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EC number: 485-430-0 | CAS number: 923954-49-8
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: U. S. EPA Health Effects Test Guidelines OPPTS 870.2600
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF AG
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 485-430-0
- EC Name:
- -
- Cas Number:
- 923954-49-8
- Molecular formula:
- SnxZnyTi2Oz with x = 0,5 – 1,7 y = 0,5 – 1,7 z = 5,5 – 7,5
- IUPAC Name:
- oxygen titanium zinc λ²-stannane
- Details on test material:
- Test-substance No.: 07/0285-1
- Analytical purity: 99.61 g/100 g (analytical report No. 07L00144)
- Lot/batch No.: GV 33900-66
- Stability under test conditions: regarding the precision of the methods used, the test item showed no significantly differences to the characterization 07L00144
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 6 – 12 weeks
- Weight at study initiation: 19.5 g – 22.6 g
- Housing: single housing in Makrolon cage, type II
- Diet (e.g. ad libitum): Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 3, 10, 50%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
The selection of concentrations took into account available information on the chemical/physical properties, the composition and on acute toxicity and primary irritation/corrosion potential of the test substance. Additionally, the results of a pretest with a 50% test substance preparation were considered, which showed slightly increased ear weights and lymph node weights as indication of ear irritation. The 50% preparation was the maximum technically applicable concentration.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Murine Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: The increase SI of cell count by a factor of >1.5 and/or of 3H-thymidine incorporation by a factor of ≥ 3 as compared to the concurrent vehicle control group is generally considered as indicating a sensitizing potential of a test substance
TREATMENT PREPARATION AND ADMINISTRATION:
- Body weight determination: individual body weights on day 0 prior to the first application and on day 5 prior to the sacrifice of the animals.
- Signs and symptoms: no detailed clinical examination of the individual animals was performed but any obvious signs of systemic toxicity and/or local inflammation at the application sites were noted in the raw data.
- Form of application: epicutaneous application is simulating dermal contact with the compound which is possible to occur under practical use conditions.
- Application volume: 25 μL per ear
- Site of application: dorsal part of both ears
- Frequency of application: 3 consecutive applications (day 0 – day 2) to the same application site
- Observations: twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
- ³H-thymidine injection: on study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μl of sterile saline into a tail vein
- Terminal procedures: the animals were sacrificed on study day 5 about 5 hours after 3H-thymidine injection by cervical dislocation. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: ³H-thymidine incorporation [DPM/Lymph Node Pair]: - control: 254.3 +/- 58.4 - 3%: 250.6 +/- 84.2 - 10%: 301.5 +/- 83.6 - 50%: 525.7 +/- 141.8 - positive control: 1225.6 +/- 453.6
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- animals 1-5, 0%
- Parameter:
- SI
- Value:
- 0.99
- Test group / Remarks:
- aniamls 6-10, 3%
- Parameter:
- SI
- Value:
- 1.19
- Test group / Remarks:
- animals 11-15, 5%
- Parameter:
- SI
- Value:
- 2.07
- Test group / Remarks:
- animals 16-20, 50%
- Parameter:
- SI
- Value:
- 4.82
- Test group / Remarks:
- animals, 21-25, positive control
Any other information on results incl. tables
Results:
| Test group | Treatment | Cell Counts [Counts/Lymph Node Pair] | |
| Mean | SI | ||
| 1 | vehicle | 6222600 ± 528453 | 1.00 |
| 2 | 3% | 8026800 ± 3292733 | 1.29 |
| 3 | 10% | 7702800 ± 767852 | 1.24 |
| 4 | 50% | 9681600 ± 2860637 | 1.56 |
| 5 | positive control | 14400000 ± 2083175 | 2.31 |
| Test group | Treatment | 3H-thymidine incorporation [DPM/Lymph Node Pair] | |
| Mean | SI | ||
| 1 | vehicle | 254.3 ± 58.4 | 1.00 |
| 2 | 3% | 250.6 ± 84.2 | 0.99 |
| 3 | 10% | 301.5 ± 83.6 | 1.19 |
| 4 | 50% | 525.7 ± 141.8 | 2.07 |
| 5 | positive control | 1225.6 ± 435.5 | 4.82 |
| Test group | Treatment | 3H-thymidine incorporation [DPM/Lymph Node Pair] | |
| Mean | SI | ||
| 1 | vehicle | 4.5 ± 0.3 | 1.00 |
| 2 | 3% | 5.2 ± 1.3 | 1.15 |
| 3 | 10% | 5.1 ± 0.5 | 1.12 |
| 4 | 50% | 5.7 ± 1.0 | 1.26 |
| 5 | positive control | 7.9 ± 0.9 | 1.73 |
SI: stimulation index
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
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