Fatty acids, tall-oil, compds. with triethanolamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 April 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

26 July 2013

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall oil, compds. with triethanolamine

Cas Number:

68132-46-7

IUPAC Name:

Fatty acids, tall oil, compds. with triethanolamine

Test material form:

solid

Remarks:

(paste)

Details on test material:

- Name of test material as cited in the report: TOFA TEA salt
- Physical appearance: amber paste
- Test material storage: at room temperature

Specific details on test material used for the study:

- No correction factor for purity required.
- Stability at higher temperatures: not stable above 25°C

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

SOURCE OF COLLECTED EYES
- Source: young cattle, obtained from the slaughterhouse Vitelco, 's-Hertogenbosch, The Netherlands.
- Storage, temperature and transport conditions of ocular tissue: eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Subsequently, eyes were collected an transported in physiological saline in a suitable container under cooled conditions.
- The eyes were checked for unacceptable defects and those exhibiting defects were discarded.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: excessive amount (on a filter paper, cornea completely covered)

NEGATIVE CONTROL: Physiological saline
- Amount applied: 750 µL

POSITIVE CONTROL: Ethanol
- Amount applied: 750 µL

Duration of treatment / exposure:

10 ± 1 minutes

Duration of post- treatment incubation (in vitro):

120 ±10 minutes in cMEM for opacity measurements and subsequently 90 ±5 minutes in sodium-fluorescein for permeability determinations

Number of animals or in vitro replicates:

3 for the negative control, the positive control and the treatment group each

Details on study design:

TREATMENT METHOD: The medium from the anterior compartment was removed and 750 µl of the negative control and positive control were introduced onto the epithelium of the cornea. An excessive amount of the test item (on a filter paper) was applied directly on the corneas in such a way that the cornea was completely covered. Corneas were incubated in a horizontal position for 10 ± 1 minutes at 32 ± 1°C.


REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the incubation the solutions were removed and the epithelium was washed with MEM with phenol red (Earle’s Minimum Essential Medium, Life Technologies) and thereafter with cMEM.
- POST-EXPOSURE INCUBATION: 120 ±10 minutes in cMEM for opacity measurements and subsequently 90 ±5 minutes in sodium-fluorescein for permeability determinations

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacity meter (OP-KIT)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (TECAN Infinite® M200 Pro Plate Reader, OD490). OD490 values of less than 1.500 were used in the permeability calculation.
- Other: possible pH effects of the test substance on the corneas were recorded.

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA (see table 1):
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces IVIS >55 is defined as a corrosive or severe irritant (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≤55, no prediction on irritant potency can be made.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

Mean of 3 replicates

Value:

4.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

Mean IVIS: 31

Other effects / acceptance of results:

- The corneas treated with the test item showed opacity values between 1.9 and 4.7, permeability values were ranging from 0.059 to 0.232 and IVIS were 2.9, 5.4 and 5.8 (n=3).
- Since the mean IVIS was > 3 ≤ 55 (4.7) after 10 minutes of treatment, no prediction can be made for the classification of the test item.

OTHER EFFECTS:
- The corneas were clear with spots after treatment with the test item.
- No pH effect of the test item was observed on the rinsing medium in both experiments.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, results were within the historical range (IVIS ranging from -1.8 to 1.1)
- Acceptance criteria met for positive control: yes, results were within historical range (IVIS ranging from 23.6 - 39.7). Corneas were turbid after 10 minutes of treatment.

Any other information on results incl. tables

Table 2 Historical Control Data for the BCOP Studies

	Negative control			Positive control
	Opacity	Permeability	In vitro Irritancy Score	In vitro Irritancy Score
Range	-2.9 – 3.0	-0.016 – 0.042	-2.8 – 3.0	34.7 -78.2
Mean	0.08	0.01	0.17	56.01
SD	1.04	0.01	1.14	12.51
n	84	77	78	55

SD = Standard deviation

n = Number of observations

The above mentioned historical control data range of the controls were obtained by collecting all data over the period of May 2014 to May 2017.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

In the Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD guideline 437 and GLP principles, TOFA TEA salt induced a mean IVIS > 3 ≤ 55 (4.7) after 10 minutes. Based on these results, no prediction on the classification can be made.

Executive summary:

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

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