Registration Dossier
Registration Dossier
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EC number: 419-690-3 | CAS number: 88020-55-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD N°406 + EC 92/69/CEE, B6 guidelines + Maximization method of Magnusson et Kligman
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 419-690-3
- EC Name:
- -
- Cas Number:
- 88020-55-7
- Molecular formula:
- [(C12H25)3NH]4Mo8O26
- IUPAC Name:
- tridodecylamine hydrate molybdenum
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Mixture of dimethylacetonide, acetone and alcohol
- Concentration / amount:
- Concentration of test material / induction phase (treated group) :
Intradermal : NORCAT M at 1 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol ,
Topical : NORCAT M at 20 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol
Concentration of test material / challenge phase (all groups) :
Topical : NORCAT M at 20 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol
Challengeopen allclose all
- Route:
- other: Topical
- Vehicle:
- other: Mixture of dimethylacetonide, acetone and alcohol
- Concentration / amount:
- Concentration of test material / induction phase (treated group) :
Intradermal : NORCAT M at 1 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol ,
Topical : NORCAT M at 20 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol
Concentration of test material / challenge phase (all groups) :
Topical : NORCAT M at 20 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 4.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary
test: 20 %
Signs of irritation during induction: crusts, necrosis and ulcers
Comments:
No clinical signs and no deaths were noted during the study.
Since skin irritations were comparable in both groups, they were attributed to irritant properties of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No cutaneous reactions attribuable to the sentization potential of the test substance NORCAT M ; it should not be classified
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