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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to 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

Constituent 1
Chemical structure
Reference substance name:
9-oxo-9H-thioxanthene-4-carboxylic acid
EC Number:
Cas Number:
Molecular formula:
9-oxo-9H-thioxanthene-4-carboxylic acid

Test animals / tissue source

other: Fresh bovine

Test system

Hank's balanced salt solution
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

Irritation parameter:
in vitro irritation score
Run / experiment:
Test Item 9-oxo-9H-thioxanthene-4-carboxylic acid
Negative controls validity:
Positive controls validity:

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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.