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Environmental fate & pathways

Biodegradation in water: screening tests

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Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-08-13 to 2002-09-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Test design is more suitable for less adsorptive substances.
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 A (Ready Biodegradability: DOC Die Away Test)
Version / remarks:
adopted 17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.4-A (Determination of the "Ready" Biodegradability - Dissolved Organic Carbon (DOC) Die-Away Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic (adaptation not specified)
Details on inoculum:
- Source of inoculum/activated sludge: Sewage treatment plant, Municipal STP Marl-Ost, Germany
- Laboratory culture: no
- Method of cultivation: none
- Preparation of inoculum for exposure: Not specified
- Pretreatment: Not specified
- Initial cell/biomass concentration: Not stated
Duration of test (contact time):
28 d
Initial conc.:
5.17 mg/L
Based on:
DOC
Remarks:
Deviating from the guideline, test substance concentration was restricted to only 5.17 mg/L DOC due to its microbicidal properties.
Parameter followed for biodegradation estimation:
DOC removal
Details on study design:
TEST CONDITIONS
- Composition of medium:
KH2PO4 85 mg/l
K2HPO4 217.5 mg/l
Na2HPO4 • 2 H20 334 mg/l
NH4Cl 5 mg/l
MgSO4 • 7 H20 20.86 mg/l
CaCl2 • 2 H20 36.4 mg/l
FeCl3 • 2 H20 0.25 mg/l
- Additional substrate: no
- Solubilising agent (type and concentration if used): Not relevant; the test substance is highly soluble in water.
- Test temperature: 22.7°C
- pH: 7.4
- Aeration of dilution water: not stated
- Suspended solids concentration: 24.62 mg/l
- Continuous darkness: yes


TEST SYSTEM
- Culturing apparatus: Mechanical shaker
- Number of culture flasks/concentration: 2 (test substance, inoculum blank) / 1 (toxicity control, reference substance)
- Measuring equipment: Shimadzu T 5000A infrared analyser
- Test performed in closed vessels due to significant volatility of test substance: Not required

SAMPLING
- Sampling frequency: 0 and 3 hours , then after 7, 14, 21, 27 and 28 days.


CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Abiotic sterile control: no
- Toxicity control: yes


STATISTICAL METHODS:
DOC removal according to test guidelines
Reference substance:
benzoic acid, sodium salt
Parameter:
% degradation (DOC removal)
Value:
72
Sampling time:
7 d
Parameter:
% degradation (DOC removal)
Value:
94
Sampling time:
28 d
Details on results:
The degradation of the test item was > 70% within a 10-d window (72% on day 7, 94% on day 28).
In the toxicity control, no inhibition of the inoculum was observed.
Results with reference substance:
94% degradation by day 14
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid is readily biodegradable, fulfilling the 10-d-window criterion.
Executive summary:

The ready biodegradability of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid (99.4% a.i.) was tested in the DOC die-away test (OECD 301A, EC C.4-A). The performance of the study was compliant to the stated guidelines.

Deviating from the guideline, test substance concentration was restricted to only 5.17 mg/L DOC due to its microbicidal properties. The employed concentration was below toxic levels, as also confirmed by the toxicity control.

The test substance was degraded by 94% (DOC removal) at the end of the test. The pass level of 70% was reached after 7 days, thus being within the 10-d window.

The test substance is not known to exhibit properties having impact on the results.

The validity criteria were fulfilled.

The test results indicate that the substance is readily biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-11-29 to 2001-12-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Test design is more suitable for less adsorptive substances
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 A (Ready Biodegradability: DOC Die Away Test)
Version / remarks:
1992 / Initial test item concentrations were 4 and 8 mg DOC/L. The guideline specifies a concentration of 10-40 mg DOC/L as the nominal sole source of organic carbon. The lower concentrations were used to prevent toxic effects.
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.4-A (Determination of the "Ready" Biodegradability - Dissolved Organic Carbon (DOC) Die-Away Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
- Source of inoculum/activated sludge: sludge taken off on 01-11-30 from Marl-Ost municipal sewage treatment plant
- Concentration of sludge: 6 mL/L
- Water filtered: no
Duration of test (contact time):
28 d
Initial conc.:
4.2 mg/L
Based on:
DOC
Initial conc.:
8.2 mg/L
Based on:
DOC
Parameter followed for biodegradation estimation:
DOC removal
Details on study design:
TEST CONDITIONS
- Composition of medium: according to OECD guideline 301A
- Test temperature: 21.0 - 23.0°C
- pH: 7.3 - 7.4
- pH adjusted: no
- Aeration of dilution water: not reported
- Suspended solids concentration: 25.86 mg/L
- Dry matter content: 4.31 g/L
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: 2000 mL conical flasks with loose aluminium foil closure
- Number of culture flasks/concentration: 2
- Measuring equipment: Infrared analyser T 500 (Shimadzu)
- Test performed in closed vessels due to significant volatility of test substance: no
- Test performed in open system: yes

