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Diss Factsheets
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EC number: 411-080-5 | CAS number: -
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Five male and female rats each received Pigment Yellow FC 26290 in daily dosages of 0 (vehicle control), 40, 200 and 1000 mg/kg body weight for 28 days. In addition, 5 male and female rats per group were treated with physiological saline solution (vehicle) or 1000 mg/kg and observed for another 2 weeks
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- content: 83.9% (free acid)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- The test compound was administered by gavage once a day, 7 days per week, 28 times in total
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 200, 1000 mg/kg bw/d
Basis:
- No. of animals per sex per dose:
- 5 males and 5 females/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Appearance and general behaviour were not influeneed by treatment up to and including 1000 mg/kg. The general condition was
temporarily reduced in some animals of the dose group 1000 mg/kg. Growth, mortality, feed and water intake were not affected by
treatment.
Hematological and histopathological investigations gave no indication of toxicologically relevant damage to blood or hematopoietic organs up to and including 1000 mg/kg. Neither clinico-chemical nor gross pathological or histopathological investigations produced any evidence of treatment-related metabolic or organ damage.
Applicant's summary and conclusion
- Executive summary:
Five male and female rats each received Pigment Yellow FC 26290 in daily dosages of 0 (vehicle control), 40, 200 and 1000 mg/kg body weight for 28 days. In addition, 5 male and female rats per group were treated with physiological saline solution (vehicle) or 1000 mg/kg and observed for another 2 weeks.
The animals were regularly observed, weighed, and their feed and water intakes were determined. In week 4 and 6 (recovery groups) urine and blood samples were collected and various parameters determined. At necropsies organs were weighed and gross pathological investigations performed. A number of organs and tissues were processed histopathologically.
Appearance and general behaviour were not influeneed by treatment up to and including 1000 mg/kg. The general condition was
temporarily reduced in some animals of the dose group 1000 mg/kg. Growth, mortality, feed and water intake were not affected by
treatment.
Hematological and histopathological investigations gave no indication of toxicologically relevant damage to blood or hematopoietic organs up to and including 1000 mg/kg. Neither clinico-chemical nor gross pathological or histopathological investigations produced any evidence of treatment-related metabolic or organ damage.
Under the conditions described the NOAEL for Pigment Yellow FC 26290 is 1000 mg/kg bw/day.
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.
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