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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-155-6 | CAS number: 17090-93-6
- 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 aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 13th April 2004
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- sodium 2-amino-3-carboxypropanoate
- Cas Number:
- 323194-76-9
- Molecular formula:
- C4H7NO4.xNa
- IUPAC Name:
- sodium 2-amino-3-carboxypropanoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name: L-aspartic acid, sodium salt monohydrate 1
Batch/Lot number: Z201125/ VG29848563
CAS number: 323194-76-9
Anhydrous substance name: L-aspartic acid, sodium salt, CAS: 17090-93-6
Appearance: Solid, white, crystalline powder
Purity: 98%
Expiry date: 24 November 2022
Storage conditions: Room temperature (15-25 ºC), protected from humidity (tight closed
container)
Constituent 1
- Specific details on test material used for the study:
- Name: L-aspartic acid sodium salt monohydrate
Lot number : VG29848563
CAS number: 323194-76-9
Description: Solid, crystalline powder, white
Expiry date: 24 November 2022
Purity: 100 %
Storage conditions: Room temperature (15-25ºC, below 70% relative humidity)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The analytical phase of the study was conducted at the Test Facility. For determination of the test item
concentration, samples were taken from the test solutions and the controls at the start and at the end of
the experiment. Samples were shipped immediately after collection for concentration measurement to
the Test Facility.
The concentration analyses were conducted under the control of the Analyst, based on the analytical
method validation and in compliance with the relevant SOPs of the Test Facility. The results are
included in the Study Report as Appendix 2.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The stock solutions was prepared in the daphnia media using 100 mg/L test item. Twenty Daphnia per test group and control, divided into four groups of five animals, each group in approx. 50 mL test medium.
A stock solution of 100 mg/L was first prepared by dissolving the test item in the ISO water. The test
solutions were prepared by appropriate dilution (10, 100, 1000 and 10000 fold) of this stock solution.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
Species and strain: Daphnia magna laboratory strain
Sex: Female
Source: 100 female D. magna were issued from the National Institute of Pharmacy and were cultured and maintained further in the Test Site’s laboratory.
Justification of species: Daphnia magna is the standard species of the acute immobilisation test.
Number of animals: There were 20 animals at each group (concentration and untreated control) divided into 4 replicates
(5 animals/1 parallel)
Age of animals: Less than 24 hours old at the beginning of the test. The first breeding of the previous generation was not used.
Acclimatization: To avoid the necessity of adaptation prior to the test, the environmental conditions used in the experiment were similar to the culture conditions (water temperature, pH and light period).
Holding water: Same water was used as test water (see 3.2.3.).
Food and Feeding: The Daphnia group was fed with concentrated algal suspension of Raphidocelis subcapitata. Test animals were not fed during the exposure.
Breeding conditions: Daphnids were cultured in 5 L beakers in an incubator operated for this purpose, with a dark-light cycle (16 hours light) and temperature control (22 ± 1 °C). The system was located in the Test Site.
During the maintenance of the stock, the phenological appearance of the animals were constantly monitored and only healthy animals were kept in the culture.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 22+-1 C
- pH:
- The pH was measured in the control(s) and in the test solutions at the start and at the end of the experiment. The pH did not vary by more than 1.5 units in any test.
- Dissolved oxygen:
- The oxygen concentration was ≥ 3 mg/L of the air saturation value at the temperature used
- Nominal and measured concentrations:
- measured
- Details on test conditions:
- The test was conducted in a static system layout.
The vessels were held for the duration of the study in a climate chamber under controlled conditions, The test temperature was 22 ± 1 °C. The water temperature was determined daily in one control test vessel and continuously with a min/max thermometer in the climate chamber.
The oxygen concentration and pH were measured in the control(s) and in the test solutions at the start and at the end of the experiment. The oxygen concentration was ≥ 3 mg/L of the air saturation value at the temperature used. The pH did not vary by more than 1.5 units in any test.
The light-dark cycle during the test was 16 hours light (artificial illumination) and 8 hours darkness. - Reference substance (positive control):
- yes
- Remarks:
- For the evaluation of the quality of the Daphnia clones and the experimental conditions, Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- One immobilised daphnid was seen in the highest dose at 24 hours, no other abnormality or any other adverse effects (including abnormal behaviour) was observed during the test at any concentrations and at any exposure time.
- Results with reference substance (positive control):
- For the evaluation of the quality of the Daphnia clones and the experimental conditions, Potassium
dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this 48-hour acute toxicity test with Daphnia magna, the 48 h EC50 and EC100 values were
determined to be higher than 100 mg/L, and the 48 h NOEC was determined as 100 mg/L. The results are based on the nominal concentration of the test item L-aspartic acid sodium salt monohydrate. - Executive summary:
The aim of the study was to evaluate the acute toxicity of the test material using the Daphnia sp., acute immobilisation test, conducted on Daphnia magna, under GLP circumstances.
The study was conducted in accordance with OECD Guideline for testing of chemicals on Daphnia sp., Acute Immobilisation Test (No. 202, adopted by the council on 13th April 2004).
As only one animal died during the non-GLP preliminary study, a limit test was performed. The test animals were exposed to aqueous test media containing the test item for 48 hours at only one technical concentration (100 mg/L) plus a control in order to demonstrate that the test item has no influence on the mobility of Daphnia up to at least this test concentration. Considering the information about the stability of the test item, a static test was performed.
Samples were taken and analysed from the test concentration and the control at the start and at the end of the experiment. The quantification of the test item was performed by the analytical laboratory of the test facility. As the concentration of the test item in the treated group did not fall more than 4%, the results are given based on the nominal concentration.
There was no mortality/immobilization in the daphnids exposed to either test item treated or control group. In addition to immobility, no abnormal behaviour or appearance of test animals was detected.
Accordingly, the 48-h NOEC was determined as 100 mg/L. The 48-h EC50 and EC100 values were determined to be higher than 100 mg/L. All biological results are related to the nominal test item concentration.
Conclusion: In this 48-hour acute toxicity test with Daphnia magna the 48 h EC50 and EC100 values were determined to be higher than 100 mg/L, and the 48 h NOEC was determined as 100 mg/L.
The results are based on the nominal concentration of L-aspartic acid sodium salt monohydrate.
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.