Ammonium oleate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Rabbit Eye Irritation Test: Collaborative Study

Author:

Marzulli, F., Ruggles, D.

Year:

1973

Bibliographic source:

Journal of the AOAC 56 (4): 905-914

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not applicable

Principles of method if other than guideline:

Several substances were tested in 12 different laboratories to compare their assessments.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Potassium oleate

EC Number:

205-590-5

EC Name:

Potassium oleate

Cas Number:

143-18-0

Molecular formula:

C18H34O2.K

IUPAC Name:

potassium octadec-9-enoate

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-2.5 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

Eyelids were held together for 1 second, substance was not washed out

Observation period (in vivo):

observations were recorded at 24, 48, 72 hours and 7 days after application

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM:
according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

>= 0 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

>= 0.42 - <= 2.1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

>= 0 - <= 1.62

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

After 24 hours 5 out of 12 collaborating laboratories found signs of irritancy in the rabbits’ eyes caused by the analogue substance and 5 laboratories assessed borderline findings. Two collaborators did not find signs indicating eye irritation. After 48 hours signs indicating irritation were evaluated by one out of 12 collaborators and 2 collaborators recorded borderline findings. 9 collaborators evaluated the substance as non-irritating. After 72 hours, the total number of animals showing any signs of eye irritation had decreased and still 9 collaborators evaluated the substance as non-irritant, 3 as borderline substance. On day 7 all tested animals were assessed symptom free. After 24 hours the mean scores for each six rabbits were between 0 and 2.0 (range 0) for corneal opacity, 0 - 0.65 for iritis, 0.42 - 2.1 for conjunctival redness and 0 - 1.62 for chemosis. Mean scores after 48 and 72 hours are not given in the publication.