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Toxicity to microorganisms

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Endpoint:
activated sludge respiration inhibition testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The full justification for the waiving of this endpoint is detailled in the document enclosed "Toxicity to microorganisms_waiving argumentation".
The studies mentionned in the justification enclosed are detailled as weight of evidence in the other endpoints of the section 6.1.7 of the IUCLID dossier.
Validity criteria fulfilled:
not applicable
Conclusions:
The study of this end-point is scientifically unjustified. MMVF fibres are inorganic which are slightly soluble through non-reversible leaching of inorganic chemical species, which are naturally occurring in drinking water and which leaches to a concentration level (see 4.8 Water solubility) not exceeding the level that can be expected in the influent of the sewage treatment plant. Adaptation according to column 2 of Annex VIII.
Endpoint:
activated sludge respiration inhibition testing
Type of information:
other: ECHA guidance "How to fulfil your information requirements at tonnages 1-10 and 10-100 tonnes per year”
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Official documentation from ECHA
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:
This practical guide is indicating from pages 98 to 100 is presenting elements to help understand if this test is feasible and necessary, and if not how to justify it.
Figure 50 is of interest as it indicates a desicion scheme in order to help deciding if performing an activated sludge microorganisms test is required or not.
Conclusions:
This practical guide is indicating from pages 98 to 100 is presenting elements to help understand if this test is feasible and necessary, and if not how to justify it.
Figure 50 is of interest as it indicates a desicion scheme in order to help deciding if performing an activated sludge microorganisms test is required or not.
Executive summary:

This practical guide is indicating from pages 98 to 100 is presenting elements to help understand if this test is feasible and necessary, and if not how to justify it.

Figure 50 is of interest as it indicates a desicion scheme in order to help deciding if performing an activated sludge microorganisms test is required or not.

Endpoint:
activated sludge respiration inhibition testing
Type of information:
other: ECHA guidance
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: ECHA official documentation
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:
Guidance used for the description of the registration exemption conditions of glass.
Conclusions:
Guidance used for the description of the registration exemption conditions of glass.
Executive summary:

Guidance used for the description of the registration exemption conditions of glass.

Endpoint:
activated sludge respiration inhibition testing
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 required
Principles of method if other than guideline:
No testing performed.
GLP compliance:
not specified
Remarks:
not applicable
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:
« L’ion calcium est un second messager universel, utilisé par tous les types cellulaires dans les étapes précoces de la réponse à de nombreux stimulus. »
=> Calcium ion is the second universal messenger, used by all cells types in the early stages of the answer to several stimuli.
Conclusions:
« L’ion calcium est un second messager universel, utilisé par tous les types cellulaires dans les étapes précoces de la réponse à de nombreux stimulus. »
=> Calcium ion is the second universal messenger, used by all cells types in the early stages of the answer to several stimuli.
Executive summary:

« L’ion calcium est un second messager universel, utilisé par tous les types cellulaires dans les étapes précoces de la réponse à de nombreux stimulus. »

=> Calcium ion is the second universal messenger, used by all cells types in the early stages of the answer to several stimuli.

Endpoint:
activated sludge respiration inhibition testing
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 followed
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:
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 compositions 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:
activated sludge respiration inhibition testing
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 (ICP-AES). Based on the measurements the dissolution rates were calculated. A dissolution rate si for the network kSi was calculated based on the dissolutio
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:
activated sludge respiration inhibition testing
Type of information:
other: Scientific litterature
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 followed
Principles of method if other than guideline:
No testing performed, general information on microorganisms.
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 microorganisms (e.g. bacteria) are composed of 95% of C, H, O, N, S, P, K, Ca, Mg, Fe. All of these elements constitute the elementary needs. To feed, microorganisms do not ingest and do not phagocytose. Nutrients are absorbed and diffuse through their walls by simple diffusion, facilitated diffusion or active transport. The microorganisms of the STPs (bacteria, fungi, etc.) are therefore not impacted by the fibrous form of the glass fibres. They are, in view of their mode of nutrition, sensitive to the chemical composition of their environment.
Conclusions:
The microorganisms (e.g. bacteria) are composed of 95% of C, H, O, N, S, P, K, Ca, Mg, Fe. All of these elements constitute the elementary needs. To feed, microorganisms do not ingest and do not phagocytose. Nutrients are absorbed and diffuse through their walls by simple diffusion, facilitated diffusion or active transport. The microorganisms of the STPs (bacteria, fungi, etc.) are therefore not impacted by the fibrous form of the glass fibres. They are, in view of their mode of nutrition, sensitive to the chemical composition of their environment.
Executive summary:

The microorganisms (e.g. bacteria) are composed of 95% of C, H, O, N, S, P, K, Ca, Mg, Fe. All of these elements constitute the elementary needs. To feed, microorganisms do not ingest and do not phagocytose. Nutrients are absorbed and diffuse through their walls by simple diffusion, facilitated diffusion or active transport. The microorganisms of the STPs (bacteria, fungi, etc.) are therefore not impacted by the fibrous form of the glass fibres. They are, in view of their mode of nutrition, sensitive to the chemical composition of their environment.

