Registration Dossier
Registration Dossier
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EC number: 949-344-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.11. 2018 - 25.01.2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride
- EC Number:
- 949-344-1
- Molecular formula:
- C12H16N2O4.ClH and KCl
- IUPAC Name:
- Reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: All cells used were purchased or derived from tissue obtained by MatTek Corporation from accredited institutions.
- Source strain:
- other: Keratinocyte Strain 267S3A
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg
- Duration of treatment / exposure:
- 60 ± 1 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 6 (2 experiments with each 3 replicates)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1
- Value:
- 48.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 2
- Value:
- 38.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as “skin irritant” in accordance with UN GHS “Category 2”. However, as no follow-up studies regarding the endpoint "skin corrosion" were performed, the test item is concluded as " skin corrosive" in accordance with UN GHS “Category 1”.
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