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EC number: 229-792-8 | CAS number: 6737-68-4
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of Arylmethane dyes in Salmonella
- Author:
- Antonio M. Bonin, Janice R. Farquharson And Robert S.U. Baker
- Year:
- 1 981
- Bibliographic source:
- Mutation Research, 89 (1981) 26-34
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Gene mutation toxicity study was performed to determine the mutagenic nature of crystal violet
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- EC Number:
- 208-953-6
- EC Name:
- [4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- Cas Number:
- 548-62-9
- Molecular formula:
- C25H30ClN3
- IUPAC Name:
- N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):Gentian violet- IUPAC name: N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride- Molecular formula : C25H30N3.ClMolecular weight : 407.986 g/mol- Smiles notation: C(\c1ccc(N(C)C)cc1)(c1ccc(N(C)C)cc1)=C1\C=C\C(=[N+](/C)C)C=C1.[ClH-]- InChl:1S/C25H30N3.ClH/c1-26(2)22-13-7-19(8-14-22)25(20-9-15-23(16-10-20)27(3)4)21-11-17-24(18-12-21)28(5)6;/h7-18H,1-6H3;1H/q+1;/p-1- Substance type: Organic - Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- Details on test material
- Name of test material: Crystal violet
- IUPAC name: 4-{bis[4-(dimethylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium chloride
- Molecular formula: C25H30ClN3
- Molecular weight: 407.986 g/mol
- Substance type: Organic
- Physical state:
- Purity: 97% dye
- Impurities (identity and concentrations): 3 %
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was prepared from male Sprague Dawley rats pretreated with Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 0.1, 0.32, 1.0 or 3.2 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- Pooled data
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- other: β- propiolactone
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data
- Exposure duration: 72 hrs
- Expression time (cells in growth medium): 72 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Duplicate
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyloidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- Criteria for mutagenicity were (a) a dose-response and, (b) reproducibility of the result.
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1537 and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: Dose ranges for mutagenesis were determined first by preliminary pour-plate toxicity tests at 10, 1, 0.1, 0.01 mg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table: Experimental controls
Agent |
Dose (µg/plate) |
S9 |
His+revertant colonies/plate |
||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1538 |
|||
Positive control: 2-acetylaminofluorene |
1000 |
- |
34±6 |
144±6 |
31±9 |
7±2 |
26±5 |
|
+ |
10900±1344 |
2649±223 |
38±8 |
61±10 |
6232±259 |
|
320 |
- |
25±4 |
144±10 |
34±14 |
11±2 |
23±4 |
|
|
+ |
8550±1047 |
4102±453 |
42±6 |
63±6 |
7960±791 |
|
100 |
- |
29±4 |
150±5 |
45±15 |
8±2 |
25±2 |
|
|
+ |
1728±108 |
746±118 |
24±4 |
25±7 |
1231±95 |
|
32 |
- |
29±6 |
150±5 |
45±15 |
8±2 |
25±2 |
|
|
|
+ |
1728±108 |
746±118 |
24±4 |
24±7 |
1231±95 |
Positive control:βpropiolactone |
1000 |
- |
28±3 |
150±5 |
45±16 |
8±2 |
25±2 |
|
+ |
44±11 |
1979±457 |
1585±108 |
53±26 |
26±6 |
|
320 |
- |
28±2 |
764±224 |
642±126 |
12±1 |
24±3 |
|
|
+ |
54±18 |
1297±260 |
646±405 |
17±2 |
29±8 |
|
100 |
- |
28±2 |
764±224 |
642±126 |
12±1 |
24±3 |
|
|
+ |
49±12 |
640±146 |
355±102 |
14±6 |
33±15 |
|
32 |
- |
25±1 |
222±15 |
116±14 |
12±1 |
15±8 |
|
|
+ |
43±18 |
212±42 |
119±29 |
16±3 |
30±9 |
|
Negative control (pooled data) |
0 |
- |
31±6 |
159±28 |
40±11 |
12±3 |
22±5 |
|
+ |
51±10 |
137±16 |
22±5 |
16±4 |
37±8 |
Table: Ames test data
Agent |
Dose (µg/plate) |
His+revertant colonies/plate |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1538 |
|||||||
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
||
Crystal violet |
32 |
25 |
48 |
T |
159 |
88 |
19 |
17 |
16 |
18 |
22 |
1.0 |
35 |
51 |
82 |
145 |
96 |
18 |
16 |
13 |
17 |
20 |
|
0.32 |
27 |
41 |
100 |
137 |
187 |
28 |
15 |
13 |
19 |
25 |
|
0.1 |
33 |
43 |
108 |
140 |
61 |
20 |
10 |
13 |
18 |
21 |
|
0 |
33 |
50 |
106 |
150 |
52 |
23 |
15 |
16 |
20 |
24 |
T: Toxicity
Applicant's summary and conclusion
- Conclusions:
- Crystal violet did not induce gene mutagenicity in the Salmonella typhimurium TA98, TA100, TA1537 and TA1538 strains in the presence and absence of S9 mix and in strain TA1535 in the presence of S9 mix. It however induced gene mutation in the strain TA1535 at low concentration in the absence of S9 mix and the response was not dose related. Hence the test chemical is considered to be negative for gene mutation as per the criteria mentioned in CLP regulation.
- Executive summary:
Salmonella / mammalian microsome mutagenicity assay was performed to study the mutagenic potential of Crystal violet both in the presence and absence of metabolic activator S9 mix. The study was performed using Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 at dose levels of0, 0.1, 0.32, 1.0 or 3.2µg/plate. The test chemical was dissolved in DMSO and used for the study.Plates were incubated at 37°C for 72 hrs before counting his+revertant colonies and each dose point was determined from at least two plates, unless indicated otherwise. Criteria for mutagenicity were (a) a dose-response and, (b) reproducibility of the result. Dose-responses were not always evident at concentratrations selected for initial testing. Crystal violet did not induce gene mutagenicity in the Salmonella typhimurium TA98, TA100, TA1537 and TA1538 strains in the presence and absence of S9 mix and in strain TA1535 in the presence of S9 mix. It however induced gene mutation in the strain TA1535 at low concentration in the absence of S9 mix and the response was not dose related. Hence the test chemical is considered to be negative for gene mutation as per the criteria mentioned in CLP regulation.
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