Registration Dossier
Registration Dossier
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EC number: 419-710-0 | CAS number: 42774-15-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OCDE n°406 (1992) Directive CEE 92/69 (1992) - annexe V - méthode B6
- GLP compliance:
- yes
- Type of study:
- not specified
Test material
- Reference substance name:
- N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide
- EC Number:
- 419-710-0
- EC Name:
- N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide
- Cas Number:
- 42774-15-2
- Molecular formula:
- C26H42N4O2
- IUPAC Name:
- N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- other: Cobaye albinos Hartley
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
- Injection intradermique: product 10% solution in
absolute ethanol.
- Application topique: dough product 60% in
absolute ethanol.
Concentration of test material and vehicle used for each challenge:
60% product in absolute ethanol.
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
- Injection intradermique: product 10% solution in
absolute ethanol.
- Application topique: dough product 60% in
absolute ethanol.
Concentration of test material and vehicle used for each challenge:
60% product in absolute ethanol.
- 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:
- 60%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60%. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60%
- 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: 60%. 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: 60 %
Signs of irritation during induction:
Irritation after application of sodium lauryl sulfate (10%);
Evidence of sensitisation of each challenge concentration:
1 sensitized animal.
Other observations:
Histopathological examination was performed on an animal with low reaction (1), that review did not give
result for a sensitization reaction.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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