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EC number: 215-523-1 | CAS number: 1328-51-4 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 74180.
- 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
Description of key information
Repeated dose subacute toxicity study was performed to determine the toxic nature of Direct blue 86 (EC name: Disulfo copper phthalocyanine amine salt). The chemical was administered by oral gavage route at dose levels of 0 or 1000 mg/Kg bw/day to 20 male and 20 females rats in a standard volume of 10 mL/kg. The treatment period was followed by a 15 day recovery period. 22 daily doses were given over a period of 30 days i.e 5 times/week, 1 dose/day for 4 weeks plus Monday and Tuesday of the last week. The doses were selectedwere selected on the basis of acute oral LD50 study. The oral LD50 value in rats was in excess of 5000 mg/Kg bw/day and no signs of toxicity were noted and hence the dose was subacute study was selected to be 1000 mg/Kg bw/day. Each day, clinical signs and body weights were recorded. Food intake was determined on a weekly basis. At the end of the treatment and the recovery period, hematology, blood chemistry, and urinalysis measurements were carried out by standard methods on animals from control and test groups. At the end of the treatment period or after the recovery period, each rat was examined externally and by dissection for macroscopic abnormalities. Each rat was autopsied and selected organs, including liver, kidneys, adrenals, and spleen were submitted for histopathological examination, following determination of the organ weights. Other organ tissues were fixed in formalin and are held for reference in the archives. Appropriate statistical analyses were performed on the different measurements. No mortality or signs of toxicity were observed during the study period and food and water consumption were within the normal range following treatment with the eight selected colorants. There was evidence of absorption, based on the coloration of urine and/or tissues following treatment with Direct Blue 86. Comparison of the urinalysis of test and control animals, and all bilirubin and urobilinogen tests were negative. The clinical examinations of liver function revealed no signs of toxicity following treatment and recovery. No overall effects were observed on the hematological profiles of the test animals compared with the controls. The statistical analyses did not reveal evidence for any treatment-related effects on liver or adrenals weights. The kidney weights were increased at termination of treatment with Direct Blue 86, and Direct Blue 15, but were normal after the 2-week recovery. This effect may relate to the morphological changes of the tubules of the kidneys, which were seen at the end of the treatment period, but not after the recovery period. Other histopathological examinations of selected tissues showed no significant effects related to the treatment.
The No Observed Adverse Effect Level (NOAEL) for Direct blue 86 in male and female rats is 1000 mg/Kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Subacute toxicity study was performed to determine the toxic nature of Direct Blue 86 upon repeated exposure by oral route
- GLP compliance:
- not specified
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of the test material: Disulfo copper phthalocyanine amine salt
- EC name: Disulfo copper phthalocyanine amine salt
- Molecular formula: C32H14CuN8O6S2.2Na
- Molecular weight: 780.1706 g/mol
- Substance type: Organic
- Purity: No data - Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: Rats were housed under standardized conditions
- Diet (e.g. ad libitum): pelleted standard diet ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data - Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- other: Vehicle was used. Details are not mentioned
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Direct Blue 86 was dissolved in appropriate vehicle to give a final dose range of 0 or 1000 mg/Kg bw/day
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Concentration in vehicle: 1000 mg/Kg bw/day
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- 22 Daily doses over a period of 30 days i.e 5 times/week, 1 dose/day for 4 weeks plus Monday and Tuesday of the last week
- Remarks:
- 0 or 1000 mg/Kg bw/day
- No. of animals per sex per dose:
- Total: 80
0 mg/Kg bw/day: 20 males and 20 females
1000 mg/Kg bw/day: 20 males and 20 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses were selected on the basis of acute oral LD50 study. The oral LD50 value in rats was in excess of 5000 mg/Kg bw/day and no signs of toxicity were noted and hence the dose was subacute study was selected to be 1000 mg/Kg bw/day
- Rationale for animal assignment (if not random): No data
- Rationale for selecting satellite groups: After termination of treatment 10 females and 10 males of each group were given a 2-week recovery period, if effects had been observed or suspected in the main study.
