Registration Dossier
Registration Dossier
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EC number: 275-177-2 | CAS number: 71077-34-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994 - 1995
- 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:
- 1 995
- Report date:
- 1995
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:
- Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate
- EC Number:
- 275-177-2
- EC Name:
- Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate
- Cas Number:
- 71077-34-4
- Molecular formula:
- C14H14N2O4S.Na
- IUPAC Name:
- sodium 4-[(3-amino-4-methylbenzoyl)amino]benzenesulfonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Chbb: NZW (SPF)
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.4 - 3.2 kg
- Housing: in fully air-conditioned rooms, separate cages
- Diet: Altromin 2123 maintenance diet - rabbits (ad libitum) and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Lighting time: 12 hours daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: isotonic saline at approx. 37°C.
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Cornea: 0 - 4; Iris: 0 - 2;
Conjunctiva: Redness: 0 - 3; Chemosis: 0 - 4; Discharge: 0 - 3
TOOL USED TO ASSESS SCORE: UV-light / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- 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:
- Testing of Amionotoluene sulfanilic acid Na salt for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
- Executive summary:
The substance was tested for eye-irritation according to OECD guideline 405 with 3 femal rabbits.
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluoresceinsodium solution. Only animals without ocular abnormalities were used for the study.
100 mg of the substance was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. 24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours, the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.
One hour up to 24 hours after application the conjunctiva of the animals showed sporadically definitely injected blood vessels to more diffuse, deeper crimson red. A very slight swelling of the conjunctiva was observed one hour after application. Clear colorless discharge occurred one hour p.a. Two days after application all irritations were reversible.
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