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Toxicological information

Skin sensitisation

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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 peer reviewed journals

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: The cumulative contact enhancement test (CCET)
Principles of method if other than guideline:
Cumulative contact enhancement test (CCET) was performed on guinea pigs to assess the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
other: The cumulative contact enhancement test (CCET)
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
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
Test material form:
solid: particulate/powder
Details on test material:
- Name (IUPAC): 4-aminobenzene-1-sulfonic acid
- Name of test material (as cited in study report): 4-aminobenzene-1-sulfonic acid
- Molecular formula: C6H7NO3S
- Molecular weight: 173.191 g/mol
- Smiles notation): S(c1ccc(N)cc1)(O)(=O)=O
- InChl : 1S/C6H7NO3S/c7-5-1-3-6(4-2-5)11(8,9)10/h1-4H,7H2,(H,8,9,10)
- Substance type: organic
- Physical state: Orthorhombic plates

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:
unchanged (no vehicle)
Concentration / amount:
25% of the test chemical
Day(s)/duration:
twice weekly for 2 weeks using 24 hours occlusive patches
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: 0.9% NaCl/PEG400 (50/50, v/v)
Concentration / amount:
25% in 0.9% NaCl/PEG400 (50/50, v/v)
Day(s)/duration:
48 hours
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:Preliminary irritation tests were carried out to determine concentrations of sulphanilic acid suitable for induction of sensitization and for sensitization challenge

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: twice weekly for 2 weeks using 24 hours occlusive patches
- 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% in 0.9% NaCl/PEG400 (50/50, v/v)
- Evaluation (hr after challenge): 24 hrs and 48 hrs

OTHER: 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 and 48 hours.
Challenge controls:
No data available.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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
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

Table: Sensitization potential of Sulphanilic acid in the CCET test

Induction exposure

Challenge result

Topical exposure -25%#(*4)

0%(0)

#- 25% in 0.9% NaCl/PEG400 (50/50, v/v)

 Results are expressed as %age of test animals sensitized, the mean erythema score on positive animals in parenthesis

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
0% guinea pigs were sensitized when evaluated after the challenge exposure. Sulphanilic Acid failed to induce any evidence of sensitization at higher concentrations in the cumulative contact enhancement test (CCET). Therefore, the test chemical was considered to be not sensitizing.
Executive summary:

Cumulative contact enhancement test (CCET) was performed on guinea pigs to assess the dermal sensitization potential of the test chemical. Preliminary irritation tests were carried out to determine concentrations of the test chemical suitable for induction of sensitization and for sensitization challenge. Dunkin-Hartley Guinea pigs weighing approximately 350 grams, 10 in the test group and 4 in the control group were used for the assay. 25% of the test chemical was applied twice weekly for 2 weeks using 24 hours occlusive patches to the shoulder area of test animals to induce dermal reactions. 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 non-irritant concentration (25%). 25% in 0.9% NaCl/PEG400 (50/50, v/v) was applied to the shoulder region of the test animals and observed for erythema. Challenge sites were scored for erythema (scale 0-3) at 24 and 48 hours.

0% guinea pigs were sensitized when evaluated after the challenge exposure. the test chemical failed to induce any evidence of sensitization at higher concentrations in the cumulative contact enhancement test (CCET). Therefore, the test chemical was considered to be not sensitizing.