Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 February 2018 to ****
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
Purity: >94% (nominal); This substance has an Unknown or Variable composition, is a Complex reaction product, or a Biological material (UVCB).
Sponsor Description: Brown paste to very viscous liquid
Envigo Description: Amber colored viscous liquid
Storage Conditions: Room temperature (15-25°C) in the dark

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: not specified
Vehicle:
unchanged (no vehicle)
Details on test system:
The EPISKINTM Kit consisted of one EPISKIN™ plate containing 12 reconstructed human epidermis tissues (0.38 cm2), maintenance medium (used for tissue pre-conditioning and testing purposes) and assay medium (used for MTT assay).

The test item was found to directly reduce MTT in the pre-test for direct MTT reduction and therefore additional non-viable tissues were incorporated into the testing for correction purposes. The test item was found to have the possibility to cause color interference with the MTT endpoint therefore, as a precaution, additional tissues were incorporated into the testing to correct for this.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
10 µL (26.3 µL/cm2)
Duration of treatment / exposure:
Triplicate tissues were treated with the test item for an exposure period of 15 minutes.
Duration of post-treatment incubation (if applicable):
42 hour post-exposure incubation period.
Number of replicates:
Three.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
15 minute exposure period and 42 hours post exposure
Value:
ca. 30
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the conditions of the study, the relative mean tissue viability of tissues treated with the test material was 30.0%, less than 50%.
Executive summary:

Under the conditions of the study, the relative mean viability of tissues treated with the test material was 30.0%, less than 50%, and therefore, the test item demonstrated the ability to cause a positive response as skin irritant. 

However this study does not allow the conclusion on whether the test item is Category 1 or Category 2 of Regulation (EC) No. 1272/2008 Classification, Labelling and Packaging of Substances and Mixtures (EU CLP) and United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).