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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 281-866-9 | CAS number: 84045-65-8
- 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)
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Assessment on the basis of physicochemical properties and available toxicological data, as recommended by ECHA Guidance R7.c
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- toxicokinetics
- Principles of method if other than guideline:
- Assessment on the basis of physicochemical properties and available toxicological data, as recommended by ECHA Guidance R7.c
- GLP compliance:
- no
- Conclusions:
- REACTIVE RED 218 would be absorbed primarily in gastrointestinal tract, while limited absorption via dermal and inhalation exposure can be expected. Systemic distribution would most likely occur via the serum, while metabolism would be limited and not required to facilitate renal excretion.
- Executive summary:
REACTIVE RED 218 would be absorbed primarily in gastrointestinal tract, while limited absorption via dermal and inhalation exposure can be expected. Systemic distribution would most likely occur via the serum, while metabolism would be limited and not required to facilitate renal excretion.
Reference
Absorption
Oral/gastrointestinal absorption:
Oral/gastrointestinal absorption:
Based on the molecular weight of 852.16 g/mol for REACTIVE RED 218, it can be assumed to have moderate oral absorption. However with the high water solubility of 296 g/L, REACTIVE RED 218may readily dissolve into the gastrointestinal fluids and be absorbed via passive diffusion.
In two acute oral toxicity studies with REACTIVE RED 286, several mortalities and clinical signs were seen, which indicates absorption taking place from the gastrointestinal tract.
In the 28-days repeated dose toxicity study with the structurally similar substance REACTIVE RED 286,red stained feces were noted in males and females at all dose levels (100, 300 and 1000 mg/kg bw/day). Red discoloration was also detected macroscopically in multiple organs, like kidneys, mesenteric lymphnodes and stomach.
In the micronucleus assay withstructurally similar substance REACTIVE RED 286, the animals showed discoloured urine after treatment with 2000 mg/kg b.w. indicating the bioavailability of the substance.
These findings were again indicative of absorption taking place from the gastrointestinal tract.Hence, on the basis of hydrophilic nature and the findings of the toxicological studies as discussed above, REACTIVE RED 218 is expected to be absorbed by the gastrointestinal tract when administered orally.
Dermal absorption:
Based on the molecular weight of 852.16g/mol for REACTIVE RED 218, poor dermal absorption is expected. With high solubility in water (296 g/L) and low partition coefficient (-3.06), dermal uptake is expected to be low as REACTIVE RED 218can be considered to be too hydrophilic to cross the lipid rich environment of thestratum corneum. The surface tension of 66.3 mN/m for REACTIVE RED 218 also suggests a low dermal uptake from skin surfaces.
REACTIVE RED 218 is neither corrosive nor irritating to the skin as well as eyes, while, it was not sensitising to the skin. Hence, the experimental data also suggests a low dermal uptake.However, the findings from the acute oral toxicity with REACTIVE RED 218 and repeated dose oral toxicity study with REACTIVE RED 286, indicates the potential for absorption following ingestion and it is therefore possible that the substance will also be absorbed if it is exposed dermally. Nonetheless, absorption will be limited and only substantial at higher dosage and the test substance will be quickly excreted owing to the high water solubility.
Respiratory absorption:
REACTIVE RED 218 is expected to have low volatility based on the low vapour pressure (<2.4 x 10-5Pa at 25 °C), and hence may not be available for inhalation as a vapour. Further, the high water solubility (296 g/L), indicates if vapours are produced will be trapped in the mucus. However, the effects observed in the acute oral toxicity study with REACTIVE RED 218 as well as repeated dose oral toxicity study with the structurally similar substance REACTIVE RED 286, along with the median aerodynamic diameter of24.68 µm, indicate the potential for absorption following ingestion and it is therefore possible that the substance will also be absorbed if it is inhaled. Nonetheless, absorption will be limited and only substantial at higher dosage and the test substance will be quickly excreted owing to the high water solubility.
Distribution
Systemic distribution due to the high water solubility would most likely occur via the serum. Owing to the high molecular size and hydrophilic nature of the substance (low n-octanol/water partition coefficient and high water solubility), access of REACTIVE RED 218to the central nervous system (CNS) or testes is likely to be restricted by the blood-brain and blood-testes barriers, whileaccumulation in body fat is unlikely to occur.
Metabolism
In the genetic toxicity studies including bacterial reverse mutation assays with REACTIVE RED 218, mammalian cell gene mutation assay with REACTIVE RED 286 and available toxicity studies, there was no evidence to indicate REACTIVE RED 218 or metabolite influenced hepatic metabolism. However, in a chromosomal aberration test with Chinese hamster lung fibroblasts (V79), the structurally similar substance REACTIVE RED 286, was found to be clastogenic in the absence of metabolic activation, while it was not clastogenic in the presence of metabolic activation. This indicates hepatic metabolism may lead to reduced toxicity, however, it should be taken into consideration that rat S9 fraction is not equivalent to the human metabolism.
Further the high water solubility of REACTIVE RED 218 suggests that metabolism would be limited and not required to facilitate renal excretion.
Excretion
Route of excretion for REACTIVE RED 218 has not been investigated. However owing to the hydrophilic nature of the substance, it will be expected to be predominantly excreted via urine, while any unabsorbed remaining fraction being excreted in the feces.
Description of key information
REACTIVE RED 218 would be absorbed primarily in gastrointestinal tract, while limited absorption via dermal and inhalation exposure can be expected. Systemic distribution would most likely occur via the serum, while metabolism would be limited and not required to facilitate renal excretion.
Key value for chemical safety assessment
Additional information
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)