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Diss Factsheets
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EC number: 926-771-1 | 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
Description of key information
FMMVF fibres are assessed to have no acute toxicity by ingestion, by skin contact or by inhalation. FMMVF shall not be classified as an acute toxicant according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Key value for chemical safety assessment
Additional information
Testing of acute oral and dermal toxicities is waived based on the fact that FMMVF fibres are inorganic fibres, whose physicochemical properties suggest a low potential for crossing biological membranes and consequently a low potential for absorption through the gastrointestinal tract and through the skin.Study of acute inhalation toxicity is waived because results from long-term inhalation toxicity studies are available. No man-made mineral fibre in general has shown an acute toxic effects even after very large inhalation and instillation studies where physical damage was avoided.
No treatment related lethality or acute effects are seen even after instillation or inhalation studies using very large doses, where physical damage due to the morphology of the fibres is avoided. As part of reproductive toxicity testing in a number of other MMVF of similar composition and morphology, male and female rats were treated with these substances under consideration by gavage at 250mg/kg/day and elicited no signs of toxicity. Although this is not strictly an acute toxicity test this supports our waiving argument.
Testing the acute toxicity of a material such as this is extremely difficult. In accordance with annex xi section 1 acute oral toxicity testing is not scientifically necessary. Administering sufficiently large doses to produce an acute effect would physically damage the nose, throat and mouth of any animal.
Other studies of similar MMVF have been consulted ; one study where rats were fed up to 2.5% of the MMVF in diet over two years without evident toxicity. A chronic inhalation study used a fibre test atmosphere of 28 mg/m3 without evident toxicity. Taken together with the chemically inert nature of the substance and the absence of absorption/ systemic distribution this information makes low acute inhalation toxicity of the fibres predictable and new animal testing unjustifiable. A lack of absorption and systemic distribution following repeated oral intake. Taken together with the chemically inert nature of the substance makes acute dermal toxicity predictably insignificant and new animal testing unjustifiable.
Justification for classification or non-classification
FMMVF fibres are inorganic fibres, whose physicochemical properties suggest a low potential to cross biological membranes. Thus FMMVF fibres have a low potential for absorption into the body through the skin, the airways and the gastrointestinal tract. FMMVF fibres are assessed to have no acute toxicity by skin contact or if ingested. Long-term inhalation studies showed that FMMVF fibres caused minimal collagen deposition in the lungs and induced fibrosis, but no significant neoplastic changes in the lungs or in pleura. Furthermore, the mortality rate in the exposed animals was the same as for the control animals. Based on these studies FMMVF fibres are assessed to have no acute toxicity by inhalation. FMMVF fibres shall not be classified as an acute toxicant according to the criteria in Regulation (EC) 1272/2008.
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