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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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 23ADB/50
- Expiration date of the lot/batch: 5 years
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility and stability of the test substance in the solvent/vehicle: soluble in water
- Analytical monitoring:
- yes
- Remarks:
- HPLC
- Vehicle:
- no
- Details on test solutions:
- Sample preparation
Range finding test
The test sample has been prepared at 1000 mg/L of the active ingredient in water (corresponding to about 2044 mg/L of the test item). 5 dif erent concentrations, have been tested with ten-fold dilutions from 100 mg/L to 0.01 mg/L of active ingredient.
The test has been performed on the diluted solutions.
N° of groups: 5 treated + 1 control
N° of animals: 3/tank
Definitive test (Limit test)
After the range finding test a solution of the active ingredient of the test item at 1000 mg/L has been prepared in water. Then the solution has been diluted to of 100 mg/L of active ingredient corresponding to about 204 mg/L of the test item. The test has been performed on this solution in the below conditions:
N° of groups: 1 treated + 1 control
N° of animals: 7/tank
14 fish have been used for the definitive test subdivided as follows:
GROUP Animals (N°) Administered solution Nominal concentration of the active ingredient Check point chemical- physical parameters (hours)
Control 7 Water 0-24-48-72-96
Treated 7 100 mg/L 0-24-48-72-96 - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Brachydanio rerio
- Source: Supplier: Aquarium Center
- Length at study initiation (length definition, mean, range and SD): 2 cm ± 1 cm
- Biomass-density: < 1 g/L
Maintenance
During quarantine period fish have been kept in glass tanks with a capacity of 60 litres.
The water used for the assay has been allowed to stabilize for 48 hours to greatly reduce chlorine
presence, in the event it was present if used for purification.
Hardness: 10-250 mg CaCO3/L
Temperature: 23°C ± 2°C
Aeration: continuous with porous stones
Tanks have been lighted with white light lamps with 12 h photoperiod daily.
Feeding
Type: Feedstuff in flakes
Frequency: 3 times a week with suspension 24 hours before the beginning of the test.
QUARANTINE
Before the beginning of the study, fish have been kept in quarantine for 12 days. During this period, fish
have been daily observed. No mortality or symptoms have been recorded during quarantine period.
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 10-250 mg CaCO3/L
- Test temperature:
- 23 °C ± 2 °C
- pH:
- 6.0-8.5
- Dissolved oxygen:
- >60 %
- Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Details on results:
- TABLE N. 1: Number of dead fish in control and treated groups during the definitive test
TIME
GROUP 3 hours 6 hours 24hours 48 hours 72 hours 96 hours
CONTROL 0/7 0/7 0/7 0/7 0/7 0/7
TREATED 0/7 0/7 0/7 0/7 0/7 0/7
TABLE N. 2: Symptomatology of fish in control and treated groups during the definitive test
TIME
GROUP 3 hours 6 hours 24hours 48 hours 72 hours 96 hours
CONTROL 0 0 0 0 0 0
TREATED 0 0 0 0 0 0
LEGENDA
0 Nothing abnormal R Changes to respiration
E Equilibrium loss P Changes to pigmentation
N Changes to swimming A Other
N. A. Not applicable, fish dead
TABLE N. 6: Stability of the test item in treated groups in the definitive test
Nominal conc. Measured conc (mg/L) T=0 Measured conc. (mg/L) T=96 h % Stability on measured concentration Stability
100.00 mg/L 96.24 108.29 112.52 Stable - Validity criteria fulfilled:
- yes
- Conclusions:
- The obtained results, in compliance with assay validity criteria, interpreted in accordance to OECD 203, showed that the Brachydanio rerio LC50 of the active ingredient of the test item "Trisodium (25)-2,6-bis(3-carboxylatopropanamido) hexanoate - Disuccinyl lysine sodium salt” after 96 hours is >100 mg/L.
- Executive summary:
The toxicity of the test item, "Trisodium (2s)-2,6-bis(3-carboxylatopropanamido) hexanoate - Disuccinyl lysine sodium salt", on the fish,Brachydanio rerio,has been evaluated according to OECD guideline N. 203
In particular, the assay of acute toxicity with fish Brachydanio rerio has been performed by means of a static assay in which the solution has not been changed for the whole test period.
After a range finding test, a limit test has been performed using 14 fish have been used, 7 of them treated with the test item at 100 mg/L of the active ingredient and 7 fish used as control, kept in the same assay conditions without adding the test item.
Fish have been observed for a period of 96 hours and mortality and/or possible anomalous behaviours have been observed both in control and in treated.
Temperature, pH and percentage of saturation of oxygen in the water of each tank have been measured at the beginning of the treatment and with intervals of 24 hours.
Results are referred to the active ingredient present in the test item (48.9% active ingredient).
Stability of the active ingredient of the test item in the definitive test has been performed using HPLC technique equipped with UVs detector
The active ingredient present in the test item has been measured at the beginning and at the end of the test in the control and in the treated sample.
The obtained results, in compliance with test acceptability criteria, for the active ingredient of the test item "Trisodium (2s)-2,6-bis(3-carboxylatopropanamido) hexanoate - Disuccinyl lysine sodium salt" can be summarised as follow:
LC50of the active ingredient in the test item at 96 h > 100 mg/L
Reference
Description of key information
The obtained results, in compliance with assay validity criteria, interpreted in accordance to OECD 203, showed that the Brachydanio rerio LC50 of the active ingredient of the test item "Trisodium (25)-2,6-bis(3-carboxylatopropanamido) hexanoate - Disuccinyl lysine sodium salt” after 96 hours is >100 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
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