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EC number: 610-130-5 | CAS number: 436083-99-7
- 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30th April 1997 to 19th June 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Compliant reproducibility exceed expectations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Objective of study:
- other: measure biopersistence of the substance to be registered
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ECB/TM/26 (rev 7)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide
- EC Number:
- 610-130-5
- Cas Number:
- 436083-99-7
- Molecular formula:
- Amorphous glass consisting of SinO(3n-1)2(n-1) Polymeric anions ionically bonded to Ca2+ and Mg2+ cations or other alkaline earth cations
- IUPAC Name:
- amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide
- Details on test material:
- - Name of test material (as cited in study report): Fibre A
- Substance type: calcium, magnesium silicate wool
- Physical state: solid
- Analytical purity: 99.5%
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, FRG
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: mean, 166.3g
- Housing: Makrolon (polycarbonate) cages type III (37.5 x 21.5 x 20cm), 2 rats/cage
- Individual metabolism cages: no
- Diet (e.g. ad libitum): A commercial chow in pellet form was used, identified as Altromin "1324 N Spec. prepared"
- Water (e.g. ad libitum): ad libitum in cage
- Acclimation period: 1 week before starting tube training
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): 12 hour cycle
IN-LIFE DATES: From: June 16, 1997 To: June 19, 1998
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TYPE OF INHALATION EXPOSURE: nose only
GENERATION OF TEST ATMOSPHERE / CHAMPER DESCRIPTION
- Exposure apparatus: high-pressure pneumatic disperser, flow-past nose/snout only inhalation exposure system
- Method of holding animals in test chamber: Battelle type polycarbonate tubes
- Source and rate of air: 1 l/min
- Method of conditioning air: neutralized by a Ni-63 source
- System of generating particulates/aerosols: high-pressure pneumatic disperser
- Method of particle size determination: SEM analysis of filter samples, aerosol photometer (on-line)
- Treatment of exhaust air: filtered - Duration and frequency of treatment / exposure:
- 5 days, 6hrs/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Average exposure concentration 104± 13f > 20µm long/ml as recommended in the draft EU guideline
Mean Mass Exposure 44.9mg/m3
- No. of animals per sex per dose / concentration:
- 49
- Control animals:
- yes, concurrent no treatment
- Positive control reference chemical:
- not required under EU Protocol
- Details on study design:
- Sacrifice dates, 1 day, 3 days, 17days, 1 month, 3months, 6 months and 12 months
- Details on dosing and sampling:
- The aerosol was monitored by an aerosol photometer (online), by determination of numerical concentration of fibres (SEM analysis of filter samples) and by determination of gravimetric concentration.
- Statistics:
- Differences between groups were considered statistically significant at p <0.05. Data were analysed using analysis variance. If the group means differed significantly by the analysis of variance the means of the treated groups were compared with the means of the control groups based on the Dunnett's test. The kinetic of the elimination of the fibres form the lung was calculated by regression analysis of the logarithm of the number of fibres versus time after end of inhalation. The half time T12 was calculated from the regression coefficient k by: T12 - ln(2)/ k. Additionally the method of nonlinear curve fitting was used as recommended in the protocol.
The kinetic of the elimination of the fibres form the lung was calculated by regression analysis of the logarithm of the number of fibres versus time after end of inhalation. The half time T12 was calculated from the regression coefficient k by: T12 - ln(2)/ k.
Additionally the method of nonlinear curve fitting was used as recommended in the protocol.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Biopersistence to EU protocol ECB/TM/26 (rev 7). Clearance half-time for fibres more than 20µm long was 7 days.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: see conclusion
fibre need not be treated as a carcinogen, fulfils the criteria for exoneration under Note Q of CLP regulations, - Executive summary:
The biopersistence of this fibre is below the limit in Nota Q of CLP regulations. There was no evidence of an adverse effect due to exposure to the test fibre on the parameters measured during the maintenance period (clinical observations and bodyweight) or at necropsy (organ weights). Analysis of the test atmosphere showed that the requirements of the draft protocol were met throughout the study, analysis of retained fibres by electron microscopy provided a robust estimate of biopersistence.
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