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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vitro test system

Test system:
human skin model
Details on test system:
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT
Day of delivery: 13. Nov. 2018
Batch no.: 28668
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
30 µl
Duration of treatment / exposure:
1 h
Duration of post-treatment incubation (if applicable):
23.5 h
Number of replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
1 433
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
2
Value:
1 522
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3
Value:
1 180
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

For the test item and the positive control, the following percentage values of tissue viability were calculated in comparison to the negative control:

Designation

Test-Item

Positive Control

% Tissue viability (tissue 1)

89.8%

2.8%

% Tissue viability (tissue 2)

95.4%

2.4%

% Tissue viability (tissue 3)

74.0%

2.3%

% Tissue viability (mean)

86.4%

2.5%

± SD of mean tissue viability (%)

11.1%

0.3%

Validity criteria and results are stated in the following table:

Criterion

Demanded

Found

Mean OD of negative control

≥0.8 and ≤ 2.8

1.6

Mean % tissue viability
of positive control SDS

≤20% of

negative control

2.5%

SD of mean viability of the

tissue replicates (%)

≤18%

2.9% (negative control)
0.3% (positive control)
11.1% (test item)

 

All validity criteria were met.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean value of relative tissue viability of the test item was reduced to 86.4% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin.
Executive summary:

The test item is considered as non-irritant to skin.

After the treatment, the mean value of relative tissue viability was reduced to 86.4%. This value is above the threshold for skin irritation (50%).

The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.

The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.

Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).

For these reasons, the result of the test is considered valid.