Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: - | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation 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:
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
see additional information - general population.
General Population - Hazard via inhalation 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:
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
- 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.
The hazard assessment of inorganic UVCBs for the purpose of classification and derivation of safe effect thresholds (i.e. DNELs) 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 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 DNELs of the constituent (forwarded to the risk assessment). 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 further exposure and risk assessment (CSR, Chapters 9 & 10).
The hazard profile of the inorganic UVCB and the individual constituents is dependent on their chemical speciation andhence this information needs to be collected in order to obtain a robust classification or DNEL value used for risk assessment purposes.
Depending on the level of knowledge, the following situations can be distinguished:
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. maximum concentrations across industry), using the MeClas tool. Depending on the availability of information, the UVCB classification can be refined following MeClas Tiered approach.
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 on the 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.
As this UVCB substance does not meet any criteria for classification as hazardous (according to Directives 67/548/EEC and 1272/2008/EC) nor is it considered to be a PBT/vPvB an exposure assessment and the subsequent step of risk characterisation is not required.
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.
