Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- The full waiving argumentation is detailled in the document "Long term toxicity to fish_WoE" below.
The studies mentionned in the justification enclosed are detailled as weight of evidence in the other endpoints of the section 6.1.2 of the IUCLID dossier. - Validity criteria fulfilled:
- not applicable
- Conclusions:
- This end-point is waived, because the short-term toxicity to fish test presented in endpoint 6.1.1 showed that MMVF note Q fibres have no adverse effects to fish. The leached species are inorganic ions leached at a level known not to show any long-term toxicity to fish (See 4.8 Water solubility). Consequently, no adverse effect to fish is expected on long-term from the substance.
Thus carrying out such a study is not scientifically justified. - Endpoint:
- fish early-life stage toxicity
- Type of information:
- other: Scientific review
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- The fibers chosen for this evaluation were MMVF11 (a glasswool), MMVF22 (a slagwool) with an average fiber diameter of approximately 1 pm and an average length of 15 to 25 pm. Fluid simulants used were modified Gamble's solutions. Sodium azide (0.5 mg/1) was added to both solutions as a biocidal agent. The extracellular fluid simulant was saturated with and kept under constant pressure of 5%C02/95%N2 to maintain pH 7.6 for the duration of the experiments. For the solution at pH 4, HCI was added in place of sodium bicarbonate and the level of sodium chloride adjusted to achieve the desired pH and maintain the same total cation concentration as that of the solution at pH 7.6. Experiments were performed in an in vitro flow-through system as described previously. In this system, weighed portions of each material are fixed within half-inch spacers between 0.2-pm polycarbonate membrane filters in modified air monitors which serve as the sample chambers. Fluid is pumped at a constant rate through individual polyethylene lines into the sample chambers where it is allowed to react with the fibers and the effluent is collected in individual bottles for each time increment. Aliquots of each solution are then removed for analysis. Nominal conditions used for this study were: 0.5 g fiber at a 10 ml/hr flow rate for 21 days and at a constant temperature of 37°C. Duplicate runs were made for each sample at each pH. Solutions were analyzed by inductively coupled plasma (ICP) to quantify the concentrations of the elements extracted from each fiber sample (in mg/L). The elements measured included both major and minor components of each fiber, as well as phosphorous which may be taken up from the fluid by some types of MMVF.
- GLP compliance:
- not specified
- Key result
- Dose descriptor:
- other: Not applicable
- Effect conc.:
- ca. 0 other: not applicable
- Nominal / measured:
- not specified
- Conc. based on:
- other: Not applicable
- Basis for effect:
- other: Not applicable
- Remarks on result:
- other: Not applicable
- Details on results:
- For MMVF22, total dissolution rates were over 30 times greater at pH 4 than at pH 7.6. Results in the table below (see field "any other information on results including tables") indicate that, as with total dissolution, compositional changes occurring in a particular fiber vary not only as a funct
ion of initial composition, but also with pH of the fluid. MMVF22, and to a lesser extents MMVF11, shows at least two significant changes: a progressive enrichment in both silica and alumina in the residual fiber, and loss by leaching of network-modifying alkali and alkaline earth cations. Leaching of network-modifying cations and concomitant enrichment in alumina, silica, and in some cases iron oxide was also found in fibers recovered from animal lungs from in vivo fiber durability studies on various MMVFs. - Conclusions:
- The leaching of MMVF is congruent: the silica network and the alkali and alkaline earth ions are not released with the same rate. The Si-Al network dissolution is much slower.
- Executive summary:
The leaching of MMVF is congruent: the silica network and the alkali and alkaline earth ions are not released with the same rate. The Si-Al network dissolution is much slower.
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- other: Assessemnt report on mineral fibres
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- No testing performed.
- Key result
- Dose descriptor:
- other: Not applicable
- Effect conc.:
- ca. 0 other: Not applicable
- Nominal / measured:
- not specified
- Conc. based on:
- other: Not applicable
- Basis for effect:
- other: Not applicable
- Remarks on result:
- other: Not applicable
- Details on results:
- Gravitational settling and dissolution are expected to be the principal mechanisms of removal of MMVF from water (WHO, 1988). Settling fibres will accumulate in bottom sediment. Because of their amorphous structure, abrasion of MMVF during transport in air or water will normally result in breakage into successively shorter fragments (TIMA, 1991).
