Registration Dossier

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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

Materials and methods

Test guideline
Qualifier:
according to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
human

Test system

Vehicle:
other: Dulbecco`s Phosphate Buffered Saline
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50 µL of the liquid test item were added to 1 mL of MTT solution in a 6-well plate and the mixture was incubated in the dark at 37 ± 1 °C, 5.0 ± 1 % CO2 and ≥ 95% relative humidity for 3 hours. 1 mL of MTT solution plus 50 µL of H2O demin. was used as negative control.
20 µL DPBS buffer and then incubated at 37 ± 1 °C, 5 ± 1 % CO2 and ≥ 95% relative hu-midity for 30 minutes. After that, 50 µL of the controls and the test item were applied in duplicate in one- minute- intervals
Duration of treatment / exposure:
28 minutes
Duration of post- treatment incubation (in vitro):
For post-treatment incubation, the tissues were incubated for 120 minutes
Number of animals or in vitro replicates:
two replicates for each tissue

Results and discussion

In vitro

Results
Irritation parameter:
other: %viability
Run / experiment:
1-3
Value:
> 0.8 - < 2.5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, NAPHTHA is considered non-eye irritant in the EpiOcu-larTM Eye Irritation Test.
After treatment with the test item, the mean value of relative tissue viability was reduced to 87.9 %. This value is above the threshold for eye irritation potential (≤ 60%).