Registration Dossier
Registration Dossier
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EC number: 604-770-4 | CAS number: 151012-31-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Merck study
- Data waiving:
- exposure considerations
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The in vitro alkaline/rat hepatocyte elution assay is used to assess the ability of a compound to cause DNA stand breaks. Following incubation with with rat hepaocytes, the DNA is isolated and eluted through a filter. The slope of the fraction retained by the filter over time curve is used to assess DNA damage. The test is positive if an increase in the elution slope of 0.020 or greater is induced at any non-cytotoxic concentration
- GLP compliance:
- no
- Type of assay:
- other: in vitro alkaline/rat hepatocyte elution assay
Test material
- Reference substance name:
- {1-[(4-bromophenyl)methyl]-2-butyl-4-chloro-1H-imidazol-5-yl}methanol
- EC Number:
- 604-770-4
- Cas Number:
- 151012-31-6
- Molecular formula:
- C15H18BrClN2O
- IUPAC Name:
- {1-[(4-bromophenyl)methyl]-2-butyl-4-chloro-1H-imidazol-5-yl}methanol
- Reference substance name:
- L-735,780-000W006
- IUPAC Name:
- L-735,780-000W006
- Details on test material:
- L-735,780-000W006
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- hepatocytes:
- Details on mammalian cell type (if applicable):
- Freshly isolated rat hepatocytes
- Test concentrations with justification for top dose:
- 100, 150, 200 and 250 uM
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: aflatoxin B1 and gamma irradiation 3 Gy
Results and discussion
Test results
- Species / strain:
- hepatocytes:
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Negative in the in vitro alkaline elution/rat hepatocyte assay
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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