4-Butyl-4''-ethyl-2',3'-difluor-1,1':4',1''-terphenyl

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl

EC Number:

605-092-1

Cas Number:

157248-25-4

Molecular formula:

C₂₃H₂₂F₂

IUPAC Name:

4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl

Test material form:

solid: bulk

Test system

Vehicle:

physiological saline

Controls:

yes

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

800 mg suspended in 4 mL saline

Duration of post- treatment incubation (in vitro):

240 min

Number of animals or in vitro replicates:

3

Details on study design:

According to guideline

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

mean

Value:

1.88

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

With the negative control (0.9 % NaCl solution) an increase of opacity or permeability of the corneae could not be observed. The positive control (10 % (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not considered to be an eye irritant.

Executive summary:

Study design

This in vitro study was performed to assess the corneal irritation and damage potential of the test material by means of the BCOP assay using fresh bovine corneae. Damage is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer, respectively. Both measurements are used to calculate an in vitro irritation score, which is used to assign an in vitro irritancy category.

 

After a first opacity measurement of the fresh bovine corneae (t0), the test item/saline (0.9 % (w/v) NaCl in deionised water) stock, the positive, or the negative controls were applied to the epithelial surface of three corneae each and incubated for 240 minutes at 32 ± 2 °C. After the incubation phase the test item, the positive, or the negative controls were each rinsed from the corneae and opacity was measured again (t240).

After the opacity measurements, permeability of the corneae was determined by addition of 1 mL of a fluorescein solution to the anterior chamber of the corneal holder and subsequent incubation in a horizontal position at 32 ± 2 °C for 90 minutes. The permeability of the corneae was measured quantitatively by determination of the increase in fluorescein in the posterior chamber medium.

With the negative control (0.9 % NaCl solution) an increase of opacity or permeability of the corneae could not be observed.

 

The positive control (10 % (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant.

 

Results

The test item did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro irritation score was 1.88 and therefore, the test item was classified as non eye irritant.

 

Conclusions

In conclusion, the test item is not considered to be an eye irritant in this study and under the experimental conditions reported.