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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

eye irritation: in vitro / ex vivo
Type of information:
experimental study
Ocular Irretection Assay system
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: Ocular Irritection® assay system
Principles of method if other than guideline:
The Ocular Irretection (OI) assay system is a quantitative in vitro test method that mimics acute ocular irritation test. This method is able to evaluate the potential of a test substance to cause eye irritation and corneal opacity by measuring the optical density produced by the interaction of the test substance with a mixture of proteins and glycoproteins. The basis is that the interaction of an irritating agent with cornea causes denaturation and/or disruption of local proteins. So, during the test, the induced alterations in the proteins structures are measured with the differences in turbidity of the reagents matrix at 405 nm using a spettrometer. The interpretation of results is performed by a software that compares the optical density produced by the test substance with a standard curve obtained by a set of calibration well known substances. This standard curve of calibration relates to the ocular potential in the in vivo Draize rabbits eye test. The irritancy potential of a test substance is expressed as an Irritatition Draize Equivalent (IDE) score (0-50), that is obtained by comparison of results of calibration standards with correspondent in vivo studies.
GLP compliance:
not specified

Test material

Constituent 1
Test material form:
Specific details on test material used for the study:
lot/batch: ESTER B/1 FU 150211

Test animals / tissue source

other: Ocular Irritation Assay measures the optical density produced by the interaction of the test substance with a mixture of proteins and glycoproteins
Details on test animals or tissues and environmental conditions:
mixture of proteins and glycoproteins

Test system

Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 50, 75, 100, 125 micrograms.
Duration of treatment / exposure:

Results and discussion

In vitro

Irritation parameter:
other: Irritection Draize Equivalent
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
IDE score = 9.1
ESTER B is evaluated as minimal irritant by the OI assay system.
Executive summary:

ESTER B is evaluated as minimal irritant by the OI assay system.