Registration Dossier
Registration Dossier
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EC number: 630-330-6 | CAS number: 21715-46-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 6-chloro-N-ethyl-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine
- EC Number:
- 630-330-6
- Cas Number:
- 21715-46-8
- Molecular formula:
- C17H18Cl2N2O
- IUPAC Name:
- 6-chloro-N-ethyl-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test item D4223 was applied as supplied at the dose of 16 mg, to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) during 42 minutes.
- Amount/concentration applied:
- The test item D4223 was applied as supplied at the dose of 16 mg
- Duration of treatment / exposure:
- 3 living Reconstructed Human epidermis (SkinEthic RHE® model) during 42 minutes.
- Duration of post-treatment incubation (if applicable):
- The application was followed by a rinse with 25 mL of DPBS and a 42 hours and 05 minutes post-incubation period at 37°C, 5% CO2
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 66
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean percent viability of the treated tissues was 66.0% versus 1.0% in the positive control (5% Sodium Dodecyl Sulfate).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The aim was to evaluate the possible irritating effects of the test item D4223 after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model).
The mean percent viability of the treated tissues was 66.0% versus 1.0% in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008, the test item D4223 has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required. - Executive summary:
The aim was to evaluate the possible irritating effects of the test item D4223 after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model).
The mean percent viability of the treated tissues was 66.0% versus 1.0% in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008, the test item D4223 has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.
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