Registration Dossier
Registration Dossier
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EC number: 280-676-3 | CAS number: 83733-23-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 days in January 1977
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD guideline
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)][2-[(2-hydroxybenzylidene)amino]-4-nitrophenolato(2-)-N2,O1,O2]chromate(2-)
- EC Number:
- 280-676-3
- EC Name:
- Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)][2-[(2-hydroxybenzylidene)amino]-4-nitrophenolato(2-)-N2,O1,O2]chromate(2-)
- Cas Number:
- 83733-23-7
- Molecular formula:
- C29H18CrN7O11S.2Na
- IUPAC Name:
- disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)][2-[(2-hydroxybenzylidene)amino]-4-nitrophenolato(2-)-N2,O1,O2]chromate(2-)
- 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
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3-4kg
- Housing: individually in cages
- Diet (e.g. ad libitum): Standard ssniff (R) K4 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 40 - 60%
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg - Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- 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:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very weak signs of irritation (conjunctivae redness) occurred within 24 h after treatment and were fully reversible within 48 h. No signs of corrosion observed.
Any other information on results incl. tables
| endpoint | average score per observation time and endpoint | |||
| 24h | 48h | 72h | ||
| cornea | opacity | 0.0 | 0.0 | 0.0 |
| iris | value | 0.0 | 0.0 | 0.0 |
| conjuctiva | redness | 1.5 | 0.0 | 0.0 |
| chemosis | 0.0 | 0.0 | 0.0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No significant signs of irritation related to the substance were observed. Very weak conjunctivae redness was fully reversible within 48 h. The substance is not classifiable according to CLP criteria.
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