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:
other: Peer reviewed publication, suitable for assessment

Data source

Reference
Reference Type:
publication
Title:
An objective method for the evaluation of eye irritation in vivo.
Author:
Jacobs, G.A., Martens, M.A.
Year:
1989
Bibliographic source:
Food and chemical toxicology. 27:255-258

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
iris score was not provided
Principles of method if other than guideline:
Rabbits were used in this study which was conducted in two phases (each phase separated by six months). The first phase involved testing rabbits and clinically scoring each rabbit. In the second phase in addition to the clinical examination corneal swelling was also measured using a ultrasonic pachometer.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl alcohol
EC Number:
203-470-7
EC Name:
Allyl alcohol
Cas Number:
107-18-6
Molecular formula:
C3H6O
IUPAC Name:
prop-2-en-1-ol
Details on test material:
>99% allyl alcohol obtained from UCB, Brussels, Belgium.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The eyes of each rabbit were examined with sodium fluorescein, 72 hours before testing. Only rabbits showing no lesions in the eyes were selected for testing. No further details on test animals and environmental conditions.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml undiluted allyl alcohol applied to one eye of each animal. The other untreated eye served as the control.
Duration of treatment / exposure:
Undiluted test substance was administered into the healthy eye of each test animal. Eyes were not washed following the instillation of the test substance.
Observation period (in vivo):
At 4, 24, 48, 72, 96 and 168 hours, the eyes were examined and grade of ocular reaction recorded.
Number of animals or in vitro replicates:
This study involved two phases. The first phase tested three rabbits with clinical examinations. The second phase used three additional rabbits and in addition to clinical scoring, corneal swelling was measured (using an ultrasonic pachometer). A total of 6 animals were used (3 animals for the first experiment and 3 animals for the second experiment).
Details on study design:
SCORING SYSTEM: Draize. Corneal swelling was expressed as a percentage and calculated as: (Corneal thickness at time t / Corneal thickness at time 0 -1) x 100

TOOL USED TO ASSESS SCORE: hand-slit lamp and ultrasonic pachometer (Ophthasonic pachometer, TEKNAR Inc, St Louis, MO).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema
Basis:
mean
Time point:
other: Pooled values across 24, 48 and 72h
Score:
2.89
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: n = 6
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Pooled values across 24, 48 and 72h
Score:
1.23
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: n = 6
Irritation parameter:
other: corneal opacity
Basis:
mean
Time point:
other: Pooled values across 24, 48 and 72h
Score:
2.09
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: n = 6
Irritation parameter:
other: Corneal swelling thickness
Basis:
mean
Time point:
other: Pooled values across 24, 48 and 72h
Score:
76
Max. score:
100
Reversibility:
not specified
Remarks on result:
other: n = 3

Applicant's summary and conclusion

Interpretation of results:
other: irritating to eyes
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study undiluted allyl alcohol is considered to be irritating in the eyes of rabbits.
Executive summary:

In a primary eye irritation study, 0.1 ml of undiluted allyl alcohol was instilled into the conjunctival sac of the eye in 6 New Zealand white rabbits. Eyes were not washed. Irritation was assessed at intervals over a period of 168h, according to the Draize method.

 

In this study, allyl alcohol was considered to be an eye irritant.