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EC number: 240-834-4 | CAS number: 16803-97-7
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:
- guideline study
- Justification for type of information:
- Data is from study report.
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)
- Principles of method if other than guideline:
- Assessment of a possible irritating potential to the eye and to the eve mucosa caused by the chemical 4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) according to OECD Guideline 405.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-amino-N-(4-aminophenyl)benzenesulphonamide
- EC Number:
- 240-834-4
- EC Name:
- 4-amino-N-(4-aminophenyl)benzenesulphonamide
- Cas Number:
- 16803-97-7
- Molecular formula:
- C12H13N3O2S
- IUPAC Name:
- 4-amino-N-(4-aminophenyl)benzenesulphonamide
- Details on test material:
- Name - 4-amino-N-(4-aminophenyl)benzenesulphonamide
InChI - 1S/C12H13N3O2S/c13-9-1-3-10(4-2-9)15-11-5-7-12(8-6-11)18(14,16)17/h1-8,15H,13H2,(H2,14,16,17)
Smiles - O=S(=O)(c1ccc(cc1)Nc1ccc(cc1)N)N
Mol. formula: C12H13N3O2S
Molecular Weight - 263.32 g/mole
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : 4-amino-N-(4-aminophenyl)benzenesulphonamide
- Molecular formula : C12H13N3O2S
- Molecular weight : 263.32 g/mol
- Smiles notation : O=S(=O)(c1ccc(cc1)Nc1ccc(cc1)N)N
- InChl : 1S/C12H13N3O2S/c13-9-1-3-10(4-2-9)15-11-5-7-12(8-6-11)18(14,16)17/h1-8,15H,13H2,(H2,14,16,17)
- Substance type: Organic
- Physical state : Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: GAUKIER ; D-6050 OFFENBACH/MAIN, FR G
- Age at study initiation: no data
- Weight at study initiation: male: 2.80kg; female:2.79 kg
- Fasting period before study: no data
- Housing: no bedding in the cages ; sawdust in the waste trays
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per Animal per day
- Acclimation period: At least 8-davs before the beginning of the study ; same housing conditions as during the study
-Type of cage : cage made of stainless steel with wire mesh walk floors, floor area : 40 cm x 51 cm (1 animal/ cage)
-Clipping of the fur : at least 15 hours before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h/12 h(6.00 - 18.00 hours/ 18.00 - 6.00 hours )
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1ml (27mg)
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 1h, 24h , 48h and 72 h
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: the conjunctival sac of the right eyelid
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM: Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983 (for calculation of the means of means of opacity, iris, redness and swelling only the readings of 24, 48 and 72 hours are used).
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:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of ocular lesions were observed.
Any other information on results incl. tables
RESULTS ACUTE EYE IRRITATION |
|||||||
Time (hours) |
Animal no |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Area of cornea involved |
Redness |
swelling |
Discharge |
|||
1 hours |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
2 |
0 |
0 |
0 |
1 |
0 |
1 |
|
3 |
0 |
0 |
0 |
1 |
0 |
1 |
|
24 hours |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 hours |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 hours |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
1 |
0.00 |
0.00 |
0.00 |
0.7 |
0.00 |
0.00 |
Mean |
2 |
0.00 |
0.00 |
0.00 |
0.0 |
0.00 |
0.00 |
Mean |
3 |
0.00 |
0.00 |
0.00 |
0.3 |
0.00 |
0.00 |
Mean |
|
0.00 |
0.00 |
0.3 |
0.00 |
||
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The mean eye irritation scores after 1, 24, 48 and 72 hours was 0.0. Hence based on the scores, the chemical 4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) can be considered to be not irritating to White Vienna rabbit eyes.
- Executive summary:
The eye irritation study was conducted onthree (1 male and 2 females)White Vienna rabbits to assess the irritating potential of the chemical4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) in accordance with OECD guideline (405).
About 0.1ml (27 mg) of chemical was installed into the conjunctival sac of right eye lid whereas the left untreated eye served as control. The eyes were not rinsed andscored for signs of irritation at 1, 24, 48 and 72 hours.
There were no evidence no any ocular lesions andthe mean eye irritation scores after 1, 24, 48 and 72 hours was 0.0. Hence based on the scores, the chemical4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7)can be considered to be not irritating to White Vienna rabbit eyes.
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