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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-581-0 | CAS number: 108-42-9
- 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 vivo
Description of key information
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Principles of method if other than guideline:
- In a bone marrow micronucleus evaluations, male F344/N rats received three intraperitoneal injections of m-chloroaniline dissolved in corn oil at 24-hour intervals. The total dosing volume was 0.4 mL. Solvent control rats were injected with corn oil only; the positive control animals received injections of 25 mg/kg cyclophosphamide. Twenty-four hours after the final injection, the animals were killed and smears of the bone marrow cells obtained from the femurs were prepared. Air-dried smears were fixed and stained; 2,000 polychromatic erythrocytes (PCEs) were scored for frequency of micronucleated cells in each of five animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow was scored for each dose group as a measure of toxicity.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- three intraperitoneal injections at 24-hour interval
- Frequency of treatment:
- three intraperitoneal injections at 24-hour interval
- Post exposure period:
- twenty-four hours after the final injection, the animals were killed
- Remarks:
- Doses / Concentrations:
25 or 1000 mg/kg bw
Basis:
actual ingested - No. of animals per sex per dose:
- 5 animals per dose
- Control animals:
- yes, concurrent vehicle
- Tissues and cell types examined:
- bone marrow cells of F344/N rats
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
In a bone marrow micronucleus evaluations, male F344/N rats received three intraperitoneal injections of m-chloroaniline dissolved in corn oil at 24-hour intervals. The total dosing volume was 0.4 mL. Solvent control rats were injected with corn oil only; the positive control animals received injections of 25 mg/kg cyclophosphamide. Twenty-four hours after the final injection, the animals were killed and smears of the bone marrow cells obtained from the femurs were prepared. Air-dried smears were fixed and stained; 2,000 polychromatic erythrocytes (PCEs) were scored for frequency of micronucleated cells in each of five animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow was scored for each dose group as a measure of toxicity.
The results from the in vivo rat bone marrow micronucleus tests with m-chloroaniline were negative.
Reference
Results from the in vivo rat bone marrow micronucleus tests with m-chloroaniline were negative. In the single trial performed with male rats, only two dose groups survived, but these were sufficient for a valid test; no significant increase in the number of micronucleated erythrocytes was observed in rats.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
All Ames test in salmonella typhimurium strains were negative but one assay with metabolic activation and co-treatment with norharmane m-chloroaniline was positive. Without activation in presence of norharmane the test was negative. Aspergillus nidulans revealed a slight positive result.
In one CA (CHO cells) m-chloronailine was negative whereas the other test (with CHL cells) was positive. In one HPRT test,
m-chloroaniline was positive in L5178Y mouse lymphoma cells with and without metabolic activation. Additional, the mutagenic activity of m-chloroaniline on 8AG (8-azaguanine) and OUA (ouabain) mutations in chinese hamster V79 cells was examined. m-chloroaniline was positive on 8AG and negative on OUA. An in-vitro MNT was positive.
In rat hepatocyte culture m-chloroaniline was tested for unscheduled DNA synthesis (UDS). m-chloroaniline was negative in this UDS asssay at a concentration of 50 nmole/ml.All in-vivo MNTs m-chloroaniline was negative. Also is the test for the detection of sperm-head abnormalities m-chloroaniline was negative.
Justification for selection of genetic toxicity endpoint
Several Ames Tests, 2 chromosome aberrations twests, 2 HPRT test, a sister chromatid exchange assay, an in-vitro MNT and an UDS test in vitro are available. Additional, in vivo micronucleus tests(MNT) in rat bone, MNTs in mouse rat bone and blood and a test for the detection of carcinogen-induced sperm head abnormalities in mice are available.
Justification for classification or non-classification
There are nagative and some positive in-vitro assays, but all in-vivo assays were negative. Therefore a classification is not justified.
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.