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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
THE MUTAGENIC CONSTITUENTS OF RUBIA TINCTORUM
Author:
KAWASAKI Y, GODA Y AND YOSHIHIRA K
Year:
1992
Bibliographic source:
CHEM. PHARM. BULL.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Gene mutation toxicity study was performed for test substance as a part of the Rubia tinctorum extracts
GLP compliance:
no
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Tectoquinone- IUPAC name: 2-methyl-9,10-anthraquinone- Molecular formula: C15H10O2- Molecular weight: 222.242 g/mol- Substance type: Organic- Physical state: No data- Purity: No data- Impurities (identity and concentrations): No data

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
other: TA98 and TA100
Details on mammalian cell type (if applicable):
Not Applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
Polychlorinated biphenyl induced rat liver S9 mixture
Test concentrations with justification for top dose:
300 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO - Justification for choice of solvent/vehicle: The chemical was soluble in DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: Pre IncubationDURATIONPreincubation period: No data Exposure duration: No dataExpression time (cells in growth medium): No DataSelection time (if incubation with a selection agent): No dataFixation time (start of exposure up to fixation or harvest of cells): No dataSELECTION AGENT (mutation assays): No dataSPINDLE INHIBITOR (cytogenetic assays): No dataSTAIN (for cytogenetic assays): No dataNUMBER OF REPLICATIONS: No dataNUMBER OF CELLS EVALUATED: No dataDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No dataOTHER EXAMINATIONS:- Determination of polyploidy: No data- Determination of endoreplication: No data- Other: No data
Evaluation criteria:
Spontaneous Mutation Frequency
Statistics:
No Data Available

Results and discussion

Test results
Species / strain:
other: TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data Available
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
Test substance did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likley to classify as a gene mutant in vitro.
Executive summary:

Gene mutation toxicty study was performed to determine the mutagenic nature of test substance. The study was conducted on extracts from the Plant Rubia Tinctorum which is used for medicinal applications in Oriental countries to evaluate the mutagenic effects that may exist. The extract mostly contains anthraquinones. The mutation test was conducted by the preinducation assay using Salmonella typhimurium strains TA 98 and TA100 and polychlorinated biphenyl induced rat liver S9 mixture was used for metabolic activation. The test sample was dissolved in 0.1ml DMSO. The test chemical was used at dose levels of of 300µg/plate. The sample were evaluated on the basis of spontaneous mutation frequency and ranked ‘+++’ - for activities of ten or more, ‘++’ - for activities of five or more, ‘+’ – for activities of two or more and ‘-‘ in case of no activity. The contents of the extracts were identified and verified using HPLC and GC.Test substance did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likley to classify as a gene mutant in vitro.