Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Avena Sativa leaf/stem extract
- IUPAC Name:
- Avena Sativa leaf/stem extract
Constituent 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- ca. 84.7
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 91.9
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 81.2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 81.1
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following exposure with EXT. AQ. CONC. PLANTULE AVOINE, the mean cell viability was 84.7% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid.
In conclusion, in this in vitro EPISKINTM (SM) model test with EXT. AQ. CONC. PLANTULE AVOINE (Batch number: 516), the results indicate that the test item is non-irritant to skin.
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