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EC number: 280-898-0 | CAS number: 83803-79-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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 fom 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)
- Principles of method if other than guideline:
- Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test of C.I. Basic Violet 1in Rats
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- C.I. Basic Violet 1
- IUPAC Name:
- C.I. Basic Violet 1
- Reference substance name:
- 8004-87-3
- EC Number:
- 616-846-4
- Cas Number:
- 8004-87-3
- Molecular formula:
- C24H28ClN3
- IUPAC Name:
- 8004-87-3
- Test material form:
- other: DYE
- Details on test material:
- - Name of test material (as cited in study report): C.I. Basic Violet 1- Molecular formula: C24H28ClN3- Molecular: 393.95 g/mol- Substance type: Organic-OTHER- The enclosed study provides information on a commercial mixture.The mixture contains 21 % of C.I. Basic Violet 1 in a commercial mixture of CALCOZINE black CSP powder.
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C.I. Basic Violet 1- Molecular formula: C24H28ClN3- Molecular: 393.95 g/mol- Substance type: Organic-OTHER- The enclosed study provides information on a commercial mixture.The mixture contains 21 % of C.I. Basic Violet 1 in a commercial mixture of CALCOZINE black CSP powder.
Test animals
- Species:
- rat
- Strain:
- Crj: 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
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: 0.5 % Methylcellulose aqueous solution
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dose were prepared by suspendingtest substance in 0.5 % Methylcellulose aqueous solution at 0, 1.6, 8 and 40 mg/kg bw. DIET PREPARATION - Rate of preparation of diet (frequency): - Mixing appropriate amounts with (Type of food): - Storage temperature of food: VEHICLE - Justification for use and choice of vehicle (if other than water): 0.5 % Methylcellulose aqueous solution - Concentration in vehicle: 0, 1.6, 8 and 40 mg/kg bw. - Amount of vehicle (if gavage): 5 mL/kg - Lot/batch no. (if required): - Purity:
- Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Male: 42 day Female: 41 - 48 days (from 14 days before mating to day 4 of lactation)
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1.6 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 8 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 40 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Total: 1060 mg/kg/day: 7 male, 12 female 1.6 mg/kg/day: 12 male, 12 female8 mg/kg/day: 12 male, 12 female40 mg/kg/day: 7 male, 12 femaleRecory group:0 mg/kg/day: 5 male, 5 female 40 mg/kg/day: 5 male, 5 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: - Rationale for animal assignment (if not random): - Other:
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- Survival, clinical sign, body weight, food consumption and urineanalysis, FOB, Urinalysis (Male only), were examined.
- Oestrous cyclicity (parental animals):
- Estrous cyclicity, copulation and implantation were examined.
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- Number of pups, number of live pups, sex ratio on days 0 and 4, clinical signs and body weight were examined.
- Postmortem examinations (parental animals):
- Hematology, clinical chemistry, Organ weight, gross pathology and histopathology were examined.
- Postmortem examinations (offspring):
- Gross pathology were examined.
- Statistics:
- not specified
- Reproductive indices:
- Fertility rat, gestation period, implantation index, live birth index, delivery index were examined.
- Offspring viability indices:
- Viability index on 0 and 4 day were examined.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 40 mg/kg/day, 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 were observed in dead treated rats as compared to control. Soft stool and dirty around anus in male and female and External genital bleeding in Female survival rats were observed. Colored feces were observed in 1.6 and 8 mg/kg bw treated rats.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- When treated with 40 mg/kg bw, 1 male and 4 female died and 3 male and 1 female were sacrificed due to morbidity. No effect on survival of treated rats were observed at 1.6 and 8 mg/kg bw as compared to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 40 mg/kg/day, decrease in body-weight and body-weight gain were observed in male and body weight gain in female rats as compared to control
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 40 mg/kg/day, decrease in food consumption was observed in male and female rats as compared to control.
