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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 26 june 2020
- 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
CAS number: 323194-76-9
Lot number: Z201125/ VG29848563
Description: Crystalline solid, white powder
Expiry date: 24 November 2022
Storage conditions: Room temperature (15-25 ºC), protected from humidity (tight closed container)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
In vitro test system
- Test system:
- human skin model
- Source species:
- other: EpiDerm (Source: MatTek Corporation, USA) is a three-dimensional human epidermis model.
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Source: MatTek Corporation, USA
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm (Source: MatTek Corporation, USA) is a three-dimensional human epidermis model. It consists of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. The NHEK, which are cultured on specially prepared cell culture inserts using serum free medium, attain levels of differentiation. Ultrastructurally, the EpiDerm Skin Model closely parallels human skin, thus providing a useful in vitro means to assess dermal irritancy and toxicology [5].
The EpiDerm Skin Model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. EpiDerm consists of organized basal, spinous, granular, and cornified layers analogous to those found in vivo. EpiDerm is mitotically and metabolically active. Markers of mature epidermis specific differentiation such as profilaggrin, the K1/K10 cytokeratin pair, involucrin, and type I epidermal transglutaminase have been localized in the model. Ultrastructural analysis has revealed the presence of keratohyalin granules, tonofilament bundles, desmosomes, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns characteristic of in vivo epidermis [ - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of the test item was applied on the surface of the tissues with 1 minute interval between two applications, under laminar flow hood.
- Duration of treatment / exposure:
- Following the end of the last application, all plates were placed into the incubator (37±1°C, 5±1% CO2, 90±10% RH) for 35±1 minutes.
- Duration of post-treatment incubation (if applicable):
- After 35 minutes, all plates were removed from the incubator, and kept at room temperature under the sterile hood until the period of 60-minutes exposure period had been completed for the first dosed tissue.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- >= 88.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
VIABILITY RESULTS
The results of the Optical Density (OD) measured at 570 nm of each sample and the calculated relative viability % values are presented in Table 2. The mean OD value for the test item treated skin tissues showed 88.6% of the Negative Control (NC). NC values were not below the historically established boundaries; tissues treated with the NC item reflected their ability to respond to an irritant chemical under the conditions of this study, therefore all validity criteria met according to OECD 439.
Table 2 – Viability results
Tissue treated | Optical density | Viability% | ||
Tissue number | OD mean (corrected) | Individual | Mean | |
Negative control (DPBS) | #1 | 1.784 | 104.6 | 100 |
#2 | 1.685 | 98.7 | ||
#3 | 1.650 | 96.7 | ||
Historical control range | 1.338-1.812 | – | – | |
Positive control (5% SDS) | #1 | 0.068 | 4.0 | 3.6 |
#2 | 0.071 | 4.2 | ||
#3 | 0.044 | 2.5 | ||
Historical control range | 0.006-0.160 | – | – | |
L-aspartic acid, sodium salt monohydrate | #1 | 1.448 | 84.8 | 88.6 |
#2 | 1.572 | 92.1 | ||
#3 | 1.515 | 88.8 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following exposure with the test item, the mean cell viability was 88.6% after 60-minute exposure, compared to the concurrent negative control. This is above the thresholds of 50%, therefore the test item was considered as being Non-irritant according to the UN GHS/EU CLP Classification criteria. The experiment met all the validity criteria; therefore, the study was considered to be valid.
In conclusion, based on the result of this present study, the test item L-aspartic acid, sodium salt monohydrate is considered not irritant to skin.
- Executive summary:
An in vitro skin irritation test with the test item L-aspartic acid, sodium salt monohydrate was performed in a reconstructed human epidermis model. EpiDerm™ is designed to predict and classify the irritancy potential of chemicals by measuring its cytotoxic effect as reflected in the MTT(3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay. The irritability of the test item was evaluated according to the OECD No. 439 guideline.
Three tissues per exposure time were treated for 60 minutes. Exposure of test material was terminated by rinsing with DPBS solution. The viability of each tissue was assessed by incubating the tissues for 3 hours with MTT solution. The precipitated formazan crystals were then extracted using an extractant (isopropanol) and then quantified spectrophotometrically at 570±10 nm.
DPBS and aqueous SDS solution treated tissues were used as negative and positive controls, respectively (three tissues/compound). For each treated and control tissue, cell viability was expressed as a % relative to the concurrent negative control.
Following exposure with the test item, the mean cell viability was 88.6% after 60-minute exposure, compared to the concurrent negative control. This is above the threshold of 50%, therefore the test item was considered as being Non-irritant according to the UN GHS/EU CLP Classification. The experiment met all the validity criteria; therefore, the study was considered to be valid.
In conclusion, based on the result of this present study, the test item L-aspartic acid, sodium salt monohydrate is considered not irritant to skin.
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