Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study by a laboratory having a GPL certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate on march 30th 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

This in vitro study was performed to assess the corrosive potential of Urethane Resin M2001 by means of the Human Skin Model Test.

Independant duplicate tissues of the human skin model EST-1000 were exposed either to either the test item, the negative control or the positive control for 3 minutes and 1 hour, respectively.

The liquid test (50µL) was applied to each tissue and spread evenly over the surface of the tissue.

A volume of 50µL of either the negative control (deionised water) or the positive control (8.0 N KOH) was applied to each tissue

After exposure to the negative control the absorbance values exceeded the required acceptability criterion of mean OD570 > 0.8 for both treatment intervals thereby confirming the acceptable quality off tissues.

Exposure to the positive control induced a decrease in the relative absobance as compared to the negative contol, both for the 3 minutes exposure period and for the i hour exposure period thus confirming the validity of the test system.

After exposure to the test item Urethane Resin M2001 the relative absorbance values were decreased to 60.6% after 3 minutes. After the 1 hour exposure relative absorbance values were reduced to 76.7%. Both values did not exceed the threshold for corrosivity of 50% for the 3 minutes exposure and 15% for the hour explosure. Therefore, the test item was not considered to be corrosive.

In conclusion, it can be stated that in this study and under the reported experimental conditions, the test item Urethane Resin M2001 was non corrosive to skin.

Applicant's summary and conclusion