SAMPLING
- Sampling frequency: after 0, 3 hours and 7, 14, 21, 27 and 28 days

CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 flasks
- Abiotic sterile control: no
- Toxicity control: 1 flask with test substance concentration 4.2 mg DOC/L, 1 flask with test substance concentration 8.2 mg DOC/L
Reference substance:
benzoic acid, sodium salt
Parameter:
% degradation (DOC removal)
Value:
96
Sampling time:
28 d
Remarks on result:
other: Test item concentration of 8.2 mg DOC/L
Parameter:
% degradation (DOC removal)
Value:
100
Sampling time:
28 d
Remarks on result:
other: Test item concentration of 4.2 mg DOC/L
Details on results:
Toxicity control of concentration 1: 95 % DOC-decrease within 28 days
Toxicity control of concentration 2: 99 % DOC-decrease within 28 days
The test substance is not considered inhibitory between 4.2-8.2 mg DOC/L.
Results with reference substance:
Degradation rate sodium benzoate: 100% DOC decrease after 7 days
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
The test substance is readily biodegradable.
Executive summary:

The study on biodegradability was carried out in accordance with directive 92/69/EEC C.4-A, (1992) and OECD Test Guideline 301A (1992). The sewage sludge taken off was treated in accordance with standard procedures of the laboratory (SOPs) and the test batches were inoculated with 6 mL/L of inoculum. The content of suspended solids in the test batches was 25.86 mg/L. The test substance was tested at DOC concentrations of 4.2 and 8.2 mg DOC/L. The tested DOC concentrations of the reference compound (sodium benzoate) were 16 and 26 mg DOC/L.

The content of dry matter in the inoculum used was 4.31 g/L. The percentage degradation of the reference compound (sodium benzoate) reached the pass levels (70 % DOC) by day 14 (e.g. 97 % degradation observed by 14). The test substance is not considered inhibitory between 4.2-8.2 mg DOC/L as a toxicity test, containing both the test substance and a reference compound, gave >35% degradation (based on total DOC). The removal of the test substance was 96% (DOC removal) at the end of the test. The pass level of 70% was reached after 7 days, thus being within the 10-d window. Therefore, Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid is considered to be readily biodegradable.  

Endpoint:
biodegradation in water: screening test, other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2007-06-06 to 2007-08-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 311 (Anaerobic Biodegradability of Organic Compounds in Digested Sludge: Measurement of Gas Production)
Version / remarks:
adopted 23 March 2006
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Oxygen conditions:
anaerobic
Inoculum or test system:
digested sludge
Details on inoculum:
- Source of inoculum/activated sludge: Sewage treatment plant, Municipal STP at Lennestadt, Germany
- Laboratory culture: No
- Method of cultivation: Not applicable
- Preparation of inoculum for exposure: The sludge was pre-digested, without the addition of any nutrients, at 35 ± 2 °C for 5 days.
- Pretreatment: Pre-digestion as above; suspension in oxygen-free mineral medium; centrifugation, followed by re-suspension in mineral medium; final concentration of total solids of 2.9 g dry mass/litre
- Initial cell/biomass concentration: Not stated
Duration of test (contact time):
60 d
Initial conc.:
100 mg/L
Based on:
DOC
Parameter followed for biodegradation estimation:
other: Headspace pressure, continuously measured. Dissolved inorganic carbon (DIC), measured at the end of the test.
Details on study design:
TEST CONDITIONS
- Composition of medium: Mineral test medium, according to the guideline
- Additional substrate: No
- Solubilising agent (type and concentration if used): No
- Test temperature: 35 °C
- pH: 7.0 ± 0.2 at the beginning of the test
- pH adjusted: no
- Suspended solids concentration: 2.9 g dry mass/litre
- Continuous darkness: yes
- Other: The test was run in darkness. The suspension was kept anaerobic during the whole test.

TEST SYSTEM
- Culturing apparatus: Not reported
- Number of culture flasks/concentration:
Inoculum blank: 3 vessels
Procedural control: 3 vessels
Test suspension: 3 vessels
Toxicity control: 3 vessels
- Measuring equipment: gas pressure: Sensomat measurement device by Aqualytic®, IC: TOC analyzer
- Other: Oxidation reduction indicator: Resazurin

SAMPLING
- Sampling frequency: Daily (pressure) and at test termination (DIC)


CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Toxicity control: yes, 100 mg Corg/L test substance and 100 mg Corg/L sodium benzoate


STATISTICAL METHODS:
Per cent biodegradation, according to guidelines.
Reference substance:
benzoic acid, sodium salt
Remarks:
100 mg Corg/L
Parameter:
other: Headspace pressure, continuously measured. Dissolved inorganic carbon (DIC), measured at the end of the test.
Value:
0
Sampling time:
60 d
Details on results:
No degradation of the test item was detected after 60 days.
The results give rise to the probable cause that the test substance is toxic to the bacterial population used in the test, at least at concentrations demanded by the test guideline.
Results with reference substance:
94% degradation

Table A7.1.2.1.2-4:Percent net degradation, given as mean values ±SD [% C].

