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Diss Factsheets

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Administrative data

Endpoint:
biodegradation in soil: simulation testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1994-09-15 until 1994-10-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
GLP compliance:
yes (incl. QA statement)
Oxygen conditions:
aerobic
Inoculum or test system:
sewage, predominantly domestic (adaptation not specified)
Details on inoculum:
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Anglian Water sewage treatment plant (Godmanchester), sample collected on 15 September 1994
- Preparation of inoculum for exposure: The sample was allowed to settle for approximately 30 minutes and the supernatant filtered through Whatman GFA coarse filter paper (first 250 ml discarded). The filtrate was maintained under aeration and used within 24 hours of collection.
- Pretreatment: none
Duration of test (contact time):
28 d
Initial conc.:
5 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
TEST CONDITIONS
- Solubilising agent (type and concentration if used): None
- Test temperature: 20 ± 1°C
- Other: Use of darkened glass bottles

TEST SYSTEM
- Culturing apparatus: The bottles were incubated in a water bath at 20 ± 1°C until removed for measurement
- Number of culture flasks/concentration: duplicate bottles at each sampling time
- Measuring equipment: Yellow Springs BOD Meter (Model 59)

SAMPLING
- Sampling frequency: At day 0, 4, 7, 11, 14, 18, 21, 25 and 28 (duplicate bottles at each sampling time)

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Toxicity control: yes ( 5 mg/l test substance plus 3 mg/l sodium benzoate)
Reference substance:
benzoic acid, sodium salt
Remarks:
3 mg/L
Parameter:
% degradation (O2 consumption)
Value:
8
Sampling time:
28 d
Details on results:
Cultures containing both test and standard substances combined showed an oxygen depletion value 12 % higher than that anticipated on the basi of results from separate cultures at Day 14. Consequentiy the test substance is not considered to have had an inhibitory effect on sewage bacteria under the conditions of this test.
Results with reference substance:
Sodium benzoate attained 77 % biodegradation within 28 days.
Validity criteria fulfilled:
yes
Interpretation of results:
other: Not readily biodegradable according to OECD criteria
Conclusions:
The test substance may not be termed as readily biodegradable.
There was no evidence of inhibitory effects under the conditions of this test.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP guideline sudy with analytical monitoring
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
GLP compliance:
not specified
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge (adaptation not specified)
Details on inoculum:
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): The sludge collected from ten different places in Japan were combined and cultivated for one month
- Concentration of sludge: 30 mg/L
Duration of test (contact time):
28 d
Initial conc.:
100 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
TEST CONDITIONS
- Solubilising agent (type and concentration if used): no data
- Test temperature: 25 °C +/- 1°C

CONTROL AND BLANK SYSTEM
- Toxicity control: yes (Aniline)
Reference substance:
aniline
Parameter:
% degradation (O2 consumption)
Value:
0
Sampling time:
28 d

Tab. 1: Percent biodegradability based on oxygen consumption

  Test substance Reference substance (aniline)
  day % day %
 No. 1 28 -1 28  67
 No. 2 28 0 (7)  (62)
 No. 3 28 1    

Tab. 2: Percent biodegradability based on HPLC analyses. The concentrations of the test substance in the test mediums after 28 days were determined by HPLC and biodegradabilities (%) calculated.

 

Test substance

  day concentration (mg/L) biodegradability (%)
 No. 1 28  100 
 No. 2 28  100 0
 No. 3 28 100 0
Validity criteria fulfilled:
yes
Interpretation of results:
under test conditions no biodegradation observed
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
2020
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
Principles of method if other than guideline:
Estimation of ready biodegradation in water using CATALOGIC v5.14.1.5 BOD 28 days MITI (OECD 301C) v.11.16
GLP compliance:
no
Oxygen conditions:
aerobic
Inoculum or test system:
other: Model calculation
Duration of test (contact time):
28 d
Parameter:
% degradation (O2 consumption)
Remarks:
QSAR model: based on OECD TG 301 C
Value:
1
Sampling time:
28 d
Remarks on result:
not readily biodegradable based on QSAR/QSPR prediction
Remarks:
within parameter domain, out of structural fragment domain, within metabolic domain
Details on results:
Predicted value (model result):
0.01 ± 5.68E-3
Concomitant predictions :
Not ready degradable
Primary Half Life = < 1 day
Ultimate Half Life = 7y 5m 7d
Interpretation of results:
not readily biodegradable
Conclusions:
The substance is not readily biodegradable. In total 18 metabolites at a quantity >=0.1% could be identified. None of these metabolites have logKow values indicative of a significant bioaccumulative potential.

Data source

Materials and methods

Results and discussion

Transformation products:
not measured
Remarks:
relevant degradation products are not expected

Applicant's summary and conclusion