Triethylammonium bromide

Eye irritation

Administrative data

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)

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

Deviations:

no

Test guideline 2

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)

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 temp. (20 ± 5 °C); kept away from light

Results and discussion

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.