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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Details on test system:
The 0.50 cm² reconstructed epidermises (Episkin) were received on 27 February 2018. The same day, the insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The inserts were placed in 6 wells culture plate which had been previously filled with 300 μL of growth medium (Episkin) during 2 hours and 40 minutes. Then just before treatment, the inserts were placed in 24 wells culture plate which had been previously filled with 300 μL of maintenance medium (Episkin).
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
16 mg
Duration of treatment / exposure:
during 42 minutes
Duration of post-treatment incubation (if applicable):
41 hours and 45 minutes post-incubation period
Number of replicates:
3 living Reconstructed Human epidermis

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
ca. 114.7
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The mean percent viability of the tissues treated by the positive control was 1.4%.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item 1,4-DIBROMONAPHTHALENE has to be considered as Non-irritant to skin, in accordance with the Regulation EC No. 1272/2008. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.