- Conclusions:
- Gravitational settling and dissolution are expected to be the principal mechanisms of removal of MMVF from water (WHO, 1988). Settling fibres will accumulate in bottom sediment. Because of their amorphous structure, abrasion of MMVF during transport in air or water will normally result in breakage into successively shorter fragments (TIMA, 1991).
- Executive summary:
Gravitational settling and dissolution are expected to be the principal mechanisms of removal of MMVF from water (WHO, 1988). Settling fibres will accumulate in bottom sediment. Because of their amorphous structure, abrasion of MMVF during transport in air or water will normally result in breakage into successively shorter fragments (TIMA, 1991).
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- other: Scientific review of the impact of REACH on glass
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- No testing performed.
- GLP compliance:
- not specified
- Key result
- Dose descriptor:
- other: not applicable
- Effect conc.:
- ca. 0 other: not applicable
- Nominal / measured:
- not specified
- Conc. based on:
- other: not applicable
- Basis for effect:
- other: not applicable
- Remarks on result:
- other: not applicable
- Details on results:
- Glass is fundamentall non-crystalline solids characterised by a lack of translational order of their atomic structure. Glass is also characterized by the absence of any microstructure. It is an essentially isotropic material without any internal phase boundaries. From a thermodynamic point of view, glass is an undercooled frozen-in liquid.
From the REACH point of view, glass is an UVCB substance and not a mixture. The industrial glass is made of the following raw materials: sand (SiO2), feldspar (NaAlSi3O8), dolomite (CaMg(CO3)2), limestone (CaCO3), soda ash (Na2CO3) and some other oxides in small quantities.
The raw materials are simplified as pure substances featuring the man pahse of real raw material only. The resulting glass has an oxide omposition expressed in terms of SiO2, MgO.... which is a realistic representative of a typical container glass, but it should be kept in mind that glass present no internal phase boundaries. Some of the raw materials available may be classified as harmful. But during the melting process, the raw materials lose their identities as individual substances and form a homogeneous melt. Their chemical properties are no longer reflected by the resulting glass. The individual entities form building blocks (at the atomic scale) of a new non-cristalline matrix that chemically behaves in a way different from any of the raw materials. Chemically, the matrix as a whole behaves like a substance of its own. - Conclusions:
- Glass under REACH is an UVCB substance. During the melting process, the raw materials lose their identities as individual substances and form a homogeneous melt. Their chemical properties are no longer reflected by the resulting glass.
It is exempted from registration under the entry 11 of the REACH annex V. - Executive summary:
Glass under REACH is an UVCB substance. During the melting process, the raw materials lose their identities as individual substances and form a homogeneous melt. Their chemical properties are no longer reflected by the resulting glass.
It is exempted from registration under the entry 11 of the REACH annex V.
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- other: Water quality specifications in Paris
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- according to guideline
- Guideline:
- other: Code de la Santé Publique (France - Code of Public Health)
- Key result
- Dose descriptor:
- other: Not applicable
- Effect conc.:
- ca. 0 other: Not applicable
- Nominal / measured:
- not specified
- Conc. based on:
- other: Not applicable
- Basis for effect:
- other: Not applicable
- Remarks on result:
- other: Not applicable
- Details on results:
- Composition of Paris Drinking Water: see table below.
- Conclusions:
- Composition of Paris Drinking Water: see table above.
- Executive summary:
Composition of Paris Drinking Water:
Cations Limits and quality references (mg/L) Paris drinking water (mg/L) Calcium - 90 Magnesium - 06 Sodium 200 10 Potassium 12 02 - Endpoint:
- fish early-life stage toxicity
- Type of information:
- other: Official document from WHO
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- No testing performed.
