.62



3.58



27.20



6



7.42



7.20



130.12



5.45



4.24



100.58



7



8.88



8.50



139.78



5.62



5.50



147.60



8



9.50



9.08



164.98



6.04



6.66



164.94



9



10.50



10.04



182.64



6.96



7.62



173.26



10



11.92



11.66



195.08



8.24



8.70



178.60



11



12.96



12.66



204.42



9.20



9.46



182.84



12



13.46



13.12



211.46



9.66



9.88



186.46



13



14.66



14.08



217.04



10.96



10.82



190.64



14



16.00



15.24



222.00



13.46



12.86



195.22



15



17.16



16.24



226.78



18.40



16.36



199.72



16



17.32



16.62



230.94



21.36



20.36



204.04



17



18.04



17.28



235.44



22.24



21.50



208.16



18



18.86



18.24



239.90



23.04



22.32



212.54



19



19.70



19.12



244.16



23.86



23.20



216.78



20



20.54



19.90



247.60



24.70



24.04



220.08



21



21.78



21.24



250.48



25.82



25.08



222.62



22



23.90



23.20



253.52



27.82



26.44



225.36



23



23.90



23.20



254.32



27.82



26.44



226.08



24



23.90



23.24



256.18



28.32



26.48



227.96



25



24.78



24.32



258.18



29.82



27.54



229.94



26



25.82



25.44



260.32



31.02



25.58



231.74



27



26.24



25.94



261.78



31.52



29.08



2330.04



28



26.58



26.32



262.82



31.90



29.36



234.04



Percentage Biodegradation Values




























































































































































































































































Day



% Biodegradation



Procedure Control



Test Item



Toxicity Control



R1



R2



Mean



0



0



0



0



0



0



1



0



0



0



0



0



2



0



0



0



0



0



3



0



0



0



0



0



4



3



0



0



0



0



5



17



0



0



0



4



6



31



0



0



0



16



7



42



0



0



0



24



8



50



0



0



0



27



9



56



0



0



0



29



10



59



0



0



0



29



11



62



0



0



0



30



12



64



0



0



0



30



13



66



0



0



0



31



14



67



0



0



0



31



15



68



1



0



1



32



16



69



2



1



2



33



17



70



2



1



2



33



18



72



2



1



2



34



19



73



2



1



2



35



20



74



2



1



2



35



21



74



2



1



2



35



22



74



2



1



2



35



23



75



2



1



2



35



24



75



5



1



2



36



25



76



2



1



2



36



26



76



2



1



2



36



27



76



2



1



2



36



28



76



2



1



2



36



R=Replicate

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
under test conditions no biodegradation observed
Executive summary:

The study was performed to assess the ready biodegradability of the test item in an aerobic aqueous media. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No. 301F, “Ready Biodegradability; Manometric Respirometry Test” referenced as method C.4-D of Commission Regulation (EC) No. 440/2008 and US EPA Fate, Transport, and Transformation Test Guidelines OCSPP 835.3110 (Paragraph (q)).


The test item at a concentration of 100 mg/L was exposed to sewage treatment micro-organisms with mineral medium in sealed culture vessels in diffuse light at temperatures of between 20 and 22 ºC for 28 days. Following the recommendations of the International Standards Organisation (ISO 1995), the test item was dissolved in an auxiliary solvent prior to being adsorbed onto a filter paper and subsequent dispersal in test media. Using this method the test item is evenly distributed throughout the test medium and the surface area of test item exposed to the test organisms is increased thereby increasing the potential for biodegradation. The biodegradation of the test item was assessed by the measurement of daily oxygen consumption values on Days 0 to 28. Control solutions with inoculum and the reference item, aniline, together with a toxicity control were used for validation purposes.


The test item attained 2% biodegradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301F.