di-p-tolyl(2,4,6-trimethylbenzoyl)phosphine oxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Materials and methods

Test guideline

Test guideline 1

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[bis(4-methylphenyl)phosphoroso](2,4,6-trimethylphenyl)methanone

EC Number:

884-585-5

Cas Number:

270586-78-2

Molecular formula:

C24H25O2P

IUPAC Name:

[bis(4-methylphenyl)phosphoroso](2,4,6-trimethylphenyl)methanone

Test animals / tissue source

Species:

other: Bos primigenius Taurus (fresh bovine corneas)

Strain:

not specified

Test system

Vehicle:

not specified

Controls:

yes, concurrent positive control

yes, concurrent negative control

Results and discussion

In vitro

Results

Irritation parameter:

cornea opacity score

Value:

<= 3

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD Guideline no. 437 (Jun. 2020), a substance with an IVIS ≤ 3 re-quires no classification for eye irritation or serious eye damage.

Executive summary:

Bovine corneas were used. They were collected from slaughtered cattle that were be-tween 12 and 60 months old.
The test item (di-p-tolylphosphoryl)(mesityl)methanone was applied onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured.
The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative con-trol showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Irri-tancy Score) was 1.28.
20% imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current histori-cal mean. The calculated mean IVIS was 96.91.
Under the conditions of this study, the test item (di-p-tolylphosphoryl)(mesityl)methanone showed no effects on the cornea of the bovine eye. The calculated mean IVIS was -0.27.

According to OECD Guideline no. 437 (Jun. 2020), a substance with an IVIS ≤ 3 re-quires no classification for eye irritation or serious eye damage.