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EC number: 211-190-1 | CAS number: 633-03-4
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP, no guidelines followed, poor details on test conditionsRead across from a similar substance which has the same main component and with a different counter ion that doesn't influence the characteristics related to the specific end-point
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity of Malachite Green and Leucomalachite Green in female big blue B6C3F mice
- Author:
- Roberta A. Mittelstaedt, Nan Mei, Peggy J. Webb, Joseph G. Shaddock, Vasily N. Dobrovolsky, Lynda J. McGarrity, Suzanne M. Morris, Tao Chen, Frederick A. Beland, Kevin J. Greenlees, Robert H. Heflich
- Year:
- 2 004
- Bibliographic source:
- Mutation Research 561(2004) 127-138
Materials and methods
- Principles of method if other than guideline:
- MICRONUCLEUS: were conducted on peripheral blood using the µFlow Mouse Micronucleus Analysis Kit and the manufacturer’s protocol (Litron Laboratories, Rochester, NY USA). Flow analysis was perforrned using a FACSort flow cytometer.LYMPHOCYTE Hprt: lymphocytes were removed from crushed spleens, stimulated by treatment overnight with concanavalin A, and processed for limiting-dilution cloning in 96-well dishes. LIVER CLL: High-molecular-weight DNA was extracted from the mouse livers using the RecoverEase DNA Extraction Kit (Stratagene)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Similar substance 02 and 05
- IUPAC Name:
- Similar substance 02 and 05
- Details on test material:
- - Name of test material: Malachite Green -MG-- CAS: 569-64-2- Analytical purity: 88% by HPLC-PDA- Source: Chemsyn Science Laboratories- Name of test material: Leucomalachite Green -LG- - CAS: 129-73-7- Analytical purity: 99% by HPLC-PDA- Source: Chemsyn Science Laboratories
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: purchased from Stratagene (La Jolla, CA, USA) and supplied by Taconic farm (Germantown, NY, USA)- Age at study initiation: approximately 6-week-old mice- Number of animal: 12- Diet: NIH-31; 450 ppm MG, 204 o 408 ppm LG and the remaining 12% of MG was primarily LG and the desmethyl derivatives of MG and LG. It has been used the high dose of MG and the middle and the high dose of LG used in the NTP studies.CHEMICAL ANALYSIS OF THE FEED:- Chemical analysis of the feed indicated that the actual doses were withing 3% of the target doses.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- no vehicles used
- Details on exposure:
- View diet details
- Duration of treatment / exposure:
- Six mice from each group were killed after 4 weeks and the remaining mice were killed after 16 weeks of exposure.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:450 ppmBasis:nominal in dietMG
- Remarks:
- Doses / Concentrations:204Basis:nominal in dietLG
- Remarks:
- Doses / Concentrations:408Basis:nominal in dietLG
- No. of animals per sex per dose:
- 12 mices were fed control diet (NIH-31) or diet containing 450 ppm of MG or 204 or 408 ppm of LG.
- Positive control(s):
- MICRONUCLEUS ANALYSISPositive and negative controls for the flow analysis were prepared from peripheral blood of 9-day-old neonatal B6C3F1 mice that were treated on days 1—8 with either DMSO or 200 mg/kg dideoxycytidine. These treatments were not performed concurrently with the feeding study; however, the resulting samples were analyzed for micronucleus frequency at the same time as the test samples.
Examinations
- Tissues and cell types examined:
- Micronucleus, lymphocyte hprt mutant, liver cll.
- Statistics:
- On the lymphocyte Hprt mutant frequency data has been investigated by analysis of variance (ANOVA)
Results and discussion
Test results
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
MICRONUCLEUS ANALYSIS
Feeding female B6C3F1 Big Blue mice with MG or LG for as long as 16 weeks had no significant effect on either reticulocyte or normochromatic erythrocyte peripheral blood micronucleus frequencies. Positive controls for the micronucleus assay were significantly elevated, and their frequencies consistent with previous observations.
LYMPHOCYTE Hprt MUTANT ANALYSIS
Analysis of variance (ANOVA) on the lymphocyte Hprt mutant frequency data for mice treated for 4 weeks indicated a signilicant difference among the groups. This appeared to be due to a relatively low mutant frequency in mice treated with 204 ppm LG, and Dunnett’s test indicated that there were no significant differences between the mutant frequencies in any of the treated groups and the control. Hprz lymphocyte mutant frequencies were not significantly different from the controls after 16 weeks of treatment with MG or LG.
Hprt lymphocyte mutant frequencies were not significantly different from controls after 28 days or 16 weeks.
LIVER CLL.
Mutant frequencies were determined in the livers of mice fed 450 ppm MG or 408 ppm LG for 16 weeks. Statistical analysis by ANOVA, followed by Dunnett’s test, indicated that LG increased the liver mutant frequency while MG did not. Sequencing of mutant clones revealed that the degree of mutant independence for the control and treated mice was similar. For this analysis, different mutations isolated from the same mouse were assumed to be induced independently; the same mutation identified more than once in mutants isolated from the same mouse was assumed to be derived from an expanded mutant clone and, therefore, not independent. When the all mutant frequencies were corrected for independence, the results indicated that LG did increase liver cll mutation frequency, while MG did not. Female Big Blue rats fed 543 ppm LG for 16 weeks in a previous study were also evaluated for liver cll mutant frequency. There was no increase in either cll mutant or mutation frequency inthe treated rats.
The liver cll mutants isolated from the mutant frequency assays were sequenced to analyze the specific mutations in the clI gene. A high proportion of mutations from control mice (49%) contained transitions. The spectrum of mutations from mice treated with MG was similar to that for control mice, while the mutations from mice fed LG had increased frequencies of transversions.
MG did not increase the cII liver mutation frequency after 16 weeks.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativeThese results indicate that the tested substance is not an in vivo mutagen; it resulted negative in micronucleous analysis, lynphocyte HPRT mutant analysis and mutant frequencies determined in the liver cells.
- Executive summary:
The tested substance is rapidly reduced in vivo to Leucomalachite Green (LG). In the present study transgenic female Big Blue B6C3F1 mice WERE FED with 450 ppm of MG and 204 and 408 ppm of LG and evaluated genotoxicity after 4 and 16 weeks of treatment. Neither MG nor LG increased the peripheral blood micronucleus frequency or Hprt lymphocyte mutant frequency at either time point; however, the 16-week treatment with 408 ppm LG did increase the liver cll mutant trequency. Similar increases in liver cII mutant frequency were not seen in the mice treated for 16 weeks with MG.
These results indicate that MG is not an in vivo mutagen; while the evaluation of LG is not clearly, because results are more ambiguous.
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