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Diss Factsheets
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EC number: 939-379-0 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Principles of method if other than guideline:
- Gelbpigment E4GN was administered orally by gavage to 5 male and 5 female Wistar (HsdRCCHan:Wist) rats per dose group using ethanol/ Kolliphor HS15/ tap water (10%/ 40%/ 50%; v/v/v) as vehicle, in daily doses of 0, 100, 300, 1000 mg/kg b.w. for a period of 4 weeks. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical laboratory investigation of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Gelbpigment E4GN
- IUPAC Name:
- Gelbpigment E4GN
- Details on test material:
- Test Item: Gelbpigment E4GN
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: ethanol/ Kolliphor HS15/ tap water (10%/ 40%/ 50%; v/v/v)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 100, 300, 1000 mg/kg b.w. Basis:other: nominal
- No. of animals per sex per dose:
- 5 male and 5 female rats/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 1000 mg/kg bw was the highest applied dose
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Survival was not affected by the treatment with the test substance.
At clinical observations the only treatment-related finding was that the color of feces was changed (yellowish) in cages of treatment groups. It seems to be obvious that this finding is caused by the color of Gelbpigment E4GN.
At histopathology some yellowish material was seen in the lumen of the large intestine (cecum, colon, rectum) of almost all rats treated with 1000 mg/kg and, additionally, in the rat of the 300 mg/kg group, which died during blood sampling. However, in all cases no such material was detected intracellularly or related to any other lesion seen in the affected organs. Therefore, this is assessed to be a sign of exposure and not as adverse.
Body weight development of males and females was not retarded by the treatment up to 1000 mg/kg. Mean food and water intake in treated groups was not relevantly changed.
Neither hematology nor clinical chemistry gave evidence for toxicologically relevant treatment-related effects up to 1000 mg/kg.
Applicant's summary and conclusion
- Executive summary:
Gelbpigment E4GN was administered orally by gavage to 5 male and 5 female Wistar (HsdRCCHan:Wist) rats per dose group using ethanol/ Kolliphor HS15/ tap water (10%/ 40%/ 50%; v/v/v) as vehicle, in daily doses of 0, 100, 300, 1000 mg/kg b.w. for a period of 4 weeks.
Survival was not affected by the treatment with the test substance.
At clinical observations the only treatment-related finding was that the color of feces was changed (yellowish) in cages of treatment groups. It seems to be obvious that this finding is caused by the color of Gelbpigment E4GN.
At histopathology some yellowish material was seen in the lumen of the large intestine (cecum, colon, rectum) of almost all rats treated with 1000 mg/kg and, additionally, in the rat of the 300 mg/kg group, which died during blood sampling. However, in all cases no such material was detected intracellularly or related to any other lesion seen in the affected organs. Therefore, this is assessed to be a sign of exposure and not as adverse.
Body weight development of males and females was not retarded by the treatment up to 1000 mg/kg. Mean food and water intake in treated groups was not relevantly changed.
Neither hematology nor clinical chemistry gave evidence for toxicologically relevant treatment-related effects up to 1000 mg/kg.
Under the conditions described the no observed-adverse-effect level (NOAEL) for repeated oral administration of Gelbpigment E4GN to male and female Wistar rats was >1000 mg/kg b.w.
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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