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EC number: 223-264-0 | CAS number: 3792-50-5
- 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:
- 2017-08-28 to 2017-09-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- adopted July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Version / remarks:
- April 1986
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: five replicate samples (5 mL per replicate) were taken from the test solution (100 mg/L) and from the control at the start and at the end of each water renewal periods.
- Sample storage conditions before analysis: Analyzed immediately after sampling - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Separate stock solutions of individual substances were first prepared in deionised water. The ISO medium was prepared by adding 25 mL from each of four stock solutions to one litre deionised water. The test solution used in the test was prepared by mechanical dispersion without using of any solubilising agent.
- Controls: Negative control, only ISO Test Medium without the test item
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: Akvárium magazin Kft. (Pasaréti Gyula) 1222 Budapest, Dévény u. 36
- Age at study initiation: Juveniles
- Length at study initiation: 2 ± 1 cm
- Maintenance of the brood fish: Appropriate, commercial diet for fish at least three times per week until one day before the test start
HOLDING AND ACCLIMATION
- Acclimation period: At least 12 days before test initiation
- Acclimation condition: Same as test
- Health: No significant mortality (less than 5% of the population) occurred in seven days before the start of the experiment
FEEDING DURING TEST: No - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- No
- Hardness:
- 249 mg/L CaCO3
- Test temperature:
- 22.0 - 23.0 °C
- pH:
- 7.44 – 7.80
- Dissolved oxygen:
- 71.7 – 92.6 % of the air saturation value at the temperature used
- Nominal and measured concentrations:
- Nominal Concentration: 100 mg/L
Measured concentration: 97.95 mg/L at the start and 93.88 mg/L at the end of the test - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquariums with 3 litre test liquid
- Aeration: test solutions were not aerated during the test
- Renewal rate of test solution: at day 2 of the test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.92 g/L in the control and 0.83 g/L in the test item treated group
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ultrapure water (ASTM Type I), prepared by Direct-Q 5 system, MILLIPORE
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light: 8 h dark
EFFECT PARAMETERS MEASURED: mortality, signs of intoxication
TEST CONCENTRATIONS
- Limit concentration: 100 mg/L
- Range finding study: yes, no toxic effects on Zebrafish up to a concentration of 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: measured LC50 for hydrat
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: No
- Observations on body length and weight: No
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- Positive control not conducted.
- Reported statistics and error estimates:
- Since a limit test was performed (and mortality was not occurred), no statistical analysis was necessary. The LC0, LC50, NOEC, LOEC and the LC100 values were determined directly from the raw data.
- Sublethal observations / clinical signs:
Table 1: Cumulative Mortality Data
Test group Cummulative mortality
(initial population = 10 fish / test group)4h 24h 48h 72h 96h Control 0 0 0 0 0 100 mg/L 0 0 0 0 0 Table 2: Measured and calculated Data of Body Weight
Test group Measured weight of 10 fish (g) Calculated mean weight of fish (g) Loading of testing aquarium (g fish/L testing liquid) Control 2.76 0.28 0.92 100 mg/L 2.49 0.25 0.83 Table 3: Body Length of Test Animals
Test group Body length [cm] Control 2.30 2.50 2.30 2.30 2.20 2.25 2.50 2.25 2.45 2.40 100 mg/L 2.25 2.20 2.50 2.35 2.20 2.40 2.25 2.30 2.15 2.45 - Validity criteria fulfilled:
- yes
- Conclusions:
- The 96h-LC50 of the the test item was determined to be > 100 mg/L (nominal, hydrated substance). The test item had no toxic effect on fish at the limit concentration of 100 mg/L (nominal, hydrated substance). The 96-h LC50 and 96-h NOEC was calculated to be > 89.6 mg/L and 89.6 mg/L, respectively, for the anhydrous substance.
- Executive summary:
The acute toxicity of the test substance to zebrafish (Danio rerio) was determined in a 96 -hour semi-static limit-test under GLP conditions according to OECD guideline 203, EU-Method C.1 and EPA OPPTS 850.1075. One single concentration of 100 mg/L was selected on the basis of a preliminary test. The test solution was prepared by mechanical dispersion without using of any solubilising agent and was renewed one during the test (at day 2). A negative control only with test medium (OECD Medium) ran in parallel. The vessel for the test solution and the control were loaded with 10 test organisms each. The measured concentrations of L-aspartic acid sodium salt monohydrate were in the range of 94 – 100 % of the nominal during the experiment. The measured test item concentration remained within ± 20 % of the nominal during the test period of 48 hours, therefore the biological results are based on the nominal concentration. The fish were observed at approximately 4, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. In result, the test item had no toxic effect on fish at 100 mg/L concentration (i.e. limit test concentration). Accordingly, the 96-h LC50 value was determined to be > 100 mg/L (nominal, hydrated substance). The 96-h NOEC was determined to be 100 mg/L (nominal, hydrated substance). The 96-h LC50 and 96-h NOEC was calculated to be > 89.6 mg/L and 89.6 mg/L, respectively, for the anhydrous substance. All validity criteria were met.
Reference
Description of key information
In a acute toxicity test with fish, conducted according to OECD TG 203, EU Method C.1 and OPPTS 850.1075, the 96h-LC50 of the test item was determined to be > 100 mg/L (reference 6.1.1 -1).
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
The acute toxicity of the test substance to zebrafish (Danio rerio) was determined in a 96 -hour semi-static limit-test under GLP conditions according to OECD guideline 203, EU-Method C.1 and EPA OPPTS 850.1075 (reference 6.1.1-1). One single concentration of 100 mg/L was selected on the basis of a preliminary test. A negative control only with test medium (OECD Medium) ran in parallel. The vessel for the test solution and the control were loaded with 10 test organisms each. The measured concentrations of the test item were in the range of 94 – 100 % of the nominal during the experiment. The fish were observed at approximately 4, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. In result, the test item had no toxic effect on fish at 100 mg/L (hydrat) concentration. Accordingly, the 96-h LC50 value was determined to be > 100 mg/L (nominal, hydrated) and calculated as 89.6 mg/L
for the anhydrous substance. The 96-h NOEC was determined to be 100 mg/L (nominal, hydrated substance) and 89.6 mg/L (calculated for the anhydrous substance), respectively. All validity criteria were met.
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.
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