Fatty acids, C16-18 (even numbered) and C18 (unsaturated) (9Z)-octadec-9-enyl esters.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 2, 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Reference 2

Reference Type:

publication

Title:

An Alternative to Draize Test.

Author:

Kemper, F.H. & Luepke, N.P.

Year:

1986

Bibliographic source:

FD Chem. Toxic. 24, p 495-496.

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: HET-CAM test (Kemper and Luepke, 1986)

Principles of method if other than guideline:

The chorioallantoic membrane of the chick embryo, were used as it has been shown to respond to injury with a complete inflammatory reaction that corresponds with that of the rabbit eye. Please refer to attached full test report for additional details on the methods.

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Fatty acids, C16-18 (even numbered) and C18 (unsaturated) (9Z)-octadec-9-enyl esters.

EC Number:

701-212-2

Cas Number:

869110-10-1

Molecular formula:

R1, R2, R3: C15-, C17- saturated, C17- unsaturated alkyl chains

IUPAC Name:

Fatty acids, C16-18 (even numbered) and C18 (unsaturated) (9Z)-octadec-9-enyl esters.

Specific details on test material used for the study:

Lipex Shea WM, 50% in Akosun Batch 1019002-A

Test animals / tissue source

Species:

chicken

Strain:

other: Hen's Egg Test

Details on test animals or tissues and environmental conditions:

Fresh, fertile White Leghorn eggs were obtained from Meyer's Chickc, Inc., in Quakertown, Pennsylvania. Please see attached full test report for further details.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.3 ml

Duration of treatment / exposure:

20 seconds

Observation period (in vivo):

30 sec, 2 and 5 minutes after exposure

Number of animals or in vitro replicates:

4 in each group

Details on study design:

Please see the attached test report for further details.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

other: CAM effects score

Remarks:

Please see table below and attached report

Run / experiment:

0.5 min

Value:

0

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

other: CAM effect score

Remarks:

Please see table below and attached report

Run / experiment:

2 min

Value:

> 0 - <= 3

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

other: CAM effects score

Remarks:

Please see table below and attached report

Run / experiment:

5 min

Value:

> 0 - <= 1

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Reactions of the CAMs, the blood vessels including the cappilaries, and the albumin were examined for irritant effects and scored as seen below:

		Score
Effect	time (min)	0.5	2	5
Hyperemia		5	3	1
Minimal hemorhage ("feathering"		7	5	3
Hemorhage (obvoius bleeding)		9	7	5
Coagulation and/or thrombosis		11	9	7

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not an eye irritant.

Executive summary:

The substance was tested for eye irritability in the hens egg's test. The test was performed on the chorioallantoic membrane of the chick embryo, as it has been shown to respond to injury with a complete inflammatory reaction that corresponds with that of the rabbit eye. Based on the study, it is concluded that the substance would have practically no ocular irritaion potential in vivo.