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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
long-term toxicity to aquatic invertebrates
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 teh document "Long term toxicity to aquatic invertebrates_WoE" below.
The studies mentionned in the justification enclosed are detailed as weight of evidence in the other endpois of the seciotn 6.1.4 of the IUCLID dossier.
Validity criteria fulfilled:
not applicable
Conclusions:
This endpoint is waived, because the short-term toxicity to invertebrates presented in the end-point 6.1.1 showed that MMVF note Q fibres have no adverse effects to invertebrates. The leached species are inorganic ions leached at a level known not to show any long-term toxicity to invertebrates (See 4.8 Water solubility). Consequently, no adverse effect to invertebrates is expected on long-term from the substance. Thus carrying out such a study is not scientifically justified.
Endpoint:
long-term toxicity to aquatic invertebrates
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.
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:
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 function 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 days 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:
long-term toxicity to aquatic invertebrates
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:
long-term toxicity to aquatic invertebrates
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
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:
long-term toxicity to aquatic invertebrates
Type of information:
other: Publication
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 required
Principles of method if other than guideline:
The Gut Transit Time (GTT) was calculated at the beginning of each experiment, adapted and slighty modified from Hawkins et al. (1996).
GLP compliance:
not specified
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
other aquatic mollusc: M. galloprovincialis
Details on test organisms:
Mussels, M. galloprovincialis, were collected from a mussel aquaculture farming site in Alfacs Bay (Ebro Delta) the day before each experiment. Ten individuals per experiment were collected (shell length 36–87 mm, according to the season), and epiphytes and other encrusting organisms were removed from the shells. Once cleaned, the mussels were hung back on the raft where the experiments were performed. Acclimation was not necessary as the mussels were permanently submerged in the bay water.
Test type:
not specified
Water media type:
not specified
Limit test:
no
Hardness:
Not specified
Test temperature:
Not specified
pH:
Not specified
Dissolved oxygen:
Not specified
Salinity:
Not specified
Conductivity:
Not specified
Nominal and measured concentrations:
Not specified
Duration:
0 min
Dose descriptor:
other: Not applicable
Effect conc.:
0 g/L
Details on results:
Fiberglass was found in the bay water, and in the stomach, feces and pseudofeces of mussels. There were no significant differences between the sizes of fiberglass from the different types of samples (p > 0.05). Average lengths and widths of fiberglass were 280.09 ± 301.69 lm and 7.62 ± 1.27 lm, respectively. Though the lengths counted were very variable (minimum of 28.12 lm and maximum of 1908.57 lm), the distribution pattern showed a high abundance of shorter fiberglass (<200 lm), with a mode value of 65.83 lm.
Conclusions:
The lengths of the fiberglass in the different types of samples studied are within the threshold of mussel ingested particles. The fiberglass found in all types of samples in these experiments varied greatly in lengths; the mussels from Alfacs Bay did not, therefore, reject the fiberglass on the basis of its length. Authors suggests that the selection efficiency of bivalves should be interpreted in the context of the particle composition and concentration of the water in their natural habitats. Authors do not know why mussels ingested fiberglass but, the reason does not seem to be related to size, it could, however, be related to other factors. In this sense, the major chemical component found in the fiberglass was Si, which is excreted by mussels and is usually dependant on the amount of diatoms ingested.
The results of their analysis showed that calcium was the third main component of the fiberglass. The shells of bivalves are formed by the deposition of crystals of calcium carbonate in an organic matrix. Calcium for shell growth is obtained from either their diet or from sea water. Thus, calcium from MMVF could be of use to mussels.
Executive summary:

The lengths of the fiberglass in the different types of samples studied are within the threshold of mussel ingested particles. The fiberglass found in all types of samples in these experiments varied greatly in lengths; the mussels from Alfacs Bay did not, therefore, reject the fiberglass on the basis of its length. Authors suggests that the selection efficiency of bivalves should be interpreted in the context of the particle composition and concentration of the water in their natural habitats. Authors do not know why mussels ingested fiberglass but, the reason does not seem to be related to size, it could, however, be related to other factors. In this sense, the major chemical component found in the fiberglass was Si, which is excreted by mussels and is usually dependant on the amount of diatoms ingested.

