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Registration Dossier
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EC number: 202-000-8 | CAS number: 90-51-7
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 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:
- 1 992
- 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
- 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
Constituent 1
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.
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