Fatty acids, tall-oil, reaction products with triethylenetetramine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 23, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 437 and EU Method B.47, in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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:

yes

Remarks:

"The measurement of the opacity was performed with a photometer (570 nm) instead of an opacitometer." This deviation was considered as uncritical, because the opacity can be calculated from the absorbance.

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:

yes

Remarks:

"The measurement of the opacity was performed with a photometer (570 nm) instead of an opacitometer." This deviation was considered as uncritical, because the opacity can be calculated from the absorbance.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with triethylenetetramine

EC Number:

272-905-0

EC Name:

Fatty acids, tall-oil, reaction products with triethylenetetramine

Cas Number:

68919-79-9

Molecular formula:

Not applicable for this UVCB.

IUPAC Name:

Fatty acids, tall-oil, reaction products with triethylenetetramine

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals / tissue source

Species:

other: Bos primigenius Taurus (fresh bovine corneas)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: in vitro test

Amount / concentration applied:

791.6, 1,063.8 and 1,199.9 mg (applied directly on the cornea using a weight board)

Duration of treatment / exposure:

4 h

Results and discussion

In vivo

Results

Irritation parameter:

other: in vitro irritancy score (IVIS)

Basis:

mean

Time point:

other: 4 h

Score:

5.17

Irritant / corrosive response data:

In the negative control, no signs of eye irritation were observed. The positive control induced serious eye damage, which would be classified as GHS category 1.

The test substance produced effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 5.170.

The experiment is considered as sufficient for the classification of the test substance, because all three replicates of the test substance lead to the same assessment for the test substance.

Any other information on results incl. tables

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

Table 1: Absorbance and Opacity Values Negative Control

Parameter	Negative Control
Absorbance before exposition	0.1524	0.1586	0.1575
Absorbance after exposition	0.3357	0.2667	0.2902
Opacity before exposition	1.4204	1.4408	1.4371
Opacity after exposition	2.1662	1.848	1.9507
Opacity Difference	0.7458	0.4072	0.5136

 

Mean opacity difference of the negative control was 0.5555

  

Table 2: Absorbance and Opacity Values Test Substance and Positive Control

Parameter	Test substance			Positive Control
Absorbance before exposition	0.2603	0.1417	0.1195	0.1184	0.1849	0.1239
Absorbance after exposition	0.2702	0.2478	0.2602	1.6291	1.8528	1.7304
Opacity before exposition	1.821	1.3858	1.3167	1.3134	1.5307	1.3301
Opacity after exposition	1.8629	1.7693	1.8205	42.5696	71.2525	53.7527
Opacity Difference	0.042	0.3835	0.5038	41.2562	69.7217	52.4225

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:

Table 3: Optical density at 490 nm

Repl.	Negative Control			Test Substance			Positive Control
Meas.	0.0041	0.0029	0.0028	0.0921	0.0734	0.0609	0.3978	0.2436	0.3568
Corr.	0.0205	0.0145	0.0140	0.4605	0.3670	0.3045	1.9890	1.2180	1.7840
Mean	0.0163			----

Table 2: IVIS

Test group	IVIS	Mean IVIS	Relative standard deviation IVIS
Negative Control 0.9% NaCl	1.053	0.801	28.0%
	0.625
	0.724
Test substance	6.149	5.170	18.2%
	5.088
	4.271
Positive Control 20% imidazole solution	70.3	78.6	10.8%
	87.2
	78.4

Applicant's summary and conclusion

Conclusions:

The test substance produced effects on the cornea of the bovine eye with a calculated IVIS (in vitro irritancy score) of 5.170, according to OECD Guideline 437. The experiment is considered as sufficient for the classification of the test substance because all three replicates of the test substance lead to the same assessment (Andres, 2015).

Executive summary:

A study was conducted to assess the corneal damage potential of the test substance in bovine cornea by measuring opacity and permeability according to OECD Guideline 437 and EU Method B.47, in compliance with GLP. The pure test substance was brought onto the cornea of a bovine eye for 4 h at 32 ± 1°C, which had been previously incubated in cMEM, without phenol red, at 32 ± 1°C for 1 h. After removal of the test substance, opacity and permeability values were measured. Under the study conditions, the test substance produced effects on the cornea of the bovine eye with a calculated IVIS (in vitro irritancy score) of 5.170. The negative control (physiological sodium chloride solution) and the positive control (20% imidazole solution) met the validity criteria. The experiment was considered as sufficient for the classification of the test substance as eye irritant because all three replicates of the test substance lead to the same assessment (Andres I, 2015b).