10-oxo-10H-dibenzo[b,e]thiopyran-4-carboxylic acid

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

Reference Type:

study report

Title:

Unnamed

Year:

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

9-oxo-9H-thioxanthene-4-carboxylic acid

EC Number:

849-175-2

Cas Number:

51762-56-2

Molecular formula:

C14H8O3S

IUPAC Name:

9-oxo-9H-thioxanthene-4-carboxylic acid

Test animals / tissue source

Species:

cattle

Strain:

other: Fresh bovine

Test system

Vehicle:

Hank's balanced salt solution

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Replicate Amount
1 200.8 mg
2 202.0 mg
3 200.9 mg

Duration of treatment / exposure:

4 hours

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

Test Item 9-oxo-9H-thioxanthene-4-carboxylic acid

Value:

-0.53

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Two experiments were performed. The first experiment was not valid, because the IVIS value of the negative control was above the acceptable limit. This experiment is not reported, but the raw data are kept in the GLP-archive of the test facility. The repetition was valid and the results are presented in this report.

This in vitro study was performed to assess corneal damage potential of 9-oxo-9H-thioxanthene-4-carboxylic acid by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test item 9-oxo-9H-thioxanthene-4-carboxylic acid was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. 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.

The test item was tested neat, without dilution or preparation of a solution
Under the conditions of this test, the test item 9-oxo-9H-thioxanthene-4-carboxylic acid showed no effects on the cornea of the bovine eye. The calculated mean IVIS was -0.53.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

The negative control (HBSS) and the positive control (20% imidazole solution) have met the validity criteria.

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.