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Toxicological information

Skin sensitisation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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)

Inductionopen allclose all
Route:
other: Epicutaneous
Vehicle:
water
Concentration / amount:
Group 1: 30% Eusolex 232 – sodium salt solution
Group 2: 5% Eusolex 232 – sodium salt solution
Group 3: 2% DNCB solution
Challengeopen allclose all
Route:
other: Epicutaneous
Vehicle:
water
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 group
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.