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EC number: 221-305-7 | CAS number: 3061-88-9
- 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
- Study period:
- 20.05.2020 - 29.05.2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- L-alanyl-L-tyrosine dihydrate
- Cas Number:
- 2219303-86-1
- Molecular formula:
- C12H16N2O4.2 H2O
- IUPAC Name:
- L-alanyl-L-tyrosine dihydrate
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST SYSTEM
- EpiDerm Skin Model (EPI-SIT, Lot no.: 30869 Kit Q)
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
TREATMENT
Before the assay was started the tissues were transferred to new 6-well plates containing 0.9 mL Assay medium per well. At least 25 mg solid was added into the 6-well plates on top of the skin tissues. Test items tissues were moistened before application of the test item with DPBS (25 µL), to ensure close contact to the tissue. Three tissues were treated with 30 µL DPBS (negative control) and 3 tissues with 30 µL 5% SDS (positive control) respectively.
After the exposure period with the test item (35 ± 1.0 minutes at 37.0 ± 1.0°C and the remaining period of the 60 ± 1 minutes test item exposure at room temperature ), the tissues were thoroughly rinsed with Dulbecco’s phosphate buffered saline (DPBS) to remove residual test item. If necessary cotton wool swabs were used to remove any remaining test item. After rinsing the cell culture inserts were each dried carefully and moved to a new well on 0.9 mL pre-warmed assay medium until all tissues were dosed and rinsed. Subsequently the skin tissues are incubated for 24 ± 2 hours at 37°C. The tissues were transferred to 0.9 mL fresh Assay medium and placed back for a post-incubation period of 18 ± 2 hours at 37°C.
CELL VIABILITY MEASUREMENT
After incubation, cell culture inserts were dried carefully to remove excess medium. The cell culture inserts were transferred into a 24-wells plate prefilled with 0.3 mL MTT-medium (1.0 mg/mL). The tissues were incubated for 3 hours ± 5 minutes at 37°C. After incubation the tissues were placed on blotting paper to dry the tissues. After incubation the tissues were washed with DPBS and formazan was extracted with 2 mL isopropanol for at least 2 hours at room temperature with gentle shaking. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the TECAN Infinite® M200 Pro Plate Reader.
Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test item was classified according to remaining cell viability following exposure of the test item.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- A test item is considered irritant in the skin irritation test if:
The relative mean tissue viability of three individual tissues after 60 minutes of exposure to the test item and 42 hours of post incubation is ≤ 50% of the mean viability of the negative controls.
- A test item is considered non-irritant in the in vitro skin irritation test if:
The relative mean tissue viability of three individual tissues after 60 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 38.2 to 40.6 mg
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 99
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test item was checked for possible direct MTT reduction and color interference in the Skin corrosion test using EpiDerm as a skin model (Test Facility Study No. 20245940). Because the solutions did not turn blue / purple and/or a blue / purple precipitate was observed and/or the OD for the test item solution was ≤0.08, therefore it was concluded that the test item did not interfere with the MTT endpoint.
The relative mean tissue viability obtained after 60 ± 1 minutes treatment with the test item compared to the negative control tissues was 99%. Since the mean relative tissue viability for the test item was above 50% the test item is considered to be non-irritant.
The positive control had a mean cell viability of 3.9% after 60 ± 1 minutes exposure. The absolute mean OD570 of the negative control tissues was slightly above the laboratory historical control data range, but well within the acceptance limits of OECD439 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8). As the laboratory historical control data is limited and the OECD439 range is leading, this is acceptable. The standard deviation value of the percentage viability of three tissues treated identically was less than 2%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- L-Alanyl-L-Tyrosine (L-Ala-L-Tyr) is non-irritant in the in vitro skin irritation test under the experimental conditions described.
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