Registration Dossier
Registration Dossier
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EC number: 921-112-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Sample submitted to INTOX PVT. LTD. , 375, Urawade, Tal. Mulshi, Dist. Pune, Maharashtra, 412115, India for analysis.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 40 days
- Reliability:
- 1 (reliable without restriction)
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 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl-L-threonyl-L-lysyl-L-Serine
- EC Number:
- 921-112-4
- Molecular formula:
- C53H91N7O11
- IUPAC Name:
- N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl-L-threonyl-L-lysyl-L-Serine
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- isolated skin discs
- Remarks:
- Epidermal surface of skin
- Source species:
- rat
- Cell type:
- other:
- Cell source:
- other: Epidermal surface of skin
- Source strain:
- Wistar
- Vehicle:
- water
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 150 mg
- Duration of treatment / exposure:
- The test item was applied for upto 24 hours at 22°C
- Number of replicates:
- 3 replicates each for Test item, Positive control and Negative control.
Test animals
- Species:
- rat
- Strain:
- Wistar
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- 24 hours
- Value:
- >= 9.61 - <= 9.61
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: Non Corrosive
- Conclusions:
- The In-Vitro Skin Corrosion Study by TER ( Transcutaneous Electrical Resistance Test Method) for N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl- L-threonyl-L-lysyl-L-Serine is Non-corrosive as per the United Nations (UN) Gloally Harmonised System (GHS) for classification of Chemicals. The Study is performed as per OECD Guideline for testing of Chemicals Guideline No. 430.
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