1,3-difluorobenzene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,3-difluorobenzene

EC Number:

206-746-5

EC Name:

1,3-difluorobenzene

Cas Number:

372-18-9

Molecular formula:

C6H4F2

IUPAC Name:

1,3-difluorobenzene

Test animals / tissue source

Species:

other: Bovine corne

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

2 h

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Value:

1.01

Negative controls validity:

valid

Results 2

Irritation parameter:

in vitro irritation score

Value:

100.81

Positive controls validity:

valid

Results 3

Irritation parameter:

in vitro irritation score

Value:

49.83

Any other information on results incl. tables

Bovine corneas were used. They were collected from slaughtered cattle that were between 12 and 60 months old.

The test item1,3-DIFLUOROBENZENEwas brought 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 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.

Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (In VitroIrritancy Score) is 1.01.

Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated IVIS is 100.81.

 

Under the conditions of this study, the test item1,3-DIFLUOROBENZENEshowed effects on the cornea of the bovine eye. The calculated IVIS is 49.83.

According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage with the BCOP study only. In this case no prediction can be made.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

1,3-DIFLUOROBENZENE showed effects on the cornea of the bovine eye. The calculated IVIS is 49.83.