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Diss Factsheets
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EC number: 270-096-9 | CAS number: 68411-04-1
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Statement on Toxicokinetics
- Type of information:
- other: Statement on Toxicokinetics
- Adequacy of study:
- supporting study
- Study period:
- 2013
- Reliability:
- 2 (reliable with restrictions)
- Objective of study:
- other: Assumption on toxicokinetic following the procedure indicated in the “Guidance on information requirements and chemical safety assessment chapter R.7c” of the ECHA guidance document (version 1.1, November 2012).
- Principles of method if other than guideline:
- Assumption on toxicokinetic following the procedure indicated in the ECHA guidance R.7c (version 1.1, November 2012).
- GLP compliance:
- no
- Details on absorption:
- Absorption is anticipated to be negligible / very low by oral, dermal and inhalation routes based on the physic-chemical properties: high molecular weight (740.31 < MW < 1232.98), low log Pow (calculated <-0.2) and slow solubility in water in an OECD TG 105 study with the saturation equilibrium not reached at 34 days.
Low absorption is confirmed by a 14 day oral gavage pilot study specifically designed to investigate potential compound uptake, distribution and excretion based on the intensive blue color of the compound. - Details on distribution in tissues:
- Based on the low log Pow (<-0.2, calculated) and the slow solubility in water it is not likely that C.I. Direct Blue 264 distributes into cells. This assumption is supported by the 14 day pilot toxicity study in which no adverse effects were observed at the limit dose 1000 mg/kg bw/day. As indicated above blue color was seen only in the intestinal tract No other organ was colored blue. Furthermore, photometry of urinary samples gave no evidence that the test substance was excreted with the urine.
Based on the photometric urine analysis and the necropsy findings in this 14 day pilot study specifically designed to investigate potential compound uptake, distribution and excretion, no systemic absorption was observed. - Details on excretion:
- Based on the low absorption potential of C.I. Direct Blue 264 excretion is anticipated mainly, if not exclusively, via the feces. This is supported by the 14 day pilot toxicity study. The only finding at clinical examinations was changed feces color, which was observed for all treated animals and is assumed to be due to the color of the test substance. Photometry of urinary samples gave no evidence that the test substance was excreted via urine.
- Details on metabolites:
- In vitro genotoxicity data do not indicate any genotoxic metabolites. C.I. Direct Blue 264 is not genotoxic in absence or presence of S9 extracts [Ames test, in-vitro micronucleus test and gene mutation assay in mammalian cells (HPRT)].
- Executive summary:
Absorption of C.I. Direct Blue 264 is assumed to be low via oral, dermal and inhalation routs based on physicochemical properties. This assumption is confirmed by a 14 day oral gavage pilot study specifically designed to investigate potential compound uptake, distribution and excretion based on the intensive blue color of the compound.
In this study no adverse effects were observed at the limit dose 1000 mg/kg bw/day.
Compound related blue color was seen only in the intestinal tract. No other organ was colored blue. Furthermore, photometry of urinary samples gave no evidence that the test substance was excreted with the urine.
Based on the photometric urine analysis and the necropsy findings in this 14 day pilot study systemic absorption of C.I. Direct Blue 264 is unlikely.
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 14 day pilot study specifically designed to investigate potential compound uptake, distribution and excretion based on the intensive blue color of C.I. Direct Blue 264.
- Objective of study:
- other: 14 day pilot study specifically designed to investigate potential compound uptake, distribution and excretion based on the intensive blue color of the compound.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 14 day oral gavage pilot study. The aim of the study was to investigate if there is evidence that C.I. Direct Blue 264 is absorbed after oral dosing and to investigate potential toxicity after repeated oral dosing.
- GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: Cremophor El (2% in tapwater; v/v)
- Duration and frequency of treatment / exposure:
- 14 days; once per day
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day - No. of animals per sex per dose / concentration:
- 3 males and 3 females
- Control animals:
- yes, concurrent vehicle
- Details on absorption:
- There were no toxicologically significant effects on survival, clinical examinations, body weight, food intake and water intake. The only finding at clinical examinations was blue feces color, which was observed for all treated animals and is due to the color of the test substance. Findings clearly related to the oral administration of the test compound were noticed at necropsy only in the intestinal tract in males starting at 100 mg/kg bw/day and in females starting at 500 mg/kg bw/day. Changes in content, blue, was observed in small intestine, cecum and large intestine. No other organ was colored.
- Details on distribution in tissues:
- Findings clearly related to the oral administration of the test compound were noticed at necropsy only in the intestinal tract in males starting at 100 mg/kg bw/day and in females starting at 500 mg/kg bw/day. Changes in content, blue, was observed in small intestine, cecum and large intestine. No other organ was colored.
Single males of this study displayed pale discoloration of the kidney. These observations are not necessarily indicative for a systemic effect on the kidneys induced by a test compound because they could have developed perimortally as a consequence of interindividual differences in the grade/status of exsanguination. Occasionally these gross observations do not have any histopathologic correlate at all or may show an equivocal histopathologic finding of the kidneys. - Details on excretion:
- To investigate potential uptake and excretion of the compound the color of the urine was investigated photometrically in this study. Urine has be collected during a period of about 16 hours at room temperature from all animals of the control and high dose groups near the end of the study. The color of the urine did not differ between these groups. Furthermore, photometry of urinary samples gave no evidence that the test substance was excreted with the urine.
