Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01/03/2016 - 26/04/2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
OECD Guideline for the Testing of Chemicals No. 439: In Vitro Skin Irritation: Reconstructed human Epidermis Test Method, 28 July 2015
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
The test material corresponded to the approximately 45% of the registration substance in water.

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: EPISKIN-SM™ (SkinEthic)
Vehicle:
unchanged (no vehicle)
Remarks:
The test material corresponds to the approximately 45% of regstration substance in water.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
10 µl
Duration of treatment / exposure:
15 min
Duration of post-treatment incubation (if applicable):
42h
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
100.8
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the present study, the registration substance is not skin irritating.
Executive summary:

The skin irritation property of the registration substance was investigated according to the OECD Gudieline 439. The reconstructed skin model was used as test system. No significant reduction in the cell viability was found after 15 min treatment with 10 µl test material which corresponded to 45% of the registration substance in water. No significant skin irritation property could be derived. No classification is warranted.