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EC number: 822-536-1 | CAS number: 2180952-76-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.
- EC Number:
- 270-145-4
- EC Name:
- Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.
- Cas Number:
- 68411-75-6
- Molecular formula:
- Unspecified
- IUPAC Name:
- Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Fluorescent Yellow D131 1577-123
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals and Animal Care:
Six young adult New Zealand White rabbits were obtained from New York State Rabbit Development, Hartwick, New York for use in this study.
All housing and care conformed to the standards established in "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 78-23. The rabbits were individually housed in wire mesh bottom cages in an environment-controlled room and provided NIH Animal Feed A (certified) and water ad libitum. Animals were identified with ear tags and color coded cage cards and acclimated for a minimum of 5 days prior to study initiation.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye served as control.
- Amount / concentration applied:
- 0.1 ml of undiluted material was applied to the eye of the rabbit. The other eye served as the untreated control.
- Duration of treatment / exposure:
- Single exposure. Eyes are not irrigated after test article installation.
- Observation period (in vivo):
- The treated eyes were examined with the aid of sodium fluorescin and the grade of ocular reaction was recorded for all animals at 1, 24, 48, 72 and 96 hours using the Draize Scale for Scoring Ocular Lesions. Readings were made every 3 days thereafter, if injury persisted, for at least 13 days after treatment or until all signs of reversible toxicity subsided.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The treated eyes were examined with the aid of sodium fluorescin and the grade of ocular reaction was recorded for all animals at 1, 24, 48, 72 and 96 hours using the Draize Scale for Scoring Ocular Lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Individual Rabbit Eye Irritation Scores
|
|
|
Reading |
|||
Rabbit Number |
Item |
Tissue |
1 hr |
24 hr |
48 hr |
72 hr |
3149 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
1 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
4 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
4 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3150 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
2 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
2 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3152 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3154 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
2 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
2 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3155 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
2 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
2 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3156 |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
1 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
4 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
4 |
0 |
0 |
0 |
Initial Body Weights:
Animal Number Initial Body Weight (kg)
83 -3149 2.18
83 -3150 2.20
83 -3152 2.58
83 -3154 2.48
83 -3155 2.60
83 -3156 2.32
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- All animals were clear of effects on corneal opacity, iris, redness or chemosis at the 24 hr time-point and thereafter.
- Executive summary:
The primary ocular irritation potential of Fluorescent Yellow #131 was evaluated in this study with New Zealand White rabbits. One group of six albino rabbits received a single, unwashed exposure. Each 0.1- ml dose of the test article was instilled into the lower conjunctival sac of one eye. The other eye served as an untreated control. The eyes were examined for ocular reactions in accordance with the method of Draize at 1, 24, 48 and 72 hours after dosing. All animals were free of effects on corneal opacity, iris, redness and chemosis at the 24 hr timepoint and thereafter.
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