Registration Dossier
Registration Dossier
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EC number: 282-366-3 | CAS number: 84195-61-9 Substance resulting from the smelting of lead and its alloys obtained from primary and secondary sources and including recycled plant intermediates. Composed primarily of arsenic, lead and iron and may contain other residual non-ferrous metals and their compounds.
Toxicological Summary
Administrative data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
