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EC number: 418-310-3 | CAS number: 126050-54-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 to 20 August 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with US EPA test guideline in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Environmental Protection Agency Good Laboratory Practice Standards, 40 CFR 792 (November 29, 1983)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test Material: Mark HP-10
Physical Description: White powder
Purity and Stability: Sponsor assumes responsibility for purity and stability determinations (including under test conditions).
Storage and Retention: The test material was stored at room temperature.
Any unused material will be discarded according to HLA Standard Operating Procedure.
Safety Precautions: Normal handling procedures were used according to HLA Standard Operating Procedure.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animal: Adult albino rabbits, Hra:(NZW)SPF, were procured, maintained individually in screen-bottom cages in temperature- and humidity-controlled quarters, provided access to water ad libitum and a measured amount of High Fiber Rabbit Chow® 5326, Purina Mills, Inc., and held for an acclimation period of at least 7 days. Animal husbandry and housing at HLA comply with standards outlined in the “Guide for the Care and Use of Laboratory Animals". If variations from the prescribed environmental conditions existed, they were documented and considered to have no effect on the study outcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study.
Three male and three female acclimated animals, weighing from 2020 to 2390 g, were chosen at random for the test.
Reason for Species Selection: Historically, the New Zealand White albino rabbit is the animal of choice based upon its large orbit and non pigmented iris.
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.04 g (0.1 ml weight equivalent)
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males & 3 females
- Details on study design:
- The animals' eyes were examined approximately 24 hours prior to test material administration using sodium fluorescein dye procedures. Only those animals with no sign of ocular injury or irritation were used on the test. Test animals were identified by animal number and corresponding ear tag.
Preparation of Test Material: A bulk density determination was made to determine the weight equivalent of a 0.1-ml dose. An individual dose of 0.04 g was weighed out for each animal.
Treatment: Each rabbit received 0.04 g (0.1 ml weight equivalent) of the test material placed into the everted lower lid of one eye, with the contralateral eye serving as the untreated control. The upper and lower lids were gently held together for 1 second to prevent loss of material and then released. The eyes of the rabbits remained unflushed.
Reason for Route of Administration: Historically, the ocular route is the route of choice based on the method of Draize.
Observations: The treated eyes were observed for ocular irritation at 1, 24, 48, and 72 hours after treatment.
At the 72-hour reading, sodium fluorescein was used to aid in revealing possible corneal injury. Irritation was graded and scored according to the Draize technique.
Animals were weighed just prior to test material administration.
Termination: At study termination all animals were euthanatized and discarded.
Statistical Methods: No statistical method was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not apllicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No pain response was elicited from any animal following instillation of the test material.
- Other effects:
- Blanching of the conjunctivae was seen in one animal at 1 hour.
Any other information on results incl. tables
Table 1 Individual Eye Irritation Scores
Animal Number |
Observation Period (Hour) |
Cornea |
Score AXBX5 |
Iris A |
Score A X 5 |
Conjunctivae |
Score (A+B+C)X2 |
|||
A |
B |
A |
B |
C |
||||||
F29713 |
1 |
0 |
0 |
0 |
1 |
5 |
3 |
1 |
3 |
14 |
24 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
|
48 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
F29714 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
24 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
F29715 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
1 |
6 |
24 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
F29722 |
1 |
0 |
0 |
0 |
2 |
5 |
2 |
0 |
1 |
6 |
24 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
F29717 |
1 |
0 |
0 |
0 |
1 |
5 |
2 |
0 |
1 |
6 |
24 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
F29718 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
1 |
6 |
24 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Cornea Conjunctivae
A – Degree of opacity A – Redness
B – Area of involvement B – Chemosis
C – Discharge
Table 2 Sodium Fluorescein Examination
Animal Number |
Observation Period |
|
Pre-initiation |
72 Hour |
|
F29713 |
NEG |
NEG |
F29714 |
NEG |
NEG |
F29715 |
NEG |
NEG |
F29722 |
NEG |
NEG |
F29717 |
NEG |
NEG |
F29718 |
NEG |
NEG |
NEG – No stain retention
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, Mark HP-10, produced iridal involvement and moderate to severe conjunctival irritation when instilled into the eyes of six albino rabbits. All ocular irritation cleared within 72 hours after instillation of the test material.
- Executive summary:
Objective: To assess the relative level of irritation produced following a single exposure of a test material to one eye of albino rabbits.
Regulatory Compliance: This study was conducted in accordance withtheU.S. Environmental Protection Agency Good Laboratory Practice Standards, 40 CFR 792 (November 29, 1983), the Food and Drug Administration Good Laboratory Practice Regulations, 21 CFR58,and the proposed Organisation for Economic Cooperation and Development's Principles of Good Laboratory Practice,
Annex 2, C(81)30 . The in-life portion of the study was done before the effective date of the revised EPA standards (September 18, 1989).
The test material, Mark HP-10, produced iridal involvement and moderate to severe conjunctival irritation when instilled into the eyes of six albino rabbits. All ocular irritation cleared within 72 hours after instillation of the test material.
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