- Key result
- Dose descriptor:
- other: not applicable
- Effect conc.:
- ca. 0 other: not applicable
- Conc. based on:
- other: not applicable
- Basis for effect:
- other: not applicable
- Remarks on result:
- other: not applicable
- Details on results:
- The chemical derived contaminants for which a threashold is fixed by the WHO are the following
ones:
Acrylamide
Alachlor
Aldicarb
Aldrin and dieldrin
Aluminium
Ammonia
Antimony
Asbestos
Atrazine and its metabolites
Barium
Bentazone
Benzene
Beryllium
Boron
Bromate
Bromide
Brominated acetic acids
Cadmium
Carbaryl
Carbofuran
Carbon tetrachloride
Chloral hydrate
Chloramines (monochloramine, dichloramine, trichloramine)
Chlordane
Chloride
Chlorine
Chlorite and chlorate
Chloroacetones
Chlorophenols (2-chlorophenol, 2,4-dichlorophenol, 2,4,6-trichlorophenol)
Chloropicrin
Chlorotoluron
Chlorpyrifos
Chromium
Copper
Cyanazine
Cyanide
Cyanobacterial toxins: Microcystin-LR
Cyanogen chloride
2,4-D
2,4-DB
DDT and metabolites
Dialkyltins
1,2-Dibromo-3-chloropropane
1,2-Dibromoethane
Dichloroacetic acid
Dichlorobenzenes (1,2-dichlorobenzene, 1,3-dichlorobenzene, 1,4-dichlorobenzene)
1,1-Dichloroethane
1,2-Dichloroethane
1,1-Dichloroethene
1,2-Dichloroethene
Dichloromethane
1,2-Dichloropropane
1,3-Dichloropropane
1,3-Dichloropropene
Dichlorprop
Di(2-ethylhexyl)adipate
Di(2-ethylhexyl)phthalate
Dimethoate
1,4-Dioxane
Diquat
Edetic acid
Endosulfan
Endrin
Epichlorohydrin
Ethylbenzene
Fenitrothion
Fenoprop
Fluoride
Formaldehyde
Glyphosate and AMPA
Halogenated acetonitriles (dichloroacetonitrile, dibromoacetonitrile, bromochloroacetonitrile, trichlo
roacetonitrile)
Hardness
Heptachlor and heptachlor epoxide
Hexachlorobenzene
Hexachlorobutadiene
Hydrogen sulfide
Inorganic tin
Iodine
Iron
Isoproturon
Lead
Lindane
Malathion
Manganese
MCPA
Mecoprop
Mercury
Methoxychlor
Methyl parathion
Methyl tertiary-butyl ether
Metolachlor
Molinate
Molybdenum
Monochloroacetic acid
Monochlorobenzene
MX
Nickel
Nitrate and nitrite
Nitrilotriacetic acid
Nitrobenzene
N-Nitrosodimethylamine
Parathion
Pendimethalin
Pentachlorophenol
Petroleum products
2-Phenylphenol and its sodium salt
Polynuclear aromatic hydrocarbons
Potassium
Propanil
Selenium
Silver
Simazine
Sodium
Sodium dichloroisocyanurate
Styrene
Sulfate
2,4,5-T
Terbuthylazine
Tetrachloroethene
Toluene
Total dissolved solids
Trichloroacetic acid
Trichlorobenzenes (total)
1,1,1-Trichloroethane
Trichloroethene
Trifluralin
Trihalomethanes (bromoform, bromodichloromethane, dibromochloromethane, chloroform)
Uranium
Vinyl chloride
Xylenes
Zinc - Conclusions:
- The presence of potassium, sodium, calcium, magnesum and barium ions, that can be released from MMVF during leaching, is not resticted in drinking water.
- Executive summary:
The presence of potassium, sodium, calcium, magnesum and barium ions, that can be released from MMVF during leaching, is not resticted in drinking water.
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- All measurements involved the constant flow of a fluid at a controlled rate through a mat of well characterised fibres at a temperature of 37 ± PC, as described in principle by e.g. Scholze and Conradt (1987), Potter and Mattson (1991), Mattson (1994), Christensene/a/. (1994), Thelohan etal. (1994).Bauer el al. (1994), Guldberg et al. (1995). Knudsen et al. (1996). Different F/A (flow-rate/initial surface area) were used for each fibre type. The simulated lung fluids were similar with respect to chemical composition and ionic strength to the modified Gamble's solutions used in the measurements of the dissolution rate at neutral pH (Zoitos el al. (1997)), but were modified to obtain a pH 4.5-5 by using different buffering systems or by adding hydrochloric acid. The fibre samples were characterised with respect to chemical composition and length-weighted fibre diameter distribution using either scanning electron microscopy (SEM) or optical microcopy (OM).(Christensen el al. (1993), Koenig et al.(1993)).
