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Toxicological information

Eye irritation

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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:
other: Well documented publication, acceptable for assessment with restriction.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1973

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
>= 0 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
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
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.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU