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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- 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 J check
Data source
Reference
- Reference Type:
- other: J check
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 8004-87-3
- EC Number:
- 616-846-4
- Cas Number:
- 8004-87-3
- Molecular formula:
- C24H28ClN3
- IUPAC Name:
- 8004-87-3
- Reference substance name:
- C.I. Basic Violet 1
- IUPAC Name:
- C.I. Basic Violet 1
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of the test material: C.I. Basic Violet 1
- Molecular weight: 393.95
- Molecular formula: C24H28ClN3
- Appearence: Dark yellow-green to dark green crystal (nub)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation of dosing: 10 weeks old
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % Methylcellulose aqueous solution
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- - Male: 42 days
- Female: 41 - 48 days (from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- - Female: 41 - 48 days (from 14 days before mating to day 4 of lactation)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1.6, 8, 40 mg/Kg bw (actual ingested)
Basis:
- No. of animals per sex per dose:
- - Male: 7 rats/group (control and high dose groups of main study) + 5 rats/group (control and high dose groups of recovery).
12 rats/group (low and middle dose groups of main study).
- Female: 12 rats/group (all groups of main study) + 5 rats/group (control and high dose groups of recovery). - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
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: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- 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 data
CLINICAL CHEMISTRY: Yes
- 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 data
URINALYSIS: Yes (Males only)
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Clinical signs:
1.6 mg/Kg bw: Test article-colored feces
8 mg/Kg bw: Test article-colored feces
40 mg/Kg bw:
Found dead or killed in extremis:
Decreased spontaneous activity, Prone position, Bradypnea, Abnormal respiratory tones, Hypothermia, Abnormal gait, Soft stool, Emaciation, Abdominal distention, Dirty around anus, Soiled perineal region, External genital bleeding and test article-colored feces
Survivals:
Soft stool and dirty around anus (Male/Female),
External genital bleeding (Female)
Mortality:
1.6 mg/Kg bw: Male: 0/12, Female: 0/12
8 mg/Kg bw: Male: 0/12, Female: 0/12
40 mg/Kg bw: Male: 4/12 (day 9, day 11 (3 animals)), Female: 5/12 (day 20 (2 animals), gestational day 6, 18, 21)
BODY WEIGHT AND WEIGHT GAIN: Decrease in the body weight and decrease in the body weight gain (Male), Decrease in the body weight gain (Female) was noted in 40 mg/Kg bw dosed animals
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Decrease in the food consumption was noted in 40 mg/Kg bw dosed animals
FOOD EFFICIENCY: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
HAEMATOLOGY: Increase in the PLT was noted in 40 mg/Kg bw dosed animals
CLINICAL CHEMISTRY:
Killed in extremis:
Increase in the AST and ALT (Male), Increase in the CPK (Male/Female), Increase in the BUN (Male/Female) in 40 mg/Kg bw dosed animals
Survivals:
Decrease in the TP, Increase in the Alb, Decrease in the alpha 1-glb and increase in the A/G (Male), Increase in the BUN (Male), Increase in the BUN (tendency) (Female) in 40 mg/Kg bw dosed animals
URINALYSIS: No adverse effects were noted in any of the dosed grouped animals
NEUROBEHAVIOUR: No data available
ORGAN WEIGHTS: No adverse effects were noted in any of the dosed grouped animals
GROSS PATHOLOGY
1.6 mg/Kg bw: No adverse effects were noted
8 mg/Kg bw: Light violet aqueous content in stomach and cecum (Male 3/12)
40 mg/Kg bw:
Found dead and killed in extremis (Male 4/12, Female 5/12):
Light violet aqueous content and discoloration of mucus membrane in all of the alimentary tract containing oral cavity, subcutaneous tissues and uterus (sporadically noticed in Male and Female), Hydrothorax in thoracic cavity (Male 1/4, Female 2/5), Small thymus (Male 3/4, Female 2/5), Small spleen (Male 1/4, Female 2/5), Edema in thymus (Male 1/4), Reddish urine in gallbladder (Male 1/4), Red discoloration in mucosa of the bladder (Male 1/4), Red discoloration of testis (Male 1/4), Red discoloration of adipose tissue around the testis (Male 1/4), Dilatation of stomach (Female 4/5), Enlargement of adrenal (Female 4/5), Gas retention in stomach (Female 2/5), Dark red viscous retention in vagina (Female 2/5), Dilatation of cecum (Female 1/5), Gas retention in cecum (Female 1/5)
Survivals:
Light violet aqueous content in alimentary tract (Male/Female)
HISTOPATHOLOGY:
40 mg/kg bw:
Found dead or killed in extremis:
Trachea; Desquamation of epithelium and inflammatory cell infiltration of mucosa (Male 1/4, Female 2/5) Glandular stomach; Atrophy of epithelial cell (Male 1/4, Female 1/5) Small/large intestine; Hypertrophy of epithelial cell (sporadically observed in Male and Female) Liver; Hypertrophy of centrilobular hepatocyte (Male 3/4, Female 3/5), Necrosis (Male 1/4, Female 2/5), Vacuolation (Male 1/4) Adrenal; Hypertrophy of zona fasciculata (Male 2/4, Female 5/5) Bone marrow; Deficient erythropoiesis and granulopoiesis (Male 3/4, Female 2/5) Spleen; Atrophy of follicle / marginal zone (Male 2/4, Female 5/5) and periarterial lymphatic sheath (Male 3/4, Female 5/5) Thymus; Atrophy (Male 4/4, Female 3/5) /necrosis of lymphocyte (Male 3/4, Female 4/5) Lymph node; Atrophy of follicle / paracortex (Male 3/4, Female 5/5) Spinal cord / fourth ventricle / testis / urinary bladder; Hemorrhage or hemorrhagic infarction (Male 1/4) Vagina; Hemorrhage (Female 2/5), Mucoid degeneration of mucosa (Female 2/5) Lung; Hemorrhage of alveolus, edema of alveolus and inflammatory cell infiltration (Female 1/5)
Survivals:
Liver; Hypertrophy of centrilobular hepatocyte (Male 2/4) Duodenum; Hypertrophy of epithelial cell (Male 2/4, Female 6/7) Mesenteric lymph node; Sinus histiocytosis (Male 1/4, Female 3/7)
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 8 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Male/Female 40 mg/kg/day: Death, Hypertrophy of epithelial cell of intestinal tract, Hypertrophy of centrilobular hepatocyte, Necrosis of centrilobular hepatocyte
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test compound C.I. Basic Violet 1 is found to be 8 mg/Kg bw.
- Executive summary:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) was performed to determine the toxic nature of the test compound C.I. Basic Violet 1(CAS no 8004 -87 -3) upon repeated exposure to Crl:CD (SD) strain rats. The test chemical was dosed at levels of 0, 1.6, 8 or 40 mg/Kg bw (Actual ingested dose). Male rats were treated for 42 days and female rats were treated from 41 - 48 days (from 14 days before mating to day 4 of lactation). Based on the effects noted at 40 mg/Kg bw, the No Observed Adverse Effect Level (NOAEL) for the test compound C.I. Basic Violet 1 is likely to be 8 mg/Kg bw.
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