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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-922-5 | CAS number: 18015-76-4
- 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 vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The experiment is scientifically acceptable, nevertheless details about the tested substance composition are missing. Read across from a similar substance which has the same main component and with a different counter ion that does not influence the characteristics related to the specific end-point.
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the Clastogenic Effects of Biologic Stains and Dyes.
- Author:
- Au W. and Hsu T. C.
- Year:
- 1 979
- Bibliographic source:
- Environmental Mutagenesis 1: 27-35 (1979)
Materials and methods
- Principles of method if other than guideline:
- Chinese hamster ovary cell line (CHO) was used for the study. Exponentially growing cultures in 10 ml medium were treated with 20 µM of Malachite Green. Cultures treated with the same amount (0.1 ml) of water or ethanol were used as controls. All cultures were incubated for five hours after the introduction of the test chemical. All cultures were harvested for conventional cytogenetic preparations, stained with Giemsa, and coded.
- GLP compliance:
- no
- Remarks:
- pre GLP
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Malachite Green
- IUPAC Name:
- Malachite Green
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- Chinese hamster ovary cell line (CHO) routinely maintained in the testing aboratory in McCoy 5a medium was used for the study.
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 20 µM/ml
- Vehicle / solvent:
- Vehicle/solvent used: water or ethanol
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water or ethanol
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: exponentially growing cultures in 10 ml medium were treated with chemical.
EXPOSURE DURATION: cultures were incubated for 5 hours after the introduction of the test chemical.
DETERMINATION OF CYTOTOXICITY: Colcemid (0.04 µg/ml final concentration) was added to each culture during the last hour of incubation and all cultures were harvested for conventional cytogenetic preparations, stained with Giemsa, and coded.
RECOGNITION OF CHROMOSOMAL ABERRATION: 50 well-spread metaphases were scored for chromosome aberration for each experimental point. The average number of breaks per metaphase was calculated and was used for comparing the clastogenic activities of different compounds.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Additional information on results:
- Malchite Green did not show significant increase in induced chromosome damage.
Malachite Green number of breaks per metaphase: 0.26
Water number of breaks per metaphase (4 relicates): 0, 0.04, 0.12, 0.16
Ethanol number of breaks per metaphase (4 relicates): 0.04, 0.08, 0.16, 0.20 - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
Malchite Green did not show significant increase in induced chromosome damage. - Executive summary:
We have surveyed the clastogenic potential of 12 different groups of stains and dyes totalling 48 compounds. We observed that 18 compounds induced significant increase in chromosome damage.
Chinese hamster ovary cell line (CHO) routinely maintained in the testing laboratory in McCoy 5a medium was used for the study. Exponentially growing cultures in 10 ml medium were treated with 20 µM of Malachite Green. Cultures treated with the same amount (0.1 ml) of water or ethanol were used as controls. All cultures were incubated for five hours after the introduction of the test chemical. Colcemid (0.04 p g / d final concentration) was added to each culture during the last hour of incubation and all cultures were harvested for conventional cytogenetic preparations, stained with Giemsa, and coded. 50 well-spread metaphases were scored for chromosome aberration for each experimental point. The average number of breaks per metaphase was calculated and was used for comparing the clastogenic activities of different compounds.
Malachite Green number of breaks per metaphase: 0.26
Water number of breaks per metaphase (4 relicates): 0, 0.04, 0.12, 0.16
Ethanol number of breaks per metaphase (4 relicates): 0.04, 0.08, 0.16, 0.20
Conclusion
Malchite Green did not show significant increase in induced chromosome damage.
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.