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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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 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 was considered to be non sensitizing.