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Toxicological information

Skin irritation / corrosion

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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:
other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Copper iodide.
- Analytical purity: 99.7%.
- Lot/batch No.: 108701/2 REACH STANDARD 290911
- Storage condition of test material: room temperature in the dark.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: Relative mean viability
Remarks on result:
other: Basis: other: reconstructed human epidermis model. Time point: 240 minute exposure period. Remarks: The relative mean viability of the test item treated tissues was 67.7% after a 240 minute exposure period.
Irritation / corrosion parameter:
other: Relative mean viability
Remarks on result:
other: Basis: other: reconstructed human epidermis model. Time point: 60 minute exposure period. Remarks: The relative mean viability of the test item treated tissues was 84.7% after a 60 minute exposure period.
Irritation / corrosion parameter:
other: Relative mean viability
Remarks on result:
other: Basis: other: reconstructed human epidermis model. Time point: 3 minute exposure period. Remarks: The relative mean viability of the test item treated tissues was 94.2% after a 3 minute exposure period.

Any other information on results incl. tables

RESULTS

Direct MTT Reduction

An assessment found the test item was able to directly reduce MTT. Therefore, an additional procedure using water-killed tissues was performed during the determination of skin corrosion potential. However, the results obtained showed a negligible degree of interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the water-killed tissues for quantitative correction of results or for reporting purposes.

Test Item, Positive Control Item and Negative Control Item

Mean OD540 values and viabilities for the negative control, positive control and test item are given in Table 1 (attached).

The relative mean viability of the test item treated tissues was as follows:

240 minutes exposure: 67.7%

60 minutes exposure: 84.7%

3 minutes exposure: 94.2%

The 3, 60 and 240 minute exposures induced viabilities greater than 35% and therefore the test item did not trigger a corrosive classification.

Quality Criteria

The relative mean tissue viability for the positive control treated tissues was 4.8% relative to the negative control treated tissues following the 240-Minute exposure period. The positive control acceptance criterion was therefore satisfied.

The mean OD540 for the negative control treated tissues was 0.189. The negative control acceptance criterion was therefore satisfied.

The test item was considered to be non-corrosive to the skin.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Copper acetate monohydrate is not classified as corrosive to skin.
Executive summary:

A GLP-compliant study was conducted in accordance with OECD Guideline 431 and EU Method B.40 BIS.  Duplicate tissues were treated with the test itemfor exposure periods of 3, 60 and 240 minutes. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.

At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µl samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density (OD) was measured at 540 nm (OD540).

Data were presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues). The relative mean viability of the test item treated tissues was:

240 minutes exposure: 67.7%

60 minutes exposure: 84.7%

3 minutes exposure: 94.2%

The quality criteria required for acceptance of results in the test were satisfied. 

The test item was considered to be Non-Corrosive tothe skin.