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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:
18/11/15 to 20/11/15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline for Testing of Items 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying items not requiring classification and labelling for eye irritation or serious eye damage
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Light brown solid
Details on test material:
- Name of test material (as cited in study report): SPE1415
- Physical state: Light brown solid
- Analytical purity: Not supplied
- Lot/batch No.: 9
- Expiration date of the lot/batch: 20th February 2016
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:
other: EpiOcular cornea epithelial model
Strain:
other: Not applicable

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
A disc of the substance was applied to the tissue culture surface
Duration of treatment / exposure:
6 hours
Observation period (in vivo):
Not applicable
Number of animals or in vitro replicates:
Not applicable

Results and discussion

In vivo

Results
Irritation parameter:
other: Relative mean viability (%)
Basis:
other: Epiocular tissue
Remarks on result:
other: The treated tissues had a relative mean viability of 4.2% following an exposure period of 6 hours
Irritant / corrosive response data:
The treated tissues had a relative mean viability of 4.2% following an exposure period of 6 hours. A score of less than 60% gives a prediction of irritant.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance gave a response in an RHE assay which predicts as irritant.