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Diss Factsheets
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EC number: 926-099-9 | 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
Description of key information
For Note Q man-made vitreous fibres (MMVFs), inhalation is the key route of exposure. By the physical properties of these fibres, acute dermal toxicity upon exposure to Note Q MMVFs is not of concern. Oral exposure to Note Q MMVFs is an unlikely route of human exposure; thus, acute oral toxicity is also not of concern.
No studies specifically addressing the acute inhalation toxicity potential of Note Q MMVFs were identified. Nevertheless, there are long-term studies with inhalation exposure of up to 2 years on Note Q MMVFs available. In the study by Hesterberg et al. (1993), Fischer 344 male rats were exposed to the Note Q-fulfilling MMVF 11 to the concentrations of 3, 16 and 30 mg/m³ using nose-only inhalation chambers for 6 hr/day, 5 days/week for 24 months. No difference in mortality was observed between the MMVF 11-exposed rats and filtered air (negative control)-exposed rats at the end of the study. Another study by Kamstrup et al. (2001) used the same chronic exposure design as the Hesterberg et al. (1993) study but tested another Note Q MMVF (MMVF 34/HT at 30 mg/m³) on Fischer 344 male rats. No difference in mortality was observed between MMVF 34-exposed and filtered air-exposed rats at the end of the study. It should be mentioned that 30 mg/m³ has been tested and demonstrated to be the maximum tolerated dose (MTD) for MMVFs such that exposure above this MTD would lead to nonspecific lung pathology due to overload of the lung (see Hesterberg et al. 1996. Fundam Appl Toxicol, 32, 31-44).
The chemical composition of the Note Q MMFs also does not lead to any concern related to acute toxicity. Submitted data of the REACH registration dossier indicated minimal to no indication of acute toxicity (no CLP classification). The majority of tests for some of the individual key components of Note Q MMVFs such as silicon oxide, aluminium oxide, diboron trioxide and calcium oxide were performed according to the OECD test guideline 403 for acute inhalation toxicity (please refer to the respective registration dossiers) .
Altogether, there is consistent evidence showing no concern of acute inhalation toxicity of Note Q MMVFs based on the lack of lethal effects seen in chronic inhalation studies of Note Q MMVFs as well as the lack of acute toxicity of some of the main chemical components of these fibres. Thus, Note Q MMVFs do not warrant classification for acute toxicity taking a weight-of-evidence approach.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
MMVF note Q fibres are inorganic fibres, whose physicochemical properties suggest a low potential to cross biological membranes. Thus MMVF note Q fibres have a low potential for absorption into the body through the skin, the airways and the gastrointestinal tract. MMVF note Q fibres are assessed to have no acute toxicity by skin contact or if ingested. Long-term inhalation studies showed that MMVF note Q fibres caused minimal collagen deposition in the lungs and did not induce fibrotic or neoplastic changes in the lungs or in pleura. Furthermore, in a comparable to guideline study, the mortality rate in the exposed animals was the same as for the control animals. Based on these studies MMVF note Q fibres are assessed to have no acute toxicity by inhalation. MMVF note Q fibres shall not be classified as an acute toxicant according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
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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