Weighed amounts of fibres were mounted in cells (filter cassettes), through which the liquid passed at a controlled flow rate. From the weighed amount of fibres, the measured flow-rate, and the initial specific surface area of the sample (calculated from the fibre diameter distribution and the density, or in some cases measured using gas adsorption techniquies (BET)), the F/A-ratio for each test was determined. In most cases a replicate of cells (2-3) were used for each test. The effluent was analysed for several of the fibre dissolving elements (Si, Ca, Mg Al, B, Fe) by means of atomic absorption spectrophotometry (AAS) or inductively coupled plasma atomic emission spectrometry (ICPAES). Based on the measurements the dissolution rates were calculated. A dissolution rate si for the network kSi was calculated based on the dissolution of Si. As leaching (incongruent dissolution) was observed at pH 4.5 for all fibres investigated here, an additional dissolution rate kk.jch was similarly calculated for the leaching elements, represented by Ca and Mg. Apart from Ca and Mg, Na, K, and B dissolve as leaching elements, while Fe, Ti and Al are neither allocated as leaching nor as belonging to the residual glass, although Al is known to leach at low pH (Elmer (1984)). The calculated dissolution rates were based on the dissolution during 25-30 days, or until either 95% of the leaching elements or 75% of the total fibre mass had dissolved, whichever happened first. - GLP compliance:
- not specified
- Key result
- Dose descriptor:
- other: not applicable
- Effect conc.:
- ca. 0 other: not applicable
- Nominal / measured:
- not specified
- Conc. based on:
- other: not applicable
- Basis for effect:
- other: not applicable
- Remarks on result:
- other: not applicable
- Details on results:
- For MMVF22, the dissolution rate at pH 4.5 of the alkali and alkaline earth ions is 4 times higher than the dissolution rate at pH 7.4 (459 ng/cm2h at pH=4.5, 119 ng/cm2h at pH=7.4).
For MMVF21, the dissolution rate at pH 4.5 of the alkali and alkaline earth ions is 3 times higher than the dissolution rate at pH 7.4 (72 ng/cm2h at pH=4.5, 23 ng/cm2h at pH=7.4). - Conclusions:
- The leaching is more important at acidic pH than at neutral pH. In addition the leaching of alkali and alkaline earth ions is much more favorable that the leaching of the silica/alimina network. It means that the ionic species from alkali and alkaline earth elements will be released first and in a mcuh higher concentration than those of Si and Al.
- Executive summary:
The leaching is more important at acidic pH than at neutral pH. In addition the leaching of alkali and alkaline earth ions is much more favorable that the leaching of the silica/alimina network. It means that the ionic species from alkali and alkaline earth elements will be released first and in a mcuh higher concentration than those of Si and Al.
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- other: Study on glass fibres corrosion
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- No testing performed.
- Dose descriptor:
- other: not applicable
- Effect conc.:
- ca. 0 other: not applicable
- Conc. based on:
- other: not applicable
- Basis for effect:
- other: not applicable
- Remarks on result:
- other: not applicable
- Details on results:
- Composition of MMVF10: see table below
- Conclusions:
- Composition of MMVF10:
SiO2: 57.2 %wt
SO3: 0.12 %wt
Fe2O3: 0.07 %wt
Al2O3: 5.1 %wt
CaO: 7.5%wt
MgO: 4.1%wt
Na2O: 15%wt
K2O: 1.1%wt
B2O3: 8.8%wt
F: 0.8%wt - Executive summary:
Composition of MMVF10
Oxides %wt SiO2 57.2 SO3 0.12 Fe2O3 0.07 Al2O3 5.1 CaO 7.5 MgO 4.1 Na2O 15 K2O 1.1 B2O3 8.8 F 0.8 - Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- No testing performed specific to this endpoint.
