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Diss Factsheets
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EC number: 700-042-6 | CAS number: 177997-13-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- The assessment entity approach was used for the classification of NCA; this endpoint is assessed on the basis of the toxicological properties of the relevant constituents (= assessment entities) of the UVCB.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: CLP Regulation 1272/2008 - Annex I (mixture rules)
- Principles of method if other than guideline:
- The skin sensitization potential of NCA (generic worst-case composition) was determined by classifying based on Mixture rules from EU CLP.
- GLP compliance:
- not specified
- Key result
- Remarks on result:
- other: A reliable assessment, based on the CLP mixture rules and using the MeClas Classification Tool, was conducted on a generic NCA sample. The assessed generic NCA composition is classified a Skin Sensitizer, Cat. 1.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The assessment of the skin sensitizing properties of NCA is based on the skin sensitizing properties of its constituents (oxide forms of Al, Co, Li, Ni) (Assessment Entity Approach).
A reliable assessment, based on the CLP mixture rules and using the MeClas Classification Tool, was conducted on a generic NCA sample (composition based on worst-case concentrations for each constituent, as defined in IUCLID section 1.2). The assessed generic NCA composition is classified a Skin Sensitizer, Cat. 1. - Executive summary:
The study provides a conservative estimate of the effect concentration, 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A study was performed to assess the skin sensitisation potential of the test material (NCA, typical composition) in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following: OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted) and Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 25% w/w, this concentration was selected as the highest dose investigated in the main test. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a suspension in propylene glycol at concentrations of 25, 10 or 5% w/w. A further group of four animals was treated with propylene glycol alone.
The Stimulation Index for each dose level (expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group) signified a negative result. Therefore the test material (NCA with typical concentration) was considered to be a non sensitiser under the conditions of the test.
A reliable assessment, based on the CLP mixture rules and using the MeClas Classification Tool, was also conducted on a generic NCA sample (composition based on worst-case concentrations for each constituent, as defined in IUCLID section 1.2). The assessed generic NCA composition is classified a Skin Sensitizer, Cat. 1. It should be noted that concentration levels of critical constituents in generic NCA are higher than the concentration levels in the tested material, and it was therefore decided to retain the classification conclusion that is based on the MeClas calculation.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- The assessment entity approach was used for the classification of NCA; this endpoint is assessed on the basis of the toxicological properties of the relevant constituents (= assessment entities) of the UVCB.
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- The respiratory sensitization potential of NCA (generic worst-case composition) was determined by classifying based on Mixture rules from EU CLP.
- Interpretation of results:
- Category 1 (respiratory sensitising) based on GHS criteria
- Conclusions:
- The assessment of the respiratory sensitizing properties of NCA is based on the respiratory sensitizing properties of its constituents (oxide forms of Al, Co, Li, Ni) (Assessment Entity Approach).
A reliable assessment, based on the CLP mixture rules and using the MeClas Classification Tool, was conducted on a generic NCA sample (composition based on worst-case concentrations for each constituent, as defined in IUCLID section 1.2). The assessed generic NCA composition is classified a Respiratory Sensitizer, Cat. 1. - Executive summary:
The study provides a conservative estimate of the effect concentration, 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A reliable assessment, based on the CLP mixture rules and using the MeClas Classification Tool, was also conducted on a generic NCA sample (composition based on worst-case concentrations for each constituent, as defined in IUCLID section 1.2). The assessed generic NCA composition is classified a Respiratory Sensitizer, Cat. 1. It should be noted that concentration levels of critical constituents in generic NCA are higher than the concentration levels in the tested material, and it was therefore decided to retain the classification conclusion that is based on the MeClas calculation.
Justification for classification or non-classification
In accordance with the criteria for classification of mixtures as defined in Annex I, Regulation 1272/2008, the test material is classified as Skin/Resp. Sensitizer, Cat.1.
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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