Registration Dossier

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:
2018
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

Constituent 1
Reference substance name:
Avena Sativa leaf/stem extract
EC Number:
948-064-7
IUPAC Name:
Avena Sativa leaf/stem extract

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.