Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
28 July 2015
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
23 July 2009
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder

In vitro test system

Test system:
human skin model
Source species:
human
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
16 mg per 0.50 cm² of human skin model
Duration of treatment / exposure:
42 minutes
Duration of post-treatment incubation (if applicable):
42 hours post-treatment incubation-period in fresh medium at 37°C, 5% CO2.
Number of replicates:
3 living Reconstructed Human epidermis

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable
Remarks:
the mean viability was not evaluable due to a dark purple coloration of the epidermis treated with BLACK 407.
Other effects / acceptance of results:
After the incubation period of 42 hours a dark purple coloration of the epidermis treated with BLACK 407 was noted.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under these experimental conditions, the purple coloration was very marked and was to high to conclude on the classification of the test item. Therefore, this test is not adapted for the test item.

Categories Display