Triethylammonium bromide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October - November 2013

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Deviations:

no

Principles of method if other than guideline:

None as known.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Triethylammonium bromide

EC Number:

211-263-8

EC Name:

Triethylammonium bromide

Cas Number:

636-70-4

Molecular formula:

C6H15N.BrH

IUPAC Name:

N,N-diethylethanaminium bromide

Test material form:

solid: crystalline

Details on test material:

Name triethylammonium bromide
Batch no. 32541
Appearance white crystals
Composition triethylammonium bromide, water
CAS No. 636-70-4
EINECS-No. 211-263-8
Molecular formula C6H16BrN
Molecular weight 182.10 g/mol
Purity 98.2 % (argentometry)
Homogeneity homogeneous
Production date 11. Sep. 2013
Expiry date 10. Sep. 2028
Storage room temperature, (20 ± 5°C); kept away from light

Test system

Type of coverage:

other: Commercially available Epi-200-Kit

Results and discussion

Any other information on results incl. tables

Findings and Result

Measured Values

The absorption values of negative control, test item and positive control are given in the following table:

Negative Control		Test Item		Positive Control		Incubation
Tissue 1	Tissue 2	Tissue 1	Tissue 2	Tissue 1	Tissue 2
2.163	1.836	1.937	1.867	0.378	0.416	3 min
2.137	1.826	1.967	1.826	0.405	0.415
2.132	1.818	1.932	1.847	0.405	0.416
1.830	1.878	1.485	1.423	0.179	0.198	1 hour
1.866	1.864	1.550	1.455	0.192	0.201
1.832	1.858	1.565	1.443	0.194	0.199
Mean		Mean		Mean
1.985		1.896		0.406		3 min
1.855		1.487		0.194		1 hour

 

Comparison of Formazan Production

For the test item and the positive control, the following percentage values of mean formazan production were calculated in comparison to the mean of the negative controls:

Test Item	Positive Control	Incubation
95.5 %	20.4%	3 min
80.2 %	10.5 %	1 hour

 

Corrosivity of the Test Item

The relative absorbance values were reduced to 95.5 % after three minutes treatment. This value is above the threshold for corrosivity (50 %). After one hour treatment, the relative absorbance values were reduced to 80.2%, lying above the threshold for corrosivity (15 %). Therefore, the test item is considered as not corrosive.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

 Triethylammonium bromide is considered as not corrosive in the Human Skin Model Test.

Executive summary:

Two tissues (each) of the human skin model EpiDerm^TMwere treated with triethylammonium bromide for three minutes and one hour, respectively.

In average, 25 mg of the solid test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control, 8M KOH was used as positive control. After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT which can be reduced to a blue formazan. Formazan production was measured by measuring the optical density (OD) of the resulting solution.

After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD≥0.8 and ≤2.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals.

After three minutes treatment with the test item, the relative absorbance values were reduced to 95.5 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 80.2 %. This value, too, is well above the threshold for corrosion potential (15 %). In the guideline, values greater or equal to the threshold are considered as “non-corrosive to skin”.