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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Nov - 03 Dec 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- Guideline srudy

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Secretariat général du GIPC- DGCIS*SI - 12, rue Villiot, 75572 Paris cedex 12, France
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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%
- Lot/batch No.: 09303322/1
- Production date: 30 Jun 2009
- Expiration date of the lot/batch: 29 Jun 2011
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER, 53940 Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 195-200 g
- Fasting period before study: 24 h before dosing, 4h after administration food was redistributed
- Housing: in groups of three in solid-bottomed clear polycarbonate cages
- Diet (e.g. ad libitum): M20, rat/mouse maintenance ad libitum
- Water (e.g. ad libitum): tap water from public distribution ad libitum
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4 g in 10 mL
- Amount of vehicle (if gavage): 5mL/kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: assumed limit dose
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 animals in step 1 and step 2, respectively)

Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed daily; animals were weighed just before substance administration and then on days 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

current control study:
- study date: 04 Aug to 18 Aug 2009
- according to OECD 423
- 3 animals received the control item olive oil, administered by gavage (10 mL/kg bw)
- results: cinical examination: nothing to report, animals normal; Body weight evolution: normal during test, Necropsy: No treatment related changes.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: According to the OECD Guideline 423, the LD50 cut-off of the test item may be considered higher than 5000 mg/kg bw.
Mortality:
No mortality occured during the observation period.
Clinical signs:
other: No clinical signs related to the administration of the test item were observed.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion