2,4,6-trifluorobenzamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 March 2020 to 24 April 2020

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

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

Test material

Test material information

Constituent 1

Reference substance name:

2,4,6-trifluorobenzamide

Cas Number:

82019-50-9

IUPAC Name:

2,4,6-trifluorobenzamide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Lot Number: ALL-H81956-016^
Physical Description: White powder
Reciept date: 12 February 2020
Storage: Room temperature

Test animals / tissue source

Species:

cattle

Strain:

not specified

Test system

Vehicle:

other: Deionised water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

20% (w/v) dilution in sterile, deionized water

Duration of treatment / exposure:

Three corneas were incubated in the presence of the test article at 32 ± 1 °C for 4 hours. Three corneas were incubated in the presence of each control at 32 ± 1 °C for 4 hours. After removal of the test or control article from the corneas, a final opacity was determined.

Observation period (in vivo):

The corneas did not receive a postexposure incubation

Number of animals or in vitro replicates:

3

Details on study design:

Three corneas were incubated in the presence of the test article at 32 ± 1 °C for 4 hours. Three corneas were incubated in the presence of each control at 32 ± 1 °C for 4 hours.
The test article was dosed and rinsed from the corneas using the open chamber method. In the open chamber method, the anterior chamber windows were removed and the test article was applied directly onto the exposed epithelium of the corneas. After exposure, the test article was directly rinsed from the exposed corneas. Prior to rinsing, the white particles in the test article dilution were observed to be floating on the surface of the solvent which may have affected the ability of these particles to contact the cornea during the exposure.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

ca. -1.3

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

After rinsing, tissue peeling was observed on one of the corneas treated with test article. However, since an increase in the permeability values was not observed in any of the corneas, it is likely that the tissue peeling was either very minimal, or that the observation was not actual tissue loss from the cornea. Additionally, a very small circular area of opacity was observed in the middle of another cornea # 21. This did not have an adverse impact on the study results since the opacity value for this cornea was consistent with the opacity values for the other 2 corneas treated with the test article.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the in vitro score of -1.3, and the prediction model found in OECD test guideline 437, the test article is predicted to not require classification or labelling for ocular irritation (GHS No Category) and the test article is predicted to be a non-irritant.