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EC number: 206-585-0 | CAS number: 355-42-0
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Expert statement
- Adequacy of study:
- key study
- Study period:
- November 2019
- Reliability:
- other: Not relevant for an expert statement
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2019
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- This theoretical assessment was prepared, taking all currently available relevant information into account, based on the REACH Guidance: Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c Endpoint specific guidance.
- GLP compliance:
- no
- Remarks:
- Not applicable
Test material
- Reference substance name:
- Tetradecafluorohexane
- EC Number:
- 206-585-0
- EC Name:
- Tetradecafluorohexane
- Cas Number:
- 355-42-0
- Molecular formula:
- C6F14
- IUPAC Name:
- tetradecafluorohexane
- Test material form:
- liquid
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- 5. TOXICOKINETIC ASSESSMENT
A substance can enter the body via de gastrointestinal tract, the lungs, and the skin1. Since different parameters are relevant for absorption via the different routes of exposure, the uptake via these three routes will be addressed individually.
After oral administration, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract.1 Since the water solubility of Tetradecafluorohexane is very low (≤0.1 mg/L), the substance is expected to be poorly dissolved in gastrointestinal fluids,
therefore the availability for uptake is limited. Based on its moderate molecular weight (338), uptake via passive diffusion might occur, but might be too big for passage through aqueous pores or carriage across membranes with the bulk passage of water, also because its water solubility is low. Tetradecafluorohexane has a relatively high partition coefficient (log Pow ≥ 4.5), which is considered not favourable for passive diffusion, but the uptake via micellular solubilisation by bile salts can be expected to take place, enhancing the absorption. The substance does not have ionisable groups that could than can influence its absorption. For risk assessment purposes, oral absorption of Tetradecafluorohexane is set at 10%, based on its low water solubility, moderate molecular weight and high log Pow. The oral toxicity data do not provide reasons to deviate from the proposed oral absorption factor.2
Tetradecafluorohexane has low water solubility, so its dissolution in mucus lining in the respiratory tract may be limited. Moreover, Tetradecafluorohexane has a high partition coefficient (log Pow ≥ 4.5), which is considered not favourable for passive diffusion through biological membranes. However, Tetradecafluorohexane has a high vapour pressure (30.9 kPa at 20°C), which indicates that Tetradecafluorohexane is highly volatile (vapour pressure
>25 kPa) and exposure by inhalation is possible. Very lipophilic vapours (log Pow >4) have the ability to reach the deep lung, where absorption through gas exchange may occur.2 Tetradecafluorohexane is a liquid, which indicates that exposure via areosols is also possible. Aerosols can reach the tracheobronquial region of the respiratory tract. Taking in consideration all these factors together, it is concluded that for risk assessment purposes, as a worst case scenario, the inhalation absorption should be set at 100%.2
Tetradecafluorohexane is a liquid with very low water solubility, it will only dissolve to a very small extent into the surface moisture of the skin to allow uptake. The relatively high log Pow (>4) indicates the crossing of epidermal barriers will be limited. According to the criteria given in the REACH Guidance2, a default value of 100% dermal absorption has been established if the molecular weight is lower than 500 and log P between -1 and 4. The physical/chemical properties of Tetradecafluorohexane do not fully meet the criteria for full dermal absorption (MW 338; log Pow ≥4.5). As it is generally accepted that dermal absorption is not higher than oral absorption, for risk assessment purposes a dermal absorption of 10% will be considered as a more realistic worst case2. Tetradecafluorohexane is neither skin irritating nor corrosive, so enhanced uptake related to local effects need not to be considered.
Once absorbed, distribution of the substance throughout the body is expected to be limited based on its very low water solubility, relatively high log Pow and moderate molecular weight. Orally absorbed Tetradecafluorohexane may be metabolized in the gastrointestinal tract or the liver and excreted through bile and urine. As a very volatile substance, it may be excreted through exhaled air.3 Based on its relatively high partition coefficient (log Pow ≥ 4.5), Tetradecafluorohexane may accumulate in adipose tissue (intracellular concentration may be higher than the extracellular concentration). However, based on its very low water
solubility and high molecular weight, the overall bioaccumulation potential of Tetradecafluorohexane is expected to be low.
6. CONCLUSION
A toxicokinetic assessment was performed based on the available data of the substance. Based on the physical/chemical properties of the substance, absorption factors for this substance are derived to be 10% (oral), 100% (inhalation) and 10% (dermal) for risk assessment purposes. The bioaccumulation potential is expected to be low. - Executive summary:
A toxicokinetic assessment was performed based on the available data of the substance. Based on the physical/chemical properties of the substance, absorption factors for this substance are derived to be 10% (oral), 100% (inhalation) and 10% (dermal) for risk assessment purposes. The bioaccumulation potential is expected to be low.
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