Silicic acid, aluminum salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 Nov - 26 Nov 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:

2009

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe Interministeriel Des Produits Chimiques, Secrétariat général du Groupe Interministeriel Des Produits Chimiques - DGCIS-SI - 12, rue Villiot, 75572 Paris cedex 12, France

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum salt

EC Number:

215-628-2

EC Name:

Silicic acid, aluminum salt

Cas Number:

1335-30-4

Molecular formula:

[SiO4]a * [AlO3]b a: 0.735-0.885, b: 0.115-0.265

IUPAC Name:

Silicic acid, aluminum salt

Details on test material:

- Name of test material (as cited in study report): Silicic acid, aluminium salt
- Physical state: White powder
- Analytical purity: >99%
- Lot/batch No.: 1000168802
- Expiration date of the lot/batch: 01 Apr 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: 182 - 211 g
- Fasting period before study: Food was removed at D-1 and then redistributed 4 h after test item administration.
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; each cage contains sawdust bedding which was changed at least 2 times a week; each cage was installed in conventional air conditioned animal husbandry.
- Diet: ad libitum (M20, rat/mouse maintenance, made from the formulation EXTRALABO from PIETREMENT)
- Water: ad libitum (tap water from public distribution system, microbiological and chemical analyses carried out every six months by the Institut europeen de l'Environnement de Bordeaux)
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25°C
- Humidity: 30 to 70%
- Air changes (per hr): approx. 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 (7:00 to 19:00)/(19:00-7:00)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

In the first and in the second step of the study, 2 g of the test item was weighed and distilled warter was added in a 10 mL volumetric flask. The preparation was magnetically agitated to abtain a white solution, just before being administered.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

single dose of 2000 mg/kg bw

No. of animals per sex per dose:

3 female animals in Step 1,
3 female animals in Step 2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations (symptoms, mortality); weighings on D0, D2, D7 and D14
- Necropsy of survivors performed: yes

On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.

Necropsy examinations: oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, adrenals, pancreas

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

No clinical signs related to the administration of the test item were observed.

Body weight:

The body weight evolution of the animals remained normal throughout the study. Mean body weight gain: 57.0 ± 5.9 g

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.