N'-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]BENZOHYDRAZIDE

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17th June 2020 to 17th June 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

1

Reference substance name:

N'-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]BENZOHYDRAZIDE

Cas Number:

1453473-00-1

IUPAC Name:

N'-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]BENZOHYDRAZIDE

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

SOURCE OF COLLECTED EYES
- Source: byproduct from freshly slaughtered animals

Test system

Vehicle:

water

Remarks:

sterile, deionized water

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

The test article was administered to the test system as a 20% (w/v) dilution in sterile, deionized water

Duration of treatment / exposure:

4 hours

Number of animals or in vitro replicates:

Three corneas were used

Details on study design:

The test article was administered to the test system as a 20% (w/v) dilution in sterile, deionized water. The positive control (20% (w/v) dilution of imidazole prepared in Complete Minimal Essential Medium (without phenol red)) and the negative control (sterile, deionized water) were
tested concurrently. After vortexing, the test article dilution was not fully soluble, and formed a cloudy white suspension with white particles.

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 control particles from the corneas, a final opacity was determined (i.e., the corneas did not receive a post-exposure incubation). Following the rinsing process, but prior to reading the opacity values for the corneas treated with the test article, a bulb burnt out in the opacitometer. The corneas treated with test article were placed back into the incubator (for approximately 30 minutes) until another opacitometer was calibrated which was then used to measure the final opacity readings.
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.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

mean of 3 runs

Value:

1.5

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the in vitro score of 1.5, 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).

Executive summary:

The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test article to isolated bovine corneas. Bovine corneas, obtained as a byproduct from freshly slaughtered animals, were mounted in special holders and exposed to the test article. An In Vitro Score was determined for the test article based on the induction of opacity and permeability (to fluorescein) in the isolated bovine corneas. The methods and procedures used in this assay were consistent with OECD Test 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 (2017). 

Based on the in vitro score of 1.5, 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).