Registration Dossier
Registration Dossier
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EC number: 831-423-6 | CAS number: 2125692-22-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5/3/18 - 31/5/18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of L-valine and ethanesulphonic acid and octadecan-1-ol and docosan-1-ol and eicosan-1-ol
- Cas Number:
- 2125692-22-8
- Molecular formula:
- C25-31H54-66NO5S
- IUPAC Name:
- Reaction mass of L-valine and ethanesulphonic acid and octadecan-1-ol and docosan-1-ol and eicosan-1-ol
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- product applied neat, 25mg
- Duration of treatment / exposure:
- 60-min exposure period
- Number of replicates:
- 3
Test system
- Vehicle:
- unchanged (no vehicle)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 105.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test material had tissue viability of 105.1%, and therefore was classified as nonirritant (NI).
- Executive summary:
Study 048-18 is intended to evaluate the skin irritation potential of topically applied test artcile using the EpiDerm Skin Irritation Test.
Study Design
EpiDerm (EPI-200), produced by MatTek Corporation, was used to evaluate skin irritation potential of a topically applied test article. Tissue viability following topical application of test article was evaluated via MTT assay.
Results
PC (5% SDS) decreased tissue viability to 2.501%. The tissue viability of tissues treated with test article was 105.1% and hence was classified as non-irritant (NI).
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