Potassium bromate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr 8-9, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The present study was performed within the framework of toxicity studies of chemicals required by regulatory authorities in accordance with the presently valid OECD Guideline 431 and the Council Regulation (EC) No. 440/2008 and was performed in compliance with the Good Laboratory Practice (GLP) regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 431

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Potassium bromate

EC Number:

231-829-8

EC Name:

Potassium bromate

Cas Number:

7758-01-2

Molecular formula:

BrHO3.K

IUPAC Name:

potassium bromate

Details on test material:

Synonym: Potassium bromate

Test system

Type of coverage:

other: in vitro human skin model

Preparation of test site:

other: in vitro human skin model

Vehicle:

water

Amount / concentration applied:

For the test item 20 mg, for positive and negative controls 40 µL were dosed per tissue

Observation period:

3 min, 1 h

Details on study design:

Positive control: Potassium hydroxide
Negative control: Distilled water

Results and discussion

Any other information on results incl. tables

The results obtained after treatment with Potassium bromate are given in the following table:

dose group	treatment interval	mean optical density	mean relative viability [%]
neg. control	3 min	1.668	100.0
	1 h	2.045	100.0
pos. control	3 min	0.310	18.60
	1 h	0.374	18.30
Potassium bromate	3 min	1.925	115.41
	1 h	1.890	92.43

Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the treatment interval thus ensuring the validity of the test system.

After treatment with the negative control the absorbance values reached the required acceptability criterion of an OD >0.8 for the treatment interval thus showing the quality of the tissues.

The mean relative tissue viability after treatment with the test item was not significantly decreased after treatment. Therefore, the test item is not considered to possess a corrosive potential.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Conclusions:

Under the experimental conditions reported, potassium bromate is not corrosive to skin.

Executive summary:

Purpose
The purpose of this assay was to identify potential of potassium bromate for skin corrosion using an in vitro method as defined by the OECD Technical Guideline for Testing of Chemicals no 431.

Study Design
The test consisted of a topical exposure of the test item to a human reconstructed model followed by a cell viability test. Cell viability was measured by dehydrogenase conversion of MTT into a blue formazan salt, that was quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict skin corrosion.

Triplicates of the human skin model RHE were treated either with the negative or the positive control for 3 minutes and 1 hour. 40 µL of the negative control (distilled water) or 40 µL of the positive control (potassium hydroxide, 8N) were applied to three tissues, respectively. For the test item, potassium bromate, three tissue per time point (3 minutes and 1 hour) was used. 20 mg of the test item were applied to each tissue, spread to match the tissue size.


Results

Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the treatment interval thus ensuring the validity of the test system.
After treatment with the negative control the absorbance values reached the required acceptability criterion of an optical density (OD) >0.8 for the treatment interval thus showing the quality of the tissues.
The mean relative tissue viability after treatment with the test item (potassium bromate) was not significantly decreased after treatment. Therefore, the test item is not considered to possess a corrosive potential.

Conclusion
Under the experimental conditions reported, potassium bromate is not corrosive to skin.