MoVNbTe mixed oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 December 2020 To 29 March 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD 439

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

To evaluate the skin irritation potential of Mo10V3TeNbO42 using Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200- SIT).

GLP compliance:

yes (incl. QA statement)

Remarks:

With GLP Certificate

Test material

Test material information

Constituent 1

Reference substance name:

niobium trivanadium decamolybdenum tellurium dotetracontaoxide

EC Number:

888-364-4

Cas Number:

146569-48-4

Molecular formula:

Mo10V3Nb1Te1O42

IUPAC Name:

niobium trivanadium decamolybdenum tellurium dotetracontaoxide

Test material form:

solid

Specific details on test material used for the study:

Physical Appearance (with color): Solid (black)
Batch No.: EX.14402.600
Date of Manufacture: Oct 2017
Date of Expiry: No change of properties known over time (endless)
Storage Conditions: Ambient (21 to 29ºC)

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: MatTek In vitro Life Science Laboratories, s.r.o, MlynskéNivy 73, 821 05, Bratislava II, Slovak Republic, www.mattek.com; Phone: [phone]; Fax: [phone].

Justification for test system used:

As recommended in OECD Guideline No. 439, Reconstructed Human Epidermal Model EpiDerm™ (EPI-200-SIT) has been selected as test system for in vitro skin irritation.

Vehicle:

unchanged (no vehicle)

Details on test system:

The Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200-SIT) was used as test system

Control samples:

yes, concurrent negative control

Amount/concentration applied:

Quantity of 30 µL of DPBS (NC) and 5% SDS (PC) were dispensed directly atop the tissue at 1 minute intervals to facilitate rinsing of the NC and PC after exposure.

The tissues were exposed to 25 mg of test item.

Duration of treatment / exposure:

1 hour and 48 hours

Duration of post-treatment incubation (if applicable):

Percentage viability of tissues was measured by performing MTT assay after 60 minutes of treatment and post incubation of 43 hours and 7 minutes.

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean of three replicates

Value:

45.7

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Based on the results obtained under the laboratory testing conditions, the test item is categorized as irritant to Reconstructed Human Epidermis (RhE) in accordance with UN GHS (Category 2 or Category 1), as the mean percentage of tissue viability was less than 50% of the negative control after 60 minutes of exposure and 43 hours and 7 minutes post incubation.
Since a subsequent study performed according to OECD TG 431 (see chapter 7.3.1) did not justify a classification as Skin Corrosive Category 1, a justification as Skin Irritant Category in accordance with UN GHS is justified.

Executive summary:

The mean OD of the negative controltissues is 1.273 which is within the range of ≥0.8 and ≤2.8, hence the tissues were considered as viable after shipping and storing procedures and under specific conditions of use.Certificate of analysis, histology report and images of EpiDerm tissues of lot No. 33783 provided by MatTekwas provided as Annexures 3, 4 and 5 respectively. Percentage viability of tissues was measured by performing MTT assay after 60 minutes of treatment and post incubation of 43 hours and 7 minutes.The mean percentage viability of test item treated tissues was 45.7 which were <50% of the negative control, hence the test item is considered as irritantand the mean percentage viability of positive controltreated tissues was 4.4 which were <50% of the negative control clearly represents the irritation potential of positive control.