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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 281-506-0 | CAS number: 83968-28-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test compound Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochloridesis not likely to be a gene mutant in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- To evaluate the genotoxicity of methyl violet in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538 and TA98.
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- No data
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538 and TA98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: strains are excision-repair deficient and contain the gal and rfa mutations.
- Metabolic activation:
- not specified
- Metabolic activation system:
- No data
- Test concentrations with justification for top dose:
- 1, 2 or 4µg/plate
- Vehicle / solvent:
- No data available
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Top agar method was used. {soft agar procedure}
- Evaluation criteria:
- Revertant colonies per plate were observed.
- Statistics:
- No data available
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538 and TA98
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data available
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test result was observed to be negative for Methyl violet in Salmonella typhimurium Strain- TA1535, TA100, TA1537, TA1538 and TA98 by soft agar procedure. - Executive summary:
Genotoxicity study for Methyl violet (CAS no 8004 -87 -3) was conducted in Salmonella typhimurium strain -TA1535, TA100, TA1537, TA1538 and TA98 bysoft agar procedure. They were exposed at the concentration of1, 2, and 4µg\plate. Revertant colonies per plate were observed. The test result was observed to be negative for Methyl violet in Salmonella typhimurium Strain-TA1535, TA100, TA1537, TA1538 and TA98. Based on the above result ,it can be summarized that Methyl violet is not likely to exhibit genetic toxicity and hence can be classified as 'non-hazardous'.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
Genetic toxicity in vitro:
Various peer reviewed publications for the alternate cas (CAS no 8004 -87 -3) and read across were studied to determine the mutagenic nature of the test compound Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides (CAS no 83968 -28 -9). The summary is as mentioned below:
Genotoxicity study for Methyl violet (CAS no 8004 -87 -3) was conducted by Shahin (1978) in Salmonella typhimurium strain-TA1535, TA100, TA1537, TA1538 and TA98 bysoft agar procedure. They were exposed at the concentration of1, 2, and 4µg\plate. Revertant colonies per plate were observed. The test result was observed to be negative for Methyl violet in Salmonella typhimurium Strain-TA1535, TA100, TA1537, TA1538 and TA98.
Gene mutation toxicity study was performed (Ministry of Economy, Trade and Industry, Japan, 2016) for the test chemical C.I. Basic Violet 1 (CAS no 8004 -87 -3) using Salmonella typhimurium strains TA100, TA98, TA1535 and TA1537 in the presence and absence of S9 metabolic activation system as per the OECD guideline 471. Preincubation protocol was followed for the test. The test compound C.I. Basic Violet 1 is not mutagenic in the Salmonella typhimurium strains TA100 and TA1535 but positive in the strains TA98 and TA1537 and in E. coli WP2 uvrA.
Mutagenicity testing of methyl violet 2B (CAS no 8004 -87 -3) was performed by Chung et al (1981) using the Salmonella-microsome mutagenicity test developed by Ames et al. The test compound was tested at five concentrations from either 1 to 1,000 or 5 to 5,000 µg. Plate incorporation and preincubation method were performed to determine the mutagenic effect. The test compound methyl violet 2B is not mutagenic to the Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100 in the presence and absence of S9 activation system.
In a gene toxicity test (Sustainability Support Services, 2015), Chinese Hamster Ovary (CHO) cells were exposed to N,N-diethylaniline (RA CAS no 91-66-7) in the concentration of 0, 1, 2.5, 5 or 10 mM and with and without S9-induced metabolic activation for 3 hours. The results showed that there was evidence of cytotoxicity after treatment with 5 mM or above. Independently of tested N,N-diethylaniline concentration, the results showed no evidence of gene toxicity with S9 metabolic activation system. Therefore, it is considered that N,N-diethylaniline in the concentration of 0, 1, 2.5, 5 or 10 mM does not cause genetic mutation(s) when CHO cells are exposed to the test chemical in the presence of metabolic activation.Treatment with 5 mM of N,N-diethylaniline showed evidence of potential gene toxicity.Therefore, it is considered that N,N-diethylaniline in the concentrations of 2.5 mM or below does not cause genetic mutation(s), while concentrations at 5 mM or above may, when CHO cells are exposed to the test chemical in the absence of metabolic activation.Thus, the results indicate that the test chemical does not give rise to gene mutation at ≤ 2.5 mM while concentrations at ≥ 5 mM could. When the mutation frequency was determined, a frequency of 5.23 x 10-4was shown after a 3 hour exposure of ENU as the positive control and in the absence of S9 liver microsomal fraction, as well as treatment with 5 mM and in the absence of S9 liver microsomal fraction resulted in a mutation frequency of -7.08 x 10-5. Since no other tested concentration ofN,N-diethylaniline in the absence of S9 liver microsomal fraction resulted in colonies at ≤ 2.5 mM, or at ≤ 10.0 mM in the presence of S9 liver microsomal fraction, we conclude thatN,N-diethylaniline does not give rise to gene mutations in organisms with fully functioning metabolic activation while organisms with non-present or impared metabolic activation may develop genetic mutation when exposed toN,N-diethylaniline at ≥ 5 mM for 3 hrs or more.