The results of their analysis showed that calcium was the third main component of the fiberglass. The shells of bivalves are formed by the deposition of crystals of calcium carbonate in an organic matrix. Calcium for shell growth is obtained from either their diet or from sea water. Thus, calcium from MMVF could be of use to mussels.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
other: Publication
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 required
Principles of method if other than guideline:
Three types of feeding experiments were conducted: The first series was directed to a comparison of gut contents after the animals were exposed to a mixture of differently sized particles. The second series was done by directly observing the feeding behaviour of single animals when particles of different sizes were offered consecutively to the same animal. In the third type of experiments small bacteria isolated from natural waters were given as food and relative feeding rates of four species were calculated after counting the number of bacteria present in the intestinal tract.

In both types of experiments the mesh sizes of the filtering apparatus of the respective animals studied were measured after the experiments by scanning electron miscroscopy.
GLP compliance:
not specified
Specific details on test material used for the study:
The feeding experiments were conducted with spherical particles of defined diameters: polystyrene latex beads (Plano GmbH, FRG), Thomaspher (Reichelt Chemie, FRG) and Sephatex particles (Pharmacia, FRG), and micronic beads (Ionics Inc., USA).
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
Daphnia sp.
Details on test organisms:
The experiments were carried out with clone cultures of two Daphnia species collected from ponds: Daphnia magna and Daphnia pulicaria, and two species originating from Lake Constance: Daphnia hyalina and Daphnia galeata.
Test type:
not specified
Water media type:
not specified
Limit test:
no
Total exposure duration:
60 min
Hardness:
Not specified
Test temperature:
Not specified
pH:
Not specified
Dissolved oxygen:
Not specified
Salinity:
Not specified
Conductivity:
Not specified
Nominal and measured concentrations:
Not specified
Reference substance (positive control):
no
Duration:
60 min
Dose descriptor:
other: Not applicable
Effect conc.:
0 g/L
Conclusions:
In all species of Daphnia the highest increase of food uptake activites or of the selectivity index occured at particle sizes about 0.5 µm. In all experiments the distributions of the indices of selectivity and the increase of the feeding activity as found for the different size classes followed very closely the pattern of the frequency distributions of mesh sizes. The change from low to high feeding activities and the shifts of the selectivity indices from negative to positive values were closely related to the observed mean mesh sizes.
This study suggests that the daphnids retain the particles smaller than the means of the mesh sizes by the partial areas of the filter combs with very fine (0.2-0.5 µm) meshes as observed near the tips of the setae. Decreased relative efficiencies of the uptake of bacteria were found by several authors who offered suspensions of both, algal cells and bacteria, to daphnia.
Executive summary:

Food size selection of four Daphnia species (D. magna, D. hyalina, D. galeata, D. pulicaria) was investigated using spherical plastic beads as artificial food and with small bacteria. The size of the particles ranged from 0.1 to 35 µm with special emphasis to the particle diameters between 0.1 and 1 µm. In one set of experiments a mixture of differently sized particles was offered as food suspension and the selectivity of filtering was determined by comparing the size spectrum of the particles found in the gut contents with the spectrum in the food suspension. In a second series of experiments suspensions of uniformly sized particles were offered to single animals and their feeding activity was observed directly. In both types of experiments the mesh sizes of the filtering apparatus of the respective animals studied were measured after the experiments by scanning electron microscopy. The mean sizes of the filter meshes were about 0.44- 0.7 µm. In all experiments the size of the particles found in the gut or those which caused high feeding activities were larger than the smallest mesh sizes of the filters. As a consequence simple mechanical sieving provides a sufficient explanation for the mechanism of particle retention of the filtering process in Daphnia. D. magna was found to feed with high efficiency on suspended freshwater bacteria, the residual species investigated showed low filtering efficiencies when bacteria were offered as food.