- Post-exposure recovery period in satellite groups: 2 weeks
- Section schedule rationale (if not random): No data - Positive control:
- No data
- 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: Every day
BODY WEIGHT: Yes
- Time schedule for examinations: Every day
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: Yes
- 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: At the end of treatment and recovery period
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: Control and test group animals
- Parameters checked in table [No.?] were examined. Hematocrit, hemoglobin, erythrocytes count, total and differential leucocyte counts, median cell volume, median
cell hemoglobin, platelet count and prothrombin time.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At the end of treatment and recovery period
- Animals fasted: No data
- How many animals: Control and test group animals
- Parameters checked in table [No.?] were examined. Serum alkaline phosphatase (SAP), serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT).
URINALYSIS: Yes
- Time schedule for collection of urine: At the end of treatment and recovery period
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. Volume, color, pH, specific gravity, bilirubin, quantitative glucose, quantitative protein, urobilinogen, and urea as well as analysis of the sediment.
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, At the end of the treatment period or after the recovery period, each rat was examined externally and by dissection for macroscopic abnormalities. Each rat was autopsied and selected organs, including liver, kidneys, adrenals, and spleen were weighed to determine the organ weight.
HISTOPATHOLOGY: Yes, At the end of the treatment period or after the recovery period selected organs, including liver, kidneys, adrenals, and spleen were submitted for histopathological examination. - Other examinations:
- No data
- Statistics:
- Statistical analyses were performed. Organ weights (liver, kidneys, adrenals) were subject to analysis of variance and analysis of covariance on final body weight
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality: No clinical signs of toxicity and mortality were observed.
Feces were found to be blue in colour
Body weight and weight gain: The body weight gain observed in test animals was in the normal range as compared to controls following treatment
Food consumption and compound intake: The food consumption in test animals was in the normal range as compared to controls following treatment
Food efficiency: No data
Water consumption and compound intake: No data
Opthalmoscopic examination: No data
Haematology: Any hematological effects observed were in the normal range as compared to controls
Clinical chemistry: The clinical examinations of liver function revealed no signs of toxicity following treatment and recovery and were in the normal range
Urinanalysis Urinanalysis effects were found to be in the normal range. Urine was found to be green-blue in colour. Urinalysis of test and control animals and all bilirubin and urobilinogen tests were negative.
Neurobehaviour: No data
Organ weights: Increased kidney weights was noted but were normal after the 2-week recovery. This effect may relate to the morphological changes of the tubules of the kidneys, which were seen at the end of the treatment period, but not after the recovery period.
Gross pathology: Kidneys and intestine showed blue colouration
Histopathology: Microscopic examination revealed normal changes observed if any. Other histopathological examinations of selected tissues showed no significant effects related to the treatment with these compounds. - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant alterations were noted at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for Direct blue 86 in male and female rats is 1000 mg/Kg bw/day.
- Executive summary:
Repeated dose subacute toxicity study was performed to determine the toxic nature of Direct blue 86 (EC name: Disulfo copper phthalocyanine amine salt). The chemical was administered by oral gavage route at dose levels of 0 or 1000 mg/Kg bw/day to 20 male and 20 females rats in a standard volume of 10 mL/kg. The treatment period was followed by a 15 day recovery period. 22 daily doses were given over a period of 30 days i.e 5 times/week, 1 dose/day for 4 weeks plus Monday and Tuesday of the last week. The doses were selectedwere selected on the basis of acute oral LD50 study. The oral LD50 value in rats was in excess of 5000 mg/Kg bw/day and no signs of toxicity were noted and hence the dose was subacute study was selected to be 1000 mg/Kg bw/day. Each day, clinical signs and body weights were recorded. Food intake was determined on a weekly basis. At the end of the treatment and the recovery period, hematology, blood chemistry, and urinalysis measurements were carried out by standard methods on animals from control and test groups. At the end of the treatment period or after the recovery period, each rat was examined externally and by dissection for macroscopic abnormalities. Each rat was autopsied and selected organs, including liver, kidneys, adrenals, and spleen were submitted for histopathological examination, following determination of the organ weights. Other organ tissues were fixed in formalin and are held for reference in the archives. Appropriate statistical analyses were performed on the different measurements. No mortality or signs of toxicity were observed during the study period and food and water consumption were within the normal range following treatment with the eight selected colorants. There was evidence of absorption, based on the coloration of urine and/or tissues following treatment with Direct Blue 86. Comparison of the urinalysis of test and control animals, and all bilirubin and urobilinogen tests were negative. The clinical examinations of liver function revealed no signs of toxicity following treatment and recovery. No overall effects were observed on the hematological profiles of the test animals compared with the controls. The statistical analyses did not reveal evidence for any treatment-related effects on liver or adrenals weights. The kidney weights were increased at termination of treatment with Direct Blue 86, and Direct Blue 15, but were normal after the 2-week recovery. This effect may relate to the morphological changes of the tubules of the kidneys, which were seen at the end of the treatment period, but not after the recovery period. Other histopathological examinations of selected tissues showed no significant effects related to the treatment.
