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Diss Factsheets
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EC number: 215-168-2 | CAS number: 1309-37-1
- 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
Not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: detailed report available
- Principles of method if other than guideline:
- Number of animals: 20
Induction: 10 intradermal injections of a 0.1 % test preparation in 3 weeks. In the second and third week Freund's adjuvant is used as vehicle.
Thereafter a 2-week rest period is followed by intradermal challenge, which is followed again by epidermal challenge 10 days later.
Evaluation parameters: skin fold thickness, erythema - GLP compliance:
- not specified
- 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:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- 10 intradermal injections of a 0.1 % test preparation in
- Route:
- intradermal and epicutaneous
- Vehicle:
- no data
- Concentration / amount:
- 10 intradermal injections of a 0.1 % test preparation in
- No. of animals per dose:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 336
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 11
- 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: 11.0. 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:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 504.0. Group: test group. Dose level: maximum subirritant dose. No with. + reactions: 4.0. Total no. in groups: 20.0.
- 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:
10 intradermal injections of a 0.1 % test preparation in 3 weeks. In the second
and third week Freund's adjuvant is used as vehicle. Thereafter a 2-week rest
period is followed by intradermal challenge, which is followed agin by epidermal
challenge 10 days later.
Evaluation parameters: skin fold thickness, erythema
result: negative (the positive reactions are considered as a unspecific foreign particle reaction)
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For Fe2O3, Fe3O4 and FeOOH no skin sensitisation potential was found. Data for skin sensitisation are not available for ZnO and Mn3O4. From human experience such an effect is unknown. Therefore no sensitisation potential can be assumed for all group members, if the results are conveyed to other compounds of the group. Two tests on humans are not assignable.
Migrated from Short description of key information:
For skin sensitisation a Maurer optimisation test was conducted for Fe3O4, Fe2O3 and FeOOH
Justification for selection of skin sensitisation endpoint:
scientifically acceptable and well documented
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 ZnO where such an effect was not described in the scientific literature.
Migrated from Short description of key information:
no data
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.
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