Gene mutation toxicity study was performed by Zeiger et al (1988) to evaluate the mutagenic nature of the test compound N, N-diethylaniline. Salmonella Ames assay was performed by the preincubation method using the Salmonella typhimurium strains TA98, TA100 and TA1535 with and without S9 metabolic activation system. The test compound gave negative result for genetic toxicity in Ames test conducted on to S. typhimurium TA98, TA100 and TA1535 with and without metabolic activation by 10% or 30% HLI/RLI S9 system. Hence, N, N-diethylaniline (RA CAS no 91 -66 -7) is not likely to classify as gene mutant in vitro.
The genotoxicity of N, N diethylaniline (RA CAS no 91 -66 -7) was performed by Yoshima et al (1988) using a DNA repair test with rat hepatocytes. N,N-diethylaniline gave negative results in the rat hepatocytes for induction of DNA repair in vitro (in all strains/cell typres tested). Hence, the test chemical is likely to be "not classified for gene mutation".
Gene mutation toxicity study was performed by Mortelmans et al (1986) to evaluate the mutagenic nature of the test compound N, N-diethylaniline. Salmonella Ames assay was performed by the preincubation method using the Salmonella typhimurium strains TA98, TA100 and TA1535 with and without S9 metabolic activation system. The test compound gave negative result for genetic toxicity in Ames test conducted on to S. typhimurium TA98, TA100 and TA1535 with and without metabolic activation by 10% HLI/RLI S9 system. Hence, N, N-diethylaniline (RA CAS no 121 -69 -7) is not likely to classify as gene mutant in vitro.
N,N-dimethylaniline (RA CAS no 121 -69 -7) was studied by Yoshimi (1988) in a DNA repair test with primary cultured rat hepatocytes to determine the mutagenic nature of the test compound. N, N-dimethylaniline failed to show any mutagenic activity on primary rat hepatocytes in an in vitro DNA repair test.
N,N-dimethyl-p-toluidine (RA CAS no 99 -97 -8) was tested by Taningher et al (1993) for gene mutation ability by performing bacterial reverse mutation assay. The test compound was tested at dose levels of 0 -100 µg/plate. The test compound did not show any reversion of mutation and hence is negative for gene mutation in vitro.
N,N-dimethyl-p-toluidine (RA CAS no 99 -97 -8) was tested (USEPA, 2012) for gene mutation ability by performing bacterial reverse mutation assay. The test compuund was tested at dose levels of 100 -5000 µg/plate using S. typhimurium TA98, TA1537, TA1538 and TA100 with and without S9 metabolic activation sytem. The test compound did not show any reversion of mutation and hence is negative for gene mutation in vitro.
The alternate cas no 8004 -87-3 used to predict the data for mutation showed negative gene mutation effects in the studies summarized. Based on the alternate cas no studies and other weight of evidence data, the result is extrapolated to the target chemical also. On this basis the test chemical Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides (CAS no 83968 -28 -9) is also not likely to classify as a gene mutant in vitro.
Justification for selection of genetic toxicity endpoint
Data is from peer reviewed publication
Justification for classification or non-classification
The alternate cas no 8004 -87-3 used to predict the data for mutation showed negative gene mutation effects in the studies summarized. Based on the alternate cas no studies and other weight of evidence data, the result is extrapolated to the target chemical also. On this basis the test chemical Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides (CAS no 83968 -28 -9) is also not 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.
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.