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)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

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)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 equilibrated to 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 19 hours and 55 minutes at standard culture conditions.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50 μL
Duration of treatment / exposure:
30 minutes
Duration of post- treatment incubation (in vitro):
2 hours post-exposure incubation
Number of animals or in vitro replicates:
2 living RhCE tissue replicates

Results and discussion

In vitro

Results
Irritation parameter:
other: tissue viability (%)
Run / experiment:
mean
Value:
ca. 12.9
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
other: UN GHS Category 2 or Category 1.
Conclusions:
In accordance with the Regulation EC No. 1272/2008, the test item Whey Lactose-low has to be identified as potentially requiring classification and labeling according to UN GHS Category 2 or Category 1.