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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
Study period:
20 March 2006 to 23 March 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The eye irritation potential of three batches of the test material was assessed in the rabbit.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Appearance: Light yellow liquid, Clear Liquid
- Stability: There was no apparent change in the physical state of the test material during administration
- Storage conditions of test material: Room temperature, protected from exposure to light

Test animals / tissue source

Species:
rabbit
Strain:
other: JW

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL/eye
Duration of treatment / exposure:
Eyes were closed for about 1 second after instillation.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male animals were exposed to each batch of test material (9 animals in total)
Details on study design:
SCORING SYSTEM
The Draize scoring system was used. Reactions were assessed 1, 24, 48 and 72 hours after test material application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritant / corrosive response data:
At the 24, 48 and 72 hour time points, no eye in any rabbit showed any reaction to the test material with regard to the cornea, iris, redness, chemosis and discharge. All scores were 0.

Any other information on results incl. tables

Table 1: Summary of Scores for the First Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

601 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

602 (left eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

603 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

 

Table 2: Summary of Scores for the Second Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

611 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

612 (left eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

0

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

613 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

 

Table 3: Summary of Scores for the Third Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

621 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

622 (left eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

0

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

623 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions this study, the test material is not classified as an ocular irritant in accordance with EU criteria.
Executive summary:

A study was conducted to assess the potential of the test material to cause irritation to the eyes of rabbits using methodology similar to that outlined in the standardised guideline OECD 405.

The eye irritation potential of three batches of the test material was assessed in male JW rabbits (three per batch). The dose level administered was 0.1 mL/eye. The eyes of the rabbits were closed for about one second after instillation. Observations were made at 1 hour after instillation and then every 24 hours for a total duration of 72 hours. The Draize scoring system was used to determine the degree of eye reaction.

At the 24, 48 and 72 hour time points, no eye in any rabbit showed any reaction to the test material with regard to the cornea, iris, redness, chemosis and discharge. All scores were 0.

Under the conditions this study, the test material is not classified as an ocular irritant in accordance with EU criteria.