Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: see attached file
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Sample reference: NBW 8809/52
- CTL reference number Y04203/002/001
- Physical state: red powder
- Supplier : ICI Colours and Fine Chemicals, Blackley, Manchester
- moisture content : 0.2 % water

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK.
- Age at study initiation: young adult
- Weight at study initiation: 3707, 4331 and 4381g.
- Housing: satinised aluminium sheet cages (60.5cm width x 49cm depth x 45.5cm height), floor of each cage made of perforated aluminium sheet and, door made of polycarbonate (MAKROLON).

Test system

Observation period (in vivo):
1-2 hours, 1, 2, 3, 4 and 7 days after application.
Number of animals or in vitro replicates:
3 females

Results and discussion

Any other information on results incl. tables

Application of the test sample into the eye caused a slight initial pain reaction (class 2 on a 0-5 scale) in all three rabbits. Immediately

following application, approximately one third of the test sample was di spl aced from the conjunctival sac of two rabbits and approximately one quarter was displaced from the conjunctival sac of the remaining rabbit.

There were no corneal or iridial effects in any animal. Conjunctival irritation, including redness, chemosis and discharge, was observed in all three animals and persisted for up to four days after application, in two animals. All signs of irritation had disappeared seven days after application.

Additional observations made during the study were red staining of the periorbital area of the eye by the test substance (two animals). In addition, one animal had convoluted eyelids. All additional signs of irritation had disappeared by Day 7.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: modified form of the Kay and Calandra system
Conclusions:
In conclusion, substance was classed as a mild irritant (class 4 on a 1-8 scale based on a modified form of the Kay and Calandra system) to the rabbit eye.
Executive summary:

mild irritant