Endpoint:
activated sludge respiration inhibition testing
Type of information:
other: Scientific demonstration of the glass exemption by Glass Alliance Europe
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Robust scientific argumentation
Qualifier:
no guideline required
Principles of method if other than guideline:
No testing performed - scientific review.
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 a substance of variable composition, which for simplicity is expressed by convention in terms of oxide of the constituents’ elements (SiO2, Na2O, CaO, B2O3, etc). Although conventionally, glass compositions are expressed as oxides of the different components, glass is a non-crystalline or vitreous inorganic macromolecular structure, which does not contain the chemical components of the different raw materials.

The glass classification is normally made considering the chemical composition. The DRAFT GLASS BREF gives four main categories:
- soda-lime-silica glass
- borosilicate glass
- lead crystal glass
- specialty glass
The principle glass compositions for each common type of glass are shown below. As stated glass may contain minor constituents but these are normally below 1%. This dossier should not be interpreted as covering glasses where such minor constituents exceed 1% unless supported by test evidence.

Soda-lime-silica glass represents more than 95 % of the glass produced in Europe. A typical soda-lime-silica glass composition is normally included between the following percentages:
- 71-75 % silicon dioxide (derived mainly from quartz sand)
- 12-16 % sodium oxide (mainly from soda ash)
- 10-15 % calcium oxide (mainly from limestone)
- 0.5-3 % aluminium oxide (mainly from feldspar or oxides of aluminium)
Low levels (normally below 1 % w/w) of other components can be present to impart specific properties to the glass.
Conclusions:
Soda-lime-silica glass represents more than 95 % of the glass produced in Europe. A typical soda-lime-silica glass composition is normally included between the following percentages:
71-75 % silicon dioxide (derived mainly from quartz sand)
12-16 % sodium oxide (mainly from soda ash)
10-15 % calcium oxide (mainly from limestone)
0.5-3 % aluminium oxide (mainly from feldspar or oxides of aluminium)
Executive summary:

Soda-lime-silica glass represents more than 95 % of the glass produced in Europe. A typical soda-lime-silica glass composition is normally included between the following percentages:

  • 71-75 % silicon dioxide (derived mainly from quartz sand)
  • 12-16 % sodium oxide (mainly from soda ash)
  • 10-15 % calcium oxide (mainly from limestone)
  • 0.5-3 % aluminium oxide (mainly from feldspar or oxides of aluminium)
Endpoint:
activated sludge respiration inhibition testing
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:
other: scientific review
Qualifier:
no guideline followed
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 tomic 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:
activated sludge respiration inhibition testing
Type of information:
other: Official document from WHO
Adequacy of study:
weight of evidence
Study period:
not determined
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
No testing performed.
Key result
Dose descriptor:
other:
Remarks:
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, trichloroacetonitrile)
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.

Description of key information

No impact on micro-organism living in STP is expected; consequently according to the section 1 of the Annex XI or REACH, OECD 209 (Activated sludge, Respiration Inhibition Test) and 224 (Determination of the Inhibition of the activity of Anaerobic bacteria) are not scientifically justified.

The fact that MMVF has no effect on micro-organisms from activated sludge of waste-water treatment plants can be deducted from:

1.      the safe profile of MMVF due to its composition

2. the absence of any specific effect due to the form of the substance (fibers) on micro-organisms present in STP

3.      the release of MMVF leachate that will have no impact on the composition of the sludge and consequently no effect on STP micro-organisms

4.      OECD relevant tests are not applicable to mineral fibres

Key value for chemical safety assessment

Additional information

No impact on micro-organism living in STP is expected; consequently according to the section 1 of the Annex XI or REACH, OECD 209 (Activated sludge, Respiration Inhibition Test) and 224 (Determination of the Inhibition of the activity of Anaerobic bacteria) are not scientifically justified.

The fact that MMVF has no effect on micro-organisms from activated sludge of waste-water treatment plants can be deducted from:

1.      the safe profile of MMVF due to its composition

2. the absence of any specific effect due to the form of the substance (fibers) on micro-organisms present in STP

3.      the release of MMVF leachate that will have no impact on the composition of the sludge and consequently no effect on STP micro-organisms

4.      OECD relevant tests are not applicable to mineral fibres