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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

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 outline toxicity effects derived for the UVCB itself. The UVCB is a complex inorganic metals-containing substance. The physico-chemical characterisation of the UVCB (see relevant section in IUCLID) demonstrates that metal species (intermetallic, 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 metals-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.


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



As



Maximum of maxima



Harmonised and self-classification



Ca



CaO



Maximum of typicals



Self classification



Cd



Cd (pyrophoric)



Maximum of maxima



Harmonised classification 



Co



Co powder



Maximum of maxima



Harmonised and self-classification 



Ni



Ni massive



Maximum of maxima



Harmonised classification



Pb



Pb massive



Maximum of maxima



Harmonised and self-classification 



 



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



Maximum of maxima



Harmonised and self-classification 



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 maxima



Harmonised classification



Se



Selenium compounds except cadmium sulphoselenide



Maximum of typicals



Harmonised classification



Te



Te compounds 



Maximum of typicals



Self-classification 



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 4.27 additional Physico-chemical Information


 


  


Selection of the DNEL(s) for the purpose of risk assessment


 


 See CSR Annex III.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

The UVCB is an intermediate, with a very limited lifecycle (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 (MvE) will be reviewed and potentially amended by further analysis, in light of any relevant outcomes of the MISA project.

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