 

test substance

Sodium benzoate

Toxicity control

Degradation [% C]

–72* ± 5

94 ± 9

–36 ± 2

*) Negative values indicate less degradation than in inoculum blank

 

Validity criteria fulfilled:
yes
Interpretation of results:
under test conditions no biodegradation observed
Conclusions:
Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid can be identified as non-biodegradable under anaerobic conditions and potentially toxic to bacteria at the concentration required by the guideline.
Executive summary:

The biodegradation of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid at a concentration of 100 mg Corg/L was investigated according to OECD guideline 311 over a 60-day period in anaerobic aqueous medium. As inoculum microorganisms from a digester of a sewage treatment plant mainly fed with municipal wastewater were used. The rate of degradation was monitored by measuring the increase in headspace pressure in the vessels resulting from the production of carbon dioxide and methane is measured. The amount of inorganic and methane carbon resulting from the biodegradation of the test item was calculated from the net gas production and net IC formation in the liquid phase in excess over blank control values. The extent of biodegradation was calculated from total IC and methane-C produced as a percentage of the calculated amount of carbon added as test compound.

The anaerobic biodegradation of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid was found to be 0 % after 60 days. Therefore, the test substance must be considered as not readily biodegradable under the chosen test conditions. The degradation in the toxicity control (–38 to –34 %) was lower than the degradation in the functional control (94 %). Due to the same concentration of reference item in both experimental approaches, degradation under 50 % in the toxicity control indicates an inhibiting effect of the test item on the degradation of the reference item. This signified an antibacterial effect of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid under test conditions.

Due to the results the test item can be identified as non-biodegradable under anaerobic conditions and potentially toxic to bacteria at the concentration required by the guideline.

The test item was employed at a concentration that is potentially toxic to micro-organisms. The test item concentration is, however, within the range demanded by the test guideline. Thus, the study is considered to be valid with restrictions only.

Description of key information

Aerobic biodegradation: readily biodegradable (OECD guideline 301A, GLP)
Anaerobic biodegradation: no biodegradation observed under experimental condictions; potentially toxic to bacteria at the concentration required by the guideline (OECD guideline 311, GLP)

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable

Additional information

Three reliable GLP studies are available testing the ready biodegradability of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid. The two key studies were performed under aerobic conditions according to OECD 301 A. A third study tested the biodegradation of the substance under anaerobic conditions according to OECD guideline 311.

Aerobic biodegradation

In the first key study, the ready biodegradability of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid (99.4% a.i.) was tested in the DOC die-away test (OECD 301A, EC C.4-A).

Deviating from the guideline, test substance concentration was restricted to only 5.17 mg/L DOC due to its microbicidal properties. The employed concentration was below toxic levels, as also confirmed by the toxicity control. The test substance was degraded by 94% (DOC removal) at the end of the test. The pass level of 70% was reached after 7 days, thus being within the 10-d window. The validity criteria were fulfilled. The test results indicate that the substance is readily biodegradable.

The second study, was also carried out in accordance with directive EC C.4-A, and OECD Test Guideline 301A. The test batches were inoculated with 6 mL/L of inoculum. The content of suspended solids in the test batches was 25.86 mg/L. The test substance was tested at DOC concentrations of 4.2 and 8.2 mg DOC/L. The test substance is not considered inhibitory between 4.2-8.2 mg DOC/L as a toxicity test, containing both the test substance and a reference compound, gave >35% degradation (based on total DOC). The removal of the test substance was 96% (DOC removal) at the end of the test. The pass level of 70% was reached after 7 days, thus meeting the 10-d window criterion. Therefore, Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid is considered to be readily biodegradable. 

 

Anaerobic biodegradation

The biodegradation of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid at a concentration of 100 mg Corg/L was investigated according to OECD guideline 311 over a 60-day period in anaerobic aqueous medium. As inoculum microorganisms from a digester of a sewage treatment plant mainly fed with municipal wastewater were used. The rate of degradation was monitored by measuring the increase in headspace pressure in the vessels resulting from the production of carbon dioxide and methane. The amount of inorganic and methane carbon resulting from the biodegradation of the test item was calculated from the net gas production and net IC formation in the liquid phase in excess over blank control values. The extent of biodegradation was calculated from total IC and methane-C produced as a percentage of the calculated amount of carbon added as test compound.

The anaerobic biodegradation of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid was found to be 0 % after 60 days. Therefore, the test substance must be considered as not readily biodegradable under the chosen test conditions. The degradation in the toxicity control (–38 to –34 %) was lower than the degradation in the functional control (94 %). Due to the same concentration of reference item in both experimental approaches, degradation under 50 % in the toxicity control indicates an inhibiting effect of the test item on the degradation of the reference item. This signified an antibacterial effect of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid under test conditions.

Due to the results the test item can be identified as non-biodegradable under anaerobic conditions and potentially toxic to bacteria at the concentration required by the guideline.

The test item was employed at a concentration that is potentially toxic to microorganisms. The test item concentration is, however, within the range demanded by the test guideline. Thus, the study is considered to be valid with restrictions only.