Single Wall Carbon Nanotubes (SWCNT)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 July 2016 - 29 July 2016

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tin dioxide

EC Number:

242-159-0

EC Name:

Tin dioxide

Cas Number:

18282-10-5

Molecular formula:

O2Sn

IUPAC Name:

Tin Dioxide

Test material form:

solid: nanoform

Details on test material:

Sample Reference: W0167

Test animals / tissue source

Species:

human

Details on test animals or tissues and environmental conditions:

The EpiOcular™ tissues

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Approximately 50 mg of the test item (83.3 mg/cm2 according to guideline)

Duration of treatment / exposure:

6 hours

Duration of post- treatment incubation (in vitro):

18 hours

Number of animals or in vitro replicates:

duplicate

Details on study design:

.

Results and discussion

In vitro

Results

Irritation parameter:

other: % formazan production compared to negative control

Run / experiment:

2 tissues

Value:

ca. 26.5

Negative controls validity:

valid

Remarks:

0.8 - 2.5 %

Positive controls validity:

valid

Remarks:

32.6 %

Other effects / acceptance of results:

The negative control OD is > 0.8 and < 2.5 (1.387 and 1.452).
The mean relative viability of the positive control is below 50% of the negative control viability (32.6%).
The difference of viability between the two relating tissues of a single item is < 20% (values between 0.9% to 2.8%) in the same run (for positive and negative control tissues and tissues of single test items). This did not apply to the killed controls (items and negative killed control) and the colorant controls which were calculated as percent values related to the viability of the relating negative control.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Irritating effects were observed following incubation with TUBALL®. Compared with the value of the negative control the relative mean absorption value corresponding to the viability of the tissues decreased below 60% (26.5%).
In conclusion, it can be stated that in this study and under the experimental conditions reported, TUBALL® possesses an eye irritating potential.

Executive summary:

This in vitro study was performed to assess the eye irritation potential of TUBALL^® by means of the Human Cornea Model Test.

Because of the intense black colour of the test item additional tests with freeze killed tissues and with viable tissues were performed.

About 50 mg of the test item and each 50 µL of the controls, respectively, were applied to each of duplicate EpiOcular^™ tissue for 6 hours.

Treatment with the positive control induced a decrease in the mean relative absorbance compared with the negative control to 32.6%, thus the validity of the test system is ensured.

The acceptance criteria were met.

Relevant irritating effects were observed following 6 hours incubation with TUBALL^®. The mean relative absorption value of the tissues corresponding to the cornea viability decreased to 26.5% compared with the value of the negative control (threshold for irritancy: ≤ 60%).