Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- The micronucleus test was employed to investigate Pigment Yellow Fe 26290 in male and female mice for a possible clastogenic effect on the chromosomes of bone-marrow erythroblasts.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- content: 83.9% (free acid), 7% H20, 6.3% Ca, 0.2% Na
Test animals
- Species:
- mouse
- Strain:
- other: Bor: NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- The femoral marrow of groups treated with Pigment Yellow FC 26290 was prepared 16, 24 and 48 hours after administration
- Frequency of treatment:
- single application
- Post exposure period:
- SACRIFICE TIME
1) 0 mg/kg - 24 h; 600 mg/kg - 16 h; 600 mg/kg - 24 h; 600 mg/kg - 48 h
2) 0 mg/kg - 24 h; 300 mg/kg - 24 h; 500 mg/kg - 24 h; 700 mg/kg - 24 h
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
T 9041202: 600 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
T 2041331: 300, 500 and 700 mg/kg body weight
Basis:
- No. of animals per sex per dose:
- Each group comprised ten mice, five males and five females
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- bone-marrow erythroblasts
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
All animals treated with Pigment Yellow FC 26290 showed symptoms of toxicity after administration. All animals treated with doses up to and including 600 mg/kg survived until the end of the test. However, two of twenty animals died before the end of the second test due to the acute intraperitoneal toxicity of 700 mg/kg Pigment Yellow FC 26290. Both experiments showed an altered ratio between polychromatic and normochromatic erythrocytes.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
The micronucleus test was employed to investigate Pigment Yellow FC 26290 in male and female mice for a possible clastogenic effect on the chromosomes of bone-marrow erythroblasts. The known clastogen and cytostatic agent, cyclophosphamide, served as positive control.
Two experiments were performed. The animals of the first experiment received a single intraperitoneal administration of either Pigment Yellow FC 26290 or cyclophosphamide. The femoral marrow of groups treated with Pigment Yellow FC 26290 was prepared 16, 24 and 48 hours after administration. All negative and positive control animals were sacrificed after 24 hours. The doses of Pigment Yellow FC 26290 and the positive control, cyclophosphamide, were 600 and 20 mg/kg body weight, respectively. The animals of the second experiment received also a single intraperitoneal administration of either Pigment Yellow FC 26290 or
cyclophosphamide. The femoral marrow of all groups was prepared 24 hours after administration. The doses of Pigment Yellow FC 26290 were 300, 500 and 700 mg/kg body weight, respectively. other conditions remained unchanged.
All animals treated with Pigment Yellow Fe 26290 showed symptoms of toxicity after administration. All animals treated with doses up to and including 600 mg/kg survived until the end of the test. However, two of twenty animals died before the end of the second test due to the acute intraperitoneal toxicity of 700 mg/kg Pigment Yellow FC 26290.
Both experiments showed an altered ratio between polychromatic and normochromatic erythrocytes.
The combined results of both experiments gave no relevant indications of a clastogenic effect of Pigment Yellow FC 26290 after a single intraperitoneal treatment with doses up to and including 700 mg/kg body weight.
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.