Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: RECONSTRUCTED HUMAN EPIDERMIS 0.5 cm2 reconstructed epidermal of normal human keratinocytes
Cell source:
other: The inserts (SkinEthicTM RHE or RHE) supplied by SkinEthic.
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Test animals

Species:
other: reconstructed human epidermis

Test system

Type of coverage:
not specified
Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 75.12
Positive controls valid:
yes

Applicant's summary and conclusion

Conclusions:
According to OECD 439:2015, under the test conditions applied, the test substance is considered NON IRRITAN.