Endpoint:
long-term toxicity to aquatic invertebrates
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
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:
long-term toxicity to aquatic invertebrates
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 for this endpoint.
Dose descriptor:
other: not appicable
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:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008.01.29 - 2008.10.31
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 202 (daphnia sp. Acute Immobilisation test)
Deviations:
not specified
GLP compliance:
yes
Specific details on test material used for the study:
Not relevant
Analytical monitoring:
yes
Details on sampling:
In order to verify the concentration of the test product in the solution, 8 subsamples of approximately 2 x 40 mL each were taken for chemical analysis of silicate (Si). The duplicate samples were taken from the following nominal concentrations and from the daphnia test medium:
100, 200, 500 and 1000 mg/L at test start.
100, 200, 500 and 1000 mg/L at t = 24 hours (at renewal)
One sample from each concentration was sent to MILANA for chemical analysis of silicate content.
Vehicle:
yes
Details on test solutions:
Nominal concentrations of 0 (control), 20, 50, 100, 200, 500 and 1000 mg/L were used. The four highest test concentrations, 100-1000 mg/L, were prepared separately by weighing out the required amount of test product directly to the measuring flasks and test medium was added to the flasks.
After stirring for 2 hours, pH was adjusted to 7.9 ± 0.1 with a sodium hydroxide solution and the mixtures were transferred to the vessels.
The test solutions at the test concentrations 20-50 mg/L were prepared by diluting a stock solution of 100 mg/L in test medium after 2 hours of stirring.
As the test product precipitated, the test was run as a semi-static test with renewal of all test solutions and the above precipitation procedure was thus repeated after 24 hours.
Test organisms (species):
Daphnia magna
Details on test organisms:
A strain of Daphnia magna Straus (Cladocera, Crustacea), collected in Langedam, Birkerod, has been cultured at DHI since 1979. The culture is fed with Pseudokirchneriella subcapitata three times a day by a peristaltic pump system. Young animals (less than 24 hours old) from this culture were exposed to a dilution series of the test product. At the beginning of the test, the individual test vessels were identified by GLP Study No., test concentration, date of start and technician's initials. Freshly produced ISO-medium was used in the tests. The medium was prepared from MQ water, and salts were added to the water according to the standard procedure.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
3 d
Post exposure observation period:
48 hours
Hardness:
252 mg/L expressed as CaCO3
Test temperature:
19.7 ± 0 °C
pH:
Start: 7.6 - 8.0. End: 7.6 - 7.2.
Dissolved oxygen:
98-100 % saturation
Salinity:
No data.
Nominal and measured concentrations:
Initiation of the test:
Nominal: 100 mg/L. Actual: 184 microgram Si/L.
Nominal: 1000 mg/L. Actual: 525 microgram Si/L.

After 24 hours:
Nominal: 100 mg/L. Actual: 164 microgram Si/L.
Nominal: 1000 mg/L. Actual: 317 microgram Si/L.

Average Si content at 1000 mg/L (nominal) extracted the content of the control samples (34 microgram/L): 387 microgram Si/L. This corresponds to an actual concentration of 2.01 mg fibre/L.
Details on test conditions:
The substance was tested for acute toxic effects on the crustacean Daphnia magna according to the OECD Guideline for testing of chemicals No. 202:Daphnia sp., Acute Immobilization Test, which is further specified in the ISO International Standard 6341 “Water quality-Determination of the inhibition of the mobility of Daphnia magna Straus (Cladocera, Crustacea) Acute toxicity test”. The following nominal test concentrations were applied: control (0); 20; 50; 100; 200; 500 and 1000 mg/L. Before preparing the test solutions the test material was divided into fine particles using a mortar. The three highest test concentrations, 200 – 1000 mg/L, were prepared separately by weighing out the required amount of the test product directly to the measuring flasks and test medium was added to the flasks. After stirring for 2 hours, the mixtures were transferred to the test beakers. The test concentrations 20 – 100 mg/L were prepared by diluting a stock solution of 100 mg/L in test medium after stirring as above. The test solution was changed every day. The reference substance was analytical grade potassium dichromate (Merck 4864, batch No. K30614564 227). For eventual verification of the actual test concentrations samples from the test solutions have been taken and stored at -20 °C.
Reference substance (positive control):
yes
Remarks:
potassium dicromate (0.4, 0.7, 1.0, 1.4, 2.0 and 3.0 mg/L)
Duration:
3 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
immobilisation
Remarks:
mobility
Duration:
3 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
immobilisation
Remarks:
mobility
Duration:
3 d
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
immobilisation
Remarks:
mobility
Details on results:
No immobilization was observed in any of the exposure concentrations. Based on the results EC10 and EC50 are indicated as > 1000 mg/L (nominal).
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- EC50: 0.79 mg/L (95% confidence interval: 0.67 - 0.92)
Reported statistics and error estimates:
EC10 and EC50 for the reference substance were calculated by use of Probit Analysis.

