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EC number: 235-804-2 | CAS number: 12767-90-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28/08/1990 to 08/10/1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Insecticide, Fungicide and Rodenticide Act (40 CFR).
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: The Toxic Substances Control Act (40 CFR).
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline (not specified)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexaboron dizinc undecaoxide
- EC Number:
- 235-804-2
- EC Name:
- Hexaboron dizinc undecaoxide
- Cas Number:
- 12767-90-7
- Molecular formula:
- B6O11Zn2
- IUPAC Name:
- hexaboron dizinc undecaoxide
- Details on test material:
- - Name of test material: XPI-187 zinc borate
- Physical state: Fine white powder
- Storage condition of test material: At room temperature in a large plastic Nalgene bottle with a lid.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: King's Wheel Rabbitry
- Age at study initiation: Young adult
- Housing: Singly in wire mesh suspension cages.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Animals were acclimated to the laboratory for at least one day prior to the test.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h dark/light cycle.
IN-LIFE DATES: From: 25/09/1990 To: 08/10/1990
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye of each animal was used as a control.
- Amount / concentration applied:
- A dose of 0.083 g was applied.
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- Eyes were examined and graded for ocular reaction at approximately 1 h, 24 h, 48 h and 74 h after application. Except for the 1 h observation and only in corneal opacity scores of 2 or less are noted, the eyes will be scored again for corneal opacity intensity and area using fluorescein.
- Number of animals or in vitro replicates:
- Six (3 males, 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of the animals were rinsed.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Fluorescein staining and ultra violet illumination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 48 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 1-870
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 72 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 48 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 24 h
- Score:
- ca. 4
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 1-870
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 1-870
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 1-870
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: Day4
- Score:
- 33
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Maximum total irritation scores for individual animals ranged from 8 to 33.
- Irritant / corrosive response data:
- The test material produced corneal opacity which had cleared by Day 10, iritis that with some fluctuation ultimately cleared by Day 10 and conjunctival irritation which had cleared by Day 13. Maximum total irritation scores for individual animals ranged from 8 to 33.
No evidence of corrosion was noted.
Any other information on results incl. tables
Primary eye irritation in rabbits following an ocular application of XPI-187 zinc borate:
Animal No.d | Reading | Corneaa | Iris | Conjunctivaa | Totalbc Score | |||
A | B | C | D | E | ||||
1-870 | 1 h | 0 | 0 | 0 | 2M | 1 | 2 | 10 |
24 h | 0/0 | 0/0 | 0 | 2N | 1 | 0 | 6/6 | |
48 h | 0/0 | 0/0 | 0 | 2M | 0 | 0 | 4/4 | |
72 h | 0/0 | 0/0 | 0 | 2M | 0 | 0 | 4/4 | |
Day 4 | 0/0 | 0/0 | 0 | 2 | 0 | 0 | 4/4 | |
Day 7 | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 10 | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 13 | 0/0 | 0/0 | 0 | 0 | 0 | 0 | 0/0 | |
2-871 | 1 h | 0 | 0 | 0 | 2W | 2 | 1 | 10 |
24 h | 1/1 | 0 | 1 | 2WGT | 3 | 2 | 24/24 | |
48 h | 1/1 | 1/1 | 0 | 3MT | 2 | 1 | 17/17 | |
72 h | 1/1 | 1/1 | 0 | 2T | 0 | 0 | 9/9 | |
Day 4 | 2/2 | 1/1 | 1 | 2T | 2 | 2 | 27 | |
Day 7 | 2/2 | 1/1 | 1 | 2 | 2 | 0 | 27 | |
Day 10 | 0/0 | 0/0 | - | 1 | 1 | 0 | 4/4 | |
Day 13 | 0/0 | 0/0 | 0 | 0 | 0 | 0 | 0/0 | |
3-872 | 1 h | 0 | 0 | 0 | 1WG | 1 | 1 | 6 |
24 h | 1/1 | 1/1 | 0 | 3WGP | 4 | 3 | 25/25 | |
48 h | 1/1 | 1/1 | 0 | 3T | 3 | 2 | 21/21 | |
72 h | 1/1 | 1/1 | 0 | 3T | 3 | 1 | 19/19 | |
Day 4 | 2/2 | 1/1 | 1 | 3 | 3 | 3 | 33/33 | |
Day 7 | 0/0 | 0/0 | 0 | 2 | 2 | 0 | 8/8 | |
Day 10 | 0/0 | 0/0 | 0 | 1 | 1 | 0 | 4/4 | |
Day 13 | 0/0 | 0/0 | 0 | 0 | 0 | 0 | 0/0 | |
4-927 | 1 h | 0 | 0 | 0 | 1WG | 2 | 3 | 12 |
24 h | 0/0 | 0/0 | 0 | 3W | 1 | 0 | 8/8 | |
48 h | 0/0 | 0/0 | 0 | 2M | 0 | 0 | 4/4 | |
72 h | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 4 | 0/0 | 0/0 | 0 | 2MTR | 1 | 0 | 6/6 | |
Day 7 | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 10 | 0/0 | 0/0 | 0 | 0 | 0 | 0 | 0/0 | |
5-928 | 1 h | 0 | 0 | 0 | 2WG | 0 | 2 | 6 |
24 h | 0/0 | 0/0 | 0 | 2W | 0 | 1 | 6/6 | |
48 h | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
72 h | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 4 | 0/0 | 0/0 | 0 | 1T | 0 | 0 | 2/2 | |
Day 7 | 0/0 | 0/0 | 0 | 0T | 0 | 0 | 0/0 | |
6-929 | 1 h | 0/0 | 0/0 | 0 | 2WG | 2 | 2 | 12 |
24 h | 0/0 | 0/0 | 0 | 3WG | 2 | 2 | 14/14 | |
48 h | 0/0 | 0/0 | 0 | 2M | 1 | 0 | 6/6 | |
72 h | 0/0 | 0/0 | 0 | 1M | 0 | 0 | 2/2 | |
Day 4 | 0/0 | 0/0 | 0 | 1T | 0 | 0 | 2/2 | |
Day 7 |
|
|
| 0 | 0 | 0 | 0/0 | |
aA = degree of opacity; B = Area affected; C = erythema; D = swelling; E = discharge
bScoring key
ctotal score is the sum of the following three sub-totals, with a maximum score of 110; (/) = score without/with sodium fluorescein:
1. Degree of opacity x area involved x 5
2. Iris score x 5
3. (Sum of scores for erythema, swelling and discharge) x 2
dDue to the nature and the amount of the sample dosed, a small amount was lost on dosing each rabbit.
W = White sample-like material throughout the eye
M = viscous, white material in the lower lid of the eye
G = Blistered appearance to the conjunctiva
T = Thickened appearance to the conjunctiva
P = Eye gently pried open prior to scoring
R = At the time of scoring, upon manipulation of the eyelid, the lower conjunctiva exhibited a moderate amount of blood-like material exuding from the conjunctival tissue.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The primary ocular irritancy of XPI-187 zinc borate was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide and Rodenticide Act (40 CFR) the Toxic Substances Control Act (40 CFR) and the OECD guidelines.
The test material produced corneal opacity which had cleared by Day 10, iritis that with some fluctuation ultimately cleared by Day 10 and conjunctival irritation which had cleared by Day 13. Maximum total irritation scores for individual animals ranged from 8 to 33. No evidence of corrosion was noted. The test material was classified in Toxicity Category II (40 CFR 156, proposed) by ocular administration.
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