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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-539-3 | CAS number: 62-53-3
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Reproducibility of microbial mutagenicity assays: I. Tests with Salmonella typhimurium and Escherichia coli using a standardized protocol.
- Author:
- Dunkel VC, Zeiger E, Brusick D, McCoy E, McGregor D, Mortelmans K, Rosenkranz HS, Simmon VF
- Year:
- 1 984
- Bibliographic source:
- Environ Mutagen. 6, Suppl 2, 1-251.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- maximum test concentration < 5000 µg/plate
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Anilinium chloride
- EC Number:
- 205-519-8
- EC Name:
- Anilinium chloride
- Cas Number:
- 142-04-1
- IUPAC Name:
- anilinium chloride
- Reference substance name:
- aniline, hydrochloride
- IUPAC Name:
- aniline, hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): aniline HCl
- Analytical purity: 98.5 + 1.2 %
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538, E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from rats, mice or hamsters treated with Aroclor 1254 (500 mg/kg)
- Test concentrations with justification for top dose:
- 0.3, 1.0, 3.3, 10, 33.3, 100, and 333.3 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol; distilled water
- Justification for choice of solvent/vehicle:
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water or ethanol
- True negative controls:
- other: a total of 59 substance were evaluated, some of which were positive
- Positive controls:
- yes
- Positive control substance:
- other: with S9: 2-AA (2-aminoanthracene); without S9: TA1537: 9-AA (9-aminoacridine), TA100 and TA1535: Na azide (sodium azide), TA98 and TA1538: 2-NF (2-nitrofluorene): E. coli: AF-2 (2-2(-furyl)-3-(5-nitro-2-furyl)acrylarnide), MNNG (N-methyl-NI-nitro-N-nitros
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
The bacterial strain, test chemical, and S-9 mix, when required, were added to 2 ml of molten top agar at 45°C. The contents were then mixed and poured onto minimal agar plates. All plates were prepared in triplicate, and concurrent positive and negative controls were run at all times. Plates were incubated at 37°C for 48 hr prior to counting.
METHOD OF APPLICATION: preincubation
The bacterial strain, test chemical, and S-9 mix, when required, were added to tubes. The contents were mixed and incubated at 37°C for 20-30 min. At the end of the incubation period 2 ml of top agar was added to each tube, and the contents were mixed and poured onto the minimal agar plates. Plates were incubated at 37°C for 48 hr.
Since the prime objective of this study was to evaluate inter-laboratory reproducibility, the laboratories were only required to do a single assay with each coded chemical.
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- A positive response was defined as a dose-related increase with at least two doses being greater than or equal to twofold background, unless the background was less than ten, in which case a threefold increase was required. A question mark (?) was defined as a test in which only a single dose was equal to or greater than twofold (or threefold) background. Low-level, non-dose-related increases were scored as negative, as were single doses whose increase was the result of widely divergent replicate plate Counts.
An experiment was designated "no test" (NT) if the majority of plates were contaminated or showed a toxic response, controls were not run, or, in the case of TA100, if the mean background Count plus the standard error of the mean was equal to or greater than 300. It must be emphasized that these rules were selected in order to facilitate comparison of data and are generally not used in any of the authors' laboratories. There were numerous instances in which the laboratory's or the authors' judgment disagreed with the results obtained from using these fixed criteria. However, these rules were necessary for comparing the results; they are not recommended for use beyond this comparison study.
Although the protocol only called for one experiment, laboratories occasionally performed additional experiments. In these cases only the initial experiment was selected for analysis and presentation to maintain comparability across laboratories. In order to obtain analyzable data for each laboratory, exceptions to this rule were made when (1) the testing laboratory repeated the experiment at the Same or lower doses because of high levels of toxicity or contamination or (2) the positive or negative control values were outside the laboratory's acceptable range. Otherwise the data are presented as reported to the study organizers. All data and supporting experimental design information were entered on standard forms. - Statistics:
- not specified
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538, E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity observed up to 333.3 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
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.