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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
Study period:
2009-08-17 - 2009-10-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, Version 7.6, September 2009
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ceramic materials and wares, chemicals
EC Number:
266-340-9
EC Name:
Ceramic materials and wares, chemicals
Cas Number:
66402-68-4
Molecular formula:
spinel of the pleonaste type containing (Mg,Fe)(Al,Fe)2O4
IUPAC Name:
not applicable

Test animals

Species:
other: Human Skin
Strain:
other: not applicable

Test system

Type of coverage:
open
Preparation of test site:
other: not applicable
Vehicle:
other: wetted with DPBS-buffer
Controls:
other: positive control: Sodium dodecylsulphate, negative control: DPBS buffer
Amount / concentration applied:
Tissue Amount
1 25.9 mg
2 25.1 mg
3 24.7 mg
Duration of treatment / exposure:
60 minutes
Observation period:
ca. 57 hours
Number of animals:
3 tissues

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: % Formazan production
Value:
113.2
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 min.. Max. score: 50.0. Reversibility: no data. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered not irritant.
After the treatment, the relative absorbance values were increased to 113.2%: The value of the test item was higher than the value of the negative control.
The optical density of the negative control was well within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 15.8 % (required: < 20%) thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item.
For these reasons, the result of the test is considered valid.
Executive summary:

The test item is considered not irritant.

After the treatment, the relative absorbance values were increased to 113.2%: The value of the test item was higher than the value of the negative control.

The optical density of the negative control was well within the required acceptability crite­rion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative ab­sorbance as compared to the negative control to 15.8 % (required: < 20%) thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item.

For these reasons, the result of the test is considered valid.