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Ecotoxicological Summary

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Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

The hazard assessment of inorganic UVCBs for the purpose of classification and derivation of safe effect thresholds (i.e. PNEC) is a cumbersome and complex process. Due to the intrinsic variability of the composition of an UVCB, it is difficult to select a sample that would unambiguously be representative for the (eco)toxicological hazard profile of the UVCB and could subsequently be used for testing. Instead of direct testing, a precautionary approach is taken where the UVCB is treated as a complex metal containing substance containing a number of discrete constituents (metals, metal compounds, non-metal inorganic compounds etc.). For each of these constituents, the hazard profile is used for deriving the proper classification of the UVCB (using the mixture rules) and/or for the derivation of the PNECs of the constituent (forwarded to the risk assessment). Using the PNEC of all individual constituents circumvents indirectly the issue of varying composition of an UVCB as it implicitly assumes that each time the UVCB substance consists of the pure substance, i.e. that each constituent would be present and bioavailable at a 100% concentration in the UVCB substance. This can be considered a conservative approach. A main outcome of the constituents’ based assessment is the selection of all the constituents for which any environmental hazard is identified. This selection defines the scope of the further exposure and risk assessment (CSR, Ch. 9&10).

 

The actual hazard profile of the inorganic UVCB substance and the individual constituents is dependent on the speciation of each and every constituent andhence this information needs to be collected in order to obtain a robust classification or PNEC value used for risk assessment purposes. Different scenarios can be encountered.

·      When the speciation of a constituent is known, this is used as such for the environmental hazard assessment.

·      When the speciation is unknown or few metal species co-exist, the worst-case speciation for the purpose of environmental hazard assessment is selected, i.e. the speciation that would lead to the most severe effects and thus the lowest PNEC.

 

For most metals, it is generally assumed that the Me-ion is the metal species of concern and therefore, the environmental hazard assessment is generally based on Me-ion speciation (ECHA, 2008.Guidance on information requirements and chemical safety assessment; Appendix R.7.13-2: Environmental risk assessment for metals and metal compounds)

 

Selection of the ecotoxicological information for the purpose of classification

 

The UVCB classification is calculated by applying the CLP mixture rules based on the classification of the known or worst-case speciation for each constituent and worst-case constituent concentration in the UVCB (i.e. maximum of the legal entity typical value), using the MeClas tool. Depending on the availability of information, the UVCB classification can be refined following MeClas Tiered approach.

 

Selection of the ecotoxicological information for the purpose of risk assessment

 

For the purpose of the environmental risk assessment for the UVCB,the hazards of each constituent will be assessed and PNEC values for all the constituentsfor which a hazard has been identifiedare compiled.

The UVCB is a complex inorganic metals containing substance. The physico-chemical characterization of the UVCB (see relevant section in IUCLID) demonstrates the presence of different metal species; intermetallic and metal sulphides which resulted in sparingly to low solubilisation potential in water for most of the metals present in the UVCB (eg Cu, Ag, As).

The UVCB is an intermediate, with a very limited life cycle (manufacturing and industrial uses only).Testing the UVCB is difficult because of the large uncertainty involved when selecting representative samples due to the variable elemental concentrations in the composition of the UVCB.Derivation of PNECs for the UVCB as such are therefore difficult to interpretbecause of the uncertainty related to the representativeness of the testing. Also, exposure to the UVCB cannot be measured or modelled because of the multi-constituent character of the UVCB.For these reasons,the UVCB environmental (hazard) assessment is driven by the assessment of the individual UVCB constituents.

For the purpose of the classification, the UVCB is treated as a complex metal containing substance with a number of discrete constituting compounds (metals, metal compounds, non-metal inorganic compounds). The hazard classifications of each compound are then factored into a combined classification of the UVCB as a whole. For environmental endpoints, additivity and/or summation algorithms are applied to quantitatively estimate the mixture’s toxicity to aquatic organisms.

