Registration Dossier
Registration Dossier
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EC number: 701-090-0 | CAS number: -
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:
- Method: other: see TC
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 agin 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:
- Conditions specified under the specific rules of adaptation (column 2) or general rules of adaptation (Annex XI) are met.
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
- Details on test material:
- IUCLID4 Test substance: other TS: iron oxide (Fe2O3 and iron yellow (Fe2O3xH2O)
Constituent 1
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 subiritant 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 subiritant dose. No with. + reactions: 1.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- 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: ambiguous
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