Registration Dossier
Registration Dossier
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EC number: 619-916-2 | CAS number: 12031-95-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- The "guinea pig maximisation test" was used as a well known and sensitive method. The use of this test is justified, as a Local Lymph Node Assay is not sensitive to metal containing test substances.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The "guinea pig maximisation test" was used as a well known and sensitive method. The use of this test is justified, as a Local Lymph Node Assay is not sensitive to metal containing test substances.
Test material
- Reference substance name:
- tetralithium(1+) 3,3-di{[oxido(oxo)titanio]oxy}-1,5-dioxotrititanoxane-1,5-bis(olate)
- EC Number:
- 619-916-2
- Cas Number:
- 12031-95-7
- Molecular formula:
- Li4Ti5O12
- IUPAC Name:
- tetralithium(1+) 3,3-di{[oxido(oxo)titanio]oxy}-1,5-dioxotrititanoxane-1,5-bis(olate)
- Details on test material:
- - Appearance: white powder.
- Lot No. 0171AV037
- Content: Ti: 51.5 %. Li: 6.2 %.
- Storage conditions: room temperature.
- Stability at storage conditions: unlimited.
- Bulk density: 688 g/L.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age: Approx. 5 - 7 weeks at the first application
- Weight: Step 1: 300 g to 377 g at the first application. Step 2: 314 g to 367 g at the first application
- Housing: Group caging in plastic containers (46 cm x 105 cm x 36 cm).
- Diet (e.g. ad libitum): Ssniff Ms-H (Guinea Pig Maintenance Diet V2233), including ascorbic acid (2400 mg/kg), ad libitum.
- Water (e.g. ad libitum): Tap water from Makrolon-bottles with stainless steel canules, ad libitum.
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 to 21.9
- Humidity (%): 52.8 to 66.7
- Air changes (per hr): ca. 12/h
- Photoperiod (hrs dark / hrs light): artificial light from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiol. saline (intradermal), water (epicutan.)
- Concentration / amount:
- 1 % suspension in physiol. saline for intradermal induction.
20 % suspension in water for epicutaneous induction.
20 % suspension in water for epicutaneous challenge.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiol. saline (intradermal), water (epicutan.)
- Concentration / amount:
- 1 % suspension in physiol. saline for intradermal induction.
20 % suspension in water for epicutaneous induction.
20 % suspension in water for epicutaneous challenge.
- No. of animals per dose:
- Negative control: 2 steps were performed with 5 animals each.
Test substance: 2 steps were performed with 10 animals each. - Details on study design:
- RANGE FINDING TESTS:
1 % test substance concentration was the highest technically feasible concentration which was suitable for the intradermal induction. 20 % test substance concentration was the highest technically feasible concentration which was suitable for the epidermal induction. No skin irritations were observed at these and at lower concentrations.
MAIN STUDY
A. INDUCTION EXPOSURE
First induction exposure: intradermal injections of the test substance, of FCA (to enhance a possible sensitisation) and of the test substance mixed with FCA. Application site was an area of approx. 2 cm x 4 cm in the interscapular region.
Second induction exposure: epicutaneous application of the test substance to the sites of the intradermal injections. Occlusive covering for 48 h. Before the epicutaneous induction exposure, the animals were pretreated with n-dodecylsulfate, sodium salt (10 % w/w, in white petrolatum) to give a slight local hyperaemia.
B. CHALLENGE EXPOSURE
Challenge exposure: epicutaneous application of the test substance to the left flanks and application of the vehicle to the right flanks of all animals. Occlusive covering for 24 h.
0.5 mL of the test substance or 0.5 mL deionised water were applied to each animal.
Reading: The application sites were examined 24 hours after the intradermal induction, 24 hours after the end of the epicutaneous induction exposure and 24 and 48 hours after the end of the epicutaneous challenge exposures (blind reading of test and control animals). - Challenge controls:
- Control animals were "challenged" in the same way as the test substance group animals.
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- The net rate of animals with a positive skin reaction, regarded as sensitised by "HEXYL CINNAMIC ALDEHYDE", was 60 %; March 2008.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance is not considered to be a sensitizer.
- Executive summary:
A guinea pig maximisation test was performed to reveal a possible sensitising potential of Lithium Titanium Oxide.
No animal of the test substance group was regarded as sensitised. The test substance is not considered to be a sensitizer.
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