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Administrative data

Description of key information

Skin irritation

Skin irritation study for 4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no:16803-97-7) was determined by Sustainability Support Services (Europe) AB. Based on the result obtained, it was concluded that the chemical 4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) is not irritating to the skin and can be classified under the category ˋ Not Classified’ as per CLP regulation.

 

Eye irritation

Eye irritation study for 4-amino-N-(4-aminophenyl)benzenesulphonamide (16803-97-7) was determined by Sustainability Support Services (Europe) AB. Based on the result obtained, it was concluded that the chemical 4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) is not irritating to the eye and can be classified under the category ˋ Not Classified’ as per CLP regulation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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 experimental report
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Assessment of a possible irritating or corrosive potential to the skin caused by the chemical 4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7).
GLP compliance:
not specified
Test material information:
Composition 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
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
- Source: GAUKIER ; D-6050 OFFENBACH/MAIN, FR G
- Age at study initiation: no data
- Weight at study initiation: 3 .10 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):
- Photoperiod (hrs dark / hrs light): 12 H/12 H(6.00 - 18.00 HOURS/ 18.00 - 6.00 HOURS )
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
500mg (0.5g)
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 minutes after removal of the test patches and 24 h, 48 m, 72 h , after the beginning of application
Number of animals:
3 (Male)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2 .5 cm (upper third of the back or flanks)
- Type of wrap if used: Test patches were secured in position with a porous dressing (four lavers of absorbent gauze + porous bandage).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1 :1)
- Time after start of exposure: after patch removal
SCORING SYSTEM: Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983 (for calculation of the means of erythema and edema only the readings of 24, 48 and 72 hours are used).

Others: Because of the natural moisture of the skin, distilled water was used so that the test has been carried out under physiological conditions as possible.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin irritaton was observed in treated rabbits.

RESULTS ACUTE SKIN IRRITATION/CORROSIVITV (OECD)

Time (hours)

Animal no

Symptoms

 

Erythema

Edema

 

4 hours

1

0

0

1sttest

2

0

0

2ndtest

3

0

0

2ndtest

24 hours

1

0

0

1sttest

2

0

0

2ndtest

3

0

0

2ndtest

48 hours

1

0

0

1sttest

2

0

0

2ndtest

3

0

0

2ndtest

72 hours

1

0

0

1sttest

2

0

0

2ndtest

3

0

0

2ndtest

Mean

1

0.00

0.00

 

Mean

2

0.00

0.00

 

Mean

3

0.00

0.00

 

Mean

 

0.00

0.00

 

Interpretation of results:
other: Not irritating
Conclusions:
The mean dermal irritation scores after 4, 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) was considered to be not irritating to White Vienna rabbit's skin.
Executive summary:

The skin irritation study was conducted onthree maleWhite Vienna rabbits to assess the irritating or corrosive potential of the chemical4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) in accordance with OECD guideline (404).

 

About 500mg (0.5g) of chemical was applied on clipped intact skin ofupper third of the back or flanks(2.5cm X 2.5cm) of each rabbit. After four hours the patches were removed, and the test site was washed withlutrol and lutrol/water (1 :1). The test sites were examined for erythema and edema at 30 - 60 minutes after removal of the test patches and 24 h, 48 h, 72 h after the beginning of application. No signs of irritation were observed.

 

The mean dermal irritation scores after 4, 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 skin under the test experimental condition.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
Reference:
Composition 0
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 information:
Composition 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
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 )
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).
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In an experimental study conducted by Sustainability Support Services (Europe) AB (1988) was designed and conducted to determine the determine the dermal irritation profile of chemical 4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) in White Vienna rabbitin accordance with OECD guideline (404). About 500mg (0.5g) of chemical was applied on clipped intact skin of upper third of the back or flanks(2.5cm X 2.5cm) of each rabbit under occlusive condition. After four hours the patches were removed, and the test site was washed with lutrol and lutrol/water (1 :1). The test sites were examined for erythema and edema at 30 - 60 minutes after removal of the test patches and 24 h, 48 h, 72 h after the beginning of application. No signs of irritation were observed. The mean dermal irritation scores after 4, 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 skin under the test experimental condition.

Eye irritation

In an experimental study conducted by Sustainability Support Services (Europe) AB (1988) was designed and conducted to determine the determine the eye irritation profile of chemical 4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) in White Vienna rabbitin 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.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7) was determined by Sustainability Support Services (Europe) AB. Based on the result obtained, it can beconcluded that the chemical4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7)is unlikely to cause skin and eye irritation. Hence4-amino-N-(4-aminophenyl)benzenesulphonamide (CAS no: 16803-97-7)can be classified under the category “Not Classified” for skin and eye as per CLP.