For the purpose of the environmental (risk) assessment, the ecotoxicological information that was taken forward is based on all hazardous constituents of all relevant UVCBs at the site for which quantitative exposure and risk assessment wasconducted. For the environment, most often, it is the metal ion that is the toxic driver (ECHA, 2008, R.7.13-2). Consequently, the PNECs expressed as metal ion are the relevant ones to forward to risk characterisation. Considering the composition of this UVCB, full solubilisation of the emissions of the various constituting speciation is metals are assessed. The physical form (powder or massive) does not lead in this case to different release potential of the elements from the UVCB and consequently no different PNECs. When quantitative exposure and risk assessment were conducted on a metalconstituent, the ecotoxicological information on this individual metal is reported in the respective summary sheet. The information is taken from the respective REACH IUCLID dossiers (see annex II of this CSR). More information on the scope of the UVCB assessment can be found in the CSR of the UVCB (Chapter 9).

 

Table48:Summary of the information on toxicological information for the purpose of riskassessment

UVCB constituent

Variability in chemical composition

 

PNECs

 

Element

Speciation used for environmental risk assessment

Cu

Metal ion

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective PNEC summary in IUCLID and table below

S

(Sulfides are transformed to) sulphates

Hazard assumed as if UVCB consists of 100% worst-case speciation

Potential pH-effect on the receiving environmental compartments

Ni

Metal ion

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective PNEC summary in IUCLID and table below

Pb

Metal ion

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective PNEC summary in IUCLID and table below

As

Metal ion

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective PNEC summary in IUCLID and table below

Zn

Metal ion

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective PNEC summary in IUCLID and table below

Co

Metal ion

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective PNEC summary in IUCLID and table below

Sn

Metal ion

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective PNEC summary in IUCLID and table below

Other minors

Metal ion

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective PNEC summary in IUCLID and table below

Oxides

Oxides

Hazard assumed as if UVCB consists of 100% worst-case speciation

Potential pH-effect on the receiving environmental compartments

For the purpose of the risk assessment, the hazard conclusions and the metal-specific PNECs (Predicted No Effect Concentration) were collected for each environmental compartment. An overview of the PNECs relevant for the Copper intermediates is given in the table below. PNEC for arsenic metal was not available. Consequently, one was derived based on arsenic oxide using molecular weight conversion. Elements for which no PNEC is reported inTable49have no relevant environmental hazards and for which there is no need to derive environmental threshold. For oxides, hydroxides and sulphates, there is a potential pH-effect on the receiving environmental compartments.

 

Table49:Overview of hazard conclusions - Predicted No Effect Concentration (PNEC) takenforward for CSA of the the Copper intermediates

Protection target

Unit

Cu

Pb

As

Ni

Cd

Zn (added)

Mn

Ag

Freshwater

μg/L

7.8

6.5

6.5

3.55

0.19

20.6

34

0.04

Marine water

μg/L

5.2

3.4

0.5

8.6

1.14

6.1

3.4

0.86

Freshwater sediment

mg/kgdw

87

174

64.8

69.2

1.8

235.6

3.3

438.13

Marine sediment

mg/kgdw

676

164

4.5

69.2

0.64

113

0.34

438.13

Soil

mg/kgdw

88

147

0.3

29.9

0.9

107

3.4

0.794

STP

μg/L

230

100

30.4

330

20

52

100,000

25

Secondary poisoning

mg/kg food

No hazard identified*

10.9

0.5

12.3

0.16

No hazard identified**

No hazard identified

No or insufficient available at present

 

Protection target

Unit

Cr

Co

Sb

Se

Hg

Ba

Te

Others

Freshwater

μg/L

4.7

0.51

113

2.67

0.0574

227.8

5.79

No hazard

Marine water

μg/L

4.7

2.36

11.3

2

0.0672

/

0.579

No hazard

Freshwater sediment

mg/kgdw

31

9.5

11.2

8.2

9.3

792.7

No exposure

No hazard

Marine sediment

mg/kgdw

31

9.5

2.24

6.2

9.3

/

No exposure

No hazard

Soil

mg/kgdw

3.2

10.9

37

0.1

0.022

207.7

No exposure

No hazard

STP

μg/L

10,000

370

2,550

1,500

2.25

50,100

3.2

No hazard

Secondary poisoning

mg/kg

No hazard identified

No hazard identified

Not needed

1

No or insufficient available at present

No or insufficient a available at present

No potential for biocuumulation

No hazard

 

