Registration Dossier
Registration Dossier
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EC number: 310-050-8 | CAS number: 102110-49-6
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- other: prediction from hazard class
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: 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:
- Reproductive 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
Test material
- Reference substance name:
- Matte leaching residue
- IUPAC Name:
- Matte leaching residue
- Reference substance name:
- Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.
- EC Number:
- 310-050-8
- EC Name:
- Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.
- Cas Number:
- 102110-49-6
- IUPAC Name:
- Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.
- Details on test material:
- No further details
Constituent 1
Constituent 2
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Remarks on result:
- not measured/tested
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- not measured/tested
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
According to MeClas, the substance is classified as Reproductive Tox. Cat. 1A - H360.
Applicant's summary and conclusion
- Conclusions:
- The study provides a conservative estimate of reproductive toxicity. The analysed UVCB sample is classified as Reproductive Tox. Cat. 1A - H360.
- Executive summary:
The study provided a conservative estimate, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample.
Validity of the model used:
1. Defined endpoint: the endpoint is a REACH compliant defined endpoint
2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria
3. Applicability domain: applicable to classify complex metal containing materials.
4. 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.