- 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
- Description (incidence and severity):
- When treated with 40 mg/kg/day, Increase in the PLT was observed in male and female rats as compared to control.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 40 mg/kg/day, Increase in the AST and ALT in male, CPK and BUN were observed in extremely killed male and female rat. Decrease in the TP and alpha 1-glb, Increase in the Alb, A/G and BUN in male and Increase in the BUN (tendency) in Female rats were observed as compared to control in survival animals.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No effect was observed in male rats as compared to control.
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 40 mg/kg/day, Bradypnea, Prone position, Decrease in spontaneous activity, Incomplete eyelid opening and abnormal gait in died animals and no effect on surviving animals were observed.
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 40 mg/kg/day, 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) were observed as compared to control in extremis killed animals. Liver; Hypertrophy of centrilobular hepatocyte (Male 2/4), Duodenum; Hypertrophy of epithelial cell (Male 2/4, Female 6/7) and Mesenteric lymph node and Sinus histiocytosis (Male 1/4, Female 3/7) were observed as compared to control in survival animals.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effect on Estrous cyclicity, copulation and inplantation were observed.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on Reproductive performance of treated male and femlae rats were observed as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (oestrous cycle)
- reproductive performance
- other: No effect
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No Clinical signs were observed in treated pups as compared to control.
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on suvival of pups were observed as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of pups were observed as compared to control.
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross pathological changes were observed in treated pups as compared to control.
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 40 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- other: No effect
- Remarks on result:
- other: not specified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 40 mg/kg/day for P and F1 generation when Crl:CD (SD) male and female rats treated with C.I. Basic Violet 1 orally by gavage.
- Executive summary:
In a Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test,Crl:CD (SD)male and female rats treated withC.I. Basic Violet 1 in the concentration of0, 1.6, 8 and 40 mg/kg/day orally by gavage in0.5 % Methylcellulose aqueous solution. 1 male and 4 female died and 3 male and 1 female were sacrificed due to morbidity at 40 mg/kg bw. No effect on survival of treated rats were observed at 1.6 and 8 mg/kg bw as compared to control, 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 were observed in dead treated rats as compared to control. Soft stool and dirty around anus in male and female and External genital bleeding in Female surviving rats at 40 mg/kg/day. Colored feces were observed in 1.6 and 8 mg/kg bw treated rats.Decrease in body-weight and body-weight gain were observed in male and body weight gain in female rats and decrease in food consumption were observed in male and female rats as compared to control at40 mg/kg/day.Bradypnea, Prone position, Decrease in spontaneous activity,incompleteeyelid opening and abnormal gait in died animals and noeffects on surviving animals wereobserved.No effect on ureinanalysis wasobserved in male rats as compared to control.Similarly,Increase in the PLT was observed in male and female ratsas compared to control at40 mg/kg/day. Increase in the AST and ALT in male, CPK and BUN were observed in extremely killed male and female rat at 40 mg/kg/day. Decrease in the TP and alpha 1-glb, Increase in the Alb, A/G and BUN in male and increase in the BUN (tendency) in Female rats were observed as compared to control in survival animals. No effect on organ weight of treated was male and female rats were observed as compared to control. 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) observed in extremely killed animals and Light violet aqueous content in alimentary tract in surviving male and female rats at 40 mg/kg/day. Light violet aqueous content in stomach and cecum were observed in male rats (3/12) at 8 mg/kg/day. 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) were observed as compared to control in extremis killed animals and Liver; Hypertrophy of centrilobular hepatocyte (Male 2/4), Duodenum; Hypertrophy of epithelial cell (Male 2/4, Female 6/7), Mesenteric lymph node and Sinus histiocytosis (Male 1/4, Female 3/7) were observed as compared to control in survival animals at 40 mg/kg/day. In addition no reproductive effect such as Estrous cyclicity, copulation and implantation, Fertility rat, gestation period, implantation index, live birth index, delivery index were observed in treated rats as compared to control. No effect on viability, development and growth of pups were observed in treated rats as compared to control. Therefore, NOAEL was considered to be 40 mg/kg/day for P and F1 generation whenCrl:CD (SD)male and female rats treated withC.I. Basic Violet 1 orally by gavage.
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