Registration Dossier
Registration Dossier
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EC number: 401-100-0 | CAS number: 109037-78-7 TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study by GLP laboratory
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Maximisation test)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
- EC Number:
- 401-100-0
- EC Name:
- Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
- Cas Number:
- 109037-78-7
- Molecular formula:
- C24 H46 O10 P2 Ti2 (typical - see 'Remarks' below.
- IUPAC Name:
- butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- other: 20% and 50% v/v in acetone.
- Concentration / amount:
- a) 0.5% v/v acetone containing 5% w/v alembicol D
b) undiluted
Challengeopen allclose all
- Vehicle:
- other: 20% and 50% v/v in acetone.
- Concentration / amount:
- a) 0.5% v/v acetone containing 5% w/v alembicol D
b) undiluted
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20
Study design: in vivo (LLNA)
- Concentration:
- Concentration of test material and vehicle used at induction:
a) 0.5% v/v in acetone containing 5% alembicol D.
b) undiluted
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: no data in SNIF#001-4.1.70-01
- Group:
- test chemical
- Dose level:
- 0.5% v/v in acetone containing 5% alembicol D
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: no data in SNIF#001-4.1.70-01. Group: test group. Dose level: 0.5% v/v in acetone containing 5% alembicol D. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- other: no data in SNIF#001-4.1.70-01
- Group:
- negative control
- Dose level:
- 0.5% v/v in acetone containing 5% alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: no data in SNIF#001-4.1.70-01. Group: negative control. Dose level: 0.5% v/v in acetone containing 5% alembicol D. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: no data in SNIF#001-4.1.70-01
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: no data in SNIF#001-4.1.70-01. Group: test group. Dose level: undiluted. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- other: no data in SNIF#001-4.1.70-01
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: no data in SNIF#001-4.1.70-01. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Evidence of sesitisation of each challenge concentration: Evidence of sensitisation was observed in 3 animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Executive summary:
Although tests carried out under protocols existing at time of test (1986) these results are still considered valid.
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