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Diss Factsheets
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EC number: 413-110-2 | CAS number: 135861-56-2
- 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)
Description of key information
A toxicokinetic assessment was conducted in accordance with REACH Annex VIII 8.8.1. The substance Flyadd-3 is a white solid. It is a mono constituent organic substance (>= 99.64%) with <= 0.36% impurities.
No studies on the toxicokinetics of the substance are available. Only limited data has been provided by ECHA via an inquiry result. No human data is available and the toxicokinetic analysis is based on data from physicochemical data and in vivo animal models. In vivo studies covering the oral route are available (acute and 28 day repeated dose toxicity). In vivo studies covering the dermal route are available (acute, skin irritation, skin sensitisation). There are no studies covering the inhalational route available. For further details on study summaries, reference is made to the appropriate sections in the IUCLID 5 registration dossier.
Absorption is expected to be low, wide distribution is unlikely and the substance is likely to be excreted in the faeces. The absorption rates of 50% (oral), 50% (dermal) and 100% (inhalation) are accepted for chemical risk assessment purposes.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
In accordance with the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7C Section R.7.12 (Endpoint Specific Guidance), the physicochemical properties can provide an insight into the potential behaviour of Flyadd-3 in the body. This information can be combined with the in vivo study data for the toxicokinetic assessment.
Absorption:
Oral/GI absorption
The molecular weight of Flyadd-3 (414 g/mol) is in the range for favourable oral absorption (<500 g/mol). The log P of Flyadd-3 (3.4 @ 22 °C) indicates it is lipophilic and is in the range of favourable oral absorption by passive diffusion. However the water solubility (0.0476 mg/L @20°C) indicates it is poorly soluble and typically solids have to dissolve before they can be absorbed, so oral absorption is expected to be low. The acute oral toxicity study did not indicate any effects up to the limit dose (LD50: >5000 mg/kg). The only change observed in the oral 28 day repeated dose studies was an increase in absolute and relative liver weights in males at 1000 mg/kg bw/day, but there was no supporting histopathological data. The NOEL was 200 mg/kg bw/day and the NOAEL was 1000 mg/kg bw/day. The in vivo study data together with the physicochemical information indicates that the substance is poorly absorbed via the oral route. For chemical safety assessment purposes, based on the physicochemical properties and information in the dossier, an oral absorption of 50% is accepted.
Respiratory absorption-Inhalation
The particle size distribution report for Flyadd-3 indicates the following volume median diameters: d10: 0.62 µm, d50: 1.339 µm, d90: 23.491 µm. This indicates that Flyadd-3 particles have the potential to be available in the inhalable fractions of air and may reach the thoracic (<50 µm) and alveolar regions (<15 µm). As Flyadd-3 is poorly water soluble (0.0476 mg/L), the rate at which the particles dissolve into the mucus will limit the amount that can be absorbed directly. The fraction that may reach the thoracic region will mainly be cleared from the lungs by the mucocilliary mechanism and swallowed (see oral absorption). The fraction that may reach the alveolar region would mainly be engulfed by alveolar macrophages. The macrophages will then either translocate particles to the ciliated airways or carry particles into the pulmonary interstitium and lymphoid tissues. Due to the low vapour pressure (0.000001 Pa) negligible exposure via the inhalational route may be expected. However, as there is no inhalational study data available for this substance, for chemical safety assessment purposes, an inhalation absorption rate of 100% is accepted.
Dermal absorption
The molecular weight of 414 g/mol is above the range for favorable dermal absorption (<100 g/mol). The log P (3.4) is the favourable range for dermal absorption (log P 1-4) however the physical state, and poor water solubility (0.0476 mg/L) indicate that dermal absorption is unlikely. The acute dermal toxicity study did not indicate any effects (systemic or local) up to the limit dose (LD50: >2000 mg/kg). The in vivo skin irritation study in rabbits indicted that the substance caused a mild transient erythema and in the skin sensitisation study in guinea pigs the substance was not sensitising. The available dermal toxicity data together with the physicochemical data indicates that any significant dermal absorption is unlikely. The ECHA guidance criteria (Chapter R.7C) state that 10% dermal absorption is used when the molecular weight of the substance is >500 and the log Pow is <-1 or >4, otherwise 100% dermal absorption is used. In general, dermal absorption will not be higher than oral absorption, so for chemical safety assessment purposes a dermal absorption rate of 50% is accepted.
Distribution/Metabolism
The molecular weight (414 g/mol) and water solubility (0.0476 mg/L) are unfavourable for wide distribution. There is no direct evidence to indicate how the substance is metabolised. As absorption is likely to be low, Flyadd-3 is expected to be excreted unchanged in the faeces.
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.