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Registration Dossier
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EC number: 266-007-8 | CAS number: 65996-74-9 The oxidized surface of steel produced during reheating, conditioning, hot rolling, and hot forming operations. This substance is usually removed by process waters used for descaling, roll and material cooling, and other purposes. It is subsequently recovered by gravity separation techniques. Composed primarily of high-purity iron oxides. May contain varying amounts of other oxides, elements, and trace compounds.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Mill scale is mainly and primarily composed of high-purity iron oxides (on average above 65%, i.e. FeO, Fe2O3, Fe3O4). Besides, other metal oxides and spinels, elements, and trace compounds such as oil residues <1% for all the uses except for batteries and Melting charge for which <3% can be found in the mill scale. More information on the justification of read across can be found in the attached document in the endpoint summarie of section 7.
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:
- publication
- Title:
- Prädikative Evaluierung allergener Wirkungen von Arznei- und Färbemitteln im Tierexperiment
- Author:
- Maurer T
- Year:
- 1 979
- Bibliographic source:
- Acta Pharm Technol Suppl 8, 37-44
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guinea pig Optimization Test. Number of animals: 20 (Induction) : 10 intradermal injections of a 0.1 % test preparation during the first 3 weeks. A 2-week rest period follows and threafter, intradermal challenge (6th week), which is followed again by epidermal challenge 10 days later. Evaluation parameters: skin fold thickness, erythema.
- GLP compliance:
- not specified
- Remarks:
- It is not customary to refer to GLP compliance in publications.
- Type of study:
- Maurer optimisation test
Test material
- Reference substance name:
- Diiron trioxide
- EC Number:
- 215-168-2
- EC Name:
- Diiron trioxide
- Cas Number:
- 1309-37-1
- Molecular formula:
- Fe2O3
- IUPAC Name:
- diiron trioxide
- Reference substance name:
- iron(III) oxide
- IUPAC Name:
- iron(III) oxide
- Reference substance name:
- Triiron tetraoxide
- EC Number:
- 215-277-5
- EC Name:
- Triiron tetraoxide
- Cas Number:
- 1317-61-9
- Molecular formula:
- Fe3O4
- IUPAC Name:
- iron(II) diiron(III) oxide
- Reference substance name:
- iron(II,III) oxide
- IUPAC Name:
- iron(II,III) oxide
- Reference substance name:
- Goethite (Fe(OH)O)
- EC Number:
- 215-176-6
- EC Name:
- Goethite (Fe(OH)O)
- Cas Number:
- 1310-14-1
- IUPAC Name:
- 1310-14-1
- Reference substance name:
- iron oxide yellow
- IUPAC Name:
- iron oxide yellow
- Details on test material:
- FeO.Fe2O3 (iron oxide black), Fe2O3 iron oxide red and iron oxide yellow Fe2O3xH2O
No further information available on the test material, no data on purity.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Freund's adjuvant during the 2nd and 3rd week of induction
- Concentration / amount:
- 0.1 % test preparation
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's adjuvant during the 2nd and 3rd week of induction
- Concentration / amount:
- 0.1 % test preparation
- No. of animals per dose:
- 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: after intradermal challenge
- Group:
- other: test goup: iron oxide black
- Dose level:
- 0.1%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after intradermal challenge. Group: other: test goup: iron oxide black. Dose level: 0.1%. No with. + reactions: 7.0. Total no. in groups: 20.0.
- Reading:
- other: after intradermal challenge
- Group:
- other: control 40% propylene glycol
- Dose level:
- 0.1%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after intradermal challenge. Group: other: control 40% propylene glycol. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 20.0.
- Reading:
- other: after intradermal challenge
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after intradermal challenge. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: after intradermal challenge
- Group:
- other: tets group iron oxide red
- Dose level:
- 0.1%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after intradermal challenge. Group: other: tets group iron oxide red. Dose level: 0.1%. No with. + reactions: 11.0. Total no. in groups: 20.0.
- Reading:
- other: after intradermal challenge
- Group:
- other: test group iron oxide yellow
- Dose level:
- 0.1%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after intradermal challenge. Group: other: test group iron oxide yellow. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- other: after epidermal challenge
- Group:
- other: control 40% propylene glycol
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after epidermal challenge. Group: other: control 40% propylene glycol. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- other: after epidermal challenge
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after epidermal challenge. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: after epidermal challenge
- Group:
- other: test group iron oxide black
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: other: after epidermal challenge. Group: other: test group iron oxide black. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- other: after epidermal challenge
- Group:
- other: iron oxide red
- Dose level:
- 0.1%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after epidermal challenge. Group: other: iron oxide red. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 20.0.
- Reading:
- other: after epidermal challenge
- Group:
- other: test group iron oxide yellow
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after epidermal challenge. Group: other: test group iron oxide yellow. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- All three iron oxides can be considered as non sensitizing
- Executive summary:
In a dermal sensitization study withiron oxides: FeO.Fe2O3 (iron oxide black), Fe2O3 iron oxide red and iron oxide yellow Fe2O3xH2O inguinea pigs. The animals were intradermally injected 10 times with a 0.1 % test preparation, in a period of 3 weeks.In the second and third week Freund's adjuvant was used as vehicle. A 2-week rest period follows and threafter, intradermal challenge (6th week), which is followed again by epidermal challenge 10 days later. Evaluation parameters were skin fold thickness and erythema. The results were deemed as negative. In this study,all three iron oxides are not considered asa dermal sensitizer.
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