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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
- Flammability
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- Oxidation reduction potential
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
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Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 2018 - September 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
- Deviations:
- yes
- Remarks:
- Ammonium chloride was omitted from the medium to prevent nitrification.
- Principles of method if other than guideline:
- Minor deviations from the guidelines of the Closed Bottle test (OECD TG 301 D) were introduced; a) ammonium chloride was omitted from the medium to prevent oxygen consumption due to nitrification (omission does not result in nitrogen limitation as shown by the biodegradation of the reference compound), and b) river water instead of an effluent/extract/mixture was used as inoculum.
- GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- natural water: freshwater
- Remarks:
- river water instead of an effluent/extract/mixture was used as inoculum.
- Details on inoculum:
- River water was sampled from the Rhine near Heveadorp, The Netherlands (13-07-2018). The nearest plant (Arnhem-Zuid) treating domestic wastewater biologically was 3 km upstream. The river water was aerated for 7 days before use to reduce the endogenous respiration (van Ginkel and Stroo, 1992). River water without particles was used as inoculum. The particles were removed by sedimentation after 1 day while moderately aerating.
- Duration of test (contact time):
- 60 d
- Initial conc.:
- 4 mg/L
- Based on:
- test mat.
- Remarks:
- 27.8% purity
- Initial conc.:
- 1.112 mg/L
- Based on:
- act. ingr.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- The Closed Bottle test (OECD TG 301 D) was performed according to the study plan. The study plan was developed from ISO Test Guidelines (1994). Use was made of 10 bottles containing only river water with nutrient, 6 bottles containing river water with nutrients and sodium acetate, 10 bottles containing river water with nutrients and test substance. The concentrations of the test substance (active), and sodium acetate in the bottles were 4.0 and 6.7 mg/L, respectively. Each of the prepared solutions was dispensed into the respective group of BOD bottles so that all bottles were completely filled without air bubbles. The zero time bottles were immediately analyzed for dissolved oxygen using an oxygen electrode. The remaining bottles were closed and incubated in the dark. Two duplicate bottles of all series were withdrawn for analyses of the dissolved oxygen concentration at day 7, 14, 21, and 28. One extension from the protocol of the Closed Bottle test was introduced. The Closed Bottle test was prolonged by measuring the course of the oxygen decrease in the bottles of day 28 using a special funnel. This funnel fitted exactly in the BOD bottle. Subsequently, the oxygen electrode was inserted in the BOD bottle to measure the oxygen concentration. The medium dissipated by the electrode was collected in the funnel. After withdrawal of the oxygen electrode the medium collected flowed back into the BOD bottle, followed by removal of the funnel and closing of the BOD bottle (van Ginkel and Stroo 1992).
- Reference substance:
- other: Not included in the screening test
- Test performance:
- Test conditions
The pH of the media was 7.6 (test) and 7.8 (control and reference) at the start of the test.
The pH of the medium at day 28 was 7.8 (test and control). The temperature ranged from 22.5 to 22.9°C which is within the prescribed temperature range of 22 to 24°C. - Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 2
- Sampling time:
- 28 d
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 33
- Sampling time:
- 60 d
- Details on results:
- Theoretical oxygen demand (ThOD)
The theoretical oxygen demand (ThOD) of the active ingredient of the Substitued amino acid (2) solution is 1.15 g oxygen /g test substance. The ThOD of sodium acetate is 0.78 g/g
Toxicity
Inhibition of the degradation of a well-degradable compound, e.g. sodium acetate by the test substance in the Closed Bottle test was not determined because possible toxicity of the test
substances to microorganisms degrading acetate is not relevant. Inhibition of the endogenous respiration of the inoculum by the test substance at day 7 was not detected (Table I).
Therefore, no inhibition of the biodegradation due to the "high" initial test substance concentration is expected.
Validity of the test
The validity of the test is demonstrated by an endogenous respiration of 1.2 mg/L at day 28 (Table I). Furthermore, the differences of the replicate values at day 28 were less than 20%.
