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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 466-490-7 | 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Basic assessment based on phys.-chem. properties and available toxicological data
- Adequacy of study:
- weight of evidence
- Study period:
- 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Basic assessment based on physchem properties and available tox data
- GLP compliance:
- no
- Details on absorption:
- Oral/gastrointestinal absorption:
Based on the molecular weight of 1272.65 g/mol for Reactive Brown 051, it can be assumed to have low oral absorption. However, substances with such high molecular weights can get absorbed to some extent via pinocytosis and/or persorption. With high water solubility of >306 g/L, Reactive Brown 051 may readily dissolve into the gastrointestinal fluids and may get absorbed via passive diffusion, which may be limited by the rate at which the substance partitions out of the gastrointestinal fluid. No findings signifying absorption were reported in an acute oral toxicity study conducted in rats. In the 28-days repeated dose oral toxicity study, discolored faeces and urine were seen with animals treated at high dose group (1000 mg/kg bw/day). The urine discoloration was also reported in females treated at 200 mg/kg bw/day. Both the findings were reversible during the recovery period. In the reproductive and developmental toxicity screening test conducted using oral gavage, decreased fertility and conception indices, and decreased numbers of corpora lutea and implantation sites were the adverse effects observed at the high dose of 1000 mg/kg bw/day. At 300 mg/kg bw/day, the mean number of living pups at first litter check was decreased. These findings support the hypothesis that some absorption is to be expected via gastrointestinal tract. In an erythrocyte micronucleus test, red to orange discoloration of urine was seen with the treated animals. Hence, the systemic distribution and the bioavailability of the test substance could be confirmed. Thus, the high water solubility and the findings of the oral toxicity studies suggests that Reactive Brown 051 may get absorbed to an extent when administered via oral route at high doses.
Dermal absorption:
The molecular weight 1272.65 g/mol for Reactive Brown 051, indicates it being too large for dermal absorption. With high solubility in water (>306 g/L) and low partition coefficient (<-5.4), dermal uptake is expected to be low as Reactive Brown 051 is considered to be too hydrophilic to cross the lipid rich environment of the stratum corneum. The substance is not irritating to skin, and therefore an enhancement of dermal absorption can be ruled out. In support of this low dermal absorption hypothesis, the systemic toxicity of the test substance via the skin is low (acute dermal toxicity, LD50 value of >2000 mg/kg bw for rats). Taking into account the findings from oral dose toxicity studies as discussed under oral absorption section, Reactive Brown 051 can be expected to get absorbed to limited extent when administered via dermal route at sufficiently high doses.
Respiratory absorption:
No experimental data is available concerning the respiratory absorption of Reactive Brown 051. However, it has low vapour pressure (3.06E-37 Pa) and high melting point >250 °C, hence low volatility is to be expected, which implies that the substance may not be available for inhalation as dust/aerosol. The median particle size for Reactive Brown 051 was determined to be <5.5 µm, which indicates possibility of of Reactive Brown 051 reaching lower respiratory tract, when inhaled. However, the high water solubility (>306 g/L), indicates if dust is produced, it may get trapped in the mucus. Thus, Reactive Brown 051 can be expected to be cleared from the respiratory system if it gets inhaled. However, as seen with oral route, absorption via respiratory exposure may take place to a limited extent at sufficiently high doses. - Details on distribution in tissues:
- The systemic distribution due to 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 Brown 051 to the central nervous system (CNS) or testes is likely to be restricted by the blood-brain and blood-testes barriers, while accumulation in body fat is unlikely to occur. In an in vivo micronucleus test in mouse, urine of the animals treated with Reactive Brown 051 was discolored red to orange. Similar, urine discoloration was seen with the animals treated at 1000 mg/kg bw/day and females treated at 200 mg/kg bw/day in the 28 days repeated dose oral toxicity study. These findings indicate the systemic distribution of the test item and its bioavailability.
- Details on excretion:
- The route of excretion for Reactive Brown 051 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 faeces. The urine discoloration reported in the 28 days repeated dose oral toxicity study as well as the micronucleus assay supports the conclusion that excretion through urine will play major role in excretion of this hydrophilic substance. Excretion via faeces was confirmed in the 28-day repeated dose oral toxicity study , wherein, dark discoloration of the faeces was reported in animals at high dose group (1000 mg/kg bw/day), which might be the result of unabsorbed portion of Reactive Brown 051 being excreted through the faecal matter.
- Metabolites identified:
- no
- Details on metabolites:
- Currently no investigation regarding metabolism of Reactive Brown 051 is available. There was no evidence to indicate Reactive Brown 051 or metabolite influenced hepatic metabolism in the available genetic toxicity studies. Hence, the high-water solubility of Reactive Brown 051 along with absence of supporting findings for hepatic metabolism suggests that metabolism would be limited and mostly not required to facilitate renal excretion.
- Conclusions:
- Reactive Brown 051 would have some degree of absorption from gastrointestinal tract when administered via oral route at sufficiently high doses, while low absorption is expected on dermal and inhalation exposure. The systemic distribution would most likely occur via the serum, while metabolism is expected to occur but would be limited and not required to facilitate renal excretion.
Reference
Description of key information
Reactive Brown 051 would have some degree of absorption from gastrointestinal tract when administered via oral route at sufficiently high doses, while low absorption is expected on dermal and inhalation exposure. The systemic distribution would most likely occur via the serum, while metabolism is expected to occur but would be limited and not required to facilitate renal excretion.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 100
Additional information
In the absence of the experimental data though, the absorption rate for oral and inhalation routes is considered to be 100 % as a conservative estimate.Based on exposure model from ATG Textilien des Bundesinstituts fur Risikobewertung (BfR), the dermal penetration rate for dyes through the skin was found to be less than 2 %. Taking this information into account, 10 % absorption rate was taken as a worst case for the oral to dermal route to route extrapolation.
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.