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Diss Factsheets
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EC number: 944-232-9 | 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:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Study period:
- 17 October 2016
- Reliability:
- other: A written assessment based on toxicological profile of the substance
- Rationale for reliability incl. deficiencies:
- other: See 'Remark'
- Remarks:
- A written assessment of toxicokinetic behaviour is considered appropriate for the substance. The substance displays only minor toxicological effects in any of the studies proposed, and is deemed to be be not harmful for health effects. As such, it is deemed inappropriate in terms of animal welfare to conduct a toxicokinetic assessment when no harmful effects are predicted based on known toxicology. A written assessment has therefore been prepared to address this endpoint.
- Objective of study:
- other: Assessment of toxicokinetic behaviour
- Principles of method if other than guideline:
- Written assessment based on toxicological profile.
- GLP compliance:
- no
- Species:
- other: Not applicable
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Not applicable
- Remarks:
- Doses / Concentrations:
Not applicable - No. of animals per sex per dose / concentration:
- Not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- Not applicable
- Details on dosing and sampling:
- Not applicable
- Statistics:
- Not applicable
- Metabolites identified:
- not measured
- Details on metabolites:
- Not applicable
- Conclusions:
- The following absorption factors will be used for the chemical safety assessment:
Dermal route: 10% (based on molecular weight > 500 and Log Kow > 4)
Oral route: 50% (worst case)
Inhalation route: 50% (worst case)
The substance is not predicted to be bioaccumulative based on the very high log Kow value and low solubility in n octanol. - Executive summary:
No signs of toxicity were observed in the key acute oral toxicity study at a dose level of 2000 mg/kg body weight, however, dark red discoloured faeces and bedding were noted during the first day of the study. In the supporting acute oral toxicity studies, signs of toxicity were observed at dose levels from 4640 mg/kg to 15380 mg/kg body weight. In the oral combined repeated dose toxicity study with the reproduction/developmental toxicity screening study, signs of toxicity were not observed at a dose level of 1000 mg/kg body weight per day, however, orange staining in the cage tray was observed. This staining was considered to be due to excretion of metabolised substance, which indicates that the lower molecular components of this UVCB substance are somewhat absorbed by the oral route. Poor oral absorption of the main component of the substance may be predicted based on its molecular weight, log Kow value and low water and fat solubility. The substance is classified as a skin sensitiser, however, the molecular weight (> 500), high estimated log Kow value (12.23) and poor solubility in water do not favour dermal absorption. No signs of toxicity were observed in an acute inhalation toxicity study conducted with the test material.
The following absorption factors will be used for the chemical safety assessment:
Dermal route: 10% (based on molecular weight > 500 and Log Kow > 4)
Oral route: 50% (worst case)
Inhalation route: 50% (worst case)
There are no data available on the distribution of the substance. The main component of the substance is not absorbed at all, as it is not soluble in water or in organic solvents. The lower molecular components and impurities, which are absorbed, are likely to undergo metabolism to more polar conjugated metabolites, which are then excreted. The results of the in vivo micronucleus study indicate that the substance is not metabolised to genotoxic structures. The substance is not predicted to be bioaccumulative based on the very high log Kow value and low solubility in n octanol.
Reference
Description of key information
A written assessment of toxicokinetics was conducted based on the toxicological profile of the substance.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 50
Additional information
No signs of toxicity were observed in the key acute oral toxicity study at a dose level of 2000 mg/kg body weight, however, dark red discoloured faeces and bedding were noted during the first day of the study. In the supporting acute oral toxicity studies, signs of toxicity were observed at dose levels from 4640 mg/kg to 15380 mg/kg body weight. In the oral combined repeated dose toxicity study with the reproduction/developmental toxicity screening study, signs of toxicity were not observed at a dose level of 1000 mg/kg body weight per day, however, orange staining in the cage tray was observed. This staining was considered to be due to excretion of metabolised substance, which indicates that the lower molecular components of this UVCB substance are somewhat absorbed by the oral route. Poor oral absorption of the main component of the substance may be predicted based on its molecular weight, log Kow value and low water and fat solubility. The substance is classified as a skin sensitiser, however, the molecular weight (> 500), high estimated log Kow value (12.23) and poor solubility in water do not favour dermal absorption. No signs of toxicity were observed in an acute inhalation toxicity study conducted with the test material.
The following absorption factors will be used for the chemical safety assessment:
Dermal route: 10% (based on molecular weight > 500 and Log Kow > 4)
Oral route: 50% (worst case)
Inhalation route: 50% (worst case)
There are no data available on the distribution of the substance. The main component of the substance is not absorbed at all, as it is not soluble in water or in organic solvents. The lower molecular components and impurities, which are absorbed, are likely to undergo metabolism to more polar conjugated metabolites, which are then excreted. The results of the in vivo micronucleus study indicate that the substance is not metabolised to genotoxic structures. The substance is not predicted to be bioaccumulative based on the very high log Kow value and low solubility in n octanol.
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.
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