Registration Dossier
Registration Dossier
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EC number: 411-760-1 | CAS number: 116633-53-5 COMMERCIAL DRAGON II
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
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:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- M&K GPMT
- Deviations:
- not specified
- Principles of method if other than guideline:
- Magnusson and Kligman Guinea Pig Maximisation Test.
- GLP compliance:
- not specified
- Type of study:
- other: Annex V (Maximisation)
Test material
- Reference substance name:
- Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate
- EC Number:
- 411-760-1
- EC Name:
- Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate
- Cas Number:
- 116633-53-5
- Molecular formula:
- C18 H42 Mn2 N6 O3 . 2 F6 P
- IUPAC Name:
- dimanganese(4+) bis(1,4,7-trimethyl-1,4,7-triazonane) bis(hexafluoro-λ⁵-phosphanuide) hydrate trioxidandiide
- Details on test material:
- no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 20 animals in test group and 10 animals in negative control group
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.9% physiological saline
- Concentration / amount:
- Induction: 1% in 0.9% physiological saline, intradermal & 10% in 0.9% physiological saline, topical
Challenge: 2.5% in 0.9% physiological saline, topical
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% physiological saline
- Concentration / amount:
- Induction: 1% in 0.9% physiological saline, intradermal & 10% in 0.9% physiological saline, topical
Challenge: 2.5% in 0.9% physiological saline, topical
- No. of animals per dose:
- 20 animals in test group and 10 animals in negative control group
- Details on study design:
- Sensitization was induced in guinea pigs by intradermal injections of bot test substance and Freund's Complete Adjuvant. The induction process was supplemented seven days later by application of the test substance to the shoulder injection sites under occlussion for 48 hours.
- Challenge controls:
- Thirteen days lateer the guinea pigs were challenged by a 24 hour occulded patch.
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- not specified
- Concentration:
- no data
- No. of animals per dose:
- no data
- Details on study design:
- no data
- Statistics:
- no data
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- slight irritation was observed following the 10% topical induction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: slight irritation was observed following the 10% topical induction.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- slight irritation was observed following the 10% topical induction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: slight irritation was observed following the 10% topical induction.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: no data
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: No data
Any other information on results incl. tables
Number of animals showing evidence of sensitisation at each challenge concentration: 0 out of 20
| Challenge concentrations of test substance | Number of animals showing skin reaction after | ||||
| 1st challenge | 2nd challenge | ||||
| 24hr | 48hr | 24hr | 48hr | ||
| test group | 2,5% | 0 | 0 | ||
| negative control group | 2,5% | 0 | 0 | ||
Signs of irritation during induction: Slight irritation was observed following the 10% topical induction.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Commercial Dragon II was not a skin sensitiser in an Annex V Guinea Pig Maximisation test following either 1% intradermal or 10% topical induction and challenge at 2.5%.
- Executive summary:
There was no evidence of sensitization reactions in any of the 20 test guinea pigs when challenged with Commercial Dragon II
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