Registration Dossier
Registration Dossier
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EC number: 256-380-5 | CAS number: 49564-57-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-5-methoxy-N,2-dimethylbenzenesulphonamide
- EC Number:
- 256-380-5
- EC Name:
- 4-amino-5-methoxy-N,2-dimethylbenzenesulphonamide
- Cas Number:
- 49564-57-0
- Molecular formula:
- C9H14N2O3S
- IUPAC Name:
- 4-amino-5-methoxy-N,2-dimethylbenzene-1-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): Kresidinsulfmethylamid TF 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, breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.9 - 3.2 kg
- Housing: fully air conditioned rooms in single cages
- Diet: Altromin 2123 ad libitum and 15 gr hay
- Water: tap water 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 eye of each animal served as control
- Amount / concentration applied:
- 100 mg of the test item into the conjunctival sac of the left eye
- Duration of treatment / exposure:
- 24 h after instillation eyes were washed with physiol. saline
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: physiolog. saline solution
- Time after start of exposure: 24 hours
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs odf irritation (cornea) at any time
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: # 2, and 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs orf irritation (iris) at any time
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 2, and 3 each
- Time point:
- other: mean of 24, 48,72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (chemosis) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1, and 2 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- 1 to 24 h post instillation: clear colorless or white viscous discharge. All symptomes were fully reversible within 48 h
- Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- not irritating to eyes
- Executive summary:
The test item was tested for eye irritation/corrosion in rabbits according to OECD 405. 100 mg of the undiluted test item were applied into the conjunctival sac of the left eye from each of three rabbits. The right eye remained untreated and served as control. After 24 h exposure time the eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, and 72 h after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each rabbit
Based on the findings in this test the test substance was considered not to be a eye irritant.
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