Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 415-110-8 | CAS number: 54417-53-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- (R)-1,2,3,4-tetrahydro-6,7-dimethoxy-1-veratrylisoquinoline hydrochloride
- EC Number:
- 415-110-8
- EC Name:
- (R)-1,2,3,4-tetrahydro-6,7-dimethoxy-1-veratrylisoquinoline hydrochloride
- Cas Number:
- 54417-53-7
- Molecular formula:
- C20H25NO4.HCl
- IUPAC Name:
- (1R)-1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-1,2,3,4-tetrahydroisoquinoline hydrochloride
- Test material form:
- solid: crystalline
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other:
- Details on mammalian cell type (if applicable):
- Human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitone/beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 500 ... 2000 μg/ml
Concentration range in the main test (with metabolic activation): 1500 ... 2500 μg/ml
Concentration range in the main test (without metabolic activation): 500 ... 2000 μg/ml
Concentration range in the main test (without metabolic activation): 250 ... 500 μg/ml - Vehicle / solvent:
- Dimethyl sulphoxide
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 4 hours
Fixation time:
24 - 48 hours
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mammalian cell line, other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >2500 μg/ml
- Species / strain:
- mammalian cell line, other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1000 μg/ml
- Additional information on results:
- No evidence of mutagenic activity was seen at any dose level
of R-THP in either mutation test.
Any other information on results incl. tables
In experiment 2 in the absence of metabolic activation the exposure time was increased to 24 hours.
Applicant's summary and conclusion
- Conclusions:
- No evidence of mutagenic activity (with and without metabolic activation) was seen in this in vitro chromosome aberration test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
