Registration Dossier
Registration Dossier
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EC number: 290-272-9 | CAS number: 90106-49-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 july to 8 august 2018
- 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes
- Remarks:
- GLP certificate in annex 1 of the final report
Test material
- Reference substance name:
- Sage, Salvia lavandulifolia, ext.
- EC Number:
- 290-272-9
- EC Name:
- Sage, Salvia lavandulifolia, ext.
- Cas Number:
- 90106-49-3
- Molecular formula:
- no relevant UVCB
- IUPAC Name:
- Sage, Salvia lavandulifolia, ext.
- Test material form:
- liquid
- Details on test material:
- UVCB
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: Reconstructed human epidermis
- Cell type:
- other:
- Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- after a treatment of 3 min and 1 hour (see annexes 2 and 3 of the final report)
- Duration of treatment / exposure:
- 3 minutes at room temperature and 1 hour at 37°C +/- 1°C
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- dose of 50 µL
- Duration of treatment / exposure:
- 3 minutes and 1 hour
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min
- Value:
- 102.77
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 1 hour
- Value:
- 35.86
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- 3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 102.77% (considered as 100%) and 35.86%, versus 8.19% and 0.66%, respectively, with the positive control item (potassium hydroxide 8N).
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item SPANISH SAGE OIL (Salvia lavandulifolia) does not have to be classified in Category 1 “Corrosive”.
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