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EC number: 269-056-3 | CAS number: 68186-94-7 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77494.
- 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
For skin sensitisation a Maurer optimisation test was conducted for Fe3O4, Fe2O3 and FeOOH as surrogates for (Fe,Mn)3O4 - all three compounds are not irritant to skin and eye, and have no skin sensitizing potential (for further details see category justification).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: main features of study described
- Principles of method if other than guideline:
- Test concentration : 0.1 % in 40% propylene glycol in water Induction:
10 intradermal injections in 3 weeks
Elicitation:
intradermal: injection 5 weeks after start of study
epidermal : occlusive, ca. 7 weeks after start of study - GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- According to the REACH regluation (EC) No. 1097/2006, the LLNA test is the first-choice method for in vivo testing and in exceptional circumstances another test can be used. Since the study was carried out before the regulation entered into force and the Maurer optimisation test was an acceptable method for testing skin sensitisation at the time of study conduct, it is not justified to conducted an additional LLNA test due to animal welfare.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- other: 1st induction 0.1 % intracutaneous
- Vehicle:
- other: 40% propylene glycol in water
- Concentration / amount:
- 0.1 %
- Route:
- other: 2nd challenge 0.1 % intracutaneous; 3rd challenge 0.1 % occlusive epicutaneous
- Vehicle:
- other: 40% propylene glycol in water
- Concentration / amount:
- 0.1 %
- No. of animals per dose:
- 19
- Reading:
- 1st reading
- Hours after challenge:
- 336
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 336.0. Group: test group. Dose level: 0.1%. No with. + reactions: 7.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 336
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 336.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 504
- Group:
- test chemical
- Dose level:
- maximum subirritant dose
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 504.0. Group: test group. Dose level: maximum subirritant dose. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 504
- Group:
- negative control
- Dose level:
- maximum subirritant dose
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 504.0. Group: negative control. Dose level: maximum subirritant dose. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
Guinea pigs were treated according the following procedure (test concentration 0.1% in
propylene glycole/water).
Induction: 10 intradermal injections. Elucidation (intradermal) injection 5 weeks after
start of the study; (epidermal)occlusive, 7 weeks after start of the study. As a result
epicutan application of the test substance is not sensitising.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For the representatives of the group members (Fe3O4, Fe2O3 and FeOOH) no skin sensitisation potential was found in Maurer optimisation tests with members of the Category.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
All group members of the iron oxide group are insoluble in water and inert. A sensitisation of the respiratory tract is not expected. This statement is supported by the human evidence on Fe2O3, Fe3O4, FeOOH and manganese oxides where such an effect was not described in the scientific literature.
Justification for classification or non-classification
Based on the available data a classification is not justified.
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.

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