Alcohols, C14-18 and C16-18-unsatd.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to OECD and EC guidelines and in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Unjecol 85AN

IUPAC Name:

Unjecol 85AN

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): Unjecol 84AN
- Physical state: Liquid
- Analytical purity: 98%
- Lot/batch No.: 5253
- Expiration date of the lot/batch: 30 October 2015
- Storage condition of test material: Room Temperature

Test animals / tissue source

Species:

other: Bovine eyes

Strain:

not specified

Details on test animals or tissues and environmental conditions:

- No animals required for In-Vitro test
-Bovine eyes supplied and excised by abottoir, collected soon after slaughter.
-Eyes obtained from cattle approximately less than 30 months.
_Excised eyes maintained and transported to laboratory, at ambient temperarture, sufficient HBSS containing 1% (v/v) penicillin/streptomycin solution to cover eyes.
-Used witnin 4 hours of slaughter.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

-Undiluted substance used.
-750 µl applied

Duration of treatment / exposure:

10 minutes ± 30 seconds at 32 ºC ± 1ºC , post incubation 2 hrs with cMEM at 32ºC ± 1ºC

Observation period (in vivo):

- 1 mL sodium fluorescein solution added and incubated for 90 ± 5 minutes in a waterbath at 32ºC ± 1ºC.
- Aliquote of medium removed and transfered to cuvette for spectrophotometric read at 490 nm.

Number of animals or in vitro replicates:

Corneas were treated in triplicate with either the test substance, positive control (ethanol) or negative control (0.9% saline).

Details on study design:

- No animals required for In-Vitro test
The test substance and the positive control were tested undiluted.
-All eyes examined macroscopically, for defects.
-Surrounding tissue around the eyeball pulled away from the cornea, leaving 2-3mm of sclera present around the cornea.
-Stored in HBSS plus 1% penicillin/streptomycin solution until all the corneas had been dissected. Once all the corneas had been dissected, they were rinsed in fresh HBSS plus 1% penicillin/streptomycin solution prior to mounting.
-Mounted in the cornea holders with the endothelial side against the O-ring of the posterior half of the holder, cornea flattened, holders screwed into position.
-Compartments filled with HBSS plus 1% penicillin/streptomycin, incubated overnight, in upright position at room temperature.
- HBSS plus 1% penicillin/streptomycin removed and replaced with cMEM, incubated for 60mins in upright position at 32 ºC ± 1°C in waterbath, medium removed, compartments refilled with cMEM.
-Posterior compartment plugged and basal opacity measurements performed.
-Opacitometer used to measure light transmission through centre of each mounted cornea.
-pH of test substance diluents recorded.
- Corneas treated in triplicates with either the test substance, positive control (ethanol) or negative control (0.9% saline).

Results and discussion

In vitro

Results

Irritation parameter:

cornea opacity score

Value:

-1

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

other: No prediction can be made

Remarks on result:

no indication of irritation

In vivo

Irritant / corrosive response data:

Throughout the assay the corneas were examined for opaque spots or other irregularities. Following treatment with test substance, Unjecol 85AN, the corneas were noted as clear. The corneas treated with the positive control, ethanol, were opaque and the corneas treated with the negative control, 0.9% saline, were clear.

Any other information on results incl. tables

Sample	Opacity ± SD	Permeability ± SD	In vitro irritancy Score ± SD	In vitro classification
Unjecol 85AN	-1.000 ± 0.577	-0.003 ±0.004	-1.0 ±0.6	No category
Ethanol	19.667 ±1.732	2.225 ±2.438	53.0 ±35.7	No prediction can be made
0.9% Saline	2.333 ±1.155	0.025 ± 0.018	Not applicable	Not applicable

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The test substance, Unjecol 85AN, elicited an In Vitro Irritancy Score of -1.0 ± 0.6 and was predicted to have a classification of No Category according to the UN GHS.