Registration Dossier
Registration Dossier
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EC number: 215-168-2 | CAS number: 1309-37-1
Skin sensitisation
Administrative data
- 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
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
- 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.
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(3+) trioxidandiide
- Reference substance name:
- Iron(III)oxide
- IUPAC Name:
- Iron(III)oxide
- Test material form:
- not specified
- Details on test material:
- Iron oxide (Fe2O3 and iron yellow (Fe2O3xH2O)
Constituent 1
Constituent 2
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:
- no data
- Concentration / amount:
- 10 intradermal injections of a 0.1 % test preparation in
Challengeopen allclose all
- 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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)
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