4-phenylbenzophenone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Jun 2017 - 20 Jun 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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:

July 26, 2013

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-phenylbenzophenone

EC Number:

218-345-2

EC Name:

4-phenylbenzophenone

Cas Number:

2128-93-0

Molecular formula:

C19H14O

IUPAC Name:

{[1,1'-biphenyl]-4-yl}(phenyl)methanone

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Sponsor and 20161118
- Expiration date of the batch: 17 November 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light
- Solubility and stability of the test substance in the solvent/vehicle: Not soluble in physiological saline

FORM AS APPLIED IN THE TEST (if different from that of starting material): Since no workable suspension of Omnirad 4-PBZ in physiological saline could be obtained, the test item was used as delivered by the sponsor and added pure on top of the corneas.

Test animals / tissue source

Species:

cattle

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Since no workable suspension of the substance in physiological saline could be obtained, the substance was used as delivered by the sponsor and added pure on top of the corneas (318.12 to 327.82 mg).

Duration of treatment / exposure:

240 ± 10 minutes

Duration of post- treatment incubation (in vitro):

None.

Number of animals or in vitro replicates:

Triplicate.

Details on study design:

SELECTION AND PREPARATION OF CORNEAS

QUALITY CHECK OF THE ISOLATED CORNEAS
The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.

TREATMENT METHOD: open chamber

POST-INCUBATION PERIOD: no.

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: three washing steps

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea. The light was measured as illuminance (I = luminous flux per area, unit: lux) by a light meter.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490). After the incubation period, the medium in the posterior compartment of each holder was removed and placed into a sampling tube labelled according to holder number. 360 µl of the medium from each sampling tube was transferred to a 96-well plate. The optical density at 490 nm (OD490) of each sampling tube was measured in triplicate using a microplate reader (TECAN Infinite® M200 Pro Plate Reader).

SCORING SYSTEM: In Vitro Irritancy Score (IVIS) = mean opacity value + (15 x mean OD490 value)

DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used:

IVIS range UN GHS
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
>55 Category 1

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Value:

-3.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

fluorescein retention score

Value:

0.045

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

in vitro irritation score

Value:

-2.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Treatment	Mean Opacity	Mean Permeability	Mean In vitro Irritation Score
Negative control	3.4	0.021	3.7
Positive control	108	2.328	143
Substance	-3.5	0.045	-2.8

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance did not induce ocular irritation.

Executive summary:

In an in vitro eye corrosion/irritation study isolated bovine cornea was exposed to neat substance for 240-minutes. The mean in vitro irritancy score was -2.8 and resultantly, the substance is considered to be a non-irritant to the eye.