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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
2013

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

Constituent 1
Chemical structure
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

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.