Registration Dossier

Toxicological information

Eye irritation

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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: Non-GLP, non-guideline, some restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Three male and three female rabbits received 0.07 g (0.1 ml) test material on the everted lower eyelid, with the contralateral eye serving as the untreated control. Occular irritation was assessed (Draize score) after 24, 48, 72 and 96 hours and 7, 14 and 21 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Sample number: 41105731

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver PA
- Age at study initiation: 14 weeks
- Housing: individually in screen-bottom cages
- Diet: ad libitum, Teklad Laboratory Rabbit Diet
- Water: ad libitum
- Acclimation period: at least 7 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye
Amount / concentration applied:
0.07 g (0.1 ml weight equivalent)
Duration of treatment / exposure:
single application
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
The eyes of the rabbits remained unflushed. Ocular irritation was assessed (Draize score) after 24, 48, 72 and 96 hours and 7, 14 and 21 days after treatment on the everted lower eyelid. The contralateral eye serving as the untreated control. At the 7-day reading, sodium fluorescein was used to aid in revealing corneal injury.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary eye irritation score (Draize)
Basis:
mean
Time point:
other: 24 hrs
Score:
23.8
Irritation parameter:
other: Primary eye irritation score (Draize)
Basis:
mean
Time point:
other: 48 hrs
Score:
19.2
Irritation parameter:
other: Primary eye irritation score (Draize)
Basis:
mean
Time point:
other: 72 hrs
Score:
19.8
Irritation parameter:
other: Primary eye irritation score (Draize)
Basis:
mean
Time point:
other: 96 hrs
Score:
15.7
Irritation parameter:
other: Primary eye irritation score (Draize)
Basis:
mean
Time point:
other: 7 days
Score:
13.8
Irritation parameter:
other: Primary eye irritation score (Draize)
Basis:
mean
Time point:
other: 14 days
Score:
7
Irritation parameter:
other: Primary eye irritation score (Draize)
Basis:
mean
Time point:
other: 21 days
Score:
6.3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
1.22
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0.55
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: scoring was not possible at 48 and 72 hours, white necrotic areas on conjunctivae were present
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: scoring was not possible at 48 and 72 hours, white necrotic areas on conjunctivae were present
Other effects:
White necrotic areas on the conjunctivae were seen in two animals at 24, 48, 72 and 96 hours and 7 days.
Pannus was observed in two animals at 7, 14 and 21 days.
One animal exhibited corneal neovascularization at day 21.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

The acute eye irritation/corrosion of multiconstituent aluminium potassium fluoride in the rabbit was investigated in a non-guideline study. Despite some restrictions in design and/or reporting, the study is considered as adequate for assessment. A single sample 0.07 g (0.1 ml weight equivalent) of the finely ground test material was placed on the lower lid of one eye of three male and three female rabbits. The other eye served as the untreated control. The treated eyes were observed for ocular irritation at 24, 48, 72 and 96 hours and at 7 days after treatment. Because injury was present at 7 days, observations were continued at 14 and 21 days.

White necrotic areas on the conjunctivae were seen in two animals at 24, 48, 72 and 96 hours and 7 days. Pannus was observed in two animals at 7, 14 and 21 days. One animal exhibited corneal neovascularization at day 21. Based on the eye irritation scores, it is concluded that the multiconstituent aluminium potassium fluoride is irritating to eyes.