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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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from the safety assessment repot.

Data source

Reference
Reference Type:
secondary source
Title:
OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS
Author:
HEALTH AND CONSUMER PROTECTION DIRECTORATE GENERAL
Year:
2006
Bibliographic source:
OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS- SCCP/1056/06

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The skin sensitisation study was conducted on guinea pigs to determine its sensitisation potential of 2-phenyl-1H-benzimidazole-5-sulphonic acid.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid
Details on test material:
- IUPAC name:Phenylbenzimidazole Sulfonic Acid
- Molecular formula: C13H10N2O3S
- Molecular weight: 274.299g/mol
- Substance type: organic
-Physical state: solid
Specific details on test material used for the study:
-IUPAC name: 2-phenyl-1H-benzimidazole-5-sulphonic acid
- Name of test material (as cited in study report): HR 92/103089
- Molecular formula: C13H10N2O3S
- Molecular weight: 274.299g/mol
- Substance type: organic
-Physical state: solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.1ml Freund’s complete adjuvant in water
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
2-phenyl-1H-benzimidazole-5-sulphonic acid 1% w/v in arachis oil
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
Freund’s + 2-phenyl-1H-benzimidazole-5-sulphonic acid 1% w/v in arachis oil (1:1)
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Route:
other: Topical Application
Vehicle:
arachis oil
Concentration / amount:
•0.2 – 0.3 ml HR 92/103089 50% w/w in arachis oil
Day(s)/duration:
48 hours
Challenge
No.:
#1
Route:
other: Epicutaneous
Vehicle:
arachis oil
Concentration / amount:
0.1-0.2 ml 2-phenyl-1H-benzimidazole-5-sulphonic acid and 10% w/w in arachis oil
Day(s)/duration:
21 days
Adequacy of challenge:
not specified
No. of animals per dose:
20 test; 10 negative control
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 1 week
- Topical: 48 hours
- Test groups: 20
- Control group: 10
- Site: intradermal : three separate sites.
- Duration: Intradermal-1 week
Topical-48 hours
- Concentrations:
INTRADERMAL
•0.1ml Freund’s complete adjuvant in Water
•HR 92/103089 ((Phenylbenzimidazole Sulfonic Acid ) 1% w/v in arachis oil.
•Freund’s + HR 92/103089 1% w/v in arachis oil (1:1)

TOPICAL
After 1 week, a single topical application of 0.2 – 0.3 ml HR 92/103089 50% w/w in arachis oil under occlusion for 48 hours.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: On day 21
- Exposure period: No Data Available
- Test groups: 20
- Control group: 10
- Site: No Data Available
- Concentrations: 0.1-0.2 ml HR 92/103089 25 and 10% w/w in arachis oil.
- Evaluation (hr after challenge): No data available.
Challenge controls:
No Data Available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
other: 20 test; 10 negative control
Dose level:
0.1-0.2 ml 2-phenyl-1H-benzimidazole-5-sulphonic acid and 10% w/w in arachis oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No reactions were observed.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
The substance 2-phenyl-1H-benzimidazole-5-sulphonic acid was observed to be not sensitising to guinea pigs skin.
Executive summary:

The skin sensitisation study was conducted according to OECD guideline 406 on guinea pigs by Magnusson and Kligman test to determine its sensitisation potential of 2-phenyl-1H-benzimidazole-5-sulphonic acid. 20 test group and 10 negative control groups were used in this study. Intradermal injections of 0.1ml Freund’s complete adjuvant in water 2 -phenyl-1H-benzimidazole-5 -sulphonic acid 1% w/v in arachis oil, and Freund’s test material 1% w/v in arachis oil (1:1) into three separate sites. After 1 week, a single topical application of 0.2 – 0.3 ml test material 50% w/w in arachis oil under occlusion for 48 hours. On day 21 animals were challenged with0.1-0.2 ml 2-phenyl-1H-benzimidazole-5-sulphonic acid and 10% w/w in arachis oil. No reactions were observed. Thus, from the study it can be concluded that the substance 2-phenyl-1H-benzimidazole-5-sulphonic acid is not a skin sensitiser.