Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 th September 2019
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: own data
Title:
Unnamed
Year:
2020
Report date:
2020

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
50 % aq. solution

Test animals / tissue source

Species:
other: SKINETHIC Human Corneal Epithelial Model (HCE) Version 3.0 (2016)

Test system

Vehicle:
water
Controls:
yes
Amount / concentration applied:
30 μl (50 % aq. solutuion)
Duration of treatment / exposure:
30 min
Duration of post- treatment incubation (in vitro):
3 h incubation

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
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

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