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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: -
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation, other
- Remarks:
- other: prediction from hazard class
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- estimated by calculation
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Automatic calculation with MeClas tool
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: software
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
- Principles of method if other than guideline:
- Respiratory sensitisation potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.
- GLP compliance:
- no
- Remarks:
- other quality assurance was applied
Results and discussion
Any other information on results incl. tables
According to MeClas, the substance is not classified as Respiratory sensitiser under CLP.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Good quality, conservative estimate of theRespiratory Sensitising Toxicity of the UVCB substance.
The substance is not classified as respiratory sensitising. - Executive summary:
The study provided a conservative estimate, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case substance representative.
Validity of the model used:
- Defined endpoint: the endpoint is a REACH compliant defined endpoint
- Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria
- Applicability domain: applicable to classify complex metal containing materials.
- Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.
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.
