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EC number: 210-540-0 | CAS number: 618-03-1
Skin sensitisation
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:
- 2 006
- Bibliographic source:
- OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS- SCCP/1056/06
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Ensulizole
- IUPAC Name:
- Ensulizole
- Reference substance name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- EC Number:
- 248-502-0
- EC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- Cas Number:
- 27503-81-7
- IUPAC Name:
- 2-phenyl-1H-benzimidazole-5-sulfonic acid
- 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
Constituent 1
Constituent 2
- 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.
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