Fatty acids, C9, hexaesters with dipentaerythritol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 7, 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

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

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

EC Number:

267-021-7

EC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Cas Number:

67762-52-1

Molecular formula:

Not defined because UVCB

IUPAC Name:

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

Species:

other: MatTek EpiOcular tissues

Test system

Vehicle:

unchanged (no vehicle)

Controls:

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

Results

Irritation parameter:

other: Viability assay %

Run / experiment:

256 min

Value:

66.9

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

not applicable

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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).