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
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.

- Age at study initiation: 12-16 weeks.

- Weight at study initiation: 2.67-2.94 kg

- Housing: The animals were housed in suspended metal cages.

- Diet: STANRAB SQC Rabbit diet (ad libitum), Special Diets Services Ltd, Witham, Essex, UK.

- Water: Mains water (ad libitum).

- Acclimation period: Minimum of five days.


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 17-20C

- Humidity (%): 43-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
other: The test material was ground to a fine powder before use.
Controls:
other: The other eye of each animal was used as a control.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml

- Concentration (if solution): 46 mg (as measured by gently compacting the required volume into an adapted syringe)


Duration of treatment / exposure:
Single instillation of the test material.
Observation period (in vivo):
Assesment of ocular damage/irritation was made approximately 1 hour, 24, 48 and 72 hours following treatment. Total observation period was 14 days.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed


SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity tests" modified Kay and Callandra.


TOOL USED TO ASSESS SCORE: Standard optalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
2
Reversibility:
fully reversible
Remarks:
14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks:
14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Diffuse corneal opacity was noted in 2 treated eyes at the 24, 48, and 72 hour observations. Iridial inflammation was noted in 2 treated eyes at the 24 hour observation and persisted in 1 treated eye at the 48 and 72 hour observations.  Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment and persisted in 2 treated eyes at the 24 and 48 hour observations. Minimal conjunctival irritation was noted in 1 treated eye at the 24 and 48 hour observations and in 2 treated eyes at the 72 hour and 7 day observation. Overall irritation score: Maximum group mean score 27.3 at 24 hours.

All corneal and iridial scores and scores for conjunctival chemosis were normal by day 7. Conjunctival redness persisted in 2 
rabbits through day 7 but scores were 0 by day 14. The effects were therefore fully reversible.  
Other effects:
Discharge was observed from all treated eyes 1 hour after instillation and persisted in one eye for 48 hours and in another for 72  hours. 

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0 

2/2/2 

 2/2/1

24 h

 0/1/1

 0/1/1

 1/2/2

 1/2/2

48 h

 0/1/1

 0/1/0

 1/2/2

 0/2/2

72 h

 0/1/1

 0/1/0

 0/2/1

 0/1/1

Average 24h, 48h, 72h

 0/1/1

 0/1/0.3

 0.7/2/1.7

 0.3/1.7/1.7

Reversibility*)

 c

Average time (unit) for reversion

Day 14 

Day 14  

Day 14  

Day 14  

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on cornea scores of 1 in all animals and conjunctivae redness and chemosis reading of 2 in two of the animals, the test material would be a category 2 irritant according to current guidelines.
Executive summary:

In the eye irritation study, fine powder of test material was applied into the eyes of 3 rabbits. Assesment of ocular damage/irritation was made approximately 1 hour, 24, 48 and 72 hours following treatment. Total observation period was 14 days.

Diffuse corneal opacity was noted in 2 treated eyes at the 24, 48, and 72 hour observations.

Iridial inflammation was noted in 2 treated eyes at the 24 hour observation and persisted in 1 treated eye at the 48 and 72 hour observations.  Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment and persisted in 2 treated eyes at the 24 and 48 hour observations. Minimal conjunctival irritation was noted in 1 treated eye at the 24 and 48 hour observations and in 2 treated eyes at the 72 hour and 7 day observation. Overall irritation score: Maximum group mean score 27.3 at 24 hours.

All corneal and iridial scores and scores for conjunctival chemosis were normal by day 7. Conjunctival redness persisted in 2 

rabbits through day 7 but scores were 0 by day 14. The effects were therefore fully reversible.