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Toxicological information

Eye irritation

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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:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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
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.