Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
- 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
Skin sensitisation: not sensitising (modified OECD 429; GLP)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The two spinel type pigments are structurally very similar with similar composition. Both show a very low solubility in different artificial and aqueous media. Since the target substance and the source substance release the same (eco-)toxicological relevant units iron, zinc and chromium under environmental/physiological relevant conditions, the biological target will be the same for both substances. The target substance also releases titanium ions at a minute amount, which are not known to show signs of systemic toxicity (OECD SIDS, 2013). The source substance liberates small amounts of the toxic unit nickel, without showing any signs of systemic or local toxicity in various studies (acute oral and inhalation, skin/eye irritation, sensitisation).
Based on the above explanation an analogue approach for read-across of the endpoint “Skin sensitisation ” from the structural analogue to the target substance is considered justified (see also attached document under in section 13 of this technical dossier). - Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- The positive control group caused the expected increases in lymph node cell count and lymph node weight (statistically significant at p ≤ 0.01). The values for the stimulation index of lymph node cell count and lymph node weight were 1.715 and 1.544, respectively. Therefore, the study can be regarded as valid.
- Key result
- Parameter:
- SI
- Value:
- 1.051
- Test group / Remarks:
- 10 % (w/w) test item
- Remarks on result:
- other: 10 % (w/w) test item; lymph node cell count
- Key result
- Parameter:
- SI
- Value:
- 1.018
- Test group / Remarks:
- 10 % (w/w) test item
- Remarks on result:
- other: 10% (w/w) test item, lymph node weight
- Key result
- Parameter:
- SI
- Value:
- 0.951
- Test group / Remarks:
- 10 % (w/w) test item
- Remarks on result:
- other: 10 % (w/w) test item; ear weight
- Key result
- Parameter:
- SI
- Value:
- 1.017
- Test group / Remarks:
- 10 % (w/w) test item
- Remarks on result:
- other: 10% (w/w) test item; ear thickness
- Key result
- Parameter:
- SI
- Value:
- 0.917
- Test group / Remarks:
- 25 % (w/w) test item
- Remarks on result:
- other: 25 % (w/w) test item; lymph node cell count
- Key result
- Parameter:
- SI
- Value:
- 0.965
- Test group / Remarks:
- 25% (w/w) test item
- Remarks on result:
- other: 25% (w/w) test item, lymph node weight
- Key result
- Parameter:
- SI
- Value:
- 0.975
- Test group / Remarks:
- 25 % (w/w) test item
- Remarks on result:
- other: 25 % (w/w) test item; ear weight
- Key result
- Parameter:
- SI
- Value:
- 1.06
- Test group / Remarks:
- 25% (w/w) test item
- Remarks on result:
- other: 25% (w/w) test item; ear thickness
- Key result
- Parameter:
- SI
- Value:
- 0.907
- Test group / Remarks:
- 50 % (w/w) test item; ear weight
- Remarks on result:
- other: 50 % (w/w) test item; lymph node cell count
- Key result
- Parameter:
- SI
- Value:
- 1.053
- Test group / Remarks:
- 50% (w/w) test item
- Remarks on result:
- other: 50% (w/w) test item; lymph node weight
- Key result
- Parameter:
- SI
- Value:
- 0.901
- Test group / Remarks:
- 50 % (w/w) test item
- Remarks on result:
- other: 50 % (w/w) test item; ear weight
- Key result
- Parameter:
- SI
- Value:
- 1.043
- Test group / Remarks:
- 50% (w/w) test item
- Remarks on result:
- other: 50% (w/w) test item; ear thickness
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitiser.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin sensitiser.
Reference
In the main study treatment with the test item at concentrations of 10%, 25% or 50% did not reveal statistical significantly increased values for lymph node cell count. The stimulation indices of the lymph node cell count did not exceed the threshold level of 1.4. Hence, the test item is classified as not sensitising.
The threshold level for the ear weight of 1.1 was not exceeded and no increase of ear thickness was observed, i.e. no irritating properties were noted.
No signs of local or systemic intolerance were recorded. The animal body weight was not affected by the treatment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
One reliable animal study described in Haferkorn (2013) (modified OECD 429; method according to Ehlings et al. 2005; GLP compliant) is considered to be reliable without restrictions. The substance was determined not to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation
The substance does not possess a skin sensitisation potential and does not require classification as skin sensitiser according to Regulation (EC) No 1272/2008 and subsequent adaptations.
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.