Registration Dossier
Registration Dossier
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EC number: 200-081-4 | CAS number: 51-17-2
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 secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Opinion on phenylbenzimidazole sufonic acid and its salts colipa S 45, CAS no.27503-81-7
- Author:
- European commission
- Year:
- 2 006
- Bibliographic source:
- Opinion on phenylbenzimidazole sufonic acid and its salts colipa S 45, SSCP/1056/06, 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Skin sensitization study of test chemical was performed in guinea pig by Magnusson and Kligman method.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- 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
- Molecular formula:
- C13H10N2O3S
- IUPAC Name:
- 2-phenyl-1H-benzimidazole-5-sulfonic acid
Constituent 1
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)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- For intradermal injection 1%w/v
For topical application -0.2-0.3ml of test material 50% w/w in arachis oil - Day(s)/duration:
- 48hr
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 0.1-0.2ml test material 25 and 10 w/w in arachis oil
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Total :30
Test:20
Negative control:10 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period:48hr
- Test groups:20
- Control group: No data available
- Site: 3 separate site
- Frequency of applications: on 1st day and after 1 week
- Duration: 1week
- Concentrations: For intradermal injection : 1%w/v in arachis oil
For topical application :0.2-0.3ml of test material 50% w/w in arachis oil
OTHER: intradermal injections of 0.1ml Freund’s complete adjuvant in water, test material 1% w/v in arachis oil, and Freund’s + test material 1% w/v in arachis oil (1:1)
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: After 20 days
- Exposure period: No data available
- Test groups: 20
- Control group: No data available
- Site: No data available
- Concentrations: 0.1-0.2ml of test material 25 and 10 w/w in arachis oil
- Evaluation (hr after challenge): No data available - Challenge controls:
- No data available.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1-0.2ml of test material 25 and 10 w/w in arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No sensitization reaction was observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Skin sensitization study of test chemical was performed in guinea pig by Magnusson and Kligman method was found to be not skin sensitizing.
- Executive summary:
In skin sensitization study of test chemical was performed by Magnusson and Kligman method in Dunkin Hartley guinea pig. In test group 20 animals were as in negative control 10 animals were used. In induction phase,1stapplication by intradermal injections of 0.1ml Freund’s complete adjuvant in water, test material 1% w/v in arachis oil, and Freund’s + test material 1% w/v in arachis oil (1:1) was given at 3 different site. The 2ndinduction application given after 1 week as a single occlusive patch of0.2-0.3ml of test material 50% w/w in arachis oil for 48hr .The challenge was given on 21 day after 1stinduction application with concentration 0.1-0.2ml of test material 25 and 10w/w in arachis oil. No reaction were observed in any animals, hence it is considered that the test chemical was not skin sensitizing in guinea pig.
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