Reaction products of enzymatic esterification of linolenic acid and 1,2-octanediol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: COLIPA program on optimization of existing in vitro eye irritation assays for entry into formal validation: technology transfer and intra/inter laboratory evaluation of epiocular assay for chemicals

Version / remarks:

test realized before OECD 492 adopted in July 2015

Principles of method if other than guideline:

The test is based on cytotoxicity measurement. Cellular viability is quantified by MTT reduction in a tetrazolium salt (fomazan) by viable cells. Fomazan forms violet cristals which are soluble in propan-2-ol.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-hydroxyoctan-2-yl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12-dienoate; octane-1,2-diol

EC Number:

944-490-2

Molecular formula:

unknown

IUPAC Name:

1-hydroxyoctan-2-yl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12-dienoate; octane-1,2-diol

Test material form:

liquid

Specific details on test material used for the study:

Yellow oil

Test animals / tissue source

Species:

human

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Reconstructed cornea epitheliums of 0.5 cm² (EpiOcular)

Test system

Vehicle:

other: paraffin oil

Controls:

yes, concurrent vehicle

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

1% and 10%

Duration of treatment / exposure:

30 +/- 2 minutes

Duration of post- treatment incubation (in vitro):

30 +/- 2 minutes then post-incubation for 120 +/- 10 minutes

Number of animals or in vitro replicates:

2 replicates/treatment

Details on study design:

Reconstructed cornea epitheliums were wetted for 30 minutes with 20 μL of PBS and treated with 50 μL of the test item for 180 minutes.
They were rinsed, immersed for 12 minutes in culture medium, dried and cultured back during 2 hours.
A viability test was then realised with the MTT. The viability percentage of treated tissues was calculated compared to the negative control in order to classify the test substance.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

other: cellular viability

Run / experiment:

10%

Value:

ca. 100

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

Cell viability expressed as a %

Results 2

Irritation parameter:

other: cellular viability

Run / experiment:

1%

Value:

ca. 100

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

Cell viability expressed as a %

Other effects / acceptance of results:

Positive and negative controls were validated, experiment was accepted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Non irritant at 1% and 10%.

Executive summary:

In a Reconstructed Human Cornea-like Epithelium (RhCE) Test Method similar to OECD 492, test substance was non irritant at 1% and 10%.