Registration Dossier
Registration Dossier
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EC number: 266-867-4 | CAS number: 67674-28-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jun 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- EC Number:
- 266-867-4
- EC Name:
- Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- Cas Number:
- 67674-28-6
- Molecular formula:
- C26H25N5O5S.Na
- IUPAC Name:
- sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Acid Red 299
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- HC:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: mean: 3.0 Kg
- Housing: individual cages
- Diet: standard diet "ssniff K" ad libitum
- Water: tab 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:
- 0.1 ml (max. 0.1g)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes the treated eye, with physiological NaCl solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize-Grade
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:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 72h
- Irritant / corrosive response data:
- No effects on Cornea or Iris were observed. A maximum score of 1 was noted for erythema and edema at 24 and 48-hour evaluations.
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 | 1.0 | 0.7 | 0.0 |
| chemosis | 0.3 | 0.3 | 0.0 | |
* mean values of 3 animals |
||||
| DRAIZE-GRADE (time after application) | |||||||
| 1h | 24h | 48h | 72h | 7d | 14d, 21d | ||
| Animal | A B C | A B C | A B C | A B C | A B C | A B C | |
| Cornea | |||||||
| opacity | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 | n n n | |
| area | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 | n n n | |
| Iris | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 | n n n | |
| Conjunctivae | |||||||
| Erythem | superficial coloring by test item |
1 1 1 | 1 0 1 | 0 0 0 | 0 0 0 | n n n | |
| Chemosis | 1 1 1 | 0 0 1 | 0 0 1 | 0 0 0 | 0 0 0 | n n n | |
| Discharge | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 | n n n | |
n: no evaluation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance does not have eye irritating effects.
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