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EC number: 237-875-5 | CAS number: 14038-43-8
- 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 toxicity: Oral
Repeated dose oral toxicity study was performed to determine the toxic nature of Prussian blue. The test chemical was mixed with feed and was tested at dose levels of 0 or 500 mg/Kg/day for 120 days. The test chemical was given by the oral (feed) route of exposure. During the study period, Berlin blue caused a slight increase in the weight gain of treated rats but it did not show any statistical significance (P: 0.2). Based on these considerations, the No observed adverse effect level (NOAEL) for Berlin blue is considered to be 500 mg/Kg/day.
Repeated dose toxicity: Inhalation
The melting point C.I.Pigment Blue 27 is >300 C. This suggests that Prussian violet insoluble decomposes between 210°C -360 °C without melting and does not exhibit very high vapour pressure. Inhalation is therefore not the likely route of exposure and hence this end point for repeated dose toxicity be inhalation route is considered for waiver.
Repeated dose toxicity: Dermal
The Prussian blue insoluble (14038-43-8) has high molecular weight i.e 877.381 g/mol. This suggests that Prussian violet insoluble has no potential for significant rate of absorption through the skin and hence this end point for repeated dose toxicity dermal is considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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:
- 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:
- Subchronic toxicity study was performed to determine the toxic nature of Berlin Blue
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material: Prussian Blue
- Molecular formula: C6FeN6.4/3Fe
- Molecular weight: 877.3812 g/mol
- Substance type: Inorganic
- Physical state: No data
- Impurities (identity and concentrations): No data - Species:
- rat
- Strain:
- other: Albino (Heiligenberg strain)
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- not specified
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed to give dose level of 0 or 1% (500 mg/kg/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: 0 or 500 mg/Kg/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required):
- 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:
- 120 days
- Frequency of treatment:
- Twice daily
- Remarks:
- 0 or 500 mg/Kg/day
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Yes, the animals were observed for toxic side effects
- Time schedule: No data
BODY WEIGHT: Yes, body weight changes were noted
- Time schedule for examinations: During the study period
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- 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: No data
- 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: No data
- 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: No data
- 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:
- No data
- Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment related toxic side effects were noted
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- A slight increase in the weight gain of treated rats was noted but it did not show any statistical significance (P: 0.2) and hence there was no impairment of growth
- 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:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- No data
- Dose descriptor:
- NOAEL
- Effect level:
- 500 other: mg/Kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No statistically significant increase in the weight gain of growing rats was noted
- Critical effects observed:
- not specified
- Conclusions:
- The No observed adverse effect level (NOAEL) for Berlin blue is considered to be 500 mg/Kg/day.
- Executive summary:
Repeated dose oral toxicity study was performed to determine the toxic nature of Prussian blue. The test chemical was mixed with feed and was tested at dose levels of 0 or 500 mg/Kg/day for 120 days. The test chemical was given by the oral (feed) route of exposure. During the study period, Berlin blue caused a slight increase in the weight gain of treated rats but it did not show any statistical significance (P: 0.2). Based on these considerations, the No observed adverse effect level (NOAEL) for Berlin blue is considered to be 500 mg/Kg/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed publication
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
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
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data available for the target chemical has been reviewed to determine the toxic nature of Prussian blue (insoluble) (C.I.Pigment Blue 27) upon repeated exposure by oral, dermal or inhalation route of exposure. The summary is as mentioned below:
Repeated dose toxicity: Oral
Repeated dose oral toxicity study was performed by V. Pearce (Food anc chemical toxicology, 1994) and Bohne et al (Strahlentherapie, 1966) to determine the toxic nature of Prussian blue (CAS no 14038 -43 -8; IUPAC name: C.I.Pigment Blue 27). The test chemical was mixed with feed and was tested at dose levels of 0 or 500 mg/Kg/day for 120 days. The test chemical was given by the oral (feed) route of exposure. During the study period, Berlin blue caused a slight increase in the weight gain of treated rats but it did not show any statistical significance (P: 0.2). Based on these considerations, the No observed adverse effect level (NOAEL) for Berlin blue is considered to be 500 mg/Kg/day.
In another study mentioned by V. Pearce (Food and chemical toxicology, 1994) and Nigrovic (Physics in medicine and biology, 1965), Repeated dose oral toxicity study was performed to determine the toxic nature of Prussian blue (CAS no 14038 -43 -8; IUPAC name: C.I.Pigment Blue 27). The test chemical was tested at dose levels of 0 or 100 mg/Kg/day for 11 days. The test chemical was given by gastric tube to group of 6-10 Albino rats for 11 days. During the study period, Prussian blue did not affect the body weight of the animals and no treatment related toxic side effects were noted. Based on the observations made, the No observed adverse effect level (NOAEL) for Prussian blue is considered to be 100 mg/Kg/day.
Repeated dose toxicity: Inhalation
The melting point C.I.Pigment Blue 27 is >300 C. This suggests that Prussian violet insoluble (C.I.Pigment Blue 27) decomposes between 210°C -360 °C without melting and does not exhibit very high vapour pressure. Inhalation is therefore not the likely route of exposure and hence this end point for repeated dose toxicity be inhalation route is considered for waiver.
Repeated dose toxicity: Dermal
The Prussian blue insoluble (CAS no.: 14038-43-8; IUPAC name: C.I.Pigment Blue 27) has high molecular weight i.e 877.381 g/mol. This suggests that Prussian violet insoluble has no potential for significant rate of absorption through the skin and hence this end point for repeated dose toxicity dermal is considered for waiver.
Based on the data available for the target chemical and its read across, Prussian blue (insoluble) (C.I.Pigment Blue 27) is not likely to be toxic upon repeated exposure by oral, dermal and inhalation route as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the target chemical and its read across, Prussian blue (insoluble) (CAS no 14038 -43 -8) is not likely to be toxic upon repeated exposure by oral, dermal and inhalation route as per the criteria mentioned in CLP regulation.
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