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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

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:
22 Auggust 2011- 19 October 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
Version / remarks:
"Method for Testing the Biodegradability of Chemical Substances by Microorganisms" stipulated in
the "Testing Methods for New Chemical Substances" (March 31, 2011, No.0331-7, Pharmaceutical
and Food Safety Bureau, Ministry of Health, Labour and Welfare; March 29, 2011, No.5,
Manufacturing Industries Bureau, Minis-try of Economy, Trade and Industry; No. 110331009,
Environmental Policy Bureau, Ministry of the Environment, Japan)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Test item 84%4,4 thiodiethylene hydrogen -2-octadecenylsuccinate, Octadec-I -en (CAS number 112-88-9) 5%, Polyoctadecene 11%
Lot number E00298-234-001
The test item amount in the test sample was corrected by purity.
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Details on inoculum:
On-site sludge sampling was carried out at 10 locations in Japan (samples were from surface water and surface soil of rivers, lakes, and inland sea; return sludge from sewage plants). And then, the activated sludge was prepared and controlled in this laboratory according to the test method described in Section 5 (sampling period: June, 2011, initiation date of use: July 4, 2011). The activated sludge, which was cultivated for 19 hours after the addition of synthetic sewage, was used. The synthetic sewage was prepared according to the following method; glucose, peptone, and potassium dihydrogenphosphate were dissolved in purified water, and the pH of the solution was adjusted to 7.0±1.0.
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:
Six bottles were prepared as follows:
Bottle 1 - test substance in water at 100 mg/l;
Bottles 2, 3 and 4 - test substance in mineral medium at 100 mg/l;
Bottle 5 - reference compound (e.g. aniline) in mineral medium at 100 mg/l;
Bottle 6 - mineral medium only.
Inoculate vessels 2, 3 and 4 (test suspensions), 5 (activity control) and 6 (inoculum blank) with a small volume of the inoculum to give a concentration of 30 mg/l suspended solids. No inoculum is added to Bottle 1 which serves as an abiotic control. Assemble the equipment, check that it is air-tight, start the stirrers, and start the measurement of oxygen uptake under conditions of darkness.
During the incubation period, the appearance of the test solution was observed once a day. During the incubation period, BOD of the test solutions was measured continuously by a closed system oxygen consumption measuring apparatus. The incubation temperature was measured and recorded once a day.
After the end of the incubation, the test item and 2,2-thiodiethanol, which was expected to be produced, in the test solutions were determined by HPLC. In addition, other converted products, which were hard to analyze quantitatively, were analyzed qualitatively.
Although it was clear that the test item was not dissolved in the test solutions from results of the preliminary test, dissolved organic carbon (DOC) was determined by Total organic carbon analyser in order to confirm the production of water-soluble converted products.
Test performance:
A test is considered valid if the difference of extremes of replicate values of the removal of the test substance at the plateau or at the end of the test, as appropriate is less than 20% and if the percentage degradation of aniline calculated from the oxygen consumption exceeds 40% after 7 days and 65% after 14 days.

All difference between the replicate values of biodegradation were <20%. Additionally the percentage of aniline degradation was 76% after 14day which exceeds the criteria.
Therefore the performance of the test was valid according to the guideline.
Key result
Parameter:
% degradation (O2 consumption)
Value:
> 13 - < 17
Sampling time:
28 d
Key result
Parameter:
ThOD
Value:
92.2 mg O2/g test mat.
Results with reference substance:
The percentage degradation of the sludge and aniline was 77% after 28 days.

see attached background documents.

Validity criteria fulfilled:
yes
Interpretation of results:
not readily biodegradable
Conclusions:
The biodegradation of the Substance was estimated to be 13-17%. The pass level for ready biodegradability is 60% of ThOD by respirometric methods. Therefore the Substance is not considered to be readily biodegradable.
Executive summary:

The Substance was assessed for ready biodegradability in an aerobic aqueous medium using the methodology as detailed in OECD 301C MITI (I) (Ministry of International Trade and

Industry, Japan).

 

Six bottles were prepared as follows:

 

Bottle 1 - test substance in water at 100 mg/l;

Bottles 2, 3 and 4 - test substance in mineral medium at 100 mg/l;

Bottle 5 - reference compound (e.g. aniline) in mineral medium at 100 mg/l;

Bottle 6 - mineral medium only.

 

The Substance was incubated over 28 days. During the incubation period, the appearance of the test solution was observed once a day. During the incubation period, biochemical oxygen demand (BOD) of the test solutions was measured continuously by a closed system oxygen consumption measuring apparatus. The incubation temperature was measured and recorded once a day.

 

After the end of the incubation, the Substance and 2,2-thiodiethanol, which was expected to be produced, in the test solutions were determined by high-performance liquid chromatography (HPLC). The dissolved organic carbon (DOC) in each vessel was also determined by Total organic carbon analyser in order to confirm the production of water-soluble converted products. In addition, other converted products, which were hard to analyse quantitatively, were analysed qualitatively.

 

All difference between the replicate values of biodegradation were <20%. Additionally the percentage of aniline degradation was 76% after 14day which exceeds the criteria.

Therefore the performance of the test was valid according to the guideline.

 

The biodegradation of the Substance was estimated to be 13-17%. The pass level for ready biodegradability is 60% of ThOD by respirometric methods. Therefore the Substance is not considered to be readily biodegradable.

Description of key information

The biodegradation of the Substance was estimated to be 13-17%. The pass level for ready biodegradability is 60% of ThOD by respirometric methods. Therefore the Substance is not considered to be readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:
under test conditions no biodegradation observed

Additional information

The Substance was assessed for ready biodegradability in an aerobic aqueous medium using the methodology as detailed in OECD 301C MITI (I) (Ministry of International Trade and

Industry, Japan).

 

Six bottles were prepared as follows:

 

Bottle 1 - test substance in water at 100 mg/l;

Bottles 2, 3 and 4 - test substance in mineral medium at 100 mg/l;

Bottle 5 - reference compound (e.g. aniline) in mineral medium at 100 mg/l;

Bottle 6 - mineral medium only.

 

The Substance was incubated over 28 days. During the incubation period, the appearance of the test solution was observed once a day. During the incubation period, biochemical oxygen demand (BOD) of the test solutions was measured continuously by a closed system oxygen consumption measuring apparatus. The incubation temperature was measured and recorded once a day.

 

After the end of the incubation, the Substance and 2,2-thiodiethanol, which was expected to be produced, in the test solutions were determined by high-performance liquid chromatography (HPLC). The dissolved organic carbon (DOC) in each vessel was also determined by Total organic carbon analyser in order to confirm the production of water-soluble converted products. In addition, other converted products, which were hard to analyse quantitatively, were analysed qualitatively.

 

All difference between the replicate values of biodegradation were <20%. Additionally the percentage of aniline degradation was 76% after 14day which exceeds the criteria.

Therefore the performance of the test was valid according to the guideline.

 

The biodegradation of the Substance was estimated to be 13-17%. The pass level for ready biodegradability is 60% of ThOD by respirometric methods. Therefore the Substance is not considered to be readily biodegradable.