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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP, test method is under validation

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
other: OECD (2014a) Draft Proposal for a New Test Guideline: Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
equivalent or similar to guideline
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The study method is based on the assumption that chemicals inducing serious eye damage or eye irritation will induce cytotoxicity in the corneal epithelium. 3D models of human corneal epithelium are treated with test substance, followed by a recovery period and measurement of tissue viability. Relative viability (test substance vs. negative control) is used to predict whether a substance requires classification or not.
Study guideline is available at:
GLP compliance:
yes (incl. QA statement)
testing lab

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
Cas Number:
Molecular formula:
C39 H29 F3 O2
Test material form:
other: solid, white
Details on test material:
- Name of test material (as cited in study report): Ligand TFME-DPP
- Physical state: solid, white
- Test substance No.: 08/0260-2
- Batch No.: 01829-00216
- Storage condition of test material: Room temperature

Test animals / tissue source

other: not applicable (in vitro)
other: not applicable (in vitro)

Test system

unchanged (no vehicle)
not required
Amount / concentration applied:
- treated tissues: bulk volume of 50 µl of test material (about 16 mg)
- negative control: 50 µl sterile de-ionized water
- positive control: 50 µl methyl acetate (98+%)
Duration of treatment / exposure:
After application of test substances or controls, the tissues were incubated for 6 hours at 37°C. They were subsequently washed with sterile PBS and immersed in pre-warmed medium to remove residual chemical.
Observation period (in vivo):
After washing, the tissues were returned into the incubator for 18 hours prior to MTT testing.
Number of animals or in vitro replicates:
not applicable (in vitro)

Results and discussion

Any other information on results incl. tables

Due to the ability of the test substance to directly reduce MTT in pre-tests, killed controls were applied in parallel. However, the result of the killed control did not indicate an increased MTT reduction, thus it was not used for viability calculation.

The data obtained is conformant with the above-mentioned acceptance criteria.


     tissue 1  tissue 2  mean KC  mean  inter-tissue variability (%)
 NC     mean OD(570)  1.775  1.652  0.043  1.714  
 viability (% of NC)  103.6  96.4    100  7.2
 08/0260-2     mean OD(570)  1.832  1.753  0.034  1.793  
 viability (% of NC)  106 .9  102.3    105  4.6
 PC     mean OD(570)  0.398  0.363    0.381  
 viability (% of NC)  23.2  21.2    22  2.0

Applicant's summary and conclusion