Registration Dossier
Registration Dossier
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EC number: 215-478-8 | CAS number: 1327-43-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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
- IUPAC Name:
- titanium(2+) oxosilanediolate
- Details on test material:
- - Name of test material (as cited in study report): Magnapore 963 (Silicic acid, titanium salt)
- 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
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre de production Animale (F-45160)
- Weight at study initiation: 366-554 g
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 43-70
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: olive oil and paraffin oil
- Concentration / amount:
- The induction phase was performed by intradermal injection at day 0 with the test item at 0.78 % and by topical application at day 8 with test item at 12.5 % 24 hours after brushing with a solution of sodium lauryl sulfate.
In the challenge phase the test item has been used diluted at 12.5 % and at 6.25 % in paraffin oil.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil and paraffin oil
- Concentration / amount:
- The induction phase was performed by intradermal injection at day 0 with the test item at 0.78 % and by topical application at day 8 with test item at 12.5 % 24 hours after brushing with a solution of sodium lauryl sulfate.
In the challenge phase the test item has been used diluted at 12.5 % and at 6.25 % in paraffin oil.
- No. of animals per dose:
- Group 1 (negative control): 3 females, 2 males
Group 2 (treated): 4 males, 6 females - Details on study design:
- INDUCTION EXPOSURE (Group 2)
17 July 2006: first induction
- 2 intradermal injections of the test item at 0.78 %
- 2 intradermal injections of Freund´s Complete Adjuvant diluted at 50 % in a physiological saline solution
- 2 intradermal injections of a mixture with equal volumes - Freund´s Complete Adjuvant at 50 % and the test item at 1.56 %
Weighing of animals
25 July 2006: second induction
- topical application, on the same zone, with the test item at 12.5 %, 24 hours after brushing with 0.5 mL of a solution of Sodium lauryl sulfate at 10 %
REST PHASE (Group 2)
28. July -13 August 2006 (17 days)
CHALLENGE EXPOSURE (Groups 1 and 2)
14 August 2006: topical application under occlusive dressing at the following concentrations: 12.5 % and 6.25 %
16 August 2006: 24 hour reading time
17 August 2006: 48 hour reading time and weighing - Positive control substance(s):
- not specified
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.
Any other information on results incl. tables
No macroscopic cutaneous reactions attributable to allergy were recorded during the examination following the removal of the occlusive dressing from the animals of the treated group with the test item. No cutaneous intolerance reaction was recorded in animals from the negative control groups.
It was noted one death of an animal in the negative control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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