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EC number: 288-950-4 | CAS number: 85940-63-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-10-13 to 1981-11-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA-Guidelines
- Version / remarks:
- Federal Register
38, No . 187, 27. 9 .1973, p 27019
- Principles of method if other than guideline:
- 6 rabbits were exposed with 0.1 ml of the test item in the conjunctival sac of the left eye. The right eye was the untreated control. Animals were observed with a magnifying glass after 1, 7, 24, 48 and 72 h after application. 24 h after application the eyes were washed with physiological NaCl solution. 48- and 72 h values were examined with additional instillation of sodium fluorescein (1:10 000). Scoring was carried our according to the method of Draize.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- EC Number:
- 288-950-4
- EC Name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- Cas Number:
- 85940-63-2
- Molecular formula:
- C22H17N4Na3O13S4
- IUPAC Name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- OTHER SPECIFICS:
- Remazol-Brillantgelb GL fluessig 25
- Appearance: yellow-brown liquid
- Molecular weight: 675 g/mol
- Density: 1,12 g/cm3
- Water solubility: soluble in water
- Solubility in fat: not miscible in fat oils
- Compositon:14,83 % Remazol-Brillantgelb GL , F-Ware , 65 :100
1,88 % Dinatriumhydrogenphosphat
4,71 % Dispergiermittel Hoe F 2874
14,12 % eta-Caprolactam
64, 46 % Water
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Hoe: HIMK (SPFWiga)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: own breeding
- Age at study initiation: not specified
- Weight at study initiation: 2,0 to 2,6 kg
- Housing: individual housing
- Diet (e.g. ad libitum): ad libitum, food from ERKA Z-6000 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) .
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 7, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiological saline solution
- Time after start of exposure: 24 h
SCORING SYSTEM: Scoring according to the Method of Draize (see table 1 in "Any other information on results incl. tables")
TOOL USED TO ASSESS SCORE: With magnifying glass. In addition assessment after 48 and 72 was done with sodium fluorescein solution (1:10 000).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All symptoms were fully reversible within 72 h except for Animal No. 4. In this animal a conjunctivae redness score of 1 was observed after 24 and 72 h, but not after 48 h.
For individual results see table 2 in "Any other information on results incl. tables". - Other effects:
- In some animals iris was colored yellow.
Any other information on results incl. tables
Table 2: Individual Eye Irritation Scores
| Eye Irritation Scores: Animal No. 1 | ||||||
| Eye Irritation Scores Post-Application after | ||||||
| Observation | 1 h | 7 h | 24 h | 48 h | 72 h | average score (24, 48 and 72 hours) |
| Cornea - opacity | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Iris | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Conjunctivae redness | 1 | 1 | 1 | 1 | 0 | 0,7 |
| Conjunctivae chemosis | 2 | 1 | 0 | 0 | 0 | 0,0 |
| Eye Irritation Scores: Animal No. 2 | ||||||
| Eye Irritation Scores Post-Application after | ||||||
| Observation | 1 h | 7 h | 24 h | 48 h | 72 h | average score (24, 48 and 72 hours) |
| Cornea - opacity | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Iris | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Conjunctivae redness | 2 | 1 | 1 | 0 | 0 | 0,3 |
| Conjunctivae chemosis | 1 | 1 | 0 | 0 | 0 | 0,0 |
| Eye Irritation Scores: Animal No. 3 | ||||||
| Eye Irritation Scores Post-Application after | ||||||
| Observation | 1 h | 7 h | 24 h | 48 h | 72 h | average score (24, 48 and 72 hours) |
| Cornea - opacity | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Iris | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Conjunctivae redness | 2 | 1 | 1 | 1 | 0 | 0,7 |
| Conjunctivae chemosis | 2 | 1 | 0 | 0 | 0 | 0,0 |
| Eye Irritation Scores: Animal No. 4 | ||||||
| Eye Irritation Scores Post-Application after | ||||||
| Observation | 1 h | 7 h | 24 h | 48 h | 72 h | average score (24, 48 and 72 hours) |
| Cornea - opacity | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Iris | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Conjunctivae redness | 2 | 2 | 1 | 0 | 1 | 0,7 |
| Conjunctivae chemosis | 2 | 1 | 1 | 0 | 0 | 0,3 |
| Eye Irritation Scores: Animal No. 5 | ||||||
| Eye Irritation Scores Post-Application after | ||||||
| Observation | 1 h | 7 h | 24 h | 48 h | 72 h | average score (24, 48 and 72 hours) |
| Cornea - opacity | 1 | 1 | 0 | 0 | 0 | 0,0 |
| Iris | 2 | 2 | 0 | 0 | 0 | 0,0 |
| Conjunctivae redness | 1 | 1 | 1 | 0 | 0 | 0,3 |
| Conjunctivae chemosis | 2 | 1 | 0 | 0 | 0 | 0,0 |
| Eye Irritation Scores: Animal No. 6 | ||||||
| Eye Irritation Scores Post-Application after | ||||||
| Observation | 1 h | 7 h | 24 h | 48 h | 72 h | average score (24, 48 and 72 hours) |
| Cornea - opacity | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Iris | 0 | 0 | 0 | 0 | 0 | 0,0 |
| Conjunctivae redness | 2 | 1 | 1 | 0 | 0 | 0,3 |
| Conjunctivae chemosis | 1 | 1 | 0 | 0 | 0 | 0,0 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- According to this study, one of 6 animals shows irritant effects on the conjunctivae after 72 h. According to CLP criteria classification as serious eye damage - Cat. 1 is required when at least in one of 6 animals effects on cornea, iris or conjunctiva are not reversible within 21 days observation period. Since the observation period in this study is max. 72 h, it cannot be used for classification.
- Executive summary:
In a primary eye irritation study according to FDA guidelines, 0.1 ml of the test item was instilled undiluted into the conjunctival sac of the left eye of young adult Himalaya Albino rabbits for 24 h. After 24 h the eyes were washed with physiological saline. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.
All animals showed weak signs of irritation on the conjunctivae which were reversible within 72 h, except in one of six animals. According to CLP criteria classification as serious eye damage - Cat. 1 is required when at least in one of 6 animals effects on cornea, iris or conjunctiva are not reversible within 21 days observation period .
Since the observation period in this study is only 72 h, it cannot be used for classification.
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