Iodine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: 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: Guideline study not following GLPs

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Iodine

EC Number:

231-442-4

EC Name:

Iodine

Cas Number:

7553-56-2

Molecular formula:

I2

IUPAC Name:

iodine

Details on test material:

- Name of test material: Iodine
- Substance type: Inorganic
- Physical state: Solid
- Analytical purity: min 99.8%
- Impurities: None relevant for classification and labelling
- Lot/batch No.: No indicated
- Expiration date of the lot/batch: Not applicable

In vitro test system

Test system:

artificial membrane barrier model

Justification for test system used:

The Corrositex test is a standardized and reproducible method that can be employed to determine the potential corrosivity and the Packing Group classification of specified categories of chemical compounds under the hazardous materials transportation regulations administered by the U.S. Department of Transportation (DOT) and international dangerous goods codes. The Corrositex test predicts the in vivo corrosive potential of a chemical compound or mixture by using as an endpoint the amount of time it takes for a chemical to permeate through or destroy a synthetic biobarrier. A color change in a proprietary liquid Chemical Detection System (CDS) is used to indicate that the chemical has passed through the biobarrier.

Vehicle:

unchanged (no vehicle)

Details on test system:

The corrositex assay is a three step procedure. First, the sample is qualified to ensure that the test sample is compatible with the Corrositex system, then it is categorized according to pH, and finally it is classify based on the time the sample takes to break through the biobarrier.
Qualify: An aliquot of the sample was aded to the Chemical Detection System (CDS) reagent, and the vial was observed for any notable colour change. An observable colour change indicates that the test sample is compatible with the Corrositex system.
Categorize: The sample was categorized which determined cut-off times for the classification designation. A 10% aqueous solution of the sample was prepared, and the pH was measured. Based on the pH of a 10% solution, an aliquot was added to a respective Indicator Tube, based on the final pH of the Indicator Tube, a category was assigned to the sample (alternative method).
Classify: 500 mg of undiluted sample was added to 4 test vials containing biobarriers. A positive control was performed using 1.0 N sodium hydroxide. A negative control was also performed. The amount of time required for the test material to destroy the biobarrier was recorded and used to designate the classification.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: 500 mg of undiluted sample.
VEHICLE
- Amount applied: No vehicle was used.

Number of replicates:

4 for test item, one negative and one positive control

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Value:

> 65

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Non-corrosive

Any other information on results incl. tables

The results indicated that the test sample was compatible with the Corrositex assay. The sample was categorized in Category 2 (table 1)

Table 1: Summary of results of qualification and categorization step

Concentration tested:	100%
pH taken from 10% aqueous solution	4.83
Colour in tube A/B	None
pH taken from tube A/B	7.03/6.65
Category	2

The penetration time and results are presented in Table 2.

Table 2: Penetration time and results.

Corrositex time (minutes)
Replicate #1	> 65
Replicate #2	> 65
Replicate #3	> 65
Replicate #4	> 65
Mean	> 65
Positive control #1	17
Positive control #2	16
Classification	Non-corrosive

Applicant's summary and conclusion

Interpretation of results:

other: Non-Corrosive

Remarks:

Criteria used for interpretation of results: other: Dir. 67/548/EC, GHS and UN Packing Group Classification

Conclusions:

The findings of the study lead to the designation of the sample as a non-corrosive substance

Executive summary:

The test item was analyzed by the Corrositex test method to determine its corrosive potential and its classification.

The Corrositex test predicts the in vivo corrosive potential of a chemical compound or mixture by using as an endpoint the amount of time it takes for a chemical to permeate through or destroy a synthetic biobarrier. A color change in a proprietary liquid Chemical Detection System is used to indicate that the chemical has passed through the biobarrier.

The results of this study indicated that the sample was compatible with the Corrositex system and was determined to be a Category 2 sample. The results obtained from the evaluation of four replicates samples were consistent (> 65 minutes), demonstrating that a mean time of > 65 minutes was required to destroy the synthetic biobarriers. These findings lead to the classification of test item, as a Non-Corrosive material.