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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of Tocopheryl Quinones: Evolutionary Advantage of Selective Accumulation of Dietary alpha-Tocopherol.
Author:
Cornwell DG et al
Year:
2002
Bibliographic source:
Nutr Cancer 43 (1): 111-118

Materials and methods

Principles of method if other than guideline:
Method: other: according to Tindall KR and Stankowski LF (1989). Mutat Res 220: 241-253
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Reference substance name:
3,4-dihydro-2,7,8-trimethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol
EC Number:
231-523-4
EC Name:
3,4-dihydro-2,7,8-trimethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol
Cas Number:
7616-22-0
IUPAC Name:
2,7,8-trimethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol
Details on test material:
d-gamma-tocopherol; according to the authors, purity was 92.6% (no data on contaminants)

Method

Species / strain
Species / strain / cell type:
other: Chinese hamster ovary AS52 cells
Additional strain / cell type characteristics:
other: AS52 cells: cells which lack the normal X-like mammalian hypoxanthine-guanine phosphoryltransferase (hprt) gene but contain a single functional copy of the E coli xanthin- guanine phosphoribosyltransferase (gpt) gene stably integrated into the genome.
Metabolic activation:
without
Test concentrations with justification for top dose:
ca. 2.9, 14.6 ug/ml (6.8, 34 uM)
Details on test system and experimental conditions:
Cells were incubated with the test substance at concentrations of 6.8 and 34 uM (ca. 2.9 and 14.6 ug/ml) for 5 hours.
Mutagenicity was expressed as an increase in the number of thioguanine-resistant (TGr) clones; cytotoxicity was determined by measuring the cloning efficiency. Untreated controls cultured in medium and solvent controls treated with the vehicle (ethanol) were included.

Results and discussion

Test results
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: ca. 14.6 ug/ml (34 uM)
Additional information on results:
The test substance had no effect on mutant frequency. A significant decrease in cloning efficiency was observed at the high concentration when compared with controls; relative cloning efficiency was approximately 85-90% (control = 100%). The results of the cytotoxicity study are presented only graphically; no further data.
Remarks on result:
other: other: Chinese hamster ovary AS52 cells
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion