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EC number: 277-761-2 | CAS number: 74196-18-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- 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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Principles of method if other than guideline:
- Three male rabbits were administered 100 mg test item in the right eye; the left eye served as a control. The eyes were evaluated 30 minutes, 24, 48 and 72 hours and 4 and 7 days after the administration of the test item.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acid Black 076
- IUPAC Name:
- Acid Black 076
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: all animals were housed in individual cages
- Diet: a standard laboratory diet were provided ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 to 70 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours cycle dark/light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- APPLICATION
- Amount applied: 100 mg was placed undiluted into the right conjunctival sac; the eyelids were then gently held together for two seconds - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72 hours with observations at 30 minutes, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- Three male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unrinsed
- Pre-test: prior to application, the eyes of each rabbit were examined for pre-existing casual injury
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: unrinsed eye
Any other information on results incl. tables
Table 1: Summary of ocular findings.
| Treatment | unrinsed eye | |||
| Hours after instillation | 0.5 | 24 | 48 | 72 |
| Cornea, whole area | ||||
| no opacity | 3/3 | 3/3 | 3/3 | 3/3 |
| grade 1 opacity | ||||
| grade 2 opacity | ||||
| Iris function | ||||
| not impaired | 3/3 | 3/3 | 3/3 | 3/3 |
| slightly impaired | ||||
| Conjunctiva | ||||
| Redness | ||||
| no redness | 3/3 | 1/3 | 2/3 | 3/3 |
| grade 1 redness | 2/3 | 1/3 | ||
| grade 2 redness | ||||
| Chemosis | ||||
| no swelling | 3/3 | 2/3 | 3/3 | 3/3 |
grade 1 swelling |
1/3 | |||
| Discharge | ||||
| no secretion | 3/3 | 3/3 | 3/3 | 3/3 |
| very slight secretion | ||||
| Total score | 8 | |||
| Average per animal | 0.67 | |||
Table 2: Results.
| Animal no. | Findings | 30 minutes | 24 hours | 48 hours | 72 hours | 10 days | 14 days | 21 days |
| no. 4 (male) | Corneal density (A)* | 0 | 0 | 0 | 0 | |||
| Corneal area (B) | 0 | 0 | 0 | 0 | ||||
| A×B×5= | 0 | 0 | 0 | 0 | ||||
| Iris function and aspect (C)* | 0 | 0 | 0 | 0 | ||||
| C×5= | 0 | 0 | 0 | 0 | ||||
Conjunctival secretion (D) |
0 | 0 | 0 | 0 | ||||
| Conjunctival swelling (E)* | 0 | 0 | 0 | 0 | ||||
| Conjunctival redness (F)* | 0 | 0 | 0 | 0 | ||||
| (D+E+F)×2= | 0 | 0 | 0 | 0 | ||||
| no. 5 (male) | Corneal density (A)* | 0 | 0 | 0 | 0 | |||
| Corneal area (B) | 0 | 0 | 0 | 0 | ||||
| A×B×5= | 0 | 0 | 0 | 0 | ||||
| Iris function and aspect (C)* | 0 | 0 | 0 | 0 | ||||
| C×5= | 0 | 0 | 0 | 0 | ||||
| Conjunctival secretion (D) | 0 | 0 | 0 | 0 | ||||
| Conjunctival swelling (E)* | 0 | 1 | 0 | 0 | ||||
| Conjunctival redness (F)* | 0 | 1 | 0 | 0 | ||||
| (D+E+F)×2= | 0 | 4 | 0 | 0 | ||||
| no. 6 (male) | Corneal density (A)* | 0 | 0 | 0 | 0 | |||
| Corneal area (B) | 0 | 0 | 0 | 0 | ||||
| A×B×5= | 0 | 0 | 0 | 0 | ||||
| Iris function and aspect (C)* | 0 | 0 | 0 | 0 | ||||
| C×5= | 0 | 0 | 0 | 0 | ||||
| Conjunctival secretion (D) | 0 | 0 | 0 | 0 | ||||
| Conjunctival swelling (E)* | 0 | 0 | 0 | 0 | ||||
| Conjunctival redness (F)* | 0 | 1 | 1 | 0 | ||||
| (D+E+F)×2= | 0 | 2 | 2 | 0 | ||||
| 0 | 6 | 2 | 0 |
* used for calculation of eye irritation score.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC no. 1272/2008)
- Conclusions:
- The test item was found to be not irritating to the rabbit eye in vivo
- Executive summary:
The eye irritation potential of the test item was evaluated in an in vivo experimental study equivalent to the OECD guideline 405 (1987). Three male rabbits were administered 100 mg of undiluted test item to the conjunctival sac of the right eye and not removed; the left eye served as a control. The eyes were evaluated for corneal opacity, iritis, conjunctival redness and chemosis at 30 minutes, 24, 48 and 72 hours after administration.
The corneal opacity and iritis scores were 0 in all animals at all time points. The mean (24/48/72 h) chemosis scores were 0 in animals #1 and #3, and 0.33 in animal #2. Mean (24/48/72 h) conjunctival redness scores were 0, 0.33 and 0.67 in animals #1, #2 and #3 respectively. All effects observed were fully reversible within the 7-day study period.
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