- Metabolites identified:
- no
- Executive summary:
A 14 day oral gavage pilot study was performed to investigate potential compound uptake, distribution and excretion based on the intensive blue color of C.I. Direct Blue 264.
In this study no adverse effects were observed at the limit dose 1000 mg/kg bw/day.
Compound related blue color was seen only in the intestinal tract.No other organ was colored blue. Furthermore, photometry of urinary samples gave no evidence that the test substance was excreted with the urine.
Based on the photometric urine analysis and the necropsy findings in this 14 day pilot study systemic absorption of C.I. Direct Blue 264 is unlikely.
Referenceopen allclose all
There were no toxicologically significant effects on survival, clinical examinations, body weight, food intake and water intake. The only finding at clinical examinations was blue feces color, which was observed for all treated animals and is due to the color of the test substance. Findings clearly related to the oral administration of the test compound were noticed at necropsy only in the intestinal tract in males starting at 100 mg/kg bw/day and in females starting at 500 mg/kg bw/day. Changes in content, blue, was observed in small intestine, cecum and large intestine. No other organ was colored. Single males of this study displayed pale discoloration of the kidney. These observations are not necessarily indicative for a systemic effect on the kidneys induced by a test compound because they could have developed perimortally as a consequence of interindividual differences in the grade/status of exsanguination. Occasionally these gross observations do not have any histopathologic correlate at all or may show an equivocal histopathologic finding of the kidneys. To investigate potential uptake and excretion of the compound the color of the urine was investigated photometrically in this study. Urine has be collected during a period of about 16 hours at room temperature from all animals of the control and high dose groups near the end of the study. The color of the urine did not differ between these groups. Furthermore, photometry of urinary samples gave no evidence that the test substance was excreted with the urine.
Based on the photometric urine analysis and the necropsy findings in this 14 day pilot study specifically designed to investigate potential compound uptake, distribution and excretion, no systemic absorption was observed.
Description of key information
Absorption is anticipated to be negligible / very low by oral, dermal and inhalation routes based on the physic-chemical properties: high molecular weight (740.31 < MW < 1232.98), low log Pow (calculated <-0.2) and slow solubility in water in an OECD TG 105 study with the saturation equilibrium not reached at 34 days.
Low absorption is confirmed by a 14-day oral gavage pilot study specifically designed to investigate potential compound uptake, distribution and excretion based on the intensive blue color of the compound.
Based on the low log Pow (<-0.2, calculated) and the slow solubility in water it is not likely that C.I. Direct Blue 264 distributes into cells. This assumption is supported by the 14-day pilot toxicity study in which no adverse effects were observed at the limit dose 1000 mg/kg bw/day. As indicated above blue color was seen only in the intestinal tract No other organ was colored blue. Furthermore, photometry of urinary samples gave no evidence that the test substance was excreted with the urine.
Based on the photometric urine analysis and the necropsy findings in this 14-day pilot study specifically designed to investigate potential compound uptake, distribution and excretion, no systemic absorption was observed.
Based on the low absorption potential of C.I. Direct Blue 264 excretion is anticipated mainly, if not exclusively, via the feces. This is supported by the 14-day pilot toxicity study. The only finding at clinical examinations was changed feces color, which was observed for all treated animals and is assumed to be due to the color of the test substance. Photometry of urinary samples gave no evidence that the test substance was excreted via urine.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
Potential absorption and bioavailability:
Study results on C.I. Direct Blue 264:
No adverse effects were reported in a non-guideline pilot study where the C.I. Direct Blue 264 was administered orally by gavage to 3 male and 3 female rats per group, in daily doses of 0, 100, 500 or 1000 mg/kg bw/day for 14 days. There were no toxicologically significant effects on survival, clinical examinations, body weight, food intake and water intake. The only finding at clinical examinations was blue feces color, which was observed for all treated animals and is due to the color of the test substance. Findings clearly related to the oral administration of the test compound were noticed at necropsy only in the intestinal tract in males starting at 100 mg/kg bw/day and in females starting at 500 mg/kg bw/day. Changes in content, blue, was observed in small intestine, cecum and large intestine. No other organ was colored. Single males of this study displayed pale discoloration of the kidney. These observations are not necessarily indicative for a systemic effect on the kidneys induced by a test compound because they could have developed perimortally as a consequence of interindividual differences in the grade/status of exsanguination. Occasionally these gross observations do not have any histopathologic correlate at all or may show an equivocal histopathologic finding of the kidneys. To investigate potential uptake and excretion of the compound the color of the urine was investigated photometrically in this study. Urine has be collected during a period of about 16 hours at room temperature from all animals of the control and high dose groups near the end of the study. The color of the urine did not differ between these groups. Furthermore, photometry of urinary samples gave no evidence that the test substance was excreted with the urine. Based on the photometric urine analysis and the necropsy findings in this 14 day pilot study specifically designed to investigate potential compound uptake, distribution and excretion, no systemic absorption was observed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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