- GLP compliance:
- not specified
- Remarks:
- no testing performed
- Key result
- Dose descriptor:
- other: not applicable
- Effect conc.:
- ca. 0 other: not applicable
- Conc. based on:
- other: not applicable
- Basis for effect:
- other: not applicable
- Remarks on result:
- other: not applicable
- Details on results:
- Composition of Gascogne water: see table below.
- Conclusions:
- Composition of Gascogne waters (cations): see table below.
- Executive summary:
Composition of Gascogne waters (cations):
Cations (meq/L) min max moy Na+ 0.14 3.24 0.64 K+ 0.01 0.15 0.05 Ca2 + 0.74 6.25 3.89 Mg2 + 0.14 2.62 0.84 - Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2008.02.11-2007.02.15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- not defined
- Vehicle:
- yes
- Details on test solutions:
- Synthetic medium prepared from Millipore water according to the ISO 7346 Standard
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: Hørsholm dyrehandel, Hørsholm, Denmark
- Age at study initiation (mean and range, SD): juvenile
- Length at study initiation (length definition, mean, range and SD): 2.7 +/- 0.1 cm
ACCLIMATION and food
- not described - Test type:
- other: static renewal test i.e. all test media were changed every 24 h
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- Static renewal test
- Post exposure observation period:
- None
- Hardness:
- No data
- Test temperature:
- 23 +/- 1.0°C
- pH:
- 7.7 - 8.0
- Dissolved oxygen:
- No data
- Salinity:
- No data
- Nominal and measured concentrations:
- 50 mg/l: 0.087 mg/l
100 mg/l: 0.107 mg/l
200 mg/l: 0.104 mg/l
500 mg/l: 0.144 mg/l
1000 mg/l: 0.394 mg/l - Details on test conditions:
- The test was performed with juvenile zebra fish. At the start of the study, the size of the test fish was approx. 2.7 ± 0.1 cm.
Freshly produced synthetic medium was used in the test. The medium was prepared from Millipore water according to the ISO 7346 standard. The test was performed as a static renewal test, i.e. all test media were changed every 24 hours. The test was carried out at 23 ± 1.0 °C in a climate room with normal laboratory light having a daily light/dark period of 14:10 hours. At the beginning of the test, the individual test aquaria were identified by GLP Study No., test concentration, date of start and technician's initials. The acute test was run in glass aquaria with a total capacity of 4.5 L, each containing 3.5 L medium. Every 24 hours, all test solutions were renewed. The test fish were randomly chosen among the stock population and transferred from the stock population to the test aquaria within 30 minutes, making up 10 fish per concentration.
Mortality was recorded after 2; 24; 48; 72 and 96 hours. Records were kept of visible abnormalities, i.e loss of equilibrium, changes in swimming behaviors, respiratory function and pigmentation. These effects were recorded daily in the study records. Temperature, pH, and dissolved oxygen were measured daily before and after renewal of test medium and at the start and at the end of the test. Room temperature was recorded continuously by thermologger. A test with the reference substance potassium dichromate (K2Cr2O7, Merck 4864, Batch No. K306 14564227) was performed in order to verify the sensitivity of the test organisms. The reference test was performed at the following conditions: 0 (control); 50; 100; 200; 300; 400 mg/L. Ten fish were exposed to each concentration. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (K2Cr2O7, Merck 4864, Batch No. K30614564227)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 96 h
- Dose descriptor:
- LC10
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- - Behavioural abnormalities: No significant difference from controls, but few incidences in 200-400 mg/L
- Observations on body length and weight: na
- Other biological observations: 0
- Mortality of control: 0
- Other adverse effects control: 0
- Effect concentrations exceeding solubility of substance in test medium: The test substance is highly insoluble in water. - Results with reference substance (positive control):
- The validations criteria of the test according to the OECD test guidline for testing chemicals No 203, Fish Acute Toxicity Test 1992.07.17 were fulfilled.
The mortality in the controls did not exceed 10% at the end of the test period.
The dissolved oxygen concentration was > 60% throughout the test period. - Reported statistics and error estimates:
- Regarding the test product, no mortality was observed in any of the test solutions and therefore no statistical data treatment was performed. The LC10 and LC50 values for the acute toxicity of the reference substance K2Cr2O7 were calculated by use of the standard procedure Probit Analysis version 2.3 1990.03.20.