The biodegradation percentage of the reference compound, sodium acetate, at day 14 was 82 (Table II and Figure). Finally, the validity of the test is shown by oxygen concentrations >0.5 mg/L in all bottles during the test period.
Biodegradability
Substituted amino acid (2) solution was not biodegraded (2%) after 28 days) in the Closed Bottle test (Figure and Table I) and should therefore not be classified as readily biodegradable. In the prolonged Closed Bottle test this test substance was biodegraded by 33% at day 60. The test item should therefore not be classified as readily biodegradable. The biodegradation percentage achieved at day 60 demonstrates that the test item is inherently biodegradable. The test substance is degraded partially at the end of the test and could be degraded further in time because a plateau has not been reached. The lack of complete biodegradation in the Closed Bottle test does not mean that part of the test item is recalcitrant in nature because the stringency of the test procedures could account for the recalcitrance in the Closed Bottle test. - Results with reference substance:
- The biodegradation percentage of the reference compound, sodium acetate, at day 14 was 82
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- inherently biodegradable, not fulfilling specific criteria
- Conclusions:
- Valid test performed according to guideline OECD 301D with minor acceptable deviations applying GLP conditions.
- Executive summary:
In order to assess the biotic degradation of Substituted amino acid (2) solution, a ready biodegradability test was performed which allows the biodegradability to be measured in an aerobic aqueous medium. The ready biodegradability was determined in the Closed Bottle test performed according to slightly modified OECD, EU and ISO Test Guidelines, and in compliance with the OECD principles of Good Laboratory Practice.
The test item did not cause a reduction in the endogenous respiration at day 7. The test substance is therefore considered to be non-inhibitory to the inoculum. Sodium hydrogen substituted amino acid (2) solution was not biodegraded (2% after 28 days) in the Closed Bottle test and should therefore not be classified as readily biodegradable. In the prolonged Closed Bottle test this test substance was biodegraded by 33% at day 60. The biodegradation reached at day 60 demonstrates that this substance is inherently biodegradable. The lack of complete biodegradation in the Closed Bottle test does not mean that the test item is
recalcitrant in nature because the stringency of the test procedures could account for the recalcitrance in the Closed Bottle test.
The test is valid as shown by an endogenous respiration of 1.2 mg/L and by the total mineralization of the reference compound, sodium acetate. Sodium acetate was degraded by 82% of its theoretical oxygen demand after 14 days. Finally, the most important criterion was met by oxygen concentrations >0.5 mg/L in all bottles during the test period.
Reference
Table I Dissolved oxygen concentrations (mg/L) in the closed bottles.
Time (days) |
Oxygen concentration (mg/L) |
||
|
Oc |
Ot |
Oa |
0 |
8.7 |
8.7 |
8.7 |
|
8.7 |
8.7 |
8.7 |
Mean (M) |
8.7 |
8.7 |
8.7 |
7 |
8.0 |
8.1 |
4.1 |
|
8.1 |
8.1 |
4.2 |
Mean (M) |
8.1 |
8.1 |
4.2 |
14 |
7.6 |
7.5 |
3.1 |
|
7.6 |
7.4 |
3.4 |
Mean (M) |
7.6 |
7.5 |
3.3 |
21 |
7.5 |
7.5 |
|
|
7.6 |
7.4 |
|
Mean (M) |
7.6 |
7.5 |
|
28 |
7.5 |
6.9 |
|
|
7.4 |
7.1 |
|
Mean (M) |
7.5 |
7.0 |
|
42 |
7.1 |
6.0 |
|
|
7.2 |
6.1 |
|
Mean (M) |
7.2 |
6.1 |
|
60 |
6.8 |
5.4 |
|
|
7.0 |
5.3 |
|
Mean (M) |
6.9 |
5.4 |
|
Oc River water with nutrients.
Ot River water with nutrients, and test substance (active) (4.0 mg/L).
Oa River water with nutrients and sodium acetate (6.7 mg/L).
