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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guideline 431
Deviations:
no
Principles of method if other than guideline:
In vitro skin corrosion test: "Human Skin Model Test", April 2004 B.40 bis
3-D human skin model (EPI-200)

Evaluation criteria: The OD values obtained of each sample are used for calculating the percentage viability compared to the negative control, which is defined to be 100%. Based on this percentage of viable cells and the criteria defined below the test item is classified to be corrosive or non-corrosive.
Considered corrosive: viability after 3 min of exposure is <50%
Considered corrosive: viability after 3 min of exposure is >=50% and the viability after 1 hr of exposure is <15%
Considered non-corrosive: viability after 3 min of exposure is >=50% and the viability after 1 hr of exposure is >=15%

There were no modifications to the test procedure.

Test doses: approx. 50 µl per insert (tissue diameter: 8 mm; culture area: 0.6 cm2)

No other effects observed.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The pasty test item was applied by using an applicator made from a 1 ml disposable syringe. The application of the test item was difficult. A complete removal of the residues of the test item was not possible. --- Negative control: Distlled water (water for injections; Serumwerk Bernburg AG); Positve control: KOH as 8 N solution (preparation: 2.24 g in 5 ml distilled water)

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other:
Value:
ca. 2.23
Remarks on result:
other:
Remarks:
Time point: 3 min and 1 hr. Max. score: 2.49. Remarks: OECD 431. (migrated information)

In vivo

Irritant / corrosive response data:
The test item is non-corrosive.

Exposure time 3 min
Viability negative control: 100%
Viability positive control: 38%
Test item: 97%

Exposure time 1 hr
Viability negative control: 100%
Viability positive control: 9%
Test item: 90%

Reproducibility was very good (n=3)

Applicant's summary and conclusion

Conclusions:
Cell viability in test item group (in % of untreated control)
after 3 min: 97%; after 1 hr: 90%

OD mean score
3 min: 2.194 in test item group (negative control: 2.264; positive control: 0.857)
1 hr: 2.271 in test item group (negative control: 2.531; positive control: 0.223)

The test item is non-corrosive.