Silicon boride oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February - May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japan MAFF 8147

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Boron silicate

EC Number:

603-157-9

Cas Number:

12676-29-8

Molecular formula:

H7 B7 Si57 O128

IUPAC Name:

Boron silicate

Details on test material:

Name of test item: silicon boride oxide
CAS No.: 12676-29-8
Homogeneity: homogeneous by visual inspection.
Storage conditions: Room temperature
Physical state / color: Solid / white

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Young adult animals of comparable weight were used.
Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Individual animal identification by cage cards and tail marking.
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ± 3°C for temperature and of 30 – 70% for relative humidity. The day/night rhythm was 12 h light and 12 h darkness.
Single housing in Makrolon cages (type III).
Feeding: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
Drinking water: Tap water ad libitum
Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

0.5% solution of CMC in deionized water
A good homogeneity in water could not be guaranteed, because the test item preparation is a suspension. Therefore a 0.5% solution of CMC in deionized water was applicable.
The test item preparation was produced for each application group shortly before application by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally the homogeneity of the test item preparation during application was ensured by stirring with a magnetic stirrer.
Form of application: Suspension
Concentration used: 20 g/100 ml
Administration volume: 10 ml/kg

Doses:

2000 mg/kg b.w. (2 test groups)

No. of animals per sex per dose:

2 test groups of 3 rats

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: No abnormalities

Gross pathology:

There were no macroscopic pathological findings at the end of the observation period.