Registration Dossier
Registration Dossier
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EC number: 281-719-9 | CAS number: 84029-45-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate
- EC Number:
- 281-719-9
- EC Name:
- Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate
- Cas Number:
- 84029-45-8
- Molecular formula:
- C14H12N2O6S.Na
- IUPAC Name:
- sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate
- Details on test material:
- purity: 89,9 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3,4 - 4,8 kg
- Housing: in single cages in completely air conditioned rooms
- Diet: Altromin 2123 Haltungsdiat - Kaninchen ( ad libitum) and 15 g hay per day
- Water: deionized and chlorinated water from automatic suspensors (ad libitum):
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye was taken for control
- Amount / concentration applied:
- 100 mg in the conjunctivae sac of the left eye
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : physiol saline warmed to about 37°C
- Time after start of exposure: 24 hours
SCORING SYSTEM:
cornea: 0 - 4
iris: 0 - 2
conjunctivae: 0 - 3
chemosis: 0 - 4
TOOL USED TO ASSESS SCORE: fluorescein/ UV-light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The susbatnce has not to be classified as eye irritant.
- Executive summary:
The substance was tested for eye irritation according to OECD guideline 405. 100 mg of the test item was administered into the left eyes of 3 rabbits (New Zealand Whites). One hour to 7 days after the application the conjunctivae showed redness and were slightly swollen. by day 14 after application all signs for irritation were reversible. Therefore, the test item has to be described as slighly irritant to the eye but it is not subject for classification.
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