(5or8)-aminonaphthalene-2-sulphonic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

The skin sensitization study of Sodium phenylbenzimidazole sulfonate was conducted on guinea pigs to determine its sensitization potential.

GLP compliance:

not specified

Type of study:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium phenylbenzimidazole sulfonate

IUPAC Name:

Sodium phenylbenzimidazole sulfonate

Constituent 2

Reference substance name:

5997-53-5

Cas Number:

5997-53-5

IUPAC Name:

5997-53-5

Constituent 3

Reference substance name:

611-922-3

EC Number:

611-922-3

IUPAC Name:

611-922-3

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Eusolex 232 – sodium salt
- Molecular weight: 296.2811 g/mol
- Substance type: organic

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright white

Sex:

male/female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: Epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

Group 1: 30% Eusolex 232 – sodium salt solution
Group 2: 5% Eusolex 232 – sodium salt solution
Group 3: 2% DNCB solution

Challenge

Challenge 1

Route:

other: Epicutaneous

Vehicle:

water

Challenge 2

Concentration / amount:

Group 1: 30% Eusolex 232 – sodium salt solution
Group 2: 5% Eusolex 232 – sodium salt solution
Group 3: 2% DNCB solution

No. of animals per dose:

Group 1: 30% Eusolex 232 – sodium salt solution-5/sex
Group 2: 5% Eusolex 232 – sodium salt solution -5/sex
Group 3: 2% DNCB solution-5/sex
Group 4: water control-5/sex
Group 5: untreated- 9 males and 11 females
Yes concurrent vehicle

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:5
- Exposure period: 2 weeks
- Test groups:5/sex
- Control group: 5/sex
- Site: left flank
- Frequency of applications: 5 times weekly for 2 weeks
- Duration: 2 weeks
- Concentrations:30% and 5%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 7 days after induction exposure
- Exposure period: No Data Available
- Test groups: 5/sex
- Control group: 5/sex
- Site: No Data Available
- Concentrations: 10% of the induction concentration
- Evaluation (hr after challenge): No Data Available

Positive control substance(s):

yes

Remarks:

2% DNCB solution

Results and discussion

Positive control results:

All animals tested with DNCB produced an erythematous reaction 3 hours after application of the elicitation dose.

In vivo (non-LLNA)

Results

Reading:

1st reading

Group:

test chemical

Dose level:

10% of the induction concentration

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

not sensitizing

Remarks on result:

other: Reading: 1st reading. Group: test group. Dose level: 10% of the induction concentration. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: not sensitizing.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material Sodium phenylbenzimidazole sulfonate (CAS No: -5997-53-5) was observed to be not sensitizing to guinea pigs.

Executive summary:

The skin sensitization studyofSodium phenylbenzimidazole sulfonate(CAS No: -5997-53-5)was performed in male and female Pirbright white guinea pigs to observed its sensitizing efficacy. During induction phase, the test chemical was applied on the left flank 5 times weekly for 2 weeks at concentrations 30% and 5 % of test solution along with positive control (2% DNCB solution) and control vehicle (water). Each group contained 5 males and 5 females. Untreated group of animals were also used which include 9 males and 11 females. After 7 days of induction exposure, animals were challenged at 10% of the induction concentration and observations were made. All animals tested with DNCB produced an erythematous reaction 3 hours after application of the elicitation dose. No reaction observed at the site of application of the test substance. Therefore based upon the observations,Sodium phenylbenzimidazole sulfonate(CAS No: -5997-53-5) was judge to be not sensitizing to guinea pigs.