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Toxicological information

Skin irritation / corrosion

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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:
2018
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

Constituent 1
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

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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