Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Remarks:
other: Using SkinEthic
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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)
Version / remarks:
The guideline is not cited, but its methodology is followed.
Principles of method if other than guideline:
SkinEthic exposed to subject material for 10 minutes. Viability of cells determined by their ability to reduce MTT.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro

Results
Irritation parameter:
other: Relative mean viability
Value:
ca. 93.3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Material is not irritating.
Executive summary:

Material is not irritating.