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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study available as unpublished report. Limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
other: Summary Report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
EpiDerm corrosivity-test in vitro
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: 2,6-Dimethyl-4-tert.-butylbenzylcyanid
- pH: ca. 5

Test animals

Species:
other: EpiDerm™ tissues (reconstructed three dimensional human epidermis model)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: negative and positive controls
Duration of treatment / exposure:
3 minutes and 1 hour
Number of animals:
2 tissues per application time
Details on study design:
Two EpiDerm tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability.
The tissue viability was calculated by reading Optical Densities (OD) using a spectrophotometer at 570 nm wavelength.

EVALUATION OF RESULTS
A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
108
Remarks on result:
other:
Remarks:
Basis: mean. Remarks: corrosion, exposure: 3 min, mean OD570: 2.312. (migrated information)
Irritation / corrosion parameter:
other:
Value:
108
Remarks on result:
other:
Remarks:
Basis: mean. Remarks: corrosion, exposure 1 hour, mean OD570: 2.725. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Conclusions:
Under the conditions of the test the substance is considered to be not corrosive to the skin.
Executive summary:

The corrosive potential was determined in an EpiDerm™ Corrosivity-Test in vitro. Two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue viability was determined after exposure to the test substance. There was no decrease in tissue viability observed after 3 minute or 1 hour exposure. Based on these results the test substance was considered to be non-corrosive.