Registration Dossier
Registration Dossier
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EC number: 947-838-1 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- prediction from hazard class
- Type of information:
- calculation (if not (Q)SAR)
- 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:
- MECLAS: Metals Classification Tool, version V5.0
- Author:
- ARCHE Consulting
- Year:
- 2 018
- Bibliographic source:
- MECLAS webpage: www.meclas.eu
- Report date:
- 2018
Materials and methods
- Principles of method if other than guideline:
- Genetic toxicity 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.
- Type of assay:
- other: prediction from hazard class
Test material
- Reference substance name:
- Germanium dioxide
- EC Number:
- 215-180-8
- EC Name:
- Germanium dioxide
- Cas Number:
- 1310-53-8
- Molecular formula:
- GeO2
- IUPAC Name:
- Germanium dioxide
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane equivalent
- Reference substance name:
- Iron sulphide
- EC Number:
- 215-268-6
- EC Name:
- Iron sulphide
- Cas Number:
- 1317-37-9
- Molecular formula:
- FeS
- IUPAC Name:
- Iron (II) Sulfide
- Reference substance name:
- Calcium carbonate
- EC Number:
- 207-439-9
- EC Name:
- Calcium carbonate
- Cas Number:
- 471-34-1
- Molecular formula:
- CH2O3.Ca
- IUPAC Name:
- calcium carbonate
- Reference substance name:
- Calcium sulfate
- EC Number:
- 231-900-3
- EC Name:
- Calcium sulfate
- Cas Number:
- 7778-18-9
- Molecular formula:
- Ca.H2O4S
- IUPAC Name:
- calcium sulfate
- Reference substance name:
- Calcium fluoride
- EC Number:
- 232-188-7
- EC Name:
- Calcium fluoride
- Cas Number:
- 7789-75-5
- Molecular formula:
- CaF2
- IUPAC Name:
- Calcium fluoride equivalent
- Reference substance name:
- Calcium dihydroxide
- EC Number:
- 215-137-3
- EC Name:
- Calcium dihydroxide
- Cas Number:
- 1305-62-0
- Molecular formula:
- Ca(OH)2
- IUPAC Name:
- Calcium hydroxide equivalent
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Reference substance name:
- Lead oxide
- EC Number:
- 215-626-1
- EC Name:
- Lead oxide
- Cas Number:
- 1335-25-7
- Molecular formula:
- PbO
- IUPAC Name:
- Lead oxide equivalent
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- Molecular formula:
- OZn
- IUPAC Name:
- Zinc oxide equivalent
- Reference substance name:
- Copper oxide
- EC Number:
- 215-269-1
- EC Name:
- Copper oxide
- Cas Number:
- 1317-38-0
- Molecular formula:
- CuO
- IUPAC Name:
- copper (II) oxide equivalent
- Reference substance name:
- Tricobalt tetraoxide
- EC Number:
- 215-157-2
- EC Name:
- Tricobalt tetraoxide
- Cas Number:
- 1308-06-1
- Molecular formula:
- Co3O4
- IUPAC Name:
- Tricobalt tetraoxide equivalent
- Test material form:
- solid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Results and discussion
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
- Remarks:
- Genetic toxicity 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.
Any other information on results incl. tables
According to MeClas, the substance is not classified as germ cell mutagen.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is not classified for germ cell mutagenicity. - 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.
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