The No Observed Adverse Effect Level (NOAEL) for Direct blue 86 in male and female rats is 1000 mg/Kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is from K2 reliable publication
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Peer reviewed publication was reviewed to determine the toxic nature of Disulfo copper phthalocyanine amine salt. The study was performed on rats for a duration of 30 days. The details of the study are mentioned as below:
Leist ( Ecotoxicology And Environmental Safety, 1982) performed repeated dose subacute toxicity study to determine the toxic nature of Direct blue 86. The chemical was administered by oral gavage route at dose levels of 0 or 1000 mg/Kg bw/day to 20 male and 20 females rats in a standard volume of 10 mL/kg. The treatment period was followed by a 15 day recovery period. 22 daily doses were given over a period of 30 days i.e 5 times/week, 1 dose/day for 4 weeks plus Monday and Tuesday of the last week. The doses were selectedwere selected on the basis of acute oral LD50 study. The oral LD50 value in rats was in excess of 5000 mg/Kg bw/day and no signs of toxicity were noted and hence the dose was subacute study was selected to be 1000 mg/Kg bw/day. Each day, clinical signs and body weights were recorded. Food intake was determined on a weekly basis. At the end of the treatment and the recovery period, hematology, blood chemistry, and urinalysis measurements were carried out by standard methods on animals from control and test groups. At the end of the treatment period or after the recovery period, each rat was examined externally and by dissection for macroscopic abnormalities. Each rat was autopsied and selected organs, including liver, kidneys, adrenals, and spleen were submitted for histopathological examination, following determination of the organ weights. Other organ tissues were fixed in formalin and are held for reference in the archives. Appropriate statistical analyses were performed on the different measurements. No mortality or signs of toxicity were observed during the study period and food and water consumption were within the normal range following treatment with the eight selected colorants. There was evidence of absorption, based on the coloration of urine and/or tissues following treatment with Direct Blue 86. Comparison of the urinalysis of test and control animals, and all bilirubin and urobilinogen tests were negative. The clinical examinations of liver function revealed no signs of toxicity following treatment and recovery. No overall effects were observed on the hematological profiles of the test animals compared with the controls. The statistical analyses did not reveal evidence for any treatment-related effects on liver or adrenals weights. The kidney weights were increased at termination of treatment with Direct Blue 86, and Direct Blue 15, but were normal after the 2-week recovery. This effect may relate to the morphological changes of the tubules of the kidneys, which were seen at the end of the treatment period, but not after the recovery period. Other histopathological examinations of selected tissues showed no significant effects related to the treatment.
The No Observed Adverse Effect Level (NOAEL) for Direct blue 86 in male and female rats is 1000 mg/Kg bw/day.
Based on the key study summarized, Disulfo copper phthalocyanine amine salt is not likely to be toxic upon repeated exposure by oral route.
Justification for classification or non-classification
Based on the key study summarized, Disulfo copper phthalocyanine amine salt (CAS no 1328 -51 -4) is not likely to be toxic upon repeated exposure by oral route.
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