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Registration Dossier
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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.
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.
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