Registration Dossier
Registration Dossier
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EC number: 283-892-6 | CAS number: 84775-63-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Indigofera tinctoria, Leguminosae.
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: SCCS opinion 1439/11
- Adequacy of study:
- key study
- Study period:
- 20 December 2005 – 24 April 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- SCCS Opinion on Indigofera tinctoria COLIPA no C170
- Author:
- Scientific Committee on Consumer Safety
- Year:
- 2 012
- Bibliographic source:
- 978-92-79-30776-8
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Indigofera tinctoria, ext.
- EC Number:
- 283-892-6
- EC Name:
- Indigofera tinctoria, ext.
- Cas Number:
- 84775-63-3
- Molecular formula:
- n/a
- IUPAC Name:
- Indigofera tinctoria, ext.
- Test material form:
- solid: particulate/powder
- Details on test material:
- composed as a powder of dried leaves.
Content of the main active ingredient Indican (indoxyl-β-D-glucosid):
3.56% (HPLC) respectively 2.01% after autoclaving.
Constituent 1
- Specific details on test material used for the study:
- Content of the main active ingredient Indican (indoxyl-β-D-glucosid): 3.56% (HPLC) respectively 2.01% after autoclaving
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 0, 3, 10, 33, 100, 333, 1000, 2500 and 5000 g/plate, without and with S9-mix
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- other: according to OECD guideline
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- experiment 1: direct plate incorporation with at least 48 h incubation,without and with S9-mix
experiment 2: pre-incubation method with 60 minutes pre-incubation and at least 48 h incubation, without and with S9-mix - Rationale for test conditions:
- not specified
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- not determinable
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions used Indigofera tinctoria was not genotoxic (mutagenic) in this gene mutation tests in bacteria.
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