Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
9 September 1992 - 7 October 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles. Limited information available to verify the composition of the used test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: 2,4 -bis(N'-(4-methylphenyl)ureido)toluene; 2,6 -bis(N'-(4-methylphenyl)ureido)toluene
EC Number:
411-070-0
EC Name:
A mixture of: 2,4 -bis(N'-(4-methylphenyl)ureido)toluene; 2,6 -bis(N'-(4-methylphenyl)ureido)toluene
Molecular formula:
C23H24N4O2
IUPAC Name:
3-(2-methyl-5-{[(4-methylphenyl)carbamoyl]amino}phenyl)-1-(4-methylphenyl)urea
Details on test material:
- Name of test material (as cited in study report): KY-ET
- Substance type: light yellow solid
- Physical state: solid
- Stability under test conditions: stable at least 48 hours in water
- Storage condition of test material: RT in the dark

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
- Source of inoculum/activated sludge: Municiple sewage treatment plant Waterschap de Aa, Schijndel, The Netherlands
- Preparation of inoculum for exposure: The activated sludge was aerated for 4 hours aeration. After 0.5 hours settling, the supernatant was decanted to provide a significantly large volume for a 1% inoculum for each test flask
Duration of test (contact time):
28 d
Initial test substance concentrationopen allclose all
Initial conc.:
10 mg/L
Based on:
test mat.
Initial conc.:
20 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
TEST CONDITIONS
- Test temperature: The temperature varied between 18.5 and 21.5 degrees Celsius, except for day 0 when the medium temperature was 17 degrees Celsius
- pH: 4.8-5.5
- pH adjusted: no
- Continuous darkness: yes - brown vessels

TEST SYSTEM
- Number of culture flasks/concentration: 1
- Test performed in closed vessels due to significant volatility of test substance:
- Details of trap for CO2 and volatile organics if used: barium hydroxide (CO2 produced in each bottle reacted with the barium hydroxide in the gas scrubbing bottle and precipitated out as barium carbonate; amount of CO2 produced was determined by titrating the remaining Ba(OH)2 with 0.05 N standardized HCl.

SAMPLING
- Sampling frequency: d2, 5, 7, 9, 12, 16, 21 and 28
Reference substance
Reference substance:
other: sodium acetate

Results and discussion

% Degradationopen allclose all
Parameter:
% degradation (CO2 evolution)
Value:
13
Sampling time:
28 d
Remarks on result:
other: concentration 10 mg/l
Parameter:
% degradation (CO2 evolution)
Value:
6
Sampling time:
28 d
Remarks on result:
other: concentration 20 mg/L
Details on results:
Based on the calculated ThCO2 for the test substance, only 13% and 6% biodegradation, respectively for the low (10mg/L) and high (20 mg/L) nominal test concentrations, was observed. Therefore KY-ET was judged not readily biodegradable.

BOD5 / COD results

Results with reference substance:
The reference substance was biodegraded more than 60% (62%) within 12 days and was degraded to 97% by the end of the testing period (28d). The total CO2 release within the blank was 9.4 mg CO2.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
other: under test conditions little biodegradation observed
Conclusions:
Under the conditions of the test KY-ET was not readily biodegradable.
Executive summary:

A Modified Sturm Test (CO2 evolution) was performed according to OECD 301B. There were no protocol or other deviations and the data was judged reliable. The nominal concentrations of 10 mg/L and 20 mg/L showed only 13% and 9% degradation, respectively, via CO2 evolution. Therefore the test substance was judged not readily biodegradable.