Registration Dossier
Registration Dossier
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EC number: 229-158-0 | CAS number: 6420-33-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 November 1985 to 11 November 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)
- EC Number:
- 229-158-0
- EC Name:
- Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)
- Cas Number:
- 6420-33-3
- Molecular formula:
- C37H28N6Na4O15S4
- IUPAC Name:
- tetrasodium 3-({4-[({4-[(4,8-disulfonato-2-naphthyl)diazenyl]-2-methoxy-5-methylphenyl}carbamoyl)amino]-5-methoxy-2-methylphenyl}diazenyl)naphthalene-1,5-disulfonate
- 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: by Nottingham UnÍversity, School of Agriculture, Sutton BonÍngton, Leicestershire, U.K
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.54-3.12 kg
- Housing: individually
- Diet: Rabbit Diet, A.l.l. Tindall Limited, Holbeach, Lincolnshire UK ad libitum
- Water:. ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 °C
- Humidity (%): 45-55%
- Air changes (per hr): ca 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL (48 mg)
- Observation period (in vivo):
- at 1, 24, 48, 72 hours and at day 7 (one rabbit only)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM:Draize
TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)
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:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- at the 1 hour observation dulling of the cornea was observed in all 3 rabbits
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- one animal reversible within 7 days others within 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no irritation observed
- Other effects:
- at the 1 hour observation dulling of the cornea was seen and areas of yellow staining
Any other information on results incl. tables
| Animal no | 1 | 2 | 3 | ||||||||||
| 1 | 24 | 48 | 72 | 7 | 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | |
| cornea | D | 0 | 0 | 0 | 0 | D | 0 | 0 | 0 | D | 0 | 0 | 0 |
| iris | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| conjunctivae | |||||||||||||
| redness | 2 | 2 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 2 | 1 | 1 | 0 |
| chemosis | 2 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
D= dulling of the cornea
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eyes
- Executive summary:
In a test according to OECD 405 3 rabbits received 0.1 mL of the substance in the eye. Initial signs of irritation were fully reversible over the 72 hour (7 day) observation period. The substance is considered not irritating to the eyes.
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