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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

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
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
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. QA statement)

Test material

Constituent 1
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

other: EpiOcular cornea epithelial model
other: Not applicable

Test system

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

Irritation parameter:
other: Relative mean viability (%)
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:
Migrated information Criteria used for interpretation of results: EU
The substance gave a response in an RHE assay which predicts as irritant.