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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 240-185-7 | CAS number: 16044-24-9
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July to September 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD toxicological method No. 005
- Version / remarks:
- 1980
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- 1. Ames, B.N.; Durston, W.W.; Yamasaki, E.; Lee, F.D.: Carcinogens are mutagens: A simple test system combining liver homogenates for activation and bacteria for detection. Proc. Nat. Acad. Sci. USA, /2, 2281 - 2285 (1973)
2. Ames, B.N.; McCann, J.; Yamasaki, E.: Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mut. Res., 21, 347 - 364 (1975)
3. McCann, J.; Ames, B.N.: Detection of carcinogens as mutagens in the Salmonella/microsome test: Assay of 300 chemicals. Proc. Nat. Acad. Sci. USA, 72, 5135 - 5139 (1975)
4. McCann, J.; Ames, B.N.: Detection of carcinogens as mutagens in the Salmonella/microsome test: Assay of 300 chemicals: Discussion. Proc. Nat. Acad. Sci, USA,
22, 950 - 954 (1976)
5. Purchase, I.F.H.; Longstaff, E.; Ashby, 3.; Styles, J.A.; Anderson, D.; Lefevre, P.A.; Westwood, F.R.: An evaluation of six short term tests for detecting organic chemical carcinogens Br. J. Cancer, 27, 837 - 959 (1978)
6. Ames, B.N.; Lee, F.D.; Durston, W.E.: An improved bacterial test system for the detection and classification of mutagens and carcinogens. Proc. Nat. Sci. USA, 70, 782 - 786 (1973)
7. McCann, J.; Spingarn, N.E.; Kobori, J.; Ames, B.N.: Detection of carcinogens as mutagens: Bacterial tester strains with R factor plasmids. Proc. Nat. Acad. Sci. USA, E, 979 - 983 (1975)
8. Alvares, A.P.; Bickers, D.R.; Kappas, A.: Polychlorinated biphenyls: A new type of inducer of cytochrome P-448 in the liver. Proc. Nat. Acad. Sci. USA, 70, 1321 - 1325 (1973) - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- EC Number:
- 241-922-5
- EC Name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- Cas Number:
- 18015-76-4
- Molecular formula:
- C25H26N2O4
- IUPAC Name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Basic Green 4
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9-mix induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 5, 10, 20, 50, 100, 500, 2500, 5000 µg/plate with S9
2.5, 5, 10 , 20, 50, 100, 500, 2500, 5000 µg/plate without S9 - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterility check
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- other: 2-aminoanthracene (2-AA), N-methyl-N'-nitro-N-nitroso-guanidine (MNNG), 4-nitro-o-phenylendiamine
- Details on test system and experimental conditions:
- Standard Plate Test
Incubation at 37°C for 48 hours
Quadruple testing - Evaluation criteria:
- Cytotoxicity: reduced growth rate or thinning of bacterial lawn
Positive: - dose-related and reproducible increase in number of revertant colonies
- doubling of spontaneous mutation rate in at least one tester strains either with or without S9 - Statistics:
- NA
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Basic Green 4 is not mutagenic in this bacterial test system either with or without exogenous metabolic activation at the dose levels investigated.
- Executive summary:
Compound T 2015 - 6 (Basic Green 4 oxalate) was tested for mutagenicity with the strains TA100, TA1535, TA1537, TA98 of Salmonella typhimurium according to the procedure developed by Ames and co-workers and following the instructions of the ETAD toxicological method No. 005 July 1980.
The studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. In a first step, a range of 20, 50, 100, 500, 2500, 5000 µg/plate was used. Due to the high cytotoxicity of Basic Green 4, additional dose levels of 5, 10, 20, and 50 µg/plate with S9 -mix and 2.5, 5, 10 , and 20 µg/plate without S9 -mix were tested.
Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.
Toxicity: T 2015 -6 proved to be toxic to the bacteria and additional lower dose levels were added to the test. The test substance proved to be toxic at 2.5 µg/plate and above without S9 and at 20 µg/plate and above with S9. No bacterial growth was observed from 100 µg/plate onward with or without S9 -mix.
Mutagenicity: In the absence of the metabolic activation system the test compound did not show an influence on the number of revertants in any of the bacterial strains. Also in the presence of metabolic activation system, treatment of the cells with T 2015 - 6 did not result in an increase in the number of the revertant colonies with any of the strains used.
Summarizing, it can be stated that T 2015 - 6 is not mutagenic in this bacterial test system either with or without exogenous metabolic activation at the dose levels investigated.
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.