Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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
Remarks:
The test material is not the full substance (methyl ionone) but the pure main constituent (alpha-isomethyl ionone) from which a read-across is possible. The test material was tested only at 12.5%. Nevertheless, as the substance is classified as eye irritant based on this data, these restrictions are considered acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Test material (0.1 ml) was instilled into the right eye of 3 albino rabbits with no further treatment. The untreated left eye served as a control. Both eyes were examined every 24 hours for 4 days and on day 7. Scoring was according to the Draize scale for ocular lesions.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: stated as "albino"

Test system

Vehicle:
not specified
Controls:
other: left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 12.5 %
Duration of treatment / exposure:
single application, substance remains in eye
Observation period (in vivo):
Both eyes were examined every 24 hours for 4 days and on day 7.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: acc. Draize scale for ocular lesions

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
>= 2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
> 1
Max. score:
4
Reversibility:
fully reversible within: 7 d

Any other information on results incl. tables

12.5 %: irritant effects

- intense conjunctival irritation from days 1 to 4 involving chemosis and discharge that cleared by day 7

- no corneal opacity or iris congestion

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In this eye irritation study, fully reversible irritant effects were observed when a 12.5% solution of alpha-isomethyl ionone (the pure main constituent and structural analogue of methyl ionone) was used.
Due to the clearly described irritation effects, the analogue alpha-isomethyl ionone is regarded as an eye irritant. Choosing a conservative approach, an eye irritating potential is also assumed for the target substance methylionone.