*Based on the copper risk assessment, it was concluded that secondary poisoning is not relevant. The main arguments are: Copper is an essential trace element, well regulated in all living organisms. Difference in copper uptake rates are related to essential needs, varying with the species, size, life stage, seasons... Copper homeostasic mechanisms are applicable across species with specific processes being active depending on the species, life stages…. The use of BAFs are therefore not adequate. There is overwhelming evidence to show the absence of copper biomagnification across the tropic chain in the aquatic and terrestrial food chains. Field evidence has further provided evidence on the mechanisms of action of copper in the aquatic and terrestrial environment and the absence of a need for concern for secondary poisoning.

**Based on the ICDZ data on bioaccumulation of zinc in animals and on biomagnification (i.e. accumulation and transfer through the food chain), it is concluded that secondary poisoning is considered to be not relevant in the effect assessment of zinc. Major decision points for this conclusion are the following. The accumulation of zinc, an essential element, is regulated in animals of several taxonomic groups, for example in molluscs, crustaceans, fish and mammals. In mammals, one of the two target species for secondary poisoning, both the absorption of zinc from the diet and the excretion of zinc, are regulated. This allows mammals, within certain limits, to maintain their total body zinc level (whole body homeostasis) and to maintain physiologically required levels of zinc in their various tissues, both at low and high dietary zinc intakes. The results of field studies, in which relatively small differences were found in the zinc levels of small mammals from control and polluted sites, are in accordance with the homeostatic mechanism. These data indicate that the bioaccumulation potential of zinc in both herbivorous and carnivorous mammals will be low. Based on the above data, secondary poisoning and the related issues bioaccumulation and biomagnification are not further discussed in this report (Zn RAR).

Conclusion on classification

Environmental classification justification

Grade 1 and 2:

Hazards to the aquatic environment (short-term): Aquatic Acute 1 H400: Very toxic to aquatic life

Hazards to the aquatic environment (long-term): Aquatic Chronic 2 H411: Toxic to aquatic life with long lasting effects.

The estimated hazard is representative for the substance across industry, as defined by the maximum of the typical elemental concentration across industry (as outlined under IUCLID section 1.2).

The UVCB is treated as a complex metal containing substance with a number of discrete constituting compounds (metals, metal compounds, non-metal inorganic compounds). The hazard classifications of each compound are then factored into a combined classification of the UVCB as a whole. The classification was derived using Meclas (MEtals CLASsification tool - see www.meclas.eu), a calculation tool that follows classification guidance and implementation in accordance to legal rules and technical guidance from ECHA and CLP.See IUCLID section 13 attachment for MeClas classification conclusions.

 

Table50:Summary of the information on ecotoxicological information for the purpose ofclassification

UVCB constituent

Variabiliy of elemental composition

Classification according each relevant endpoint

Element

Speciation taken forward for Tier 2 environmental classification

 

 

Cu

Elemental ion

Maximum of typicals

Self-classification of the speciation, see MECLAS report in CSR Annex I

Fe

Elemental ion

Maximum of typicals

Not classified

Pb

Elemental ion

Maximum of typicals

Harmonised and self- classification of the speciation, see MECLAS report in CSR Annex I

Ni

Elemental ion

Maximum of typicals

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

Zn

Elemental ion

Maximum of typicals

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

Al

Elemental ion

Maximum of typicals

Not classified

As

Elemental ion

Maximum of typicals

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

Co

Elemental ion

Maximum of typicals

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

Sn

Elemental ion

Maximum of typicals

Not classified

Sb

Elemental ion

Maximum of typicals

Not classified

S

Elemental ion

Maximum of typicals

Taken into account in corresponding metal sulfides already

Minors: Ag, Au, Ba, Bi, C, Cd, Cr, Mo, Nb, Rh, Se, Sn, Te, Ti

Elemental ion

Maximum of typicals

Below 0.8% and/or the speciation not impacting classification, see MECLAS report in CSR Annex I

oxides

Elemental ion

Maxiumum of typicals

Below 5% and/or the speciation not impacting classification, see MECLAS report in CSR Annex I

* Detailed information on speciation can be found in IUCLID Section 4.23 Additional Physcio-chemical information