- Validity criteria fulfilled:
- yes
- Remarks:
- within range normally found at the CRO
- Conclusions:
- No mortality or behavioral effects were observed during the test. The LC10 and LC50 values are thus indicated as > 1.60 mg/L for the test substance (>1000 mg/L).
- Executive summary:
The test product "Roxul 1000 fibers. Sample No FI990571 -00" was tested for acute toxic effects on juvenile zebra fish (Danio rerio) according to the OECD guideline for Testing of Chemicals No 203 "Fish Acute Toxicity Test".
According to the chemical analysis the concentration of silicate Si were between 87 microgram/L in the lowest test concentration (50 mg/L) and 394 microgram/L in the highest test concentration (1000 mg/L) at the imitation of the test. Subtracting the concentration of silicate Si (86 microgram/L) in the control sample, a concentration of 308 micro gram silicate Si/L is obtained in the highest test concentration of 308 micro gram silicate Si/L is obtained in the highest test concentration and a concentration of 1 microgram/L in the lowest test concentration, respectively. Based on the information obtained from the sponsor, a concentration of 308 micro gram silicate Si/L corresponding to an actual concentration of app. 1.60 mg Roxul 1000 Fibers. These results also confirm the statement given in the MSDS that mineral fibers are insoluble in water.
No mortality or behavioral effects were observed during the test. The LC10and LC50 values are thus indicated as > 1.60 mg "Roxul 1000 fibers: sample No FI990571 -00" (>1000 mg/L).
Referenceopen allclose all
Table: Average fibre composition after 21 -day exposure to synthetic physiological media (%wt of main components)
MMVF22 original | MMVF22 pH=4 | MMVF22 pH=7.6 | |
SiO2 | 38.4 | 58.3 | 44.5 |
Al2O3 | 10.8 | 27.8 | 12.8 |
Fe2O3 | 0.3 | 0.7 | 0.4 |
Na2O | 0.4 | 0.9 | 3.5 |
K2O | 1.2 | 0.4 | 0.1 |
CaO | 37.5 | 8.3 | 29.3 |
MgO | 9.9 | 1.8 | 7.9 |
Total mass loss | 61.9 | 16.2 |
Composition of Paris drinking water:
Cations | Limits and quality references (mg/L) | Paris drinking water (mg/L) |
Calcium | - | 90 |
Magnesium | - | 06 |
Sodium | 200 | 10 |
Potassium | 12 | 02 |
Composition of MMVF10
Oxides | %wt |
SiO2 | 57.2 |
SO3 | 0.12 |
Fe2O3 | 0.07 |
Al2O3 | 5.1 |
CaO | 7.5 |
MgO | 4.1 |
Na2O | 15 |
K2O | 1.1 |
B2O3 | 8.8 |
F | 0.8 |
Composition of Gascogne waters (cations):
Cations (meq/L) | min | max | moy |
Na+ | 0.14 | 3.24 | 0.64 |
K+ | 0.01 | 0.15 | 0.05 |
Ca2+ | 0.74 | 6.25 | 3.89 |
Mg2+ | 0.14 | 2.62 | 0.84 |
Product/Substance | Endpoint | Lethality (mg/L) |
Test substance | LC10 | > 1.60 (>1000)* |
Test substance | LC50 | > 1.60 (>1000) |
Potassium dichromate K2Cr2O7 | LC50 | 257 [198 -216]** |
* figures in paranthesis are nominal test concentrations
** 95% confidence interval
Description of key information
No adverse effects have been identified on the long term for fish given the behaviour of fibres in surface waters and their safe profile due to its composition. Consequently according to the section 1 of the Annex XI or REACH, an OECD 210 study (Fish, Early-life Stage Toxicity Test) is not scientifically justified.
Key value for chemical safety assessment
Additional information
No adverse effects have been identified on the long term for fish given the behaviour of fibres in surface waters and their safe profile due to its composition. Consequently according to the section 1 of the Annex XI or REACH, an OECD 210 study (Fish, Early-life Stage Toxicity Test) is not scientifically justified.
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.