Registration Dossier

Administrative data

Endpoint:
skin corrosion: 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:
not specified

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
Vehicle:
unchanged (no vehicle)
Amount/concentration applied:
16 mg
Duration of treatment / exposure:
42 h

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean
Value:
83.8
Positive controls valid:
yes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean percent viability of the treated tissues was 83.8% versus 1.0% in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008, the test item D305 has to be considered as Non-irritant to skin.
Executive summary:

The irritation potential was evaluated according OECD 439 method.

The mean percent viability of the treated tissues was 83.8% versus 1.0% in the positive control (5% Sodium Dodecyl Sulfate).

In accordance with the Regulation EC No. 1272/2008, the test item D305 has to be considered as Non-irritant to skin.