Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-11-09 to 2009-11-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

Gautheron P. and al (Fundam. Appl. Toxicol. 1992, 18, 442-449)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

EC Number:

944-892-8

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

Test material form:

liquid: viscous

Test animals / tissue source

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Corneas of calves aged less than 8 months, fresh and conserved.
Bovine eyes were collected in the abatoirs of Sobeval Boulazac 24759 - France, immediately after killing of the animals, and transported in a Hank's buffered saline solution to the laboratory.
The eyes were carefully examined and these showing a visible defect were eliminated. An incision was made in each selected eye on the scleral ring taking care to leave approximately 2 to 3 mn of scleral ring to ease the further hadlings.
Then the corneas were used or kept for a maximal of 24 hours at 4°C +/- 2°C in a preservative medium.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

The test element was tested as supplied.
750 µL of test element and negative control were introduced by one of the openings of the holder.

Duration of treatment / exposure:

The treatment lasted (time of contact) 30 minutes and 4 hours.

Duration of post- treatment incubation (in vitro):

1 hour and 30 minutes of post treatment incubation for the measurements of the corneal permeability with a fluorescein solution.

Number of animals or in vitro replicates:

For each time of contact 3 corneas served as negative control and 3 corneas received the test element.

Details on study design:

Preparation of the test element:
The test element was tested as supplied. The test element was tested at room temperature.

Mounting of corneas:
Corneas were deposited, epithelial side upwards, on the lower part of cornea holders. Then the upper part was firmly clamped in place with 3 screws. The anterior (epithelial side) and posterior (endothelial side) compartments were then filled with nutritive medium, with an eppendorf pipette, taking care to eliminate air bubbles and starting by the lower part. The waterlightness was insured by toric joints. Each cornea was identified by the number of the corresponding holder. As soon as the corneas were mounted, the holders were maintained at 32°C for 1 hour (pre-incubation) in a bain-marie, in horizontal position, immersed at the three-quarters of their height. After this period of pre-incubation, the opacity at T0 (OPT0) was determined.

Treatment of corneas:
At the end of pre-incubation, both compartments were completely and carefully emptied starting by the anterior compartment. The posterior compartment was filled again with nutritive medium whereas the anterior compartment received the test element: 750µL was introduced by one of the openings of the holder. For each time of contact 3 corneas served as negative control and 3 corneas received the test element. The control corneas received 750 µL of nutritive medium. A chronometer was set off for each series of three corneas. The holders were then incubated, in bain-marie (32°C) in vertical position and immersed in such a way that the test element remained in contact with the cornea. The treatment lasted (time of contact) 30 minutes and 4 hours.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

30 minutes

Value:

1.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Weakly irritant

Results 2

Irritation parameter:

cornea opacity score

Run / experiment:

4 hours

Value:

1.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Weakly irritant

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

According to the defined grading scale, the test element 5 alpha AVOCUTA(R) - Code: 8700492 / CAS: 934551 -20 -9 tested as supplied was judged weakly irritant to the calf cornea. The response obtained for the test element cannot be compared, due to a lack of historical data in that category of product (cosmetic ingredient).

Executive summary:

Title: Assessment of the irritant potential of a test element after application to the isolated calf cornea (BCOP)

Objectives: The aim of the study was to assess quantitatively the irritant potential of a test element after application to the isolated calf cornea. The assessment was based on the measurement of two parameters: the opicty and permeability of the cornea whose deteriorations reflected the damage of the tissue. The test element was let in contact with the isolated cornea for 30 minutes and 4 hours. On the basis of the results obtained for each time of contact, a corneal score was calculated and the test element classified.

Test item: 5 alpha AVOCUTA(R) - Code : 8700492 / CAS: 934551 -20 -9 - BATCH: 0809402304

Test System: Corneas of calves aged less than 8 months, fresh and conserved. Bovine eyes were collected in the abattoirs of Sobeval Boulazac 24759 - France.

Conlusion: According to the defined grading scale, the test element 5 alpha AVOCUTA(R) - Code: 8700492 / CAS: 934551 -20 -9 tested as supplied was judged weakly irritant to the calf cornea. The response obtained for the test element cannot be compared, due to a lack of historical data in that category of product (cosmetic ingredient).