Registration Dossier
Registration Dossier
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EC number: 228-940-9 | CAS number: 6375-55-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 23 to October 25, 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)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium 4,4'-bis(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-ylazo)-1,1'-biphenyl-2,6'-disulphonate
- EC Number:
- 228-940-9
- EC Name:
- Disodium 4,4'-bis(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-ylazo)-1,1'-biphenyl-2,6'-disulphonate
- Cas Number:
- 6375-55-9
- Molecular formula:
- C32H24N8Na2O8S2
- IUPAC Name:
- NA
- 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: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
- Weight at study initiation: mean weight of 2.5 kg
- Housing: the rabbits were individually housed in polystyrene cages 0.35 x 0.55 x 0.32 m. Each cage was equipped with a food container and a water bottle.
- Diet: animals were fed ad libitum with a certified pelleted Rabbit diet Ref. 112C (U.A.R., Villemoisson sur Orge, France) during the study.
- Water: free access to tap water filtered with Millipore filters in water bottles. Routine bacteriological and chemical analysis of water were made, in order to detect major contaminants, by the Laboratoire Municipal, 76000 Rouen, France.
- Acclimation period: at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 50 ± 20 %
- Air changes: the incoming non-recycled air was filtered by an absolute filter
- Photoperiod (hrs dark / hrs light): the light/dark cycle was 12 hours per day.
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- Thirty seconds
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: both eyes of three animals (n° 01, 02, 03) were rinsed with 10 ml of sterile salinc solution.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 01, 02, 03
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no clinical signs
- Irritation parameter:
- iris score
- Basis:
- animal: 01, 02, 03
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no clinical signs
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 01
- Time point:
- 24/48/72 h
- Score:
- ca. 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 02, 03
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 01
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 02
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 03
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no clinical signs
- Irritant / corrosive response data:
- One hour after application, conjunctival reactions were observed in all animals. From D6, no ocular reactions were observed in animals no 01, 02, 03, 04, 05. For animal 06, a slight chemosis persisted until D14, and an opacity persisted from D2 to D21.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- Non irritant
- Executive summary:
Method
The test sample was applied into the conjunctival sac of six New-Zealand rabbits. The eyes of the first three animals were rinsed thirty seconds after application. The study was conducted according to the recommendations of the OECD Guideline 405.
Results
One hour after application, a slight conjunctival reactions were observed in all animals. On Day 5, they had disappeared in five animals. A slight chemosis persisted until Day 14 in animal 06. On Day 2, a diffuse area of opacity, greater than half the corneal surface, was observed in one animal (n° 06). The reaction regressed but persisted until Day 21.
No effect on the iris and cornea of the rinsed animals was observed.
Conclusion
Non irritant.
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