4,4'-bis(diethylamino)benzophenone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 February 2018 - 15 February 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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:

adopted October 09, 2017

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-bis(diethylamino)benzophenone

EC Number:

202-025-4

EC Name:

4,4'-bis(diethylamino)benzophenone

Cas Number:

90-93-7

Molecular formula:

C21H28N2O

IUPAC Name:

4-[4-(diethylamino)benzoyl]-N,N-diethylaniline

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 171116
- Expiration date of the lot/batch: 16 November 2019

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light

Test animals / tissue source

Species:

cattle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Substance: 329.10 to 362.21 mg.
750 µl of the negative control.
750 µl 20% (w/v) Imidazole solution (positive control).

Duration of treatment / exposure:

240 ± 10 minutes

Duration of post- treatment incubation (in vitro):

None.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

-1.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 144 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, the substance induced an IVIS ≤ 3, therefore no classification is required for eye irritation or serious eye damage.

Executive summary:

The eye hazard potential of the substance as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea was assessed using the Bovine Corneal Opacity and Permeability test (BCOP test). The eye damage of the substance was tested through topical application for approximately 240 minutes.  The substance did not induce ocular irritation for both endpoints (opacity and permeability), resulting in a mean in vitro irritancy score (IVIS) of -1.7 after 4 hours of treatment. In conclusion, since the substance induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage and the substance is considered to be a non-irritant to the eye.