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Diss Factsheets
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EC number: 402-400-4 | CAS number: 54660-00-3
- 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)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: evaluation
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Materials and methods
- Objective of study:
- toxicokinetics
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
- Executive summary:
Detailed literature search about toxicokinetic behaviour of the substance Versalovy sarlatDPEK (C.I. Pigment Red 255) was performed. Because no relevant toxicokinetic references were found, about behaviour of the test substance in organism of experimental animals was presumed only from results of toxicological testing, which was performed previously.
The slight systemic effect without mortality was described aftersingle oral administrationof the substance Versalovysarlat DPEKto rats. It is not possible to rule out absorption of the test substance from digestive tract after single administration of the test substance in dose level 5000 mg/kg.
The mutagenic influence on erythrocyte was not documented after single exposure of the dose level 5000 mg/kg.
Aftersingle applicationof test substance to theskinof rats or rabbits, systemic toxic effects were not detected - the substance obviously does not penetrate through the skin after acute exposure. No irritation potential was found out after application on skin of animals.
The test substance is not a skin sensitizer.
Aftersingle applicationof the substance to conjunctival sac of the rabbit eye no changes were recorded — the substance is not irritating to the eye. Systemic toxic effects were not described - the test substance does not penetrate to the body after acuteeye exposure.
Based on results ofrepeated administrationof the test substance -28-day studyin rats, it could be deduced that the test substance is not absorbed from gastrointestinal tract and had not toxic effect.
Results ofReproduction/Developmental studyin rats revealed that the test substance Versalovy sarlat DPEK had influence on parental males - decreased weight of prostate gland and changed motility of sperms without effect on fertility of males.
There was no evidence that the substance could get through placenta and affect the embryo or fetus. Development of pups was unaffected.
Absorption
Absorption of Versalovy sarlat DPEK from the digestive system and its distribution throughout the body of experimental rats after exposition of the test substance at the dose 100 mg/kg/day was not noted. Some absorption should be presumed at the dose of 160 - 1000 mg/kg at least in males because non adverse changes were detected in Reproduction/ Developmental Toxicity Screening test.
There was no evidence that the substance could get through placenta and affect the embryo or fetus.
Excretion
Unabsorbed substance is excreted via faeces what is evidenced by red colouring of faeces. There is no information about the fate of potentially absorbed part of the substance.
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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