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EC number: 211-189-6 | CAS number: 632-99-5
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro gene mutation study in Bacteria was conducted by U. S. National Library of Medicine(CCRIS ;, 2017) to evaluate the mutagenic potential of target chemical((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5), Other Name; Magenta and Basic Fuchsin.In the study Magenta was assessed for its possible mutagenic potential. For this purpose the reverse mutation assay was performed on Salmonella typhimurium TA98, TA 100, TA 1535, 1537, TA 1538 and E.Coli WP2UVRA.t material was exposed at the concentration of 5-1000 µg/plate for TA98, TA 100, E.Coli WP2UVRA and 1-200 µg/plate for TA 1535, 1537,TA 1538 in the absence of S9 metabolic activation. While all strains were exposed to the test material at the concentration of 20-5000µg/plate in the presence of S9.Cytotoxicity was also observed. No mutagenic effects were observed. Therefore Magenta was considered to be non mutagenic with and without S9. Hence the substance cannot be classified as gene mutant in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from CCRIS
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of Magenta in Salmonella typhimurium TA98, TA 100, TA 1535, 1537,TA 1538 and E.Coli WP2UVRA.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- IUPAC name:Magenta
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl - Target gene:
- Histidine for Salmonella typhimurium and tryptophan for E.Coli.
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA98, TA 100, TA 1535, 1537, TA 1538and E.Coli WP2UVRA.
- Details on mammalian cell type (if applicable):
- Not apllicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S-9, Phenobarbital and Beta-naphthoflavone
- Test concentrations with justification for top dose:
- -S9; 5-1000 µg/plate for TA98, TA 100and E.Coli WP2UVRA.
-S9; 1-200 µg/plate for TA 1535, 1537 and TA 1538
+S9;20-5000µg/plate ,For all strain - Vehicle / solvent:
- Vehicle
- Vehicle(s)/solvent(s) used: DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: Preincubation - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Evaluation was done considering a dose dependent increase in the number of revertants/plate.
- Statistics:
- Not specified
- Key result
- Species / strain:
- bacteria, other: Salmonella typhimurium TA98, TA 100, TA 1535, 1537,TA 1538 and E.Coli WP2UVRA.
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- Magenta (632-99-5) was evaluated for its mutagenic potential in Salmonella typhimurium TA98, TA 100, TA 1535, 1537, TA 1538 and E.Coli WP2UVRA. The test results were considered to be negative in the presence and absence of S9.
- Executive summary:
In the study Magenta was assessed for its possible mutagenic potential. For this purpose the reverse mutation assay was performed on Salmonella typhimurium TA98, TA 100, TA 1535, 1537, TA 1538 and E.Coli WP2UVRA.t material was exposed at the concentration of 5-1000 µg/plate for TA98, TA 100, E.Coli WP2UVRA and 1-200 µg/plate for TA 1535, 1537,TA 1538 in the absence of S9 metabolic activation. While all strains were exposed to the test material at the concentration of 20-5000µg/plate in the presence of S9.Cytotoxicity was also observed. No mutagenic effects were observed. Therefore Magenta was considered to be non mutagenic with and without S9. Hence the substance cannot be classified as gene mutant in vitro.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity in Vitro
In different studies, ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5), Other Name; Magenta, Para- Rosaniline HCL and Basic Fuchsin has been investigated for potential of mutagenic response with and without metabolic activation. The studies are based on in vitro gene mutation study in mammalian cells and bacteria for target chemical. Different studies based on these experiments are concluded below
In vitro gene mutation study in Bacteria was conducted by U. S. National Library of Medicine(CCRIS ;, 2017) to evaluate the mutagenic potential of target chemical((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5), Other Name; Magenta and Basic Fuchsin.In the study Magenta was assessed for its possible mutagenic potential. For this purpose the reverse mutation assay was performed on Salmonella typhimurium TA98, TA 100, TA 1535, 1537, TA 1538 and E.Coli WP2UVRA.t material was exposed at the concentration of 5-1000 µg/plate for TA98, TA 100, E.Coli WP2UVRA and 1-200 µg/plate for TA 1535, 1537,TA 1538 in the absence of S9 metabolic activation. While all strains were exposed to the test material at the concentration of 20-5000µg/plate in the presence of S9.Cytotoxicity was also observed. No mutagenic effects were observed. Therefore Magenta was considered to be non mutagenic with and without S9. Hence the substance cannot be classified as gene mutant in vitro.
