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EC number: 235-468-7 | CAS number: 12237-62-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 42535:3.
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- 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 publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic effects of test chemical after intra-gastric administration
- Author:
- Ketkar et.al
- Year:
- 1 982
- Bibliographic source:
- Cancer Letters, 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the toxic nature of the test chemical in male and female Sprague-Dawley rats by oral gavage for life.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- EC Number:
- 211-189-6
- EC Name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- Cas Number:
- 632-99-5
- Molecular formula:
- C20H19N3.ClH
- IUPAC Name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Basic Violet 14
- Molecular formula (if other than submission substance): C20H19N3.ClH
- Molecular weight (if other than submission substance): 337.8 g/mol
- Physical State: Solid
- Substance type: organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wiga Company, Sulzfeld, F.R.G.)
- Females (if applicable) nulliparous and non-pregnant: [yes/no] : not specified
- Age at study initiation: 12 weeks
- Weight at study initiation: no data available
- Fasting period before study: no data available
- Housing: housed, sex segregated, 3 to a Makrolon cage (Type III, E. Becker & Co. GmbH, Castrop- Rauxel, F.R.G.).
- Diet (e.g. ad libitum): pelleted diet (RMH-B, Hope Farms, Woerden,Netherlands), ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: no data available
DETAILS OF FOOD AND WATER QUALITY: no data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22 * 2”C,
- Humidity (%): relative humidity 50 + 5%
- Air changes (per hr): air change 20 times per hour
- Photoperiod (hrs dark / hrs light): no data available
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: NaCl solution.
- Details on oral exposure:
- Details on oral exposure
VEHICLE
- Justification for use and choice of vehicle (if other than water): Since the test chemical dissolve only a little in water and may not be reabsorbed by the intestinal tract, the effect which was seen in the subcutaneous tissue of rats could well be associated with the physical properties of the compounds
- Concentration in vehicle: 200 and 300 mg/kgbw/day
- Amount of vehicle (if gavage): 0.9% - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20 weeks
- Frequency of treatment:
- Twice weekly for life
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mg/kgbw
- Remarks:
- vehicle
- Dose / conc.:
- 200 other: mg/kgbw
- Dose / conc.:
- 300 other: mg/kgbw
- No. of animals per sex per dose:
- Total number of animals 240 animals
0 mg/kgbw/week,40 male and 40 females
200 mg/kgbw/week,40 male and 40 females
300 mg/kgbw/week ,40 male and 40 females - Control animals:
- yes
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule:Twice daily
- Cage side observations checked in table [No.?] were included.: Animals weer observed twice daily for mortality and morbidity
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice daily
BODY WEIGHT: Yes
FOOD 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: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD 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: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Not specified
CLINICAL CHEMISTRY ; Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
OTHER: - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes, Complete autopsies were performed on all animals and the organs were fixed in 10% buffered formalin.
HISTOPATHOLOGY: Yes , Paraplast sections from the liver, kidneys and urinary bladder and macroscopically observed abnormal tissue were routinely stained with haematoxylin and eosin. - Statistics:
- For statistical evaluation, only those animals were considered which had been histologically examined (effective number of animals). Survival data are from the beginning of treatment.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Dose levels of 600 and 400 mg/kg body wt. of test chemical were toxic and not well tolerated by the rats which showed rapid weight loss, diarrhoea and short average survival.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Dose levels of 600 and 400 mg/kg body wt. of test chemical were toxic and not well tolerated by the rats which showed short average survival.Therefore, after 2 and 12 weeks, respectively, treatment was discontinued for 1 week.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Dose levels of 600 and 400 mg/kg body wt. of test chemical were toxic and not well tolerated by the rats which showed rapid weight loss.
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant effects were observed at the 200 and 300mg/kgbw/week of treated group compare to control.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No significant effects were observed at the 200 and 300mg/kgbw/week of treated group compare to control.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Macroscopic alterations and microscopic observations were similar in experimental and control rats and were unrelated to the treatment. Age dependent alterations included amyloidosis of the kidneys and liver. Tumours found in the treated groups and not seen in controls were either isolated observations or were within the incidence of tumours commonly known to occur spontaneously in these animals
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 300 other: mg/kg bw/week
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effects were observed at this dose.
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 300 mg/kg bw/week for the test chemical in male and female Sprague-Dawley rats by oral gavage for chronic study.
- Executive summary:
Sprague-Dawley rats received intragastric administration of the test chemical for their lifetime.The animals were exposed at the 600 and 400 mg/kg body weight/week.The dose levels of 600 and 400 mg/kg body wt. of the test chemical was not well tolerated by the rats which showed rapid weight loss, diarrhoea and short average survival. Therefore, after 2 and 12 weeks, respectively, treatment was discontinued for 1 week. As no improvement in the general health of the rats was found after a further 6 weeks, half of the original dose levels was used for the remaining treatment. Macroscopic alterations and microscopic observations were similar in experimental and control rats and were unrelated to the treatment. Age dependent alterations included amyloidosis of the kidneys and liver. Tumours found in the treated groups and not seen in controls were either isolated observations or were within the incidence of tumours commonly known to occur spontaneously in these animals. The urinary bladder and kidneys were free of neoplastic growth in the test chemical treated rats. Therefore NOAEL was considered to be 300mg/kg bw/week for the test chemical in male and female Sprague-Dawley rats by oral gavage for chronic study.
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