Actual fibre concentrations were determined by MILANA (Denmark) by using the Koroleff method (MODAK 165). The silicate concentration of the stock solution was 184 micrograms/L (nominal 100 mg/L) and

525 micrograms/L (nominal 1000 mg/L) at initiation of the test. After 24 hours the concentrations were found to be 164 and 317 micrograms/L, respectively. Silicate concentration in the control samples was found to be 34 micrograms/L. This corresponds to an average of 2.01 mg/L test fibre in the test samples.

Results for potassium dicromate:

 Time point 24 hours 
EC10  0.30 (0.07 - 0.45) mg/L 
 EC50 0.79 (0.67 - 0.92) mg/L 
 EC90  1.28 (1.11 - 1.54) mg/L

Note. Figures in brackets are 95% confidence interval.

Validity criteria fulfilled:
yes
Conclusions:
The test substance did not show acute toxicity to Daphnia magna at the highest tested dose level (1000 mg/L). Thus NOEL >= 1000 mg/L.
Executive summary:

The substance was tested for acute toxic effects on the crustacean Daphnia magna according to the OECD Guideline for testing of chemicals No. 202: Daphnia sp., Acute Immobilization Test, which is further specified in the ISO International Standard 6341 “Water quality-Determination of the inhibition of the mobility of Daphnia magna Straus (Cladocera, Crustacea) Acute toxicity test”. The test substance did not show acute toxicity to Daphnia magna at the highest tested dose level (1000 mg/L). Thus NOEL >= 1000 mg/L.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
other: Review
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 required
Principles of method if other than guideline:
This publication is a scientific review. No Guideline required.
GLP compliance:
no
Analytical monitoring:
not required
Vehicle:
no
Details on test organisms:
zooplankton organisms
Duration:
0 min
Dose descriptor:
other: Not applicable
Effect conc.:
0 g/L
Conclusions:
The mean sizes of the filter pores (daphnia species) were about 0.4 to 0.7 µm, and in all experiments the size of the particles found in the gut were larger than the smallest filter-mesg sizes.
Executive summary:

A large number of suspension-feeding aquatic animals (e.g. bivalves, polychaetes, ascidians, bryozoans, crustaceans, sponges, echinoderms, cnidarians) have specialized in grazing on not only the 2 to 200 µm phytoplankton but frequently also the 0.5 to 2 µm free-living bacteria, or they have specialized in capturing larger prey, e.g. zooplankton organisms. We review the different particle capture mechanisms in order to illustrate the many solutions to the common problem of obtaining nourishment from a dilute suspension of microscopic food particles. Despite the many differences in morphology and living conditions, particle capture mechanisms may be divided into 2 main types:

(1) Filtering or sieving (e.g. through mucus nets, stiff cilia, filter setae), which is found in passive suspension feeders that rely on external currents to bring suspended particles to the filter, and in active suspension feeders that themselves produce a feeding flow by a variety of pump systems. Here the inventiveness of nature does not lie in the capture mechanism but in the type of pump system and filter pore-size.

(2) A paddle-like flow manipulating system (e.g. cilia, cirri, tentacles, hair-bearing appendages) that acts to redirect an approaching suspended particle, often along with a surrounding ‘fluid parcel’, to a strategic location for arrest or further transport.

Examples include (1) sieving (e.g. by microvilli in sponge choanocytes, mucus nets in polychaetes, acidians, and salps among others), filter setae in crustaceans, ‘ciliary sieving’ by stiff laterofrontal cilia in bryozoans and phoronids; and (2) ‘cirri trapping’ in mussels and other bivalves with eu-laterofrontal cirri, ciliary ‘catch-up’ in bivalve and gastropod veliger larvae, some polychaetes, entroprocts, and cycliophores. These capture mechanisms may involve contact with a particle, and possibly mechanoreception or chemoreception, or may include redirection of particles by the interaction of multiple currents (e.g. in scallops and other bivalves without eu-laterofrontal cirri).

Description of key information

No adverse effects have been identified on the long term for aquatic invertebrate given their morphology, 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 211 study (daphnia magna reproduction test) is not scientifically justified.

Key value for chemical safety assessment

Additional information

No adverse effects have been identified on the long term for aquatic invertebrate given their morphology, 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 211 study (daphnia magna reproduction test) is not scientifically justified.