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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-407-8 | CAS number: -
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- SUBCHRONIC (13-WEEK) TOXICITY STUDIES OF N,N-DIMETHYLANILINE ADMINISTERED TO FISCHER 344 RATS AND B6C3F, MICE
- Author:
- Kamal M. Abdo, Micheal P. Jokinen, Richard Hiles
- Year:
- 2 009
- Bibliographic source:
- National Toxicology Program, Research Triangle Park, North Carolina
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Subchronic toxicity study of test chemical in B6C3F1 mice to determine its toxic effects on different target organs.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- N,N-dimethylaniline
- EC Number:
- 204-493-5
- EC Name:
- N,N-dimethylaniline
- Cas Number:
- 121-69-7
- Molecular formula:
- C8H11N
- IUPAC Name:
- Aniline, N,N-dimethyl-
- Details on test material:
- - Name of test material (as cited in study report):N,N-dimethylaniline- Molecular formula (if other than submission substance): C8H11N- Molecular weight (if other than submission substance):121.18g/mol- Impurities (identity and concentrations):98.2% pure- Substance type:Organic- Physical state: Liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River Breeding Laboratories- Age at study initiation: 6-8 weeks- Weight at study initiation: No data available- Fasting period before study: N/A- Housing: Five animals per sex were housed in polycarbonate cages in a controlled environment. - Diet (e.g. ad libitum): NIH-07 diet, ad libitum- Water (e.g. ad libitum):Tap water, ad libitum- Acclimatization period: 2 weeksENVIRONMENTAL CONDITIONS- Temperature (°F): 70-74°F- Humidity (%): 48-71%- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): 12-hr dark/12-hr light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE- Justification for use and choice of vehicle (if other than water): Corn oil- Concentration in vehicle: 0, 31.25, 62.5, 125, 250 and 500 mg/kg/day- Amount of vehicle (if gavage): 5 ml corn oil/kg- Lot/batch no. (if required): No data available- Purity: No data availableOther details: Gavage solutions were prepared fresh once every week and stored in brown bottles at 4°C. Doses were adjusted weekly for changes in body weights.
- Duration of treatment / exposure:
- 13 Weeks
- Frequency of treatment:
- Once daily, 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 31.25, 62.5, 125, 250 or 500 mg/kg/dayBasis:actual ingested
- No. of animals per sex per dose:
- Control: 10 males, 10 females31.25 mg/kg/day: 10 males, 10 females62.2 mg/kg/day: 10 males, 10 females125 mg/kg/day: 10 males, 10 females250 mg/kg/day: 10 males, 10 females500 mg/kg/day: 10 males, 10 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: twice daily (once in the morning and once in the afternoon) for morbidity and mortalityBODY WEIGHT: YesTime schedule for examinations-WeeklyCAGE SIDE OBSERVATIONS: Yes - Time schedule: Twice daily - Cage side observations checked in table [No.?] were included.DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule: WeeklyBODY WEIGHT: Yes - Time schedule for examinations: WeeklyFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: NoFOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: NoWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No- Time schedule for examinations:No dataOPHTHALMOSCOPIC EXAMINATION: No- Time schedule for examinations:No data- Dose groups that were examined:No dataHAEMATOLOGY: No- Time schedule for collection of blood:No data- Anaesthetic used for blood collection: No data- Animals fasted: No data- How many animals:No data- Parameters checked in table [No.?] were examined.No dataCLINICAL CHEMISTRY: No- Time schedule for collection of blood:No data- Animals fasted: No data- How many animals:No data- Parameters checked in table [No.?] were examined. No dataURINALYSIS: No- Time schedule for collection of urine:- Metabolism cages used for collection of urine: No data- Animals fasted: No data- Parameters checked in table [No.?] were examined. No dataNEUROBEHAVIOURAL EXAMINATION: No- Time schedule for examinations:- Dose groups that were examined:- Battery of functions tested: sensory activity / grip strength / motor activity / other:OTHER:
- Sacrifice and pathology:
- GROSS PATHOLOGY: YesAll rats, including those that died during the study and those that survived to study termination, were necropsied and all gross lesions were recorded.HISTOPATOLOGY: YesTissues and organs were collected from each animal and fixed in 10% neutral buffered formalin. The fixed tissues were embedded in paraffin, sectioned at 5-6 um, and stained with hematoxylin and eosin. Selected tissues were stained with Perl's iron stain to confirm the presence of hemosiderin.
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- No mortality observed. Decrease in motor activity occurred in female mice at ≥125 mg/kg/day and in male mice in all treated groups, and lasted throughout the day.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- No mortality observed. Decrease in motor activity occurred in female mice at ≥125 mg/kg/day and in male mice in all treated groups, and lasted throughout the day.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean body weights of all treated male mice were about 8% lower than the controls. Little difference in mean body weights was observed between treated and control female mice.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Splenomegaly was present in all mice receiving ≥125 mg/kg/day, in 7 of 10 male and 8 of 10 females at 62.5 mg/kg/day, and 4 of 10 male and 4 of 10 female mice at 31.25 mg/kg/day.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Comp.-related effects were noted in spleen,liver & kidney of male & female mice.The incidence &/or severity of the lesions increased with increasing dose levels,where treatment-related effects were present in all groups of treated mice at doses >31.65 mg
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Hyperplasia of the bone marrow and hematopoiesis in the spleen were observed in all rats in a dose-related manner
- Details on results:
- Death were attributed to gavage errorsMortalityDead at dose 500 mg/kgDead at dose 250 mg/kgDead at dose 125 mg/kgDead at dose 62.5 mg/kgDead at dose 31.25 mg/kgDead at dose 0 mg/kgMice Male1321Mice Female1The gavage deaths were confirmed by the presence of the vehicle (corn oil) in the lung.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 31.25 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effct were observed at this dose
- Remarks on result:
- other: No toxic effct were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Histopathology:
Compound-related effects were noted in the spleen, liver, and kidney of male and female mice. The incidence and/or severity of the lesions increased with increasing dose levels, where treatment-related effects were present in all groups of treated mice at doses greater than 31.25 mg/kg/day.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 31.25 mg/kg body weight/day in male and female B6C3F1 mice. for test chemical
- Executive summary:
In a repeated-dose toxicity study, 0, 31.25, 62.5, 125, 250 or 500 mg/kg/day of test chemical was administered to 10 male and 10 female B6C3F1 mice per dose via gavage 5 days/week for 90 days. No mortality was observed. Dose-related increases in splenomegaly, and extramedullary hematopoiesis and hemosiderosis of the spleen were observed in the mice when given greater than 31.25 mg/kg/day of test chemical . Splenomegaly was reported as minimal in 4/10 mice, and extramedullary hematopoiesis and hemosiderois were reported as mild in 1/10 mice.Compound-related effects were noted in the spleen, liver, and kidney of male and female mice. The incidence and/or severity of the lesions increased with increasing dose levels, where treatment-related effects were present in all groups of treated mice at doses greater than 31.25 mg/kg/day. Therefore the NOAEL was considered to be 31.25 mg/kg/day in B6C3F1 mice for 13 weeks by oral gavage.
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.