4-amino-N-(4-aminophenyl)benzenesulphonamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

Sulphanilic acid: divergent results in the guinea pig maximization test and the local lymph node assay

Author:

D. A. Basketter, E. W. Scholes, M. Cumberbatch, C. D. Evans, I. Kimber

Year:

1992

Bibliographic source:

Contact Dermatitis, Volume 27, Issue 4, April 1992, Pages 209–213

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

The cumulative contact enhancement test (CCET) was carried out with Sulphanilic Acid on guinea pig to study the skin sensitization potential.

GLP compliance:

not specified

Type of study:

other: The cumulative contact enhancement test (CCET)

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sulphanilic acid

EC Number:

204-482-5

EC Name:

Sulphanilic acid

Cas Number:

121-57-3

Molecular formula:

C6H7NO3S

IUPAC Name:

4-aminobenzenesulfonic acid

Details on test material:

- Name of test material (as cited in study report): Sulphanilic Acid
- Molecular formula: C6H7NO3S
- Molecular weight: 152.1522g/mol
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report): Sulphanilic Acid
- Molecular formula: C6H7NO3S
- Molecular weight: 152.1522
- Substance type: Organic
- Physical state: 173.190 g/mol
- Purity: >99%

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 350 gm

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

other: 0.9% PEG 400 (50/50, w/w)

Concentration / amount:

25%

Day(s)/duration:

2weeks

Challenge

Route:

epicutaneous, open

Vehicle:

not specified

Concentration / amount:

25%

Day(s)/duration:

24 and 48 hour

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

10 test animals
4 control animals

Details on study design:

Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 24 hrs
- Exposure period: 24 hrs
- Test groups: 10 test animals
- Control group: 4 control animals
- Site: shoulder region
- Frequency of applications: twice weekly
- Duration: 2 weeks
- Concentrations: 25%

B. CHALLENGE EXPOSURE
- No. of exposures: 2 exposures
- Day(s) of challenge: after a 12 days rest period
- Exposure period: 48 hrs
- Test groups: 10 test animals
- Control group: 4 control animals
- Site: open application
- Concentrations: 25%
- Evaluation (hr after challenge): 24 hrs and
48 hrs

OTHER: Control group: Immediately before
the third application, the test and 4 control
guinea pigs were injected with. Freund's complete adjuvant in the shoulder region at
the site to be patched

Challenge controls:

No data available.

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Statistics:

No data available.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No sensitization reaction were observed

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No sensitization reaction was observed.

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Challenge sites were scored for erythema (scale 0-3) at 24- h and 48 h.

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

Sulphanilic Acid(121-57-3) failed to induce any evidence of sensitization at higher concentrations in the cumulative contact enhancement test (CCET) in guinea pig.

Executive summary:

The cumulative contact enhancement test (CCET) was carried out with the test material Sulphanilic Acid to study the sensitization potential.

To induce sensitization a group of 10 guinea pig were albino Dunkin-Hartley strain and weighed approximately 350 g at the start of testing were treated twice weekly for 2 weeks using 24 hrs occluded patches containing 25% sulphanilic acid in vehicle 0.9% PEG 400 (50/50, w/w) over the shoulder region.

Immediately before the third application, the test and 4 control guinea pigs were injected with Freund's complete adjuvant in the shoulder region at the site to be patched. Test and control animals were challenged after a 12 days rest period by open application at the maximum nonirritant concentration (25%). Challenge sites were scored for erythema (scale 0-3) at 24- h and 48 h. Sulphanilic Acid did not produce any positive reaction and failedto induce any evidence of sensitization at higher concentrations in the cumulative contact enhancement test (CCET). Therefore Sulphanilic Acid (121 -57 -3) was considered to be non sensitizing.