416-730-1

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline conform

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

observation period 7d only

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England or Charles River (UK) Ltd., Margate, Kent, England.
The animals were in the weight range of 2.7 to 3.9 kg and approximately 12 to 19 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the smdy. They were housed individually in plastic cages with perforated floors.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum. The batch of diet used for the study was not analysed for nutrients, contaminants or micro-organisms.
Results of routine chemical examination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly summaries.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30 - 70%. These environmental parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage, was identified by a coloured label displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

76 mg

Duration of treatment / exposure:

single application

Observation period (in vivo):

7d

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed (pilot animal see Table 1).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 2d

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1d

Irritant / corrosive response data:

Dulling of the normal lustre of the cornea was seen in two animals one hour after instillation only.
No other corneal damage or iridial inflammation was observed. Considerable swelling with partial eversion of the eyelids was seen in one animal one hour after instillation only. Temporary mild conjunctival reactions were seen in the remaining animals.
The eyes were normal two days after instillation

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Instillation of the test substance into the rabbit eye elicited dulling of the cornea and mild transient conjunctival irritation. All reaction has resolved within 2d. The substance is therefore considered to be as not-irritating.

Executive summary:

Three rabbits were each administered a single ocular dose of 76 mg of the test substance and observed for seven days after instillation.

A single instillation of the test material into the eye of the rabbit elicited dulling of the cornea and transient mild conjunctival irritation. All reactions had resolved 2 days after instillation.