Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27th October - 7th November 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
Nature of substance: Undiluted liquid

Test animals / tissue source

Species:
other: Rabbit (New Zealand White)
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: David Percival Ltd
Environmental conditions:
Housed individually in suspended solid floor cages.
Temperature: 17-23ºC
humidity: 30-70%
Acclimitisation period: 5 days
Air changes: 15 per hour
Lighting: 12 hours continuous light and twelve hours darkness
Free access to mains drinking water and food

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1 ML
Observation period (in vivo):
Assessment of occular damage/irritation was made approximatley 1 hour, 24,48 and 72 hours following treatment. Any other occular effects were also noted. Examination of the eye was facilitated by the use of a light source from a standard opthalmoscope.
An additional observation was made in one treated eye on Day 7 to assess the reversibility of the occular effects.
Number of animals or in vitro replicates:
3
Details on study design:
Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediatley after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediatley after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal , two additional animals were treated. In order to minimise pain on application of the test material , one drop of local anaethetic was instilled into both eyes of the final animal 1 to 2 minutes before treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Time point:
other: 72 hrs
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Max value at 72 hrs in one animal, 'score' calculated as average across 3 animals at the time point specified.
Irritation parameter:
chemosis score
Time point:
other: 72 hrs
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals). 'score' calculated as average across 3 animals at the time point specified.
Irritation parameter:
cornea opacity score
Time point:
other: 72 hrs
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 'score' calculated as average across 3 animals at the time point specified.
Irritation parameter:
iris score
Time point:
other: 72 hrs
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals), 'score' calculated as average across 3 animals at the time point specified.
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
Brown coloured staining of the fur was noted around the treated eyes during the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The test material produced a maximum group mean score of 9.0 and was classified as a mild irritant (Class 4 on a 1-8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Executive summary:

A GLP study in accordance with OECD guideline 405 was performed in order to assess the irritancy potential of Inhibitor AHM P500 to the eye of the New Zealand White Rabbit.

A single application of the test material to the non-irrigated eye of three rabbits produced scattered or diffuse corneal capacity, iridial inflammation and minimal conjunctival irritation. One treated eye appeared normal at the 48 hour observation, one treated eye appeared normal at the 72 hour observation and the remaining treated eye appeared normal at the 7 day observation.

The test material produced a maximum group mean score of 9.0 and was classified as a mild irritant (Class 4 on a 1-8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.