Registration Dossier
Registration Dossier
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EC number: 210-412-4 | CAS number: 615-16-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-10-28 to 2008-11-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-hydroxybenzimidazole
- EC Number:
- 210-412-4
- EC Name:
- 2-hydroxybenzimidazole
- Cas Number:
- 615-16-7
- Molecular formula:
- C7H6N2O
- IUPAC Name:
- 2-hydroxybenzimidazole
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 5, 10, 20 % (w/v)
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The obtained values are within the expected range.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 0 % (w/v) 5 % (w/v): 1.67 SI 10 % (w/v): 2.70 SI 20 % (w/v): 2.51 SI
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0 % (w/v): 4968 DPM 5 % (w/v): 8272 DPM 10 % (w/v): 13364 DPM 20 % (w/v): 12433 DPM
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item 2 -Benzimidazolon was not a skin sensitiser in this assay.
- Executive summary:
In the study the test item 2 -Benzimidazolon dissolved in DMSO was assessed for its possible contact allergenic potential.
For this purpose a LLNA was performed using test item concentrations of 5, 10 and 20%.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 1.67, 2.70, and 2.51 were determined with the test item at concentrations of 5, 10 and 20% in DMSO, respectively.
The test item 2 -Benzimidazolon was not a skin sensitiser in this assay.
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