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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 2017 - September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
C.I. Solvent Red 119
EC Number:
602-676-8
Cas Number:
12237-27-3
Molecular formula:
C32H22N10O8Cr
IUPAC Name:
C.I. Solvent Red 119
impurity 1
Reference substance name:
Unknown impurities
Cas Number:
not available
IUPAC Name:
Unknown impurities
impurity 2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
Test material form:
solid: particulate/powder

Results and discussion

In vitro

Results
Irritation parameter:
other: %tissue viability
Run / experiment:
Epi- OcularTM Eye Irritation Test.
Value:
ca. 102
Vehicle controls validity:
valid
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 the conditions of the test, Solvent Red 119 is considered non-eye irritant in the Epi-
OcularTM Eye Irritation Test.
After treatment with the test item, the mean value of relative tissue viability was 102.0 %.
This value is above the threshold for eye irritation potential (≤ 60%).
All validity criteria were met. The criterion for optical density of the negative control was
fulfilled: The OD value was 1.7 (> 0.8 and < 2.5).
The positive control induced a decrease in tissue viability as compared to the negative
control to 35.7%.
The variation within the replicates of negative control, positive control and test item was
acceptable (< 20%).
For these reasons, the result of the test is considered valid.
Executive summary:

One valid experiment was performed.

The test item Solvent Red 119 was applied to a three-dimensional human cornea tissue

model in duplicate for an exposure time of 6 hours.

The solid test item was applied to each tissue.

After treatment, the respective substance was rinsed from the tissue; then, cell viability of

the tissues was evaluated by addition of MTT, which can be reduced to formazan. The

formazan production was evaluated by measuring the optical density (OD) of the resulting

solution.

Demineralised water was used as negative control and methyl acetate was used as positive

control.

The controls showed the following results: After treatment with the negative control, the

absorbance values were within the required acceptability criterion of mean OD > 0.8 and <

2.5, OD was 1.7. The positive control showed clear eye irritating effects, mean value of the

relative tissue viability was 35.7 % (< 50%).

Variation within tissue replicates was acceptable (< 20%).

After treatment with the test item, the mean value of relative tissue viability was 102.0 %.

This value is above the threshold for eye irritation potential (≤ 60%).

Under the conditions of the test, Solvent Red 119 is considered

non-eye irritant in the EpiOcularTM Eye Irritation Test.

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