Table II Oxygen consumption (mg/L) and the percentages biodegradation of the test substance (BOD/ThOD) and sodium acetate (BOD/ThOD) in the Closed Bottle test.
Time (days) |
Oxygen consumption (mg/L) |
Biodegradation (%) |
||
|
Test substance |
Acetate |
Test substance |
Acetate |
0 |
0.0 |
0.0 |
0 |
0 |
7 |
0.0 |
3.9 |
0 |
75 |
14 |
0.1 |
4.4 |
2 |
85 |
21 |
0.1 |
|
2 |
|
28 |
0.5 |
|
11 |
|
42 |
1.1 |
|
24 |
|
60 |
1.5 |
|
33 |
|
Description of key information
The ecotoxicity data in this dossier from Sodium salts of substituted amino acid are read across from Substituted amino acid (2) solution. This read across is considered to be justified because Substituted amino acid (2) solution contains about 50% of Substituted amino acid (i.e.the L stereo isomer of Substituted amino acid (2) solution) and no ecotoxicity (EC50>100 mg/L) was observed for Substituted amino acid (2) solution in the acute daphnia and algae test. There will be no significant difference in ecotoxicity of Substituted amino acid or Sodium salts of substituted amino acid because test substances are tested in very diluted form in buffered matrixes. It is therefore considered extremely unlikely that any significant aquatic ecotoxicity will be observed for Sodium salts of substituted amino acid.
The D isomer is structurally identical to the L-isomer of Substituted amino acid only the order in which the different groups are placed around the chiral carbon is different. A ready biodegradability test with the L-isomer of Substituted amino acid is currently running to evaluate if the 33% biodegradation observed at day 60 in the test with Substituted amino acid (2) solution is caused by persistency one of both enantiomers.
The biotic degradation of Substituted amino acid (2) solution was evaluated in a ready biodegradability test in the Closed Bottle test performed according to slightly modified OECD, EU and ISO Test Guidelines, and in compliance with the OECD principles of Good Laboratory Practice.
The test substance did not cause a reduction in the endogenous respiration at day 7. The test substance is therefore considered to be non-inhibitory to the inoculum. Substituted amino acid (2) solution was not biodegraded (2% after 28 days) in the Closed Bottle test and should therefore not be classified as readily biodegradable. In the prolonged Closed Bottle test this test substance was biodegraded by 33% at day 60. The biodegradation reached at day 60 demonstrates that this substance is inherently biodegradable. The lack of complete biodegradation in the Closed Bottle test does not mean that the test item is
recalcitrant in nature because the stringency of the test procedures could account for the recalcitrance in the Closed Bottle test.
Key value for chemical safety assessment
- Biodegradation in water:
- inherently biodegradable, not fulfilling specific criteria
- Type of water:
- freshwater
Additional information
In order to assess the biotic degradation of Substituted amino acid (2) solution, a ready biodegradability test was performed which allows the biodegradability to be measured in an aerobic aqueous medium. The ready biodegradability was determined in the Closed Bottle test performed according to slightly modified OECD, EU and ISO Test Guidelines, and in compliance with the OECD principles of Good Laboratory Practice.
The test item did not cause a reduction in the endogenous respiration at day 7. The test substance is therefore considered to be non-inhibitory to the inoculum. Substituted amino acid (2) solution was not biodegraded (2% after 28 days) in the Closed Bottle test and should therefore not be classified as readily biodegradable. In the prolonged Closed Bottle test this test substance was biodegraded by 33% at day 60. The biodegradation reached at day 60 demonstrates that this substance is inherently biodegradable. The lack of complete biodegradation in the Closed Bottle test does not mean that the test item is
recalcitrant in nature because the stringency of the test procedures could account for the recalcitrance in the Closed Bottle test.
The test is valid as shown by an endogenous respiration of 1.2 mg/L and by the total mineralization of the reference compound, sodium acetate. Sodium acetate was degraded by 82% of its theoretical oxygen demand after 14 days. Finally, the most important criterion was met by oxygen concentrations >0.5 mg/L in all bottles during the test period.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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