Other confirmatory test as In vitro gene mutation study in mammalian cells was conducted by William Au and T. C. Hsu.(Environmental Mutagenesis,1979) the mutagenic potential of target chemical ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5), Other Name; Magenta and Basic Fuchsin in mammalian cell line. In Vitro Assay System Basic Fuchsin(632-99-5)was assessed for its mutagenic potential. For this purpose chromosome aberration test was performed on Chinese hamster ovary cell line (CHO). Chinese hamster ovary cell line (CHO) in McCoy 5a medium was used for this study. Exponentially growing cultures in 10 ml medium were treated with 1-20 µM of chemical. A culture treated with the same amount (0.1 ml) of water was used as controls. All cultures were incubated for five hours after the introduction of the test chemical.Colcemid (0.04 µg / d final concentration) was added to each culture during thelast hour of incubation and all cultures were harvested for conventional cytogenetic preparations, stained with Giemsa and coded. The average number of breaks per metaphase was calculated and was used for comparing the clastogenic activities of different compounds.The number of chromosome breaks per metaphase is 0.18. This was not a significant increase. The significant value for the number of chromosome breaks per metaphase by some water-soluble dyes was 0.32. Therefore Basic Fuchsin was considered to be non mutagenic in Chinese hamster ovary cell line (CHO) by chromosome aberration test. Hence test substance cannot be classified as gene mutant in vitro.
Further supported by other experimental study conducted by J. Mirsalis et.al (Abstracts of the fifteenth annual meeting of the environmental mutagen society held at San Antonio, Texas March 3–6, 1983) ,Environmental and Molecular Mutagenesis,1983) to evaluate the mutagenic potential of target chemical ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5).Genetic toxicity in vitro for Para- Rosaniline HCL was assessed for its possible mutagenic potential. For this purpose Unscheduled DNA assay was performed.Hepatocytes from male Fischer-344 rats were incubated with3H-TdR along with test substance at the test concentration of2.2ug/ml. Positive and negative controls were used .Unscheduled DNA synthesiswas measured by quantitative autoradiography as net grains/nucleus (NG). No mutagenic effects were observed in test substance as compared to the value of positive and negative control. Therefore Para- Rosaniline HCL was considered to be non mutagenic for Unscheduled DNA assay. Hence the substance cannot be classified as gene mutant in vitro.
Another supporting in vitro gene mutation study in bacteria was conducted by Mortelmans K et al.(Environmental Mutagenesis) to evaluate the mutagenic potential of target chemical ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5), Other Name; Magenta, Para- Rosaniline HCL and Basic Fuchsin.In vitro Genetic toxicity study was assessed for Basic Fuchsin to find its possible mutagenic potential. For this purpose Bacterial reverse mutation assay was performed on Salmonella typhimurium TA1535, TA1537, TA98, and TA100. The test material was exposed in the presence and absence of metabolic activation at the concentration of 0,0.030,0.1,0.160,0.3 ,0.33 ,0.670,1,3.3,10,33,100,333 and 1000µg/plate. Mutagenic effects were observed. Therefore Basic Fuchsin was considered to be non mutagenic in Salmonella typhimurium TA98, TA100, TA 1535, TA 1537 and TA97 Bacterial reverse mutation assay. Hence the substance canbe classified as gene mutant in vitro.
Another supporting in vitro gene mutation study in bacteria was conducted by Tsutomu Yamaguchi (Agric. Biol. Chem.,1988) to evaluate the mutagenic potential of target chemical ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5), Other Name; Magenta, Para- Rosaniline HCL and Basic Fuchsin.In vitro Genetic toxicity study was assessed for Basic Fuchsin to find its possible mutagenic potential. For this purpose Bacterial reverse mutation assay was performed on Salmonella typhimurium TA100. The test material was exposed in the presence and absence of metabolic activation at the concentration of 5 µg/plate. Mutagenic effects were observed. Therefore Fuchsin was considered to be non mutagenic in Salmonella typhimurium TA100 Bacterial reverse mutation assay. Hence the substance canbe classified as gene mutant in vitro.
Bacterial reverse mutation assay is a screening test for mutagenic response, while mammalian cell gene mutation assay is a confirmatory test for mutagenic response. As per the above studies the target chemical ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5), Other Name; Magenta, Para- Rosaniline HCL and Basic Fuchsin is considered to be non mutagenic because the result for in vitro chromosome abbreviation as well as Bacterial reverse mutation assay are negative. Thus basedon the majority data for the target chemical((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5)does notexhibits gene mutation toxicity in vitro. Hence, the chemical isnot likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Thus based on the majority data for the target chemical((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5)does not exhibits gene mutation toxicity in vitro.
Bacterial reverse mutation assay is a screening test for mutagenic response, while mammalian cell gene mutation assay is a confirmatory test for mutagenic response. As per the above studies the target chemical ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)(632-99-5), Other Name; Magenta, Para- Rosaniline HCL and Basic Fuchsin is considered to be non mutagenic because the result for in vitro chromosome abbreviation as well as Bacterial reverse mutation assay are negative. Hence, the chemical isnot likely to classify as a gene mutant in vitro.
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.
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