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Ecotoxicological information

Long-term toxicity to fish

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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.

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 
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.

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 
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

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 
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.

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 
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.

 

 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

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).

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.