Triethylammonium bromide

Endpoint summary

Description of key information

Triethylammonium bromide is considered as not corrosive and not irritant in the Human Skin Model Test (OECD 431 / OECD 439).
Triethylammonium bromide is not predicted as causing serious eye damage or as not classified for eye irritation/serious eye damage with the BCOP test method. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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)

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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)

Type of coverage:

other: Commercially available Epi-200-Kit

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.

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”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 2013 - December 2013

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

Principles of method if other than guideline:

None as known.

GLP compliance:

yes (incl. QA statement)

Opacity and Permeability Values

The absorption (570 nm) and opacity values which were measured before and after exposition are given in the following table:

Parameter	Negative Control
Absorption before exposition	0.1592	0.1515	0.1585
Absorption after exposition	0.2628	0.2816	0.2592
Opacity before exposition	1.4428	1.4174	1.4405
Opacity after exposition	1.8315	1.9125	1.8164
Opacity Difference	0.3887	0.4951	0.3759

 Mean opacity difference of the negative control is 0.4199.

Absorption and Opacity Values Test Item and Positive Control

Parameter	Test Item triethylammonium bromide			Positive Control
Absorption before exposition	0.1486	0.1598	0.1002	0.1483	0.1411	0.1819
Absorption after exposition	1.3111	1.2923	1.3171	1.6477	1.6445	1.6640
Opacity before exposition	1.4080	1.4448	1.2595	1.4070	1.3839	1.5202
Opacity after exposition	20.4692	19.6020	20.7539	44.4324	44.1062	46.1318
Opacity Difference	19.0612	18.1572	19.4944	43.0254	42.7224	44.6116

 

For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:

Repl.	Negative Control			Test Item triethylammonium bromide			Positive Control
Meas.	0.0052	0.0063	0.0090	0.0344	0.0306	0.0295	0.4489	0.4517	0.7295
Corr.	0.0260	0.0315	0.0450	0.1720	0.1530	0.1475	2.2445	2.2585	3.6475
Mean	0.0342			--

*In order to correct the path length, a factor of 5 was taken into account when calculating the IVIS.

One value for the positive control (given in italics) was obtained by measurement of a fivefold diluted solution and multiplication of the absorptions with factor five. This procedure is described in the standard operating procedure of the test when absorption values of the undiluted solutions lie outside the linear range which was the case in this study.

 

 IVIS Values

The calculated IVIS for each replicate and the corresponding means are presented in the following table:

Test Group	IVIS	Mean IVIS	Relative Standard Deviation IVIS
Negative Control 0.9% NaCl	0.8	0.9	15.0 %
	1.0
	1.1
Test Item	20.7	20.3	3.5 %
	19.5
	20.8
Positive Control 20% Imidazole	75.8	83.3	15.7 %
	75.7
	98.4

Interpretation of results:

other: further testing is necessary

Remarks:

Criteria used for interpretation of results: other: COMMISSION REGULATION (EU) No 1152/2010 of 8 December 2010

Conclusions:

Test item triethylammonium bromide is not predicted as causing serious eye damage or as not classified for eye irritation/serious eye damage with the BCOP test method. Because of the negative test result a sequential testing strategy is necessary.

Executive summary:

The positive control induced serious eye damage on the cornea, mean IVIS was 83.3. The negative control showed no irritation effects and no serious eye damage, mean IVIS was 0.9. The test item was tested in a 20 % solution. A mean IVIS of 20.3 was calculated.

According to OECD Guideline no. 437 (Jul. 2013), for a test item with an IVIS between >3 and≤ 55, no prediction can be made. A test item that is not predicted as causing serious eye damage or as not classified for eye irritation/serious eye damage with the BCOP test method requires additional testing (in vitro and/or in vivo) to establish a definitive classification.

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.

IVIS	UN GHS
≤3	No Category
> 3;≤55	No prediction can be made
> 55	Eye damage Category I

 

In the negative control, no signs of eye irritation were observed.

The positive control showed serious eye damage.

The test item triethylammonium bromide showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 20.3.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Because of the negative BCOP test result a sequential testing strategy is necessary.

Justification for classification or non-classification

BCOP test (CR EC 440/2008 B.47) shows that the substance has an effect on the eye:

substance: IVIS 20.3

negative control: IVIS 0.9

positive control: IVIS 83.3.

Only testing in rabbits (CR EC 440/2008 B.5) gives a reliable result, but a test result as "non-irritant" is unlikely.

To avoid testing in rabbits the substance is classified as Eye Irrit 2.