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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
August 7, 2002
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
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:
MatTek EpiOcular MTT Viability Assay.
Draize correlation
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Fatty acids, C5-9, hexaesters with dipentaerythritol
EC Number:
EC Name:
Fatty acids, C5-9, hexaesters with dipentaerythritol
Cas Number:
Molecular formula:
Not defined because UVCB
Fatty acids, C5-9, hexaesters with dipentaerythritol
Test material form:
liquid: viscous
Details on test material:
Pale yellow liquid
Used as received

Test animals / tissue source

other: MatTek EpiOcular tissues

Test system

unchanged (no vehicle)
yes, concurrent negative control
Amount / concentration applied:
100 µl test material used as received undiluted
Duration of treatment / exposure:
4, 16, 64, and 256 min
Number of animals or in vitro replicates:
Each treatment was conducted in duplicate

Results and discussion

In vitro

Irritation parameter:
other: Viability assay %
Run / experiment:
256 min
Vehicle controls validity:
not applicable
Negative controls validity:
Positive controls validity:
not applicable
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The substance produced an ET50 > 256 min, indicating that it was non- to minimally irritating under the study conditions.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the test substance according to a method similar to OECD Guideline 492. MatTek EpiOcular tissue samples were exposed to undiluted substance for 16, 64 or 256 min. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 540 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiOcular tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 256 min, indicating that it was non- to minimally irritating under the study conditions (DeGeorge, 2002).