Registration Dossier
Registration Dossier
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EC number: 815-182-4 | CAS number: 12058-75-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Dec 2011 - 13 Jan 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- An oversight in the protocol indicated that animals were to be supplied by the usual provider Harlan UK (CBA/Ca); however Charles River animals (CBA/Ca) were used.
- Deviations:
- yes
- Remarks:
- The deviation was not considered to have affected the integrity or validity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- An oversight in the protocol indicated that animals were to be supplied by the usual provider Harlan UK (CBA/Ca); however Charles River animals (CBA/Ca) were used.
- Deviations:
- yes
- Remarks:
- The deviation was not considered to have affected the integrity or validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Disodium hexatitanate
- EC Number:
- 815-182-4
- Cas Number:
- 12058-75-2
- Molecular formula:
- Na2Ti6O13
- IUPAC Name:
- Disodium hexatitanate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 12058-75-2
- Expiration date of the lot/batch: 24 Mar 2014
- Physical Appearance: white powder
- Storage: room temperature
- Purity: 100%
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd.
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified]
- Age at study initiation: 8 – 12 weeks old
- Weight at study initiation: 17.3 – 21.6 g
- Housing: solid bottomed polycarbonate cages with as stainless steel mesh lid, containing quantity of autoclaved wood flake bedding. Additionally Nestlets and a plastic shelter were included for environmental enrichment. Two animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%):40 - 70
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 10, 25 and 50% w/v
- No. of animals per dose:
- 4 per group
+ 2 mice for 50%w/v - Details on study design:
- PRE-SCREEN TESTS:
- Amount: 25µL to the dorsal surface of both ears for three consecutive days.
- Ear thickness measurements:
Mice #1 Left Ear: Day 1 – 0.22, Day 3 – 0.22, Day 6 – 0.23
Mice #1 Right Ear: Day 1 – 0.22, Day 3 – 0.22, Day 6 – 0.22
Mice #2 Left Ear: Day 1 – 0.22, Day 3 – 0.25, Day 6 – 0.25
Mice #2 Right Ear: Day 1 – 0.23, Day 3 – 0.23, Day 6 – 0.24
- Erythema scores:
Mice #1 Days 1 – 6 : 0
Mice #2 Days 1 – 6: 0 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive control substance 25% v/v hexyl cinnamic aldehyde.
Stimulation Index was 6.9, which demonstrates the validity of this study.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- 10% w/v
- Value:
- 0.9
- Key result
- Parameter:
- SI
- Remarks:
- 25% w/v
- Value:
- 1
- Key result
- Parameter:
- SI
- Remarks:
- 50% w/v
- Value:
- 1.1
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not regarded as a potential skin sensitizer.
EC3 concentration is greater than the highest tested (50%)
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