[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

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

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

foreskin from multiple donors

Justification for test system used:

It was decided to use this model as it is cited among the suitable kits both by the OECD 439: 2021 and by Reg. CE 440/2008 Annex Part B, B .46. Furthermore, the test proposed by MatTek was validated in 2007 in an international validation study involving BASF SE (Ludwigshafen, Germany), IIVS Inc. (Gaithersburg, USA) ZEBET at BfR (Berlin, Germany) and Zet-LSL (Linz , Austria)

Details on test system:

The EpiDermTM model was used which involves corneal epithelium tissue.
The kit used for the test belongs to lot #36122, derived from the keratinocyte strain 00267. In the certificate sent by the supplier, it is stated that no HIV-1, hepatitis B and hepatitis C viruses were found in the batch. Furthermore, no bacteria, yeasts or other fungi were detected.
In the lot quality certificate, the supplier reported that the functionality of the cellular barrier of the lot has passed all the required checks.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

Amount of sample tested in three replicates: Rep1 = 25.7 mg, Rep 2 = 24.8 mg, Rep 3 = 25.1 mg.

Duration of treatment / exposure:

Tissues were topically exposed to the sample for 1 hour.

Duration of post-treatment incubation (if applicable):

After exposure fresh medium was added and tissues were incubated at 37 °C and 5% CO2 for 24h. The medium was replaced with fresh one for 18h incubation. Then, tissues were transferred to MTT medium and incubated at the same conditions. After 3 hours, tissues were washed with DPBS and blotted.

Number of replicates:

3 replicates were tested

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

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

Value:

ca. 52.5

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 skin.