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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Test animals

Species:
other: EpiDermTM tissue
Strain:
not specified
Details on test animals and environmental conditions:
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
yes

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 91.8
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
3-acetylthiazolidine-4-carboxylic acid is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.