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:
data from handbook or collection of data
Justification for type of information:
data from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Eye irritation study of the test chemical
Author:
Lapczynski et al
Year:
2007
Bibliographic source:
Food and Chemical Toxicology

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
To assess the ocular irritation potential of the test chemical in rabbits
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: alpha -Ionone
- Molecular formula: C13H20O
- Molecular weight: 192.3 g/mol
- Substance type:organic
- Physical state:liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
other: No vehicle for 100% concentration and DEP for 5% concentration
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A 0.1 ml aliquot of 100% and 5% the testchemical in DEP
Duration of treatment / exposure:
not specified
Observation period (in vivo):
1, 2, 4, 24, 48 and 72 h after instillation.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: no data

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: after instillation
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Very slight conjunctival irritation was observed in all three rabbits at instillation, which cleared by 24 h

Any other information on results incl. tables

Table 1: Summary of the eye irritation studies

Dose

Vehicle

Result

100%

No

No irritation observed

5%

DEP

No irritation observed

 

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Very slight conjunctival irritation was observed in all three rabbits at instillation, which cleared by 24 hours. The instillation of test chemical did not cause any ocular irritation in 3 rabbits after 72 hours of observation. The test chemical can be considered as a non irritant to rabbit eyes
Executive summary:

An eye irritation test was conducted in three rabbits to assess the ocular irritation potential of the test chemical. A 0.1 ml aliquot of 100% and 5% the test chemical in DEP was instilled into one eye of each of three rabbits with no further treatment. The untreated eye served as a control. Observations for irritation were made immediately after instillation and again at 1, 2, 4, 24, 48 and 72 h after instillation. Very slight conjunctival irritation was observed in all three rabbits at instillation, which cleared by 24 hours. The instillation of test chemical did not cause any ocular irritation in 3 rabbits after 72 hours of observation. The test chemical can be considered as a non irritant to rabbit eyes.