Registration Dossier
Registration Dossier
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EC number: 255-911-8 | CAS number: 42613-21-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.07.2006-17.08.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP conform
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe interministeriel des produits chimiques
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Silicic acid, titanium salt
- EC Number:
- 255-911-8
- EC Name:
- Silicic acid, titanium salt
- Cas Number:
- 42613-21-8
- Molecular formula:
- TiSixOy, where x and y are unspecified.
- IUPAC Name:
- titanium(4+) bis(oxosilanebis(olate))
- Details on test material:
- - Name of test material (as cited in study report): Magnapore 963
- Substance type: black powder
- Physical state: solid
- Analytical purity: 98 %
- Lot/batch No.: lot 405; produced 01.03.2006
- Expiration date of the lot/batch: 01.09.2007
- Storage condition of test material: room temperature
- Additive: chromium (III) hydroxide, CAS No. 1308-14-1
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 and epicutaneous
- Vehicle:
- other: olive oil and paraffin oil
- Concentration / amount:
- 0, 0.78 % for first inductionby intradermal injection at D0; 2nd induction with: topical application, on the same zone, with the test item at 12.5 %, 24 h after brushing with 0.5 ml of a SDS solutionat 10 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil and paraffin oil
- Concentration / amount:
- 0, 0.78 % for first inductionby intradermal injection at D0; 2nd induction with: topical application, on the same zone, with the test item at 12.5 %, 24 h after brushing with 0.5 ml of a SDS solutionat 10 %
- No. of animals per dose:
- five controls, 10 per dose
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5
- No. with + reactions:
- 0
- Total no. in group:
- 14
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12.5. No with. + reactions: 0.0. Total no. in groups: 14.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 6.25
- No. with + reactions:
- 0
- Total no. in group:
- 14
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6.25. No with. + reactions: 0.0. Total no. in groups: 14.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5
- No. with + reactions:
- 0
- Total no. in group:
- 14
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12.5. No with. + reactions: 0.0. Total no. in groups: 14.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6.25
- No. with + reactions:
- 0
- Total no. in group:
- 14
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6.25. No with. + reactions: 0.0. Total no. in groups: 14.0. Clinical observations: none.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
