Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 948-778-9 | 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
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- 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
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Biodegradation in water and sediment: simulation tests
Administrative data
- Endpoint:
- biodegradation in water: simulation testing on ultimate degradation in surface water
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is readily biodegradable
Cross-reference
- 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:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)
- Version / remarks:
- 2014
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- The test sample consists of a brown coloured liquid contained in a plastic bottle. Batch nr 23ADB/50
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- sewage, predominantly domestic (adaptation not specified)
- Details on inoculum:
- For the preparation of the inoculum a sample of aerobic sludge has been selected by the mixed
treatment plant of urban (about 66%) and industrial (about 34%) liquid sewage situated at San Rocco -
Monza (MB), Italia.
In the laboratory, the sampled muds have been mixed and let settle, keeping them in aerobic
conditions for 3 days.
The mud samples, before their use, have been analysed to check its ability to form colony units.
Then it has been centrifuged, washed and analyzed to quantify the suspended solids concentration for
the inoculum preparation. The inoculum was prepared in order to have a concentration of suspended
solid of about 4 mg/L. - Duration of test (contact time):
- 28 d
- Initial conc.:
- 20.14 mg/L
- Based on:
- TOC
- Parameter followed for biodegradation estimation:
- inorg. C analysis
- Details on study design:
- ASSAY EXECUTION
For assay execution the following preparations have been done using deionised water.
Bottles not used have been eliminated at the end of the test.
Test sample
The elemental analysis of the test item has been determined by REDOX SnC using CHN analyser (see
results in attachment N. 2).
The sample has been used with the starting nominal concentration of 20.14 mg/L of organic carbon
(TOC).
Reference substance
Considering Sodium benzoate as reference substance using its molecular formula, a starting nominal
concentration of 20.04 mg/L of organic carbon (TOC) has been used.
Blank
As blank has been used water containing culture Medium added with the inoculum of the muds.
Test sample + Reference substance
Test sample and reference substance have been put together in order to have a final concentration
given by the sum of organic carbon (TOC) of the 2 substances (see attachment N. 3 for results).
Abiotic check
Test item has been put together with 50 mg/L HgC12 in order to check a possible abiotic degradation.
Conditions of assay
The inoculum has been added in all bottles (see bottle preparation), closed and incubation continued under stirring in darkness at 20 ± 1 °C for 28 days. Data recording is performed continuously by a validated informatic monitoring system (Labguard Evisense).
At least 1 hour before every determination of inorganic carbon (TIC) the reaction in one bottle of blank, one of reference substance and one of the test item has been stopped with the addition of 6 ml of sodium hydroxide (1 M).
Triplicate bottles have been analyzed to detection inorganic carbon (IC) at each check point, weekly, except at the end of the test where five bottles have been analyzed.
Determination of total organic carbon (TOC) and total inorganic carbon (TIC)
Determination of total inorganic carbon has been done using an automatic TOC analyser. It is a high sensitivity instrument based on the combustion catalytic oxidation method (680°C). The carbon dioxide generated by oxidation has been detected using an infrared gas analyzer (NDIR). Samples, properly diluted with deionised water with low TOC contents, have been analysed by means of an integrated sampling system directly from vials containing 40 ml volume. - Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- not performed
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 0
- Sampling time:
- 0 d
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 100
- Sampling time:
- 14 d
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 99
- Sampling time:
- 28 d
- Results with reference substance:
- See following section
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- On the basis of results obtained, interpreted in accordance to OECD 310:2014, the test item "Trisodium (2s)-2,6-bis(3-carboxylatopropanamido) hexanoate - Disuccinyl lysine sodium salt" is considered readily biodegradable in aerobic conditions.
- Executive summary:
On the test item, "Trisodium (2s)-2,6-bis(3-carboxylatopropanamido) hexanoate - Disuccinyl lysine sodium salt", the analysis of inorganic carbon for the evaluation in an aqueous medium of the aerobic biodegradability has been performed following screening method described in OECD 310: 2014.
For this purpose the amount of developed inorganic carbon has been measured and reported in comparison to the blank.
The test has been done using the test item with a fixed concentration of organic carbon. Samples have been kept at the temperature of 20°C for the whole period of the test (28 days).
On the basis of results obtained, interpreted in accordance to OECD 310:2014, the test item "Trisodium (2s)-2,6-bis(3-carboxylatopropanamido) hexanoate - Disuccinyl lysine sodium salt" is considered readily biodegradable in aerobic conditions.
Validity criteria of the test are satisfied (see table below ).
The mean amount of TIC present in the blank controls at the end of the test is <3 mg C/L
Abiotic degradation has not occurred because amount of TIC during the test in the abiotic bottles has
been lower than 10%.
TIC T=1gg (ppm) |
TIC T=28 gg (ppm) |
% INCREASE (<10%) |
CONFORMITY |
2.759 |
2.680 |
-2.86 |
CONFORM |
The biodegradation percentage of the test item during the test is summarized in the following table.
The trend of the inorganic carbon and related biodegradation percentages ( see table below - column % of biodegradation Reference substance + test item) in the bottle contained both the test sample and the reference substance confirms the absence of an inhibitory effect of the test sample on inoculum at the concentration at which it was applied in the test (14%).
CHECK POINT (Days) |
% OF BIODEGRADATIONReference substance |
% OF BIODEGRADATIONTest item |
% OF BIODEGRADATIONReference substance+ Test item |
0 |
0 |
0 |
0 |
1 |
46 |
38 |
35 |
6 |
108 |
71 |
- |
14 |
113 |
100 |
|
21 |
110 |
103 |
- |
28 |
109 |
99 |
94 |
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.