Reaction products of diazotized mixture of aniline, toluidines and xylidines coupled with mixture of aniline, toluidines and xylidines, subsequently diazotized then coupled with 2-naphthol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

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:

Reaction products of diazotized mixture of aniline, toluidines and xylidines coupled with mixture of aniline, toluidines and xylidines, subsequently diazotized then coupled with 2-naphthol

EC Number:

947-944-8

Cas Number:

70879-65-1

Molecular formula:

C23H17N4O

IUPAC Name:

Reaction products of diazotized mixture of aniline, toluidines and xylidines coupled with mixture of aniline, toluidines and xylidines, subsequently diazotized then coupled with 2-naphthol

Test animals / tissue source

Species:

human

Details on test animals or tissues and environmental conditions:

The 0.60 cm² Reconstructed human Cornea-like Epithelia (EpiOcularTM) were received on 19 September 2017. The same day, the tissues in their well shipping container were equilibrated at room temperature for 15 minutes. Then the inserts (filter + epithelium) were gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. They were placed in 6 wells culture plate which had been previously filled with 1 mL of 37°C pre-warmed assay medium and incubated during 20 hours and 03 minutes at standard culture conditions.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

50 mg of test item

Duration of treatment / exposure:

6 hours

Duration of post- treatment incubation (in vitro):

18 hours post-exposure

Number of animals or in vitro replicates:

5 replicates

Results and discussion

In vitro

Results

Irritation parameter:

other: tissue viability (%)

Run / experiment:

Mean of 5 replicates

Value:

ca. 100

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean corrected percent tissue viability of the RhCE replicates treated with the test item solvent red 24 mix was 133.25 (considered as 100%), versus 14.96% in the positive control (Methyl acetate).
Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item solvent red 24 mix does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category. No hazard statement and the signal word are required.