Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
10 Nov - 26 Nov 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Silicic acid, aluminium salt (CAS 1335-30-4). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
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

Reference
Name:
Unnamed
Type:
Constituent
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 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: 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.

Applicant's summary and conclusion