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Toxicological information

Skin irritation / corrosion

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Administrative data

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

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 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

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

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 )

Test system

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.

Results and discussion

In vivo

Results
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.

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.