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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from peer-revieded journal

Data source

Reference
Reference Type:
publication
Title:
Comparison of the local lymph node assay with the guinea pig maximization test for the detection of a range of contact allergens
Author:
D.A. Basketter and E.W. Scholes
Year:
1992
Bibliographic source:
Fd. Chem. Toxic .Vol. 30, No 1, pp.65-69,1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin sensitization study of Sulfanilic Acid was performed in guinea pig by Guinea pig maximisation test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Sulfanilic acid
- Molecular formula :C6H7NO3S
- Molecular weight : 173.191 g/mole
- Smiles notation (if other than submission substance): S(c1ccc(N)cc1)(O)(=O)=O
- InChl (if other than submission substance): 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: solid

Specific details on test material used for the study:
- Name of test material (as cited in study report): Sulfanilic acid
- Molecular formula :C6H7NO3S
- Molecular weight : 173.191 g/mole
- Smiles notation (if other than submission substance): S(c1ccc(N)cc1)(O)(=O)=O
- InChl (if other than submission substance): 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: solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Remarks:
Albino
Sex:
not specified
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation:350g
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: polyethylene glycol 400 / saline
Concentration / amount:
5%
Day(s)/duration:
8
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: polyethylene glycol 400/ saline
Concentration / amount:
5.0%
No. of animals per dose:
No data available
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:7
- Exposure period: 48hr
- Test groups: No data available

- Control group: No data available

- Site: shoulder region

- Frequency of applications: After 6-8 days epicutaneous application was carried out
- Duration: 8 days

- Concentrations: 5%



B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 10-14 days

- Exposure period:24hr

- Test groups: No data available
- Control group: No data available
- Site: on one flank

- Concentrations:5%
- Evaluation (hr after challenge): 24 and 48hr


Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
Clinical observations:
90% animals were observed positive for skin sensitizing reaction after challenge application.
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
Clinical observations:
90% animals were observed positive for skin sensitizing reaction after challenge application.
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Sensitizing
Conclusions:
The Sulfanilic Acid (121-57-3) was considered to be skin sensitizing in guinea pig.

Executive summary:

The skin sensitization study of Sulfanilic Acid (121-57-3) was performed by Guinea pig maximisation test. Albino Dunkin Hartley weighted approximately 350g were used. Preliminary irritation tests were carried out to determine the concentration of the test material suitable for induction and challenge of sensitization.

In induction phase, induction given using 5%, concentration in polyethylene glycol 400/saline by intradermal route for 6 times on shoulder region. After 6-8 day epicutaneous application was carried out using 5% concentration in same vehicle applied on same site for 48hr as occluded patch.

 In challenge phase,10-14 days latter test substance in 5 % concentration in same vehicle was applied as occlusive patch on one flank for 24 hr. Challenge site were scored for erythema (Scale 0-3) and oedema 24 and 48 hr after removal of the patch. 90% animals were observed positive for skin sensitizing reaction after challenge application. Hence the Sulfanilic Acid (121-57-3) was considered to be skin sensitizing in guinea pig.