Registration Dossier
Registration Dossier
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EC number: 413-330-9 | CAS number: 134724-55-3 SUMIKARON BRILLIANT RED S-BWF
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: Part of the SNIF file, which was accepted by the Belgian national authority for NONS
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Report date:
- 1994
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione
- EC Number:
- 413-330-9
- EC Name:
- 3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione
- Cas Number:
- 134724-55-3
- Molecular formula:
- Hill formula: C27H20O6 CAS formula: C27H20O6
- IUPAC Name:
- 6-{4-[(oxolan-2-yl)methoxy]phenyl}-12-phenyl-4,10-dioxatricyclo[7.3.0.0³,⁷]dodeca-1(12),2,6,8-tetraene-5,11-dione
- Details on test material:
- Not reported within the SNIF file
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Not reported within the SNIF file
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- little maize oil was used to prepare a paste with the test substance which was used for induction and challenge
test concentration : 500 mg
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- little maize oil was used to prepare a paste with the test substance which was used for induction and challenge
test concentration : 500 mg
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 10 - Details on study design:
- Not reported within the SNIF file
- Challenge controls:
- Not reported within the SNIF file
- Positive control substance(s):
- not specified
- Remarks:
- Not reported within the SNIF file
Study design: in vivo (LLNA)
- Statistics:
- Not reported within the SNIF file
Results and discussion
- Positive control results:
- Not reported within the SNIF file
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 500 mg
- 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: test group. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 500 mg
- 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: 500 mg. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 500 mg
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation during induction:
none
Evidence of sensitisation of each challenge concentration:
0/10
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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