Copper iodide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Copper iodide

EC Number:

231-674-6

EC Name:

Copper iodide

Cas Number:

7681-65-4

Molecular formula:

CuI

IUPAC Name:

λ¹-copper(1+) iodide

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

Results

Irritation / corrosion parameter:

other: Relative mean viability

Remarks on result:

other: Basis: other: reconstructed human epidermis model. Time point: 15 Minute exposure period. Remarks: The relative mean viability of the test item treated tissues was 16.5% after a 15 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 irritation 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

The individual and mean OD540 values, standard deviations and tissue viabilities for the test item, negative control item and positive control item are given in Table 1 (attached). The mean viabilities and standard deviations of the test item and positive control, relative to the negative control are also given in Table 1.

The relative mean viability of the test item treated tissues was 16.5% after a 15‑Minute exposure period. It was considered unnecessary to perform IL-1aanalysis as the results of the MTT test were unequivocal.

Quality Criteria

The relative mean tissue viability for the positive control treated tissues was 7.2% relative to the negative control treated tissues and the standard deviation value of the percentage viability was 3.3%. The positive control acceptance criterion was therefore satisfied.

The mean OD540 for the negative control treated tissues was 0.777 and the standard deviation value of the percentage viability was 1.6%. The negative control acceptance criterion was therefore satisfied.

The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 4.9%. The test item acceptance criterion was therefore satisfied.

CONCLUSION

The test item was considered to be irritating..

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Copper iodide was considered to be irritating to skin.

Executive summary:

A GLP-compliant in-vitro study was conducted using the EPISKIN reconstructed human epidermis modelin accordance with the requirements of OECD Guideline 439 and EU Method B.46. Triplicate tissues were treated with the test item for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. 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 was measured at540 nm. Data are 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 16.5% after the 15-Minute exposure period. The quality criteria required for acceptance of results in the test were satisfied.

The test item was classified as irritant. The following classification criteria apply: EU DSD (67/548/EEC) Irritant requires symbol “Xi” risk phrase R38 “Irritating to Skin”. EU CLP and UN GHS Hazard statement H315 “Causes Skin Irritation” Category 2.