4-acetamido-5-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]anthranilic acid, sodium salt

Skin sensitisation

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

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

Test material information

Constituent 1

Reference substance name:

4-amino benzenesulphonic acid

Cas Number:

121-57-3

Molecular formula:

C6H7NO3S

IUPAC Name:

4-amino benzenesulphonic acid

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)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

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

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

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.