Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 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.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- other: SCCS opinion /1439/11
- Adequacy of study:
- supporting study
- Study period:
- 21 March 2001 – 23 January 2003
- 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 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1997
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Test material form:
- solid
- Specific details on test material used for the study:
- 19556 Indigoblätter was investigated for the induction of micronuclei in bone marrow cells
of mice. The test item was prepared by pouring distilled water (70°C) over the test item (1
part test item:5 parts aqua distellata) and by stirring them with a glass stick until it got a
homogeneous paste. After 30 min without heating the paste was filtered using a cellulose
filter. This filtrate was used in the experiments in a concentration relating to 200 mg/ml of
the original test item. 10 mg/kg bw of the filtrate corresponds to a dose of 2000 mg/kg bw.
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- distilled water
- Duration of treatment / exposure:
- Bone marrow cells were collected 24 h and 48 h (highest dose only) after dosing. Toxicity and thus exposure of the target cells was determined by measuring the ratio between polychromatic and total erythrocytes (PCE/TE). Bone marrow preparations were stained with May-Grunwald/Giemsa and examined microscopically for the NCE/TE ratio and micronuclei.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/kg bw (total dose)
- Dose / conc.:
- 1 000 mg/kg bw (total dose)
- Dose / conc.:
- 2 000 mg/kg bw (total dose)
- Dose / conc.:
- 0 mg/kg bw (total dose)
- Control animals:
- yes
- Positive control(s):
- Positive controls were in accordance with the OECD guideline.
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- In the pre-test for toxicity, mice treated with 2000 mg/kg bw showed systemic toxic effects, i.e. lethargy at 6, 24 and 48 h after dosing. Due to this result 2000 mg/kg bw was chosen as the top dose. In the main test no signs of toxicity were found within 24 h after dosing.
However, after 48 h 3 male mice died 1-2 h before bone marrow preparation whereas 1 male and 1 female mouse showed lethargy.
The bone marrow of the 3 dead mice was collected immediately after compound-related death. Due to the process of erythropoiesis in vivo and the mechanism of micronucleus formation in the polychromatic erythrocytes false positive or false negative results can be excluded. All other bone marrow preparations were performed according to the guideline.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions used 19556 Indigoblätter did not induce a biologically
relevant increase in the number of erythrocytes with micronuclei of treated mice and,
consequently, 19556 Indigoblätter is not genotoxic (clastogenic and/or aneugenic) in bone
marrow cells of mice.
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.