Aluminum antimony nickel silicon titanium vanadium oxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 Aug - 25 Aug 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministreium für Umwelt, Landwirtschaft und Verbraucherschutz, Mainzer Str. 80, 65189 Wiesbaden, Germany

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

silicon(4+) dialuminium(3+) antimony nickel vanadium pentaoxidandiide

EC Number:

931-210-9

Cas Number:

1266534-73-9

Molecular formula:

(M2/nO*Al2O3*ySiO2*wH2O)x*(Ti,Sb,Ni,V O2)z*(Al2O3)k*(Al2Si2O7)l n is the valency of the cation M, predominantly Na, and for Na is n=1; y can range from 2 to 222; w can range from 0 to 30; x can range from 0.2 to 0.7; z can range from 0.01 to 0.05; k can range from 0.03 to 0.39; l can range from 0.26 to 0.39

IUPAC Name:

silicon(4+) dialuminium(3+) antimony nickel vanadium pentaoxidandiide

Details on test material:

- Name of test material (as cited in study report): LOOP
- Chemical name: Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony
- Analytical purity: 99%
- Impurities (identity and concentrations):
- Lot/batch No.: 09303322/1
- Expiration date of the lot/batch: 29 Jun 2011
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst, The Netherlands
- Strain: CBA/CaOlaHsd
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 18.4 - 22.5 g
- Housing: single caging
- Diet (ad libitum): pelleted standard diet
- Water (ad libitum): tap water
- Acclimation period: at least 5 days prior to the start of the dosing


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 45 - 80 %
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

propylene glycol

Remarks:

Purity: 99%

Concentration:

5, 10 and 25% (w/w) suspension in propylene glycol

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- two animals, topical application with ???% each on three consecutive days
- Compound solubility: 25% (w/w) was the highest test item concentration, which could be achieved after grinding in a mortar
- Irritation: no signs of irritation or systemic toxicity (recorded within 1h and 24 h and 7 d after application)

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: First: at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index. Second: compatibel with a conventional dose-response.


TREATMENT PREPARATION AND ADMINISTRATION:
- Dilutions were prepared individually, homogeneity was maintained using a magnetic stirrer
- Topical application: Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with the different test item concentrations. The application volume (25 µl) was spread over the entire dorsal surface (diameter 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
- Administration of 3H-Methyl Thymidine (³HTdR): Five days after the first topical application, all mice were administered with 250 µl of 78.5 µCi/mL 3HTdR (corresponds to 19.6 µCi ³HTdR per mouse) by intravenous injection via a tail vein.
- Determination of Incorporated ³HTdR: Approximately five hours after treatment with ³HTdR all mice were euthanised. The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group). The pooled lymph nodes were prepared according to the guideline. The level of ³HTdR incorporation was then measured on a beta-scintillation counter.

OBSERVATIONS
- Mortality/viability: once daily
- Body weights: prior to the first application and prior to the treatment with ³HTdR
- Clinical signs: within 1 h of each application and 24 ± 4 h after the first and second appplication as well as on the day of preparation.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

Body weight: mean values and standard deviations were calculated.
[³H]TdR incorporation was calculated as mean cpm ± SD, and stimulation indices of lymph node cell proliferation between substance-treated and vehicle-treated groups were calculated.

Results and discussion

Positive control results:

DPM per lymph node:
0 (vehicle group, acetone:olive oil (4:1)): 727.6
5 % test item: 1303.6
10 % test item: 1518.4
25 % test item: 4976.6

Stimulation index:
5 % test item: S.I. = 1.79
10 % test item: S.I. = 2.09
25 % test item: S.I. = 6.84

The positive control substance showed the expected positive result (S.I. > 3).

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: vehicle control: - 5% (w/w): 1.11 10% (w/w): 1.17 25% (w/w): 0.98

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: DPM per lymph node: vehicle control: 185.0 5% (w/w): 204.6 10% (w/w): 216.5 25% (w/w): 178.5

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information