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Toxicological Summary

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Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The hazard assessment of inorganic UVCBs for the purpose of classification and derivation of threshold values (i.e. DNELs) is a complex process. Due to the variability of the composition of an UVCB, it is not possible to select a sample that would be representative for the hazard profile of the UVCB and could subsequently be used for toxicity testing. Instead of testing, a precautionary approach is followed in which the UVCB nature of a complex metal containing substance having a number of constituents (metals and their compounds or other inorganic compounds) is acknowledged. The hazard profile of each individual constituent is used for deriving the classification of the UVCB (using the mixture rules) and for the derivation of the DNELs of the constituent. Using the unmodified DNEL values of all individual constituents addresses the varying composition of an UVCB on a pre-cautionary basis as it implicitly assumes that the UVCB entirely consists of the specific constituent, i.e. that each constituent would be present to 100% in the UVCB. Thus, this hazard assessment can be considered a conservative approach. The identification of constituents which are hazardous for human health also defines the scope of the exposure assessment and risk characterisation (Chapters 9 & 10).

 

The hazard profile of the inorganic UVCB and the individual constituents is dependent on their chemical speciation.Depending on the level of knowledge, the following situations can be distinguished:

 

·      If chemical speciation of the constituent in the UVCB is known, this is used for classification.

·      If chemical speciation of the constituent as present in the workplace is known, this is used for risk characterisation.

·      When information on chemical speciation is not complete, the worst-case speciation for the purpose of risk characterisation and classificationis assumed, i.e. the speciation that would lead to the most severe classification or to the lowest DNEL.It is noted that different chemical species could be relevant (see below).

 

Selection of toxicological information for classification

 

The UVCB classification is calculated by applying the CLP mixture rules based on the classification of the known or worst-case speciation of each constituent and worst-case constituent concentration in the UVCB (i.e. the maximum value of the typical concentration reported by the individual legal entities), using the MeClas tool.

 

Selection of toxicological information for risk assessment

 

For the purpose of the human health risk assessment for the UVCB, the hazards of each constituent will be assessed and DNEL values for constituents for which a hazard has been identified are compiled. As indicated above, workers may be exposed to different chemical species compared to those present in the UVCB. Hence, the information onthe intrinsic properties of the UVCB constituents relevant for classification can be refined if it is known which chemical species is present in the workplace. If speciation is unknown, the chemical species of an individual constituent is considered having the lowest DNEL which could be different when compared to the species used for classification.

 

For the sake of readability of the CSR and the IUCLID, the below sections therefore outlinetoxicity effects derived for the UVCBitself. Information on hazards linked to speciation occurring in case individual constituents of the UVCB (see CSR 3.0 Introduction to Classification) are released during production/use of the UVCB are reported in a annex II separate annex of this CSR, if deemed relevant for the risk assessment.

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

 

Hazard conclusions for the purpose of 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 health endpoints, UVCB classifications are based on the combined hazards of the compounds whereby additivity or key cut off levels, specified in look-up tables are used, depending on the endpoint and amount of information available for the constituting compounds. 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.

 

Table34:Summary of the information on toxicological information for the purpose of classification

UVCB constituent

Variability of elemental composition

 

Classification according each relevant endpoint

Element

Speciation* in composition

 

 

As

As2O3/ AsO3

Maximum of typicals

Harmonised classification of the speciation

Ca

CaSO4

Maximum of typicals

Self classification of the speciation

Cd

CdSO4

Maximum of typicals

Harmonised classification of the speciation

Cu

CuSO4

Maximum of typicals

Harmonised and worst-case self classification of the speciation

Mn

MnO2

Maximum of typicals

Harmonised classification of the speciation

Ni

NiSO4

Maximum of typicals

Harmonised classification of the speciation

Pb

Lead compounds with the exception of those specified elsewhere in Annex VI

Maximum of typicals

Harmonised and worst-case self classification of the speciation

S

Metal sulfides/sulphates

Maximum of typicals

Classification: see metal specific entry

Sb

Sb compounds, with the exception of the tetroxide (Sb2O4), pentoxide (Sb2O5), trisulphide (Sb2S3), pentasulphide (Sb2S5) and those specified elsewhere in Annex VI

Maximum of typicals

Harmonised classification of the speciation

Se

Selenium compounds except cadmium sulphoselenide

Maximum of typicals

Harmonised classification of the speciation

Te

Te

Maximum of typicals

Self classification of the speciation

Zn

ZnSO4

Maximum of typicals

Harmonised classification of the speciation

Minors

Sulphide/compounds or metal

Maximum of typicals

Below 0.1% and/or the speciation not impacting classification, see MECLAS report in CSR Annex I

* see IUCLID/CSR section 1.2 composition and IUCLID 4.23 additional Physico-chemical Information

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The UVCB is an intermediate, with a very limited life cycle (manufacturing and industrial uses only). Exposure of the general population to the UVCB as such is highly unlikely, derivation of DNELs for the UVCB as such is not appropriate. The exposure of the general population is considered to be already included in the dossiers of the constituents. However, DNELs for the general population and the assessment of exposure of man via the environment will be amended by further analysis.