[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 2022 to March 2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Anatase, rutile, disodium hexatitanate and sodium tetratitanate

IUPAC Name:

Anatase, rutile, disodium hexatitanate and sodium tetratitanate

Specific details on test material used for the study:

Batch No.: OP.1501019

Test animals / tissue source

Species:

human

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Amount of sample tested in two replicates: Rep 1 = 50.3 mg, Rep.2 = 50.9 mg

Duration of treatment / exposure:

Tissues were exposed for 6 hours to the raw substance by direct contact.

Duration of post- treatment incubation (in vitro):

The exposure is followed by washing with DPBS and an 18-hour post-incubation. and an incubation with MTT medium for 3 hours.

Number of animals or in vitro replicates:

Two replicates were tested

Details on study design:

In vitro "EpiOcular Eye Irritation Test" was used:
the tissues are conditioned by pre-incubation (1 hour or overnight) to release compounds related to transport stress and debris. Then they undergo a further pre-incubation phase for 18 hours. After the pre-incubation phase, the tissues are transferred to a fresh culture medium and exposed for 6 hours to the raw substance by direct contact. The exposure is followed by washing with DPBS and an 18-hour post-incubation. Two tissues are used respectively for the sample, for the negative control (C-) and for the positive control (C+). After exposure, the tissues are rinsed and dried, the test medium is replaced with the MTT medium. After 3 hours of incubation, the tissues are washed with DPBS and dried, then the blue formazan salts are extracted with isopropanol. The optical density (OD) of the formazan extract is determined by a spectrophotometer set at λ = 570 nm and the cell viability is calculated for each tissue as the percentage of the mean of the negative control tissues. The potential eye irritation caused by the test substance is determined according to the residual cell viability obtained after exposure.

Results and discussion

In vitro

Results

Irritation parameter:

percent tissue viability 

Run / experiment:

The result is an average of two measurements derived by two replicates.

Value:

ca. 94.9

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under test